COMMENTARY ARTICLE

Operations decide why quality, supply, and speed break together

Quality, supply reliability, and speed are not competing objectives, but outcomes of how operations are designed and governed across development, manufacturing, quality, and partner networks.
When operational interfaces are clear and well designed, quality supports execution and supply becomes predictable. When they are not, no amount of oversight, inventory, or technology can compensate.

This article comments on insights from 21 contributors from pharmaceutical companies, CDMOs, fine chemical manufacturers, and technology providers. Contributors discussed quality, supply-chain security, agility, digitalisation, and evolving regulatory expectations, including the implications of the EU’s Critical Medicines Act.

While viewpoints differed, a convergence emerged that quality performance, supply reliability, and execution speed are outcomes of how operations are designed, integrated, and governed across the value chain.

This article reflects on that convergence and elaborates why operational design has become the decisive factor in sustaining performance under today’s challenges.

The illusion of separation

Pharma companies, biotechs, and Contract Development and Manufacturing Organizations (CDMOs) operate under increasing pressures: cost inflation, geopolitical uncertainty, material shortages, and rising regulatory expectations. At the same time, organizations are expected to accelerate development timelines, enable real-time quality oversight, and ensure uninterrupted supply of increasingly complex products.

None of these pressures is new, but their simultaneity is. Together they expose the limits of operating models designed for stability rather than volatility. Under pressure, most failures do not originate from a lack of expertise, but a lack of integration.

Recent policy initiatives, including the EU’s reframing of medicine shortages as a systemic risk, reflect this shift. Operational weaknesses that were once tolerated are now recognized as structural threats to supply reliability.

Many organizations still organize quality, supply chain, and manufacturing as separate functions, with clear ownership and governance, while execution across interfaces remains fragmented. Each function optimizes within its own scope. Quality focuses on compliance and control, supply chain on procurement and logistics, manufacturing on throughput. Across the full value chain, including material, data and documentation flows, this functional optimization creates friction at the interfaces.

That friction appears between development and manufacturing, manufacturing and quality control, internal teams and external suppliers and partners. At these points, information, assumptions, responsibilities, and decisions must align. Too often, they do not.

Standard Operating Procedures (SOPs) describe a process that daily operations only approximate. To compensate, organizations add meetings, manual checks, escalations, and heroic efforts. Individual issues get resolved, but systemic weaknesses remain. Over time, firefighting becomes normalized, stress increases, and operational performance deteriorates.

Some of the recurring interface failures include:

Good Manufacturing Practice (GMP) campaign delayed because protocols, batch records, and reports are prepared too late, increasing data integrity risk.
Limited transparency, insufficient forecast sharing, and delayed communication of deviations or changes between sponsors and CDMOs.
Unclear ownership for troubleshooting and root cause analysis, leading to prolonged investigations and repeated issues.
Tech transfer treated as document handover rather than ongoing operational alignment across Chemistry Manufacturing and Controls (CMC), manufacturing, Quality Assurance (QA), and partners.

For CDMOs, these interface failures are no longer internal inefficiencies. They increasingly shape how sponsors assess reliability, resilience, and partnership value.

Delivering material on time, in full, and with complete documentation (quality-on-time-in-full, QUOTIF) is therefore never the achievement of one department. When clinical trials wait for material or patients are affected by shortages, the root cause is rarely chemistry alone, regulation alone, or sourcing alone.
It makes clear that operations are the backbone of the system, the integrating mechanism that translates intent into execution.

Figure 1. Operational interfaces failures.

Where friction accumulates in the value chain

Manufacturing competitiveness in life sciences has shifted. Cost, physical footprint, and quality still matter, but they are no longer sufficient differentiators on their own. What increasingly sets organizations apart is their adaptability to absorb scientific complexity, regulatory demands, geopolitical uncertainty, and late change without compromising productivity.

Operational efficiency has shifted from a cost focus to a strategic asset. In a world of complex modalities, personalized therapies, and volatile demand, predictable execution sustains competitiveness.

Yet supply chains rarely fail because a supplier disappears overnight. They fail because operational friction accumulated over time:

Materials are delayed due to incomplete, late or changing documentation.
Batches are held while awaiting test results or release decisions, often due to analytical capacity constraints or late QA involvement.
Manufacturing capacity is locked because materials, data, documentation and schedules are misaligned across functions.

This becomes particularly visible when organizations attempt to introduce dual sourcing. Without operational maturity, adding a second supplier increases complexity instead of resilience. Several contributors noted that, when introduced late in development, dual sourcing often exposes unresolved operational weaknesses.

Even in advanced modalities such as peptides and oligonucleotides, assets in specialized facilities are often underutilised. Equipment effectiveness depends less on the asset itself and on the operational system around it. Operational sustainability improves when preventable failure modes are removed, changeovers are optimized, assets are used effectively, and people are freed from constant firefighting.

True supply chain resilience does not come from adding inventory or controls. It emerges when operational flow is predictable, interfaces are explicit, and ownership is shared across the organization. Resilience cannot be added at the end. It is the result of operational design.

The false trade-off between Speed, Quality, Costs

Speed and quality are still treated as opposing forces in many organizations. Speed does not compromise quality. Poorly designed operations do.

Delays rarely originate from science or regulatory requirements. They result from fragmented documentation, late changes, unclear ownership, and rework caused by misalignment. Organizations that move faster without compromising quality redesign how work flows. They:

Integrate data, documentation, and decisions early at critical interfaces.
Remove non-value-adding activities from the critical path.
Design operational flow that can absorb change and exceptions.

Quality today goes beyond formal GMP compliance. It includes traceability across the value chain, robustness of suppliers, reproducible processes, reliable data and documentation across the operating network, sustainable operations, and secure supply. Quality becomes a dynamic system of protection rather than a static checklist of discrete compliance activities. Resilience emerges when risks are identified early, mitigated proactively, and continuously reassessed as processes evolve.

Figure 2. Traditional view (left) and integrated approach (right).

Technology alone is not the solution

Digitalization, automation, and Artificial Intelligence (AI) are often presented as solutions to operational complexity. Many organizations remain disappointed with the results, not because the technologies fail, but because expectations are misplaced.

A common misconception is that technology can compensate for unclear or poorly designed processes. This perspective was also reflected across the panel, with digitalisation and AI described as supportive only when integrated into well-designed operating models.

Digitization converts information to digital form. Digitalization makes data and documents accessible, traceable and reusable across the value chain. Automation executes predefined tasks consistently, reducing manual effort, variability, and error. This includes both equipment-level and system-level automation, from robotic handling and automated testing to report generation and system-to-system data transfer.

AI complements both digitalization and automation by detecting patterns, deepening insights, and supporting decision-making at scale. In operational contexts, AI can:

Accelerate process understanding
Identify hidden constraints
Detect early signals of deviation
Reduce downtime and production disruptions
Increase throughput and shorten cycle times
Stabilize execution under variability
Support earlier identification of risks and cost reduction opportunities

These capabilities are complementary and each can create value independently, but none can compensate for fragmented operations.

Technology must be treated as an operational and business excellence capability, not an IT project. Deployment may take months, while adoption, trust, and change take much longer. Organizations that underestimate this gap fail to realize value because their operating models do not evolve.

While data quality matters, it is not an absolute prerequisite. Context can be built through use and learning. Still, any AI model is only as effective as the data it learns from.
In many organizations, data remains siloed within departments, systems, or functions. Value emerges not from collecting more data, but from integrating data based on relevance.

Operations must be prepared and adapted before integration of any technology. Too often, organizations invest only to discover that processes are incompatible or that systems do not communicate. Digital maturity is about integrating the right capability where it matters most.

Figure 3. The capability stack.

Transformation fails without operational translation

Transformation does not begin with technology or restructuring. It begins with translation. Intent must be translated into operational logic, and strategy into actionable plans, decisions, and priorities. Knowledge into reproducible execution. Without this translation layer, transition remains fragile and transformation remains aspirational.

When translation is done well, transformation follows. When it is missing, organizations accumulate initiatives without changing outcomes.

For CDMOs, capacity alone is no longer a sufficient differentiator. Sponsors expect predictability, transparency, and reliability under pressure. Organizations that understand their own processes, including bottlenecks on the shop floor and at interfaces, can plan realistically and commit confidently.

In a crowded market, operational insight becomes a commercial advantage. Sponsors do not buy capacity, but certainty.

When technical, operational, and business functions operate in silos, decisions conflict. Only when these perspectives are integrated can organizations perform consistently. Operations are where business strategy becomes reality, translating technical excellence into business impact.

People are the integrating force

Operational systems do not run themselves. They are designed, governed, interpreted, and sustained by people.
Change often fails because the human dimension is underestimated. Technology can be deployed quickly. Adoption, however, cannot.

Building understanding, trust, and new ways of working takes longer than introducing a new technology. This explains why many initiatives lose momentum after pilots or remain isolated use cases. The limiting factor is rarely the initiative itself, but organizational readiness.
Trust is central. Trust in outputs and in the continued importance of human judgement and accountability. Technology operates within a defined context and people bring situational awareness. Experience shows that trust grows through use.

Because organizational processes move slower than technology, operations leaders must drive change as part of operational and business excellence. New capabilities must be integrated where decisions are made and work happens. When applied well, innovation and technology improve capital efficiency by enabling better decisions, faster execution, and more cost-effective operations.

Ultimately, operations integrate and people decide. Transformation succeeds when organizations invest as much effort in trust, capability building, and adoption as they do in innovation and technology.

Operations decide the outcome

The most sophisticated quality systems, the strongest supply strategies, and the most advanced technologies, tools, and agents will not deliver their promise if operational flow is poor or not adapted to their implementation.

Competitiveness today is defined by how well operations enable organizations to execute consistently, under pressure, and across the entire value chain.

The challenges facing value chains are unlikely to diminish. Cost pressures, regulatory complexity, quality requirements, and geopolitical uncertainty will remain defining features of the operating environment.

No function, including quality or supply chain, can be pursued independently. They emerge from the same foundation: how effectively operations connect people, processes, data, and decisions. Organizations that succeed do so deliberately, by examining how their operations translate vision and strategy into execution.

The real competitive advantage lies in designing systems where interfaces reinforce flow rather than fragment it. In the end, quality, supply, and speed are not independent choices. They are consequences of how operations are designed and governed.

ABOUT THE AUTHOR

Sonja Merkas, PhD
Founder & CEO, Livinovea GmbH, Basel, Switzerland

Sonja Merkas is Founder & CEO of Livinovea, a life sciences advisory firm enabling organizations to accelerate and scale development and manufacturing by aligning strategy and operations.
With over 25 years of experience across industry, consulting, and academia, she brings cross-functional expertise across technical, operational and business functions.Through Livinovea, we build operational maturity, align vision with execution and market realities, mitigate performance risk, and solve complex technical and operational challenges across the value chain.

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PANELISTS

Tom Moody
VP Technology Development and Commercialisation, Almac Sciences

Matthias Henz
Partner Alpha Lynics SA

Mark McLaws
Vice President of Process Chemistry, Asymchem Group and General Manager, Asymchem Boston Corporation

Sven Warhaut
Vice Head of Manufacturing, BioSpring

Tracey Jende¹, Anne-Louise Hemdahl², Luigi Bellone³
1. Senior Director of Quality Assurance, Cambrex Charles City
2. Director of Quality Assurance and Quality Control, Cambrex Karlskoga
3. QA Director, Cambrex Milan

Sergio Pissavini
International Business Advisor

Roger La Force¹, Alessandro Gagnoni²
1. Managing Director, Dorra Europe
2. Operations Director, Dorra Europe

Francesco Caporello¹, Anne Lise Koppe², Beatrice Trucchi³, Fabio Merlini⁴, Marco Santoro⁵
1. Corporate Supply Chain Director, Flamma
2. Corporate ESG Director, Flamma
3. Corporate R&D Project Manager, Flamma
4. Corporate IT Director, Flamma
5. Corporate QC Director, Flamma

Lara Ferro
Regulatory Affairs Manager
ICROM

Patrizia Fazio
Head of Applied Research
Coordination, Imprima

Eric Aubay
VP Flow Chemistry, KHIMOD

Rajiv Khatau
Managing Director, Lodaat Pharma

Julien Meissonnier
LifeScience Partner, MarketChemica & Associates, Zur Hadassah, Israel

Dirk Kirschneck
Strategic Director, Microinnova Engineering

Sundar Narsimhan
Chief Procurement Officer, Neuland Labs

Peter DeYoung
CEO, Piramal Global Pharma

Stéphane Varray
Chief Commercial Officer, PolyPeptide

Nicolò Rubino¹, Chiara Rigotti²
1. Chief Information Officer, Procos
2. Purchasing & Sourcing Manager, Procos

Joerg Ahlgrimm
CEO, SK pharmteco

Chris Neasham
Vice President of Global Procurement, Sterling Pharma Solutions

Max Lauwiner
CEO, Valsynthese

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Tom Moody
VP Technology Development and Commercialisation, Almac Sciences

The pharmaceutical manufacturing landscape is undergoing rapid transformation driven by cost pressures, geopolitical instability, material shortages, and evolving regulatory frameworks. CDMOs like Almac and pharma manufacturers must embrace resilience, agility, and digitalisation to maintain supply continuity and competitive advantage. This document addresses 11 critical questions shaping the industry’s future, offering insights into supply-chain strategies, technology adoption, regulatory compliance, and partnership models:

How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

CDMOs and pharma manufacturers are embedding resilience into their supply chains through multi-pronged strategies. These include supplier diversification, dual sourcing for critical raw materials, and strategic stockpiling to buffer against disruptions. Digitalisation plays a pivotal role, with real-time analytics and predictive modelling enabling proactive risk management and inventory optimisation. Many organisations are also investing in regional redundancy, creating parallel manufacturing hubs to mitigate geopolitical risk. Additionally, partnerships with logistics providers and adoption of validated cold-chain technologies ensure uninterrupted delivery of sensitive products. The overarching theme is a shift from reactive firefighting to risk-based planning and infrastructure investment, underpinned by collaborative frameworks with sponsors and regulators.

Reshoring and regionalisation are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

Reshoring offers strategic benefits, such as reducing dependency on offshore suppliers and enhancing regulatory oversight, but it faces hurdles like high capital costs, labour shortages, environmental and complex compliance requirements. Regionalisation, on the other hand, is emerging as a more sustainable model, with pharma companies building local-for-local networks to ensure supply continuity while maintaining global reach. However, the most pragmatic approach combines geographic diversification with digital transparency. Technologies such as blockchain and integrated ERP systems provide end-to-end visibility, enabling companies to manage distributed networks effectively. This hybrid strategy balances resilience with cost efficiency, avoiding the pitfalls of over-concentration or over-investment in single geographies. Companies like Almac are seeing a trend for manufacturing back to Europe to serve local and US.

How are you redefining agility in manufacturing — is it about modular capacity, accelerated tech transfer, digital batch release, or new contracting models?

Agility today is a composite of modular capacity, digitalisation, and flexible contracting. Modular facilities, supported by concepts like Module Type Package (MTP) and “ballroom” layouts, allow rapid reconfiguration for different products without extensive re-engineering. Accelerated tech transfer leverages digital twins and simulation platforms, reducing validation timelines and de-risking scale-up. Digital batch release, powered by electronic batch records and AI-driven review systems, cuts cycle times by up to 90%, enabling faster market entry. Contracting models are also evolving toward risk-sharing and milestone-based agreements, aligning incentives between CDMOs and sponsors for speed and quality.

In the race to accelerate CMC and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

Maintaining quality under compressed timelines requires embedding Quality by Design (QbD) principles early, defining critical quality attributes and process parameters upfront. CMC specialists advocate comparability studies and robust process validation at pilot scale before full commercialisation. Digitalisation and automation further enhance consistency, enabling real-time monitoring of CQAs and predictive analytics for deviation control. Regulatory engagement is also key—leveraging adaptive pathways and rolling submissions can align accelerated development with compliance expectations. Ultimately, success hinges on integrating risk-based strategies, advanced analytics, and cross-functional collaboration from the outset.

How will the EU’s Critical Medicines Act influence supply-chain design, sourcing, and partnership decisions for essential APIs and finished products?

The EU’s Critical Medicines Act (CMA) represents a paradigm shift toward strategic autonomy and resilience. By incentivising domestic manufacturing and prioritising critical medicines in procurement, the Act will drive reshoring of API production, foster regional partnerships, and reshape sourcing strategies to favour suppliers with EU-based capacity. Companies will need to integrate environmental and security criteria into their vendor selection, moving beyond cost as the primary determinant. Expect increased collaboration under public–private frameworks, accelerated regulatory support for strategic projects, and investment in green, digital-ready facilities to meet CMA’s sustainability and competitiveness goals.

As manufacturing models evolve, how can digital tools, data integrity measures, and AI support continuous GMP compliance and faster audits?

Digital transformation is redefining GMP compliance through electronic batch records, automated audit trails, and AI-driven anomaly detection. These tools enforce ALCOA+ principles, reduce manual errors, and enable real-time traceability. AI applications such as predictive maintenance and NLP-based SOP review enhance operational reliability and regulatory alignment. Cloud-based LIMS and integrated QMS platforms centralise data, supporting remote and hybrid audits with secure, role-based access. By embedding compliance into workflows rather than treating it as a post-production activity, companies achieve continuous validation and faster audit readiness, reducing inspection risk and downtime.

With virtual and hybrid audits now common, how are expectations changing? What makes an audit-ready CDMO in 2026?

Audit readiness in 2026 will hinge on digital maturity and transparency. Sponsors and regulators expect seamless access to validated electronic records, immersive virtual tours, and secure data-sharing platforms. Hybrid audits combine on-site verification with remote document review, demanding robust cybersecurity and integrated systems that link quality, operations, and ESG metrics. CDMOs must demonstrate real-time compliance dashboards, automated deviation tracking, and sustainability reporting, reflecting the industry’s shift toward holistic risk management. In short, audit readiness is no longer about tidy facilities—it’s about digital trust, operational resilience, and ESG accountability.

Cybersecurity has become a compliance and trust issue. How important are frameworks like CyberVadis or ISO 27001 certification for maintaining client confidence and regulatory alignment?

Cybersecurity frameworks such as ISO 27001 and CyberVadis assessments are now critical differentiators for CDMOs and pharma manufacturers. These standards provide structured controls for data confidentiality, integrity, and availability, aligning with global regulations like GDPR and NIS2. Beyond compliance, they signal maturity and reliability to clients, mitigating third-party risk and safeguarding sensitive IP and patient data. In an era of escalating cyber threats and digital audits, certification under recognised frameworks is not optional—it’s a prerequisite for regulatory trust, competitive positioning, and long-term partnership viability.

Which use cases of AI, ML, or predictive analytics have proven most effective for enhancing planning, quality, and supplier risk management?

High-impact AI applications include predictive maintenance, which reduces downtime and prevents costly deviations, and demand forecasting models that optimise inventory and mitigate shortages. In quality assurance, ML algorithms enable real-time trend analysis and anomaly detection, improving batch consistency and reducing out-of-spec events. For supplier risk management, AI-driven platforms assess geopolitical, financial, and ESG indicators, providing early warnings of potential disruptions. These tools transform decision-making from reactive to proactive, embedding resilience and efficiency across the pharma value chain.

What defines a “strategic partner” today when quality, data access, and ESG transparency are intertwined?

A strategic partner in 2026 is one that transcends transactional roles to become an extension of the sponsor’s value chain. This means co-owning risk, sharing KPIs, and committing to data transparency and ESG performance. Beyond technical capability, sponsors prioritise partners who demonstrate digital readiness, sustainability credentials, and governance integrity. Strategic partnerships are built on mutual trust, aligned vision, and collaborative innovation, enabling both parties to navigate regulatory complexity, geopolitical volatility, and societal expectations while accelerating patient access to therapies.

What will “quality and supply-chain excellence” look like by 2030 — and what capabilities will differentiate the leaders?

By 2030, excellence will be defined by end-to-end digital integration, predictive resilience, and ESG stewardship. Leaders will operate smart factories powered by continuous manufacturing, real-time analytics, and AI-driven quality systems. Supply chains will be geo-diversified yet digitally unified, leveraging blockchain for traceability and advanced modelling for risk mitigation. ESG metrics will be embedded into procurement and audit frameworks, making sustainability inseparable from compliance. Differentiators will include adaptive capacity, cyber-secure ecosystems, and collaborative platforms that enable transparency and trust across global networks.

Conclusion

The next decade will redefine pharmaceutical manufacturing and what we do at Almac. Success will hinge on digital transformation, strategic partnerships, and ESG integration. Organisations that invest in predictive technologies, resilient supply chains, and transparent governance will lead the industry in quality and supply-chain excellence. The future is exciting with many twists evident.

Key Takeaways

Digitalisation and AI are non-negotiable for compliance, agility, and resilience.
Hybrid strategies combining regionalisation and global diversification will dominate.
ESG and cybersecurity are now core pillars of partnership and regulatory trust.
By 2030, quality and supply-chain excellence will be defined by predictive, transparent, and sustainable operations.

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Matthias Henz
Partner Alpha Lynics SA

A Modern and Risk-Driven Framework: Lifecycle-Based Supplier Qualification and Material Control

Effective supplier and material oversight is a foundational element of pharmaceutical quality systems. Its primary objective is to ensure that any material entering the manufacturing process does not adversely affect the Critical Quality Attributes (CQAs) of the API. Achieving this requires a balanced combination of supplier reliability, material science, and process understanding.

Historically, the industry has relied heavily on extensive supplier qualification activities -comprehensive questionnaires, document exchanges, audits, and ongoing monitoring. While aligned with regulatory expectations, these efforts often become administrative exercises that overshadow the more scientifically important task: understanding materials and how they influence process performance and impurity formation.
At the same time, material-level controls – especially the scientific evaluation of Critical Material Attributes (CMAs) – are sometimes introduced too late or developed insufficiently. This imbalance can weaken process robustness and reduce the effectiveness of impurity control strategies.

This article presents a lifecycle-oriented and risk-based framework that distinguishes between two essential but separate activities:

Supplier qualification, which can begin at a basic level and increase with lifecycle maturity.
Material understanding and control, which must begin early to ensure that CMAs are understood and appropriately managed.

This approach aligns regulatory expectations with practical implementation and demonstrates that excellence requires both reliable suppliers and deep material knowledge.

Supplier Qualification

A balanced regulatory interpretation leads to a lifecycle-based model
Over the past two decades, biotechnology and CMO organizations have devoted significant resources to supplier oversight. Although well-intentioned, these programs often evolve into a one-size-fits-all approach that applies identical requirements to every supplier. This can create unnecessary administrative burden, impose disproportionate expectations on low-risk or highly mature suppliers, and refocus efforts toward documentation rather than scientific evaluation of materials.

As a result, many supplier qualification systems fail to distinguish between suppliers presenting minimal risk and those that warrant more intensive evaluation. Yet, the wording of ICH Q7 actually supports a flexible, pragmatic, and risk-proportionate approach – but is often over-interpreted in practice.

ICH Q7 Section 7.31
“Supplier approval should include an evaluation that provides adequate evidence (e.g., past quality history) that the manufacturer can consistently provide material meeting specifications.”
This broad wording supports evidence-based and proportional qualification rather than rigid procedures.

ICH Q7 Section 19.40
Full supplier qualification is not required for materials used in API batches intended for clinical trials, provided appropriate testing is performed and a CoA is available.
This reinforces that supplier oversight should scale with lifecycle stage and does not need to be exhaustive at the beginning of development.

ICH Q7 Section 1.3 further explains that the level of GMP control naturally increases as the product moves from early clinical development to commercial manufacture. Early phases require flexibility and speed, whereas late-phase and commercial supply demand established systems.

A lifecycle-based qualification model applies these principles by adjusting oversight based on:

Material criticality – whether the material directly affects API quality
Product lifecycle stage – lower early-phase needs vs. stringent commercial requirements.

An example of a phased, risk-based Supplier Qualification Model is illustrated in the following table by e.g. allowing ISO certification as sufficient evidence during clinical phase I – II and a basic audit may be performed by Supply Chain personnel during a supplier visit, provided a documented report is generated.

Material Understanding and Control

The Scientific Imperative and common Misinterpretation of ICH Q7
Understanding the Critical Material Attributes (CMAs) of starting materials is often more complex than evaluating the supplier itself. CMAs are the specific characteristics of a material – such as its purity, impurities, physical properties, or the way it degrades – that can directly affect the quality of the final API. These attributes can influence how a chemical reaction behaves or how impurities form during manufacturing. Because of this, it is essential to understand CMAs early in process development, long before the product reaches late clinical phases. Early understanding helps ensure that material variability does not negatively affect the process or the final product quality.

In many companies, too much confidence is placed on supplier Certificates of Analysis (CoAs) without truly understanding which material properties matter. This problem is sometimes made worse by misinterpreting ICH Q7 guidance, which mentions doing “full analyses” on three batches before reducing testing. Some take this to mean that every CoA value must be retested, but this is not the intent. A scientific and practical interpretation is that “full testing” should focus only on what is relevant:

Identity tests
Appearance
CMAs that impact CQA of the API.
Retesting every CoA parameter is not necessary unless there is a reason to believe it poses a risk.

Starting materials that directly become part of the API structure require the highest level of CMA scrutiny, because impurities or by-products in these materials may carry through to the API. To identify relevant CMAs, companies may need to:

Screen for process-related by-products from the starting material’s synthesis, which may be carried over
Perform stress testing to understand degradation pathways
Conduct spiking studies to observe how known impurities behave during API manufacturing.

These investigations reveal how the quality of the starting material influences impurity formation and protects the final product’s CQAs.

ICH Q3A, which defines thresholds and expectations for reporting, identifying, and qualifying impurities, underscores the importance of early CMA understanding. API impurities originate not only from the manufacturing process but also from the inherent quality of the starting materials used. Early CMA control therefore plays a central role in developing a strong impurity control strategy, ensuring appropriate starting material justification, and maintaining a compliant and reliable manufacturing process as the program advances while specifications of the API may be narrowed.

Material Statements for Starting Materials
Some aspects of material control cannot be phased in gradually. Before any material is used to manufacture API for clinical Phase I, certain mandatory safety and compliance statements must already be in place to ensure suitability for GMP use and alignment with regulatory expectations.
Required statements typically include:

TSE/BSE declarations
Nitrosamine risk assessments
Elemental impurity compliance statements
Residual solvent information or declarations on solvents used

During supplier selection, the supplier must reliably provide these statements – either for every batch or as a one-time declaration updated when relevant conditions or manufacturing steps change. This reliability is essential for using the material in any clinical manufacturing process.

Conclusion

A modern approach to supplier and material management balances regulatory expectations, scientific understanding, and practical risk management. Using a lifecycle-based qualification model together with early, thorough CMA understanding enables efficient resource use and strong quality oversight across development. These principles reinforce impurity control strategies, support defensible starting-material justification, and protect API quality from Phase I to commercial manufacture.

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Mark McLaws, Ph.D.
Vice President of Process Chemistry, Asymchem Group and General Manager, Asymchem Boston Corporation

How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

Maintaining supply continuity amid persistent cost pressures remains a fundamental challenge for our industry. While the intensity of these pressures may fluctuate over time, they are a constant consideration. We view cost control not as an isolated objective, but as a natural outcome of our broader sustainability initiatives. For example, our significant investments in advanced continuous manufacturing have enabled us to transition a substantial portion of production to continuous flow. This shift has reduced energy consumption, improved process mass intensity, and advanced our sustainability agenda, while simultaneously mitigating the impact of rising energy and material costs. Equally important has been the cultivation of a robust, collaborative supplier base, where we actively partner to promote sustainability and drive continuous improvement within their operations.

The traditional globalization model—predicated on stable, free-trade environments—is increasingly giving way to regionalization, as companies seek to mitigate geopolitical risks through geographically diversified hubs. Rather than relying solely on multi-sourcing within a single country, sourcing strategies now emphasize networks spanning multiple countries within a region, or across entirely different regions, to address risks such as political instability. In alignment with this trend, we have established services and manufacturing capacity in the United Kingdom and Boston, US, and we continue to expand our footprint across western territories and Southeast Asia outside of mainland China.

Thus far, we have largely avoided significant material shortages, though not without some impact. In limited cases, supplies of specialty, single-sourced materials have been disrupted by regional military conflicts, for example. To address such vulnerabilities, we maintain strategic reserves of materials we cannot produce internally. Over the past 15 years, we have expanded our back-integration capabilities to reduce reliance on external suppliers, opting for in-house production wherever feasible to safeguard access to critical advanced starting materials. In parallel, we are advancing research into alternative chemistries and manufacturing approaches to reduce dependence on at-risk inputs. For instance, our biocatalysis platform enables the use of enzymes in place of rare-earth elements for certain processes, significantly reducing exposure to increasingly scarce metals.

Reshoring and regionalisation are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

While reshoring has gained momentum, much of its support stems from policy incentives rather than the fundamental drivers that originally led to offshoring. Wholesale reshoring of pharmaceutical research and manufacturing is not practical; however, targeted reshoring can be appropriate in select, strategic cases. In practice, our customers are pursuing global diversification as the more sustainable approach.

As a CDMO, we are positioning ourselves to align with this shift while preserving the core strengths that have driven our past success. We continue to expand regionally to reinforce supply chains in cost-advantaged countries, while also developing reshoring and near-shoring capabilities in western territories to address geographic sensitivities.

Transparency remains a cornerstone of effective partnerships. By leveraging advanced analytics and digital data-sharing platforms, we can enhance visibility and trust across the value chain—regardless of where services or manufacturing are located. This remains an active area of investment at Asymchem.

How are you redefining agility in manufacturing — is it about modular capacity, accelerated tech transfer, digital batch release, or new contracting models?

Agility is a defining value in the CDMO space, where customers often rely on partners to address the unexpected. Whether facing a sudden surge in demand or a loss of capacity within their own networks, preferred CDMOs are those able to respond quickly and effectively. This was especially evident during the COVID-19 pandemic, when the pharmaceutical industry was called upon to deliver research and manufacturing at unprecedented speed.

At Asymchem, we have sustained a highly agile posture by applying scale-out principles. Our manufacturing facilities are designed with modularity and functionally equivalent redundancies, enabling us to bring additional equipment trains online rapidly and with minimal risk. These redundancies also provide greater scheduling flexibility and mitigate equipment-related disruptions.

This modular approach, combined with our continuous manufacturing capabilities, has allowed us to implement and scale processes in significantly reduced timeframes. Central to this agility are well-defined, data-rich workflows for technology transfer and the early engagement of integrated cross-functional teams. In one exemplary case, we redesigned an inefficient batch process into a continuous flow system, piloted the new process, and scaled out across nine reactor trains to produce more than 400 MT of an advanced intermediate in just eight months.

In the race to accelerate CMC and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

Rigorous quality standards are fundamental to a CDMO’s business model, and nothing undermines that model more quickly than the absence of a strong quality culture. A company-wide quality management system, embedded across all functions, is essential to ensure compliance with health authority regulations and to meet customer expectations.

Guided by risk-based principles, we maintain well-defined, phase-appropriate standards that safeguard compliance at every stage of product development. Partnering with a diverse range of companies provides us with broad insight into best practices in pharmaceutical sciences and regulatory compliance. We have leveraged these insights to refine our workflows and embed proven approaches into our quality system, enabling reuse across multiple programs.

Our ongoing investments in real-time analytics, computer-aided modeling, and data management have streamlined development processes and enhanced reliability. Looking ahead, continued investment in AI-driven modeling and workflow automation will further improve efficiency while simultaneously strengthening quality outcomes.

How will the EU’s Critical Medicines Act influence supply-chain design, sourcing, and partnership decisions for essential APIs and finished products?

CDMO’s that facilitate compliance with the requirements in this new regulation will naturally be preferred. Recognizing our role in supporting customers to meet these demands is essential. Transparent collaboration must remain a guiding principle, ensuring customers have the visibility needed to satisfy reporting obligations.

Strategically, the regulation aligns with our ongoing geographical diversification efforts, including the establishment of “near-EU” manufacturing capacity and multi-national raw material sourcing, as previously outlined.

As manufacturing models evolve, how can digital tools, data integrity measures, and AI support continuous GMP compliance and faster audits?

Digital tools, such as electronic PCS and QMS systems, are effective means to reduce the human-error element in GMP compliance by hard-coding GMP requirements in workflows. For routine manufacturing, these systems provide efficient and reliable mechanisms to ensure compliance.

At Asymchem, we engage not only in routine manufacture of established API’s, but also in clinical supply manufacturing to support products in development where processes are not yet fully established. In these cases, a degree of flexibility is essential and may be better supported through manual operations. For example, documentation in pre-clinical and early clinical manufacturing remains paper-based, while later-phase clinical manufacturing transitions to greater automation. As a CDMO, we manufacture a diverse portfolio of products. Digital tools, such as PAT, DSC, digital twins and AI-supported error detection are applied in proportion to the phase and need of the individual program.

With virtual and hybrid audits now common, how are expectations changing? What makes an audit-ready CDMO in 2026?

In some respects, the ability to perform virtual audits has lowered the barrier to performing audits, especially at remote facilities. The scope of a virtual audit, however, can be hampered by not being physically present. At Asymchem, virtual auditing became necessary during the pandemic and has become a routine practice. Additionally, the contracting of domestic third-party auditors has increased. The focus has generally become document-centric given that facility walk-throughs are less effective virtually. Again, transparency is essential for these alternative auditing models to be productive. Auditors need to be clear what is required of the CDMO and the CDMO needs to be responsive to auditor’s requests. Having undergone many virtual and hybrid audits, we have a good understanding of how best to facilitate and support a productive audit.

Between customer and regulatory authority audits, Asymchem is nearly constantly being audited somewhere within the organization. We host 300+ successful customer audits annually and have passed 100+ regulatory inspections to date. Being “audit-ready” as a CDMO isn’t simply a philosophy, it is a necessary reality.

Cybersecurity has become a compliance and trust issue. How important are frameworks like CyberVadis or ISO 27001 certification for maintaining client confidence and regulatory alignment?

At a minimum, expectations between parties regarding cybersecurity are codified in legal agreements such as MSAs. More importantly, a well-established and rigorously maintained digital security culture must prevail. Our strong track record of compliance has reinforced customer trust in our ability to safeguard against cybersecurity risks. To date, we have not been required to obtain third-party certification.

Which use cases of AI, ML, or predictive analytics have proven most effective for enhancing planning, quality, and supplier risk management?

Our use of AI and ML in predictive analytics has been focused on optimizing processes and workflows, detecting quality trends, and enabling predictive preventative maintenance.
Through real-time statistical analysis of process parameters and product quality data against historical baselines, we can identify emerging trends, correlate them with process variables, and uncover opportunities to mitigate failure risks, enhance robustness, and drive continuous improvement.

While these tools are primarily applied in commercial manufacturing, we also leverage advanced analytics in R&D. For example, principal component analysis has proven valuable in reagent and catalyst screening, supporting more efficient development pathways.

What defines a “strategic partner” today when quality, data access, and ESG transparency are intertwined?

A willingness to engage and a commitment to transparency are the hallmarks of a strategic partner. We strive to stay ahead of evolving ESG-related regulations both domestically and across the markets where our partnerships operate. Through participation in SBTi and Ecovadis, Asymchem has established credible sustainability targets and validated performance metrics.

Engagement in these widely adopted platforms ensures that our ESG approach and objectives remain aligned with those of the majority of our partners. We aim to serve as an extension of, and complementary component to, our partners’ environmental, quality, and social governance systems.

What will “quality and supply-chain excellence” look like by 2030 — and what capabilities will differentiate the leaders?

By 2030, quality and supply-chain management will be fully integrated, with CDMOs co-owning decision-making across R&D, manufacturing, and logistics. Quality and sustainability targets will be shared across interconnected supply-chain networks, and organizations excelling in quality management will have QbD principles embedded throughout R&D, manufacturing, and compliance practices.

For CDMOs serving diverse customer bases, integration presents unique challenges, as no two companies approach quality and supply-chain management in the same way. Yet this diversity also provides a vantage point to observe, adopt, and refine best practices, guiding investment toward areas of greatest impact. Ultimately, the leaders will be distinguished by the scale and depth of their commitment.

At Asymchem, we have invested heavily in advanced manufacturing technologies, data analytics, and industry-standard sustainability initiatives to position ourselves as a preferred partner. Our expanding global footprint, company-wide quality management culture, and integrated raw material supply chain have demonstrated resilience against shocks without chronic quality or supply disruptions. We look forward to strengthening partnerships as we help shape a highly integrated, data-driven pharmaceutical manufacturing ecosystem.

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Sven Warhaut
Vice Head of Manufacturing, BioSpring GmbH

Future-Proofing Oligonucleotide CDMOs through Secure Supply, Trusted Quality, & Agile Execution

For therapeutic oligonucleotides, the pressure on pharmaceutical supply chains is real. Specialized raw materials have become harder to secure and costs are more volatile, while development programs are expected to move faster without lowering GMP expectations. In this environment, CDMOs are tasked with managing the interconnection between supply security, agility, and quality.

As a specialized manufacturer and analytical partner for therapeutic oligonucleotides, BioSpring considers supply security essential for process stability. Therapeutic oligonucleotide programs depend on reproducible manufacturing processes based on reliable quality raw materials and tight equipment and utility controls.

To enhance reproducibility further, we employ platform processes and analytical methods tailored to specific groups of modalities, reducing onboarding costs and lead times. Supply security obviously depends on raw materials. Quality and price considerations must be carefully balanced. Resilience is built through well-established supplier relationships combined with multi-sourcing over different continents wherever feasible. In specialized oligonucleotide synthesis, supplier reliability and qualification must be treated as strategically important. Likewise, long-standing experience helps to identify critical attributes for new materials needed for modern manufacturing processes. True resilience also requires active supplier management, including adding and qualifying new suppliers based on constant risk monitoring.

In our experience, building in-house capacities is also essential. BioSpring utilizes in-house capacities, such as in-house analytics, to reduce reliance on external suppliers. Inventory buffers for high-risk materials and ready-stock warehousing further protect against short-term disruptions.

In parallel, internal research into innovative and alternative manufacturing methods or optimizations aims to reduce material costs and usage.

In terms of project management, transparent communication with clients is essential, including ensuring that drug developers have early visibility of risks, such as supply constraints, to allow for mitigation. Proactive project management is a practical part of this continuity, with project managers guiding communication, providing constant clarity on timelines and alignment between client teams and manufacturing, analytical, and quality teams of the CDMO. In today’s digital world more than ever, continuity relies on committed, approachable, and agile teams that remain flexible amid evolving demands and unexpected challenges.

Current debates on supply security often focus on reshoring and regionalization. However, for specialized oligonucleotide raw and starting materials, global networks remain necessary, supported by maintaining high standards for supplier qualification. The impact of reshoring is therefore limited in our field. This becomes even clearer in the case of rare-disease programs, where regionalization is not cost-effective for ultra-small batches and, due to regulatory requirements, would further limit patient availability and access.

The push for ever faster drug development defines another client expectation: agility. In manufacturing terms, agility is the ability to adapt quickly to changing circumstances while protecting quality. Because of increasing drug development time pressure, clients sometimes need to change their drug sequence while process development is still ongoing or even completed. Platform technology, aided by empirical know-how of adaptation, is key to accommodating such changes without the need for renewed process development. Adaptable platform technologies in manufacturing and QC allow processes to be tuned to new sequences without compromising quality.

Furthermore, unit-driven modular manufacturing approaches require scalable upstream and downstream process equipment and increase dynamic capacity. This approach helps shift resources as program needs evolve. Agility is also built into tech transfers and scale-ups. Standardized tech transfer workflows ensure seamless transfers (or integration) across phases and make it possible for us to meet (or onboard) clients where they are at in their development timeline, from early development through commercial supply. The shared focus and long-term collaboration experience of our integrated manufacturing, analytics, and QA teams allows faster decisions and controlled implementation. In addition, a modular capacity expansion strategy (as is being done in our Frankfurt and Offenbach Sites), includes fast-track options to build out dedicated lines which helps to quickly react to changing demand forecasts for high-volume therapeutic oligonucleotides.

Accelerated CMC timelines only work if quality remains consistent and evidence supporting process control is preserved.
Quality needs to be embedded across all manufacturing and analytical activities combined with an adequate understanding of regulatory compliance. Highly skilled employees, reliable cross-checks, and strong awareness of critical control points support this discipline. In the complex world of oligonucleotides, only a strong base of oligonucleotide chemistry expertise enables new chemistries to be supported quickly. Internally developed high-resolution analytical methods reduce risks of surprise impurities and support CMC progression by allowing for proper impurity characterization.

Stringent standards are required if CDMOs want to support clients globally, while experience engaging with regulatory authorities including FDA, EMA, ANVISA, and PMDA is a big plus. Regular exchange with national and international authorities is important for tracking ever-changing requirements and providing key insights that could help shape future regulation.

Maintaining that level of compliance depends increasingly on digital systems, especially data integrity and digital tools to support GMP compliance. Generally, CDMOs should rely on validated software systems to ensure data integrity and traceability from ERP, LIMS/MES, and EDMS systems. Automation of manufacturing, integration of PAT as well as analytical method development and optimization are supported by evolving software solutions. Digitalization is also central to audits, where virtual (remote) or hybrid customer audits requiring live camera tours and real-time digital document presentation become more and more common post-COVID.

The increasing use of a digitized and connected system has made cybersecurity part of how trust and reliability are assessed. That’s why CyberVadis assessments and the ISO 27001 certificate are increasingly important. Controlled data access and structured risk assessments are central as client expectations rise. The mentioned frameworks support regulatory alignment in controlled environments such as GxP, EU GMP Annex 11, and NIS2, reduce audit burden and qualification timelines, demonstrate maturity in incident response and business continuity, protect digitalized manufacturing and QC environments from disruption or data manipulation, and can be an increasingly relevant expectation during volatility.

More advanced and increasingly popular digital approaches like AI, machine learning, and predictive analytics are part of the wider industry landscape but use cases in oligonucleotide manufacturing remain limited as reliability, robustness, and compliance remain the priority. However, continuous careful consideration where advanced digital tools and approaches may reduce manual steps or error risks without weakening traceability and while allowing human oversight, is warranted.

In our experience, strategic partnership means predictable quality and timelines, clear communication channels, integrated manufacturing, analytical and regulatory support, a commitment to transparency, and long-term investment in capacities. It also depends on working relationships that stay professional, responsive, and human at the operational level, because complex oligonucleotide programs progress fastest when expert teams can collaborate directly and pragmatically.

Looking ahead, the same drivers suggest where quality and supply-chain excellence are heading by 2030: Quality and supply-chain excellence will likely mean even tighter integration of analytics into manufacturing, more real-time review, more systematic supply-risk mapping and material traceability, and redundant scalable capacity for critical manufacturing steps. CDMOs with stable but flexible platforms and strong supplier networks will lead. Excellence will also include maintaining agility to support innovation to reduce costs and make the next generation of oligonucleotide-based therapeutics possible at large scales.

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In the race to accelerate CMC and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

Combining rigorous quality standards with a risk-based approach is a proven strategy for accelerating pharmaceutical development and establishing an early regulatory roadmap. This dual focus ensures that critical quality attributes are maintained while resources are efficiently allocated to areas of highest risk, reducing delays and facilitating smoother regulatory approval.

A risk-based approach enables teams to identify and prioritize potential issues early, allowing for proactive mitigation and efficient resource allocation. When rigorous quality standards are integrated from the outset, processes become robust, reproducible, and compliant with regulatory expectations, which minimizes the likelihood of costly rework or late-stage surprises. This is especially effective when paired with early and comprehensive knowledge management. Early knowledge management involves systematically gathering, documenting, and sharing essential information about the molecule, process, and analytical methods. This practice supports rapid troubleshooting, informed decision-making, and seamless technology transfer as the product advances through development stages, ultimately expediting market entry.

To fully leverage the benefits of early knowledge management and risk-based quality standards, it is essential to involve CDMO scientists at the earliest stages of product development. Their expertise is invaluable for determining control strategies and scale-up dependent factors. Early engagement of CDMO subject matter experts ensures that potential challenges are identified and addressed before they become bottlenecks. For example, bringing analytical, pre-formulation, and solid-state chemistry resources into the process at an early stage enables rapid development of research batches, early characterization of physical and chemical properties, and the establishment of robust control strategies. This collaboration also facilitates the identification of critical process parameters and the development of scalable, transferable processes suitable for both clinical and commercial manufacturing.

How will the EU’s Critical Medicines Act influence supply-chain design, sourcing, and partnership decisions for essential APIs and finished products?

The EU’s Critical Medicines Act will significantly reshape how pharmaceutical companies design their supply chains, source materials, and form partnerships for essential APIs and finished products. Its main objective is to enhance supply-chain resilience and ensure a steady supply of critical medicines by reducing dependence on non-EU sources, particularly those vulnerable to geopolitical or logistical risks.

Manufacturing strategies will shift toward greater investment in local and regional production capabilities. Companies will need scalable, efficient, and compliant processes that can be quickly transferred between EU sites. Early knowledge management and collaboration between development and manufacturing teams will be crucial for building robust, adaptable processes that meet regulatory expectations and respond swiftly to changing supply needs. Leveraging advanced technologies and automation will further support efficient process development and validation.

Supply chain strategies must also emphasize transparency, traceability, and flexibility. Close collaboration across R&D, quality, procurement, and manufacturing, as well as sharing expertise across multiple sites, will help shorten timelines and ensure reliable access to critical medicines. Seamless transfer of processes and knowledge between sites will reduce the risk of supply interruptions and support regulatory compliance.

In summary, the Critical Medicines Act will drive companies to regionalize sourcing, invest in local production, and strengthen partnerships within the EU. This approach will secure access to essential medicines, foster supply-chain innovation, and improve preparedness for future disruptions.

As manufacturing models evolve, how can digital tools, data integrity measures, and AI support continuous GMP compliance and faster audits?

As pharmaceutical manufacturing evolves, digital tools, robust data integrity measures, and artificial intelligence (AI) are becoming vital for maintaining continuous Good Manufacturing Practice (GMP) compliance and enabling faster, more efficient audits.

Digital platforms centralize and organize manufacturing and quality data, allowing seamless information sharing across departments and sites. This ensures GMP documentation and records are always current and accessible, reducing manual errors, improving traceability, and supporting real-time compliance monitoring.

AI further strengthens these capabilities by automating data collection and integration from various electronic sources, such as manufacturing execution systems and laboratory information management systems. Advanced analytics enable rapid identification of trends, anomalies, and key compliance metrics, allowing companies to proactively address issues and foster continuous improvement.

For audits, AI-driven tools can quickly mine and analyze large datasets, giving auditors instant access to relevant records and compliance evidence. This streamlines audit preparation and execution, saving time and resources. AI-generated insights also support supplier risk assessments, helping companies identify high-risk suppliers and focus audit efforts accordingly. Continuous monitoring of supplier performance enables organizations to justify reduced audit frequency for low-risk partners, optimizing resource allocation.

What defines a “strategic partner” today when quality, data access, and ESG transparency are intertwined?

When we think about being a “strategic partner” in relation to quality, data access, and ESG transparency, there are six critical, non-negotiable characteristics that you should look for.

Deep Understanding of Business Requirements – Strategic partners must possess a thorough grasp of the client’s technical challenges, timelines, and budget constraints. This enables them to deliver tailored solutions that address specific needs and ensure that their contributions align with the client’s strategic objectives and drive measurable value.
Responsiveness – Effective partners communicate proactively, adapt swiftly to changes, and resolve issues efficiently. Their agility helps both parties manage risks and maintain momentum in a fast-paced environment, which is essential for meeting critical milestones and ensuring timely delivery of products and services.
Embracing Digitalization – Technologies like automation and AI facilitate seamless information sharing, real-time monitoring, and efficient data mining, supporting robust knowledge management and continuous improvement in quality and compliance.
Integrity and Transparency – Strategic partners operate with high ethical standards, maintain open communication, and provide clear documentation for regulatory submissions and audits. Their commitment to transparency extends to ESG practices, openly disclosing environmental and social impacts, which builds trust and fosters long-term collaboration.
Regulatory Compliance – A commitment to regulatory compliance is non-negotiable. Strategic partners invest in robust control strategies and stay current with evolving regulations, ensuring all processes and products meet or exceed industry standards.
Supply Chain Responsibility – Strategic partners take responsibility for their supply chain, including oversight of their own suppliers. They prioritize sustainable sourcing, ethical practices, and risk-based supplier assessments, working closely with clients to ensure supply continuity and support ESG transparency throughout the value chain.

Together, these characteristics enable strategic partners to deliver operational excellence, regulatory compliance, and sustainable growth in a rapidly evolving pharmaceutical landscape.

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Sergio Pissavini
International Business Advisor

CMO in fast changing future

Almost all businesses are in front of a “singularity” in the present world. I define “singularity” because there is a combination of a fast technology change, enhancement, and at the same time of a complex geo-political situation where a new equilibrium is not yet defined and multiforme forces are playing with not clear directions or future vision.

One of the dominant effects in the technology ramp-up is the development of A.I. with all related 360° consequences: ethical, security, jobs impact, speed of actions and decisions, fast data analysis, etc.

I would like to underline that the speed of technology change is accelerating, with an exponential trajectory which implies also an exponential variation of the exponent itself. This diagram represent the speed of the evolution and I believe we need all to reflect on this:

(From: The singularity is Near. – Ray Kurzweil 2005)

The graph will show even a steeper curve if we consider that based on the recent studies and experiments, we are very close to the “merging” of human intellect and artificial intelligence. CMO for the nature of its business (R&D related, plant performance related, regulatory related, supply chain fragmented and distributed, …) will probably go through important change in the operation mode and dramatic changes.

It is not the scope of this note to analyze in details all the different possible directions and weight of the impact but I am trying to summarize the two areas (A.I. and Geopolitics) and then try synthetize both in one schematic view.
The A.I. will impact severally the CMO world, the possibility to analyze fast a large vastity of genetic data, clinical data, production data, simulation exercise data will accelerate R&D, the time from R&D to production, favoring personalized medicine, optimizing production performance, … and so many other aspects creating a complex puzzle with strong interrelations among the different pieces. Herewith a preliminary view, which for sure is not including all.

The above will impact severely all the process form R&D to final production and it will require high investment cost, different people skills, different business process. It includes positive factors (green), neutral (different yellow tones) and critical ones (red).

The geopolitical dynamic is crossing this path as well due to present uncertainties and the fact that A.I. means in Geopolitical views: rare earths control and cybersecurity. In addition to political pressure for local production.

The below chart is a summary of possible geo-political impacts and the weight of the impact on CMO manufacturing world.

It is evident that CMO need to be ready to be able to adapt fast to change situation and having diversify strategy options for what supply chain is concerning, smaller modular plant, IP protection.

The “singularity” A.I. – Geopolitics is represented by the following scheme.

Again, a combination of positive, neutral and risks. CMO need to prepare to the possible scenarios. A wide and deep debate has to be conducted with a very open mind because the continuous acceleration of “evolution” is continuing and we have deep interconnections and I will not forget the “butterfly effect”.

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Roger La Force¹, Alessandro Gagnoni²
1. Managing Director, Dorra Europe
2. Operations Director, Dorra Europe

How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

RL – Supply Chain Management depends on types of products and technologies. The management for generic APIs is different from the one for peptides, oligonucleotides, ADC components or other new technology based molecules. This was initiated already before the US tariff policy and pressure to transfer manufacturing to the USA. CDMOs have started to reduce sourcing from China in order to mitigate supply interruptions as it happened during Covid. According to a market study of the Chemical and Pharmaceutical Association (CPA, Milan), before COVID, most European CDMOs depended for over 70–80% of their raw and starting materials on China. Thus, we are talking about reducing supply risks as a strategic approach.

AG – Two things we must bear in mind: first, the continuity disruption risk can (and must) be mitigated but not eliminated. Second, any operation of this kind entails an increase in costs. Regarding the differentiation of suppliers, this is the right strategy and maybe the only possible one. In fact, for most synthetic intermediates and generic APIs, the alternative with prices comparable to China is India. However, even if an Indian manufacturer is able to go back in the synthetic steps of a product, the key starting materials will always come from China, which is currently the only country that has the entire production chain, including a huge industrial fermentation capacity. This is true even when there are no pricing issues, as with innovative products. Integration with various qualified Asian suppliers is currently unavoidable. More than 95% of chemical APIs include at least one component from China in the synthesis.

Reshoring and regionalisation are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

RL – Reshoring and regionalisation is the “goodbye” to globalization, which does not mean that globalizing supply chains were only for the good. I want to stress out that global outsourcing was properly started mostly by US companies first with an India hype, then with a China hype to get lowest cost possible. Risk mitigation was not the highest priority then. Now we see a kind of a swing back to domestic or local production which will lead to other problems. Re-shoring and regionalization will not automatically lead to higher cost efficiency but to more disorder and higher costs. Many raw and starting materials cannot be competitively produced in the USA or Europe, the same applies to mature APIs and drugs. Large Pharma promises to invest in more manufacturing in the USA, but until such plants are onstream, the term of the present government will be over in 2028. It makes more sense to keep R&D and manufacturing in the countries of origin to safeguard new know-how. This approach does not work for mature or established products. Moreover, the US government has started to apply pressure on drug pricing, as such reasonable as US patients are paying higher prices for drugs than patients in other countries, raising questions of cost competitiveness. Digital transparency is also disappearing, as data exchange is increasingly used as a political tool. For example, some US clouds cannot be used in China due to the national firewall, while data stored in US clouds can potentially be accessed by US authorities. Hence, we see a rising level of uncertainty in the digital space. But we need to criticize first ourselves as we have been relying mostly of US products such as Microsoft, Apple and other Cloud solutions as examples.

AG – A massive (though not complete) reshoring of pharmaceutical production is theoretically feasible, but it requires a firm political will, huge investments, a clear industrial programme accepted by local populations, and a large pool of young talent. Such a programme would require at least 10 years. Bringing the most impactful and low-cost production back to the West is not feasible in countries where it is already difficult to operate industrial plants in highly populated areas. As always, the key to the future of pharmaceutical manufacturing in the EU and US lies in innovation combined with high quality standards. The economic system needs rebalancing, moving from a quantitative to a qualitative model.

How are you redefining agility in manufacturing?

RL – The labels are changing; agility is the new buzzword. Previously we called it flexibility or continuous improvement (for example within ISO 9001 systems). Enterprises must continuously reinvent their business models and optimize operations and workflows, which is particularly important for CDMOs. There appear to be size limits: large companies often become less flexible as they grow, while small companies may underestimate the need for continuous improvement while relying on traditional products with eroding margins without investing money and resources into innovation for small and mid-sized enterprises.

AG – Agility in manufacturing means innovation. Not only through AI and advanced technical tools, but also by innovating the commercial approach and dedicating resources to smaller projects. Medicines are moving toward precision therapy; most new drugs are complex specialties and niche products. As a consequence, small and mid-size companies are regaining importance in the CDMO landscape. For them, alliance agreements with complementary partners can be a key success factor.

In the race to accelerate CMC and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

AG – It is necessary to invest in skilled personnel: QA, QC, project management, and scientists. This is one of the reasons why Asian competitors are often very fast and effective in project execution.

RL – Compliance today is a given, for all aspects of Environmental, Health and Safety, both for patients and operators. There are still large gaps among providers in the various geographical areas. To maintain and enforce compliance, however, International and National regulations are key, and so far, the US FDA has been the gold standard. I am afraid, that cutting the budgets and resources of these institutions will invite some providers to less respect the high compliance levels, which will again the for the disadvantage of patients, the environment and worker’s safety.

How will the EU’s Critical Medicines Act influence supply-chain design?

AG – The CMA includes measures aimed at preventing excessive price competition for essential medicines, particularly those used in hospitals. These include multiple awards for tenders and evaluation criteria that consider not only price but also manufacturing location and supply reliability. This may give European manufacturers greater opportunities to compete.

RL – An important initiative, but with the diverging policies and national interests, I am afraid that the good intentions will be compromised by member countries for their particular interests.

As manufacturing models evolve, how can digital tools and AI support GMP compliance?

AG – All innovation driven by AI must be carefully studied and evaluated. However, digital tools are undoubtedly accelerating processes.

RL – Digitalization in pharma chemistry and pharma, compared to other industries, is still lagging behind. A key element to properly apply AI and digital tools is the education and training of a new generation of specialists. A critical element is the storage of data and information, where cloud solutions rely mainly on US systems; building own digital infrastructures in Europe will be key.

With virtual and hybrid audits now common, how are expectations changing?

RL – Hybrid audits can be advantageous, but since we deal with real laboratories and manufacturing sites, on-site audits remain essential to identify compliance issues. This requires well-trained auditors, which is becoming more challenging due to current US policy cuts in institutions. I fear that the “US FDA inspected” label may lose value.

AG – Virtual audits are useful to increase audit frequency, for example during innovative product launches, but they cannot replace traditional on-site audits.

Cybersecurity as a compliance issue

RL – Cybersecurity frameworks are important given the rise in cyberattacks, but difficult to manage because geopolitical power struggles are increasingly conducted through cyber means, especially for small and mid-sized enterprises, which represent still an important part of the manufacturing and CDMO landscape in our industry.

AG – Cybersecurity is of paramount importance, as in all industrial sectors.

Effective AI and predictive analytics use cases

RL – In small molecules, AI and ML are mainly used for route-of-synthesis development and high-throughput screening. Digital twin plants for simulation and predictive maintenance are emerging, though not yet fully implemented. Full digital process simulation is an expanding field, developed by large companies and startups such as DataHow (Zurich).

AG – AI is extremely useful in IP management. Patent and prior-art searches that once required months can now be completed in hours using well-trained AI agents.

What defines a strategic partner today?

RL – For a CDMO, a strategic partner is an extension of the customer’s manufacturing setup. Open-book costing, transparent communication, and honesty when problems arise are essential to build trust. The downside is that the number of key partners becomes limited, making entry into this circle increasingly difficult.

AG – When pricing pressure is low, companies can maintain strong ESG policies and extend them to suppliers. In generics, cost pressure often leads to reduced partner controls, resulting in transactional relationships rather than true strategic partnerships.

What will quality and supply-chain excellence look like by 2030?

RL – The outlook is uncertain. We are approaching 2030 amid strong technological shifts and new molecule classes such as RNA therapies, ADCs, peptides, oligonucleotides, and personalized CRISPR-based therapies. Differentiation will rely on both hard factors (technology platforms, financial strength, capacity, geography) and soft factors (transparency, proactivity, flexibility, inventory management, and sourcing strategies). In the next five years, more originator drugs from China licensed to the US and Europe will enter the market, as China becomes a true originator ecosystem.
Depending on how for US cuts in academic research, education and training will go, this could become an opportunity for Europe to increase innovation.

AG – Three drug products approved by the FDA in 2025 were developed in China: Zegfrovy (sunvozertinib), Penpulimab, and Alectinib. In the coming years, the key differentiator will be the ability to transform suppliers into real partners through solid agreements and transparent collaboration. The “supermarket model” is no longer sustainable.

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How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

Nowadays to guarantee supply continuity, we need to focus on different aspects.

A risk assessment on raw materials availability for products to be produced is the first activity to be performed to ensure a continuous supply not bound by a unique manufacturer, especially for critical raw materials.

Eventually, for manufacturers having different sites, it is mandatory to validate all sites with the aim of creating a reliable alternative within the same company (multi sites, different countries).

In addition, to minimize the potential risk related to geopolitical instability, cost pressure and material shortage, different activities must be finalized:

Work on demand forecast based on product request
Classify the different raw materials in high or low value and high or low impact on the supply chain
Consider case by case the impact to have on stock high value material
Settle a contract base order with the identified suppliers avoiding spot orders to minimize any risk related to a weak supply chain

Furthermore, with the growing global trend towards sustainability, supply continuity today means more than just stockpiling — it requires visibility, diversification, and long-term resilience. A continuity strategy can be strengthened by:

Building local partnerships to shorten supply chains and reduce transport risks.
Engaging suppliers on ESG performance, including risk exposure, ethical standards, and carbon data.
Mapping Scope 3 emissions and Corporate Carbon Footprint (CCF) not only to reduce impact, but also to identify concentration risks.
This dual lens helps to spot critical dependencies early and plan mitigation strategies — such as dual sourcing, process redesign, or investment in greener alternatives.

In this way, sustainability and resilience reinforce each other: the more transparent and low impact the supply chain, the more agile and robust it becomes under pressure.

Reshoring and regionalisation are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

There’s no one-size-fits-all. In some cases, regionalisation makes sense, especially for key starting materials or APIs where EU Green Deal regulation or client pressure demand local value chains. But for many inputs, sustainable global sourcing paired with traceability and supplier improvement plans is more realistic.

Indeed, the diversification of suppliers across different regions allows us to spread the risk and reduce the dependence on a single country or factory.

We’re investing in digital tracking tools and shared standards (EcoVadis, LCA methodologies) to drive transparency and comparability across regions to achieve a more realistic long-term strategy.

How are you redefining agility in manufacturing — is it about modular capacity, accelerated tech transfer, digital batch release, or new contracting models?

Enhancing agility in manufacturing necessitates a multifaceted approach focusing on continuous process optimization. By regularly challenging and refining our tech transfer processes, we ensure increased efficiency. Investing in the digitalization of these processes is crucial as it significantly reduces time to market. Specifically, we must leverage the full potential of our Enterprice Resource Planning systems, which are often underutilized.

Maintaining some spare capacity is essential to mitigate production disruptions, enabling us to respond swiftly and reliably to market demands. Effective forecast management also plays a pivotal role in maintaining agility. By anticipating and planning for future needs, we can enhance our responsiveness and reliability.

In summary, agility in manufacturing is achieved through a combination of continuous process improvement, strategic digital investments, maintaining spare capacity, and robust forecast management.

In the race to accelerate CMC and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

Accelerating CMC (Chemistry Manufacturing and Control) and scale-up in API development is always a balancing act, but rigorous quality doesn’t need to be sacrificed for speed. The key is to integrate quality into every stage of development rather than treating it as a checkpoint at the end:

Strong process design and early risk assessment make a big difference. By applying Quality by Design (QbD) principles from the start, identifying critical quality attributes and critical process parameters early, we reduce the likelihood of surprises during scale-up.
Real-time data and digital tools help maintain control while moving fast. Advanced analytics, digital batch records, and continuous monitoring allow for quicker decision, making and earlier detection of deviations, which in turn accelerates development without compromising compliance.
Cross-functional communication between R&D and quality teams ensures that any process change, impurity profile, or scalability issue is evaluated immediately.
Partnering with suppliers that have robust quality systems shortens timelines significantly.

A strong quality culture at every level, from raw materials to final API, reduces the need for rework and accelerates regulatory readiness. Speed and quality can align when processes are designed intelligently, monitored digitally, and supported by strong cross-functional collaboration.

How will the EU’s Critical Medicines Act influence supply-chain design, sourcing, and partnership decisions for essential APIs and finished products?

The Act pushes us to rethink not only where we source, but how responsibly we do it. For a CDMO like Flamma, it highlights the need to offer low-carbon, high-transparency manufacturing capacity within Europe, while helping client’s de-risk upstream by engaging their Tier-2 suppliers. It also reinforces the business case for investing in safer, greener technologies which reduce environmental footprint and increase process robustness.

In addition, the Act promotes a proactive approach: resilient, diversified, and transparent supply chains will be key to meeting regulatory requirements while ensuring patient access to essential medicines and minimizing exposure to geopolitical risks.

As manufacturing models evolve, how can digital tools, data integrity measures, and AI support continuous GMP compliance and faster audits?

The evolution of manufacturing toward digitalization requires a more dynamic approach to Good Manufacturing Practice (GMP) compliance. Traditional paper-based systems are no longer sufficient to support the speed and reliability demanded by modern operations. Digital tools, robust data-integrity controls, and AI-driven analytics are emerging as critical enablers of “always-on” compliance and accelerated audit readiness.

Digital platforms such as electronic batch records (EBR), manufacturing execution systems (MES), and electronic quality management systems (eQMS) provide real-time workflow enforcement, automated traceability, and immediate visibility of deviations.

Artificial Intelligence models highlight anomalous process trends, identify potential compliance risks earlier, and streamline review-by-exception workflows. When applied within validated frameworks and appropriate governance, AI reduces manual burden while enhancing decision quality and operational resilience.

Together, these capabilities dramatically improve audit efficiency. Digital systems provide a single source of truth for quality and manufacturing records, while AI can automatically assemble audit evidence, generate summaries, and support continuous audit-readiness dashboards.

In the light of this evidence, we are gradually moving towards the implementation of automation of operations, data storage and management but this transition requires time, resources and efforts from all the Departments strictly involved in supply chain, quality and production.

Cybersecurity has become a compliance and trust issue. How important are frameworks like CyberVadis or ISO 27001 certification for maintaining client confidence and regulatory alignment?

Security frameworks and certifications are not a mere compliance tick-box, but a strategic necessity. They quantify your security posture, make it transparent to clients, and align it with legal obligations, transforming cybersecurity from cost into an enabler of trust and business growth.

Organizations, especially those operating in strategic industries, must consider cybersecurity challenges as an integral part of their business to ensure not only their own continuity, but also that of the country. This includes protecting their supply chain.

Which use cases of AI, ML, or predictive analytics have proven most effective for enhancing planning, quality, and supplier risk management?

Nowadays, we do not yet use AI or predictive analytics to support supplier qualification. However, these technologies have proven highly effective in the pharmaceutical sector for several purposes. For example, they can improve demand forecasting and production planning, detect potential quality issues early through process data analysis, and anticipate supplier risks by monitoring performance, geopolitical factors, and material availability. When used effectively, AI and predictive analytics provide actionable insights that improve forecast accuracy, enable proactive quality management, and reduce supply-chain risks, helping companies become faster, more resilient, and more compliant.

What defines a “strategic partner” today when quality, data access, and ESG transparency are intertwined?

A strategic partner today must recognize two realities:

Pharma has a disproportionate weight on climate collapse through energy intensive chemistry, global supply chains, and complex manufacturing.
The industry also holds a unique moral and scientific position to show the world that human health cannot be separated from the health of ecosystems.

This means that partnership can no longer be transactional — it must be regenerative.

A true strategic partnership requires each actor in the value chain to take responsibility for the part they influence. In practice:

What Pharma Should Do

Share clear and realistic expectations and methodologies instead of pushing generic questionnaires.
Invest in supplier capability building, especially for decarbonization, circularity, and safer chemistry.
Co fund or co design pilots (low carbon solvents, packaging reduction, waste valorization) instead of shifting responsibility downstream.
Give visibility and predictability (multi-year volume commitments, stable forecasts) that allow CDMOs to justify greener CAPEX.
Include sustainability in supplier selection, not as a check-box, but as a co owning priority.

What CDMOs Should Do

Provide ESG data that is reliable, auditable, and comparable across sites and customers.
Drive process improvements that reduce solvents, energy, waste, and hazardous substances
Integrate ESG governance into everyday operations (change management, metrics, training).
Adopt frameworks such as EcoVadis, PSCI – Pharmaceutical Supply Chain Initiative-, or SBTi – Science Based
Targets initiative – where relevant, to align with pharma expectations.
Be proactive: come to clients with solutions and insights, not only reactions.

The New Definition of a Strategic Partner
A strategic partner is no longer the one who simply delivers on time and passes audits.
It is the partner who:

Helps reduce the environmental footprint of the entire molecule.
Shares transparent data so decisions are based on facts, not assumptions.
Works collaboratively to make chemistry safer, cleaner, and more efficient.
Understands that quality is evolving — from product quality to system quality, where sustainable impact is part of the value delivered.

In this new paradigm, strategic partners are those who enable healing at every level — people, supply chains, and the planet itself.

What will “quality and supply-chain excellence” look like by 2030 — and what capabilities will differentiate the leaders?

By 2030, we believe quality will evolve beyond compliance. Leaders will integrate:

Climate resilience (low-emission, energy-flexible production)
Circular practices (solvent reuse, waste valorization, flow chemistry)
Social standards (living wage, safe workplaces, Inclusive practices)
Digital ESG traceability (from batch release to carbon footprint)

The ability to deliver on sustainability while staying audit-ready will become a key differentiator — especially as big pharma tightens supplier scoring and public disclosure increases.

Conclusion: Redefining Quality Through Sustainability

Quality in life sciences has always been about precision, safety, and reliability. Now it must also be about resilience, responsibility, and regeneration. Sustainability is not just a client request — it’s becoming the future standard of excellence.

At Flamma, we believe true quality includes impact — on people, on the planet, and on the ability of supply chains to adapt and thrive.

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Lara Ferro
Regulatory Affairs Manager, ICROM Srl

Regulatory Agility in a Global API Supply Chain: How Digitalisation, Transparency, and Technical Partnerships Are Redefining the Landscape

Global pharmaceutical supply chains face unprecedented pressure — from raw-material shortages and energy-market volatility to new regulatory frameworks such as the EU Critical Medicines Act. At the same time, the demand for accelerated CMC development, real-time quality oversight, and digital compliance is forcing both pharmaceutical companies and CDMOs to redesign their operating models. Across this landscape, regulatory affairs is evolving into a structural connector bridging manufacturing, quality, supply chain, customers, and authorities. What follows is a consolidated view from industry leaders on how digitalisation, transparency, and smarter partnerships can transform disruption into opportunity.

Ensuring supply continuity under structural pressure

Supply continuity increasingly depends on the ability of regulatory teams to anticipate risk and support diversified sourcing strategies. Geopolitical instability and shortages of critical intermediates demand a level of regulatory visibility that goes beyond traditional dossier maintenance. Alternative sources must be technically viable and supported by documentation that can be updated rapidly, while digital oversight enables faster decision-making and more reliable risk assessment.

Selective relocation of critical production steps into regions with aligned regulatory frameworks reduces cross-jurisdictional variability and shortens the timelines associated with variations, inspections, and supplier qualification. For manufacturers heavily dependent on Asia, this shift also improves control over documentation and audit readiness. To sustain this evolution, accelerated regulatory processes and targeted State Aid frameworks are essential to support rapid qualification of new suppliers, expansion of regional capacity, and modernization of existing sites.

Reshoring, regionalisation, or smarter global diversification?

Full reshoring remains still economically and technically unrealistic for many API categories due to the upstream concentration of intermediates in Asia. Instead, companies are moving toward disciplined global diversification, where regionalisation is applied selectively to critical medicines. From a regulatory perspective, regionalisation delivers tangible advantages: harmonised standards, predictable audit frameworks, reduced variability in documentation, and greater inspection efficiency.

However, regulatory coherence alone is insufficient. Countries seeking to strengthen their pharmaceutical sovereignty must pair harmonised requirements with efficient State Aid mechanisms that support energy-efficient manufacturing, sustainable chemistry initiatives, and the development of new synthesis routes.
As transparency becomes a regulatory expectation, competitiveness will increasingly depend on the ability to operate within accelerated, digitally enabled regulatory pathways.

Redefining agility: modular capacity, rapid tech transfer, and digital batch release

As supply networks become more fragile and demand more variable, agility has become a strategic capability. Regulatory teams play a central role in enabling this agility by simplifying dossier lifecycles, supporting adaptive validation approaches, and ensuring high-quality data structures that accelerate technology transfers. When production of critical materials occurs within coherent regulatory regions, the timelines and risks associated with transfers and scale-up are significantly reduced.

Digital batch release—underpinned by continuous verification—can shorten release cycles and enhance operational robustness. Yet to fully unlock its potential, authorities must adopt faster, risk-based approaches to the evaluation of digital evidence. At the same time, public support incentives can catalyse the deployment of modular, flexible, and automated manufacturing platforms that allow producers to rapidly reconfigure capacity in response to supply-chain disruptions.

Accelerating CMC and scale-up while maintaining rigorous quality standards

Digital Quality-by-Design methodologies enable faster development cycles by leveraging structured data capture and predictive analytics for early definition of control strategies. Relocating critical production steps supports convergence in auditing practices, reduces friction during documentation updates, and facilitates the transition from development to commercial scale.

Digital CMC packages allow authorities to evaluate changes more quickly and thoroughly, reinforcing the need for accelerated regulatory frameworks that accommodate modern evidence formats. State Aid programmes can further stimulate innovation by funding initiatives in green chemistry, continuous processing, and advanced automation — all necessary components of a modern, resilient API ecosystem.

The EU Critical Medicines Act: regulatory and operational implications

The Critical Medicines Act introduces stronger transparency and robustness requirements across the upstream supply chain, compelling manufacturers to demonstrate redundancy, digital traceability, and reliable data-sharing practices. Producing critical APIs within European-aligned regulatory environments simplifies compliance with these expectations by reducing jurisdictional complexity and ensuring consistent communication channels with authorities.

However, meeting the Act’s objectives requires both efficient regulatory procedures and timely access to public funding. Reshoring and modernization projects for critical APIs depend on predictable State Aid mechanisms and robust digital infrastructures. Without these supports, the transition toward regionalised, technologically advanced supply ecosystems risks becoming economically unsustainable.

Digital tools, data integrity, and AI as enablers of continuous GMP compliance

Digital and AI-enabled systems function as compliance multipliers, providing increased transparency, faster audit preparation, and improved lifecycle data governance. Even partial integration can significantly reduce the burden of inspections and deviations by ensuring real-time visibility into operations.

As authorities progressively accept digital evidence — including continuous-monitoring data and AI-supported assessments — regulatory frameworks must adapt to maintain both speed and robustness. Operating within harmonised regulatory regions further enhances the consistency and reliability of data governance models.

Preparing for hybrid audits by 2026

The shift toward hybrid audits demands fully digitalised documentation repositories, controlled data access, and seamless traceability from raw materials to final release. Organisations must integrate digital audit management into their quality systems to ensure readiness for both remote and in-person inspections.

Regionalising production of critical APIs helps standardise audit expectations, reduces back-and-forth with authorities, and enables faster closure of findings and approval of post-approval changes — a critical capability in periods of rapid regulatory or market change.

Cybersecurity as a foundation of regulatory trust
As digitalisation transforms regulatory interactions, cybersecurity has become a core determinant of trust. Certifications such as ISO 27001 and rating systems like CyberVadis now function as baseline expectations for data reliability and system integrity.
Operating in aligned regulatory environments enables more homogeneous implementation of cybersecurity frameworks, reducing vulnerabilities that could disrupt supply continuity or compromise regulatory data flows.

AI, ML, and predictive analytics: where they create the most value

AI and advanced analytics are increasingly deployed to strengthen operational resilience and regulatory readiness. High-value use cases include predictive supplier-risk modelling, process-control optimisation, and AI-assisted structuring of regulatory dossiers.

When production is localised or regionalised, data quality and granularity improve, resulting in more reliable models, enhanced evidence generation, and faster, more precise regulatory submissions. This strengthens the link between regulatory agility and technological maturity.

Redefining the strategic partner in today’s ecosystem

A strategic partner is one that ensures timely access to high-resolution quality and sustainability data, collaborates early on regulatory strategy, meets evolving ESG expectations, and adapts rapidly to regulatory or operational changes. Partners integrated into regionalised supply networks are better equipped to support accelerated review cycles. They also contribute to mobilising State Aid instruments for shared innovation initiatives, plant modernization, and reshoring programmes — aligning commercial, operational, and policy goals.

What “quality and supply-chain excellence” will look like by 2030

By 2030, supply chains are expected to be more digital, predictive, and transparent, with regulatory affairs functioning as a core driver of resilience. Organisations that transform compliance into a strategic asset — through speed, digital integration, and proactive engagement with authorities — will become industry leaders.

Localising or regionalising the most sensitive elements of the supply network will enhance governance and reduce vulnerability to global disruptions. Accelerated regulatory frameworks and targeted incentives will remain critical to sustaining innovation, maintaining competitiveness, and ensuring reliable access to critical medicines.

Conclusion

Regulatory affairs is entering an era defined by structural agility, not reactive compliance. Digitalisation, transparency, and cross-border collaboration now underpin resilience for API manufacturers operating in complex global ecosystems. Selective relocation of critical-medicine production delivers clear regulatory and operational benefits, but its success depends on accelerated regulatory pathways and effective State Aid mechanisms to modernise infrastructure and support sustainable innovation.
Through the combination of regulatory agility, advanced technologies, and strategic public support, the API sector can transform today’s challenges into long-term stability and competitive strength.

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Patrizia Fazio
Head of Applied Research Coordination, Imprima

Resilience, Quality, and Agility in the Pharmaceutical and CDMO Supply Chain

Turning Global Challenges into Strategic Capabilities

The pharmaceutical industry and Contract Development & Manufacturing Organizations (CDMOs) are currently facing unprecedented challenges: increasing cost pressure, geopolitical instability, and shortages of critical materials. The pandemic, international tensions, and logistical constraints have exposed the vulnerability of the global supply chain. Supply continuity is no longer optional—it has become a strategic imperative.

Companies are therefore adopting a combination of operational and strategic levers. At the operational level, dual- or multi-sourcing of critical APIs, intelligent safety stock management based on predictive analytics, and multi-year contracts for strategic raw materials have become standard practice. Design-to-supply approaches enable the adaptation of formulations and processes according to material availability, without compromising quality. At the strategic level, partnerships with key suppliers are being strengthened, evolving beyond purely transactional relationships, while end-to-end supply chain transparency is being implemented through shared digital platforms. Continuous geopolitical analysis and country risk mapping enable proactive decision-making and the prevention of disruptions.

Regionalization vs. Global Diversification

Reshoring and regionalization are gaining attention, particularly for strategic categories such as essential APIs, antibiotics, and sterile products. In Europe and the United States, incentives have been introduced to relocate production closer to end markets. However, regionalization has significant limitations: higher costs, long implementation timelines, and often insufficient local manufacturing capacity.

Global diversification, combined with digital transparency and synchronized regional hubs, is proving to be a more viable approach. The objective is not to bring all production onshore, but to balance risk and cost by ensuring resilience through multilayer supply chains with full traceability and visibility. The strategic conclusion is that regionalization will be selective, while global diversification supported by digital transparency will become the operational standard.

Manufacturing Agility

Agility in pharmaceutical manufacturing today is not merely about speed, but about the ability to adapt to changes in products, volumes, and market conditions. Key enablers include:

Modular capacity: Reconfigurable multi-product platforms, plug-and-play skids, and integrated modules accelerate scale-up and enable flexible manufacturing campaigns.
Accelerated technology transfer: Digital twins, shared process models, and digital-first CMC packages streamline regulatory steps and reduce process comparability timelines.
Digital batch release: Paperless documentation, advanced QRM, and parametric release eliminate QC bottlenecks and accelerate product availability.
New contractual models: Outcome-based contracts and capacity-on-demand models enable true flexibility and collaboration aligned with shared objectives.

Accelerating CMC Without Compromising Quality

CMC (Chemistry, Manufacturing, and Controls) is central to acceleration strategies. The integration of Quality by Design (QbD) from preclinical stages, the use of Process Analytical Technology (PAT) for real-time control, and the adoption of digital pipelines with data integrity by design enable reduced development timelines without sacrificing quality. The use of AI to select critical parameters, optimize experiments, and predict deviations minimizes trial-and-error and increases process predictability. Early dialogue with regulatory authorities—through rolling reviews or scientific advice—supports faster and more robust approvals.

Critical Medicines Act: Strategic Impacts

The EU Critical Medicines Act will have a profound impact on supply chains, procurement, and partnerships:
Supply chain design: Incentives for European production of critical APIs and mandatory continuity plans.
Procurement: Increasing prioritization of resilience over cost alone, with incentives for suppliers ensuring multi-tier transparency
Partnerships: A push toward long-term strategic agreements and increased demand for EU regulatory compliance from non-Western partners.

These regulations transform procurement from a transactional function into a strategic lever for continuity and risk mitigation.

Digital Tools, AI, and Data Integrity for Continuous GMP

Digital integration is essential to modern quality systems. Integrated MES, eBR, and eQMS reduce errors and improve traceability, while document automation shortens batch review timelines. AI applied to deviations, CAPA, and trend analysis enables proactive quality management and accurate forecasting, supporting faster audits and real-time, data-driven operational decisions. Dashboards and digital systems ensure audit readiness, reducing variability and compliance risk.

Virtual and Hybrid Audits: The 2026 Standard

A CDMO ready for 2026 must ensure:
90–100% digitized documentation.
Secure remote access with configurable audit trails.
Structured GMP video inspections.
Standardized playbooks for virtual audits.
Trained personnel and integrated cybersecurity.
This approach ensures continuity, efficiency, and trust during inspections.

Cybersecurity and Trust

Cybersecurity is now a pillar of compliance: ISO 27001 certification and CyberVadis assessments are qualification requirements, not optional extras. Protecting CMC data and OT systems is critical, particularly with virtual audits and digital transfers. Global clients require certified evidence of cybersecurity maturity, which has become an integral component of quality and trust.

AI, Machine Learning, and Predictive Analytics

The most effective applications include:
Supply Chain: Shortage forecasting, geopolitical risk assessment, inventory optimization, and supplier early-warning systems.
Quality: Automated deviation trending, OOS/OOT prediction, and digital batch record review.
Manufacturing: Process parameter optimization, predictive maintenance, and simulations for scale-up and technology transfer.
The combined use of AI and advanced analytics enables faster, more accurate, and data-driven decision-making.

The New Strategic Partner

A strategic partner today is:
Transparent and data-driven.
ESG-compliant and regulatory robust.
Collaborative in supply chain design.
Capable of long-term investment.
Aligned with global dynamics and regulatory requirements.
Partnerships are no longer transactional, but ecosystems of shared value.

Supply Chain Excellence 2030

The distinguishing capabilities of industry leaders will be:
Digital documentation and digital-first quality systems.
Real-time or near-real-time release.
Predictive and transparent supply chains.
Integrated, multi-node partnerships.
Cybersecurity as an operational standard.
ESG as a mandatory contractual requirement.

CDMOs and pharmaceutical companies that invest today in digitalization, modularity, AI, and cybersecurity will define industry standards and global leadership by 2030.

Conclusions

The ongoing transformation is redefining the role of CDMOs: no longer mere manufacturers, but strategic partners capable of ensuring resilience, quality, transparency, and speed. Digitalization, modularity, AI, and cybersecurity will be the pillars of supply chain excellence in the pharmaceutical industry over the next decade.

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Eric Aubay
VP Flow Chemistry, KHIMOD

How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

Across Europe, manufacturers are seeking equipment and process technologies that can be sourced locally, reducing their exposure to long and fragile global supply chains. In this regard, companies such as KHIMOD play a pivotal role by supplying European-made, high-performance continuous-flow heat exchanger-reactors, which contribute to enhancing local production capacity. This shift toward domestically available technologies helps manufacturers stabilize supply, reduce logistical risks, and maintain operational continuity despite fluctuating geopolitical and economic conditions.

Reshoring and regionalisation are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

Regionalization is becoming an increasingly practical industrial strategy in Europe. France is currently one of the countries with the most advanced large-scale relocation efforts. After experiencing recurring drug shortages and recognizing its dependence on Asia for most of its APIs, France established targeted funding programs to rebuild domestic manufacturing capacity for essential medicines.

Through the France Relance and France 2030 programs, the French government has issued calls for proposals to relocate the production of APIs and finished products deemed strategically vulnerable. In early 2025, seven new projects were selected to bolster domestic production of essential medicines, receiving around €50 million in public funding. Recent beneficiaries include Ipsophene (paracetamol API), Zach System (expanded API capacity), and Euroapi, which is reshoring macrolide antibiotic API production to its French site with national and EU co-funding. These programs offer a combination of direct capital expenditures (CAPEX) support, innovation funding, and industrial loans designed to reduce the risk of investing in local pharmaceutical production.

At the EU level, broader frameworks, such as the IPCEI “Med4Cure,” the EU4Health/HERA manufacturing calls, and the forthcoming Critical Medicines Act, complement these national efforts by offering additional instruments to support resilient manufacturing technologies, including continuous processing solutions.

In this environment, regionalization is especially appealing when combined with continuous-flow chemistry and modular reactor technologies. Smaller, scalable units with lower capital expenditures (CAPEX) and on-demand production capabilities reduce the barrier to establishing or reshoring capacity. Although global diversification and digital transparency will remain important, France’s targeted relocation programs demonstrate that regionalized production is technically feasible and economically viable for APIs and critical medicines.

How are you redefining agility in manufacturing — is it about modular capacity, accelerated tech transfer, digital batch release, or new contracting models?

Increasing agility requires modular capacity and the ability to produce on demand. These two capabilities are naturally enabled by continuous chemistry. KHIMOD’s modular reactor architecture enables manufacturers to rapidly adjust capacity by adding or removing parallel units without redesigning the process.

Process Analytical Technology (PAT) plays a central role in enabling this flexibility. By continuously monitoring and adjusting critical parameters, such as temperature and pressure, PAT enables real-time optimization of operating conditions. The system self-optimizes within defined boundaries, ensuring consistent quality while allowing for rapid adaptation to changing production requirements.

In the race to accelerate CMC (chemical manufacturing) and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

KHIMOD applies a pure numbering-up strategy. Once a reaction is validated in a single channel, it can be replicated identically across hundreds of channels. The chemistry and thermal behaviour don’t change. This eliminates much of the uncertainty traditionally associated with scaling up because the process conditions remain constant and predictable.
Scale-up then becomes a matter of evenly distributing fluids rather than redesigning the reactor or reaction pathway.

This approach enables faster development timelines while maintaining stringent quality and reproducibility standards. KHIMOD’s effectiveness was recognized in 2025 when it received the Process Intensification Award for Industrial Innovation from the EFCE and EUROPIC for its milli-structured packed-bed heat exchanger reactor design. This award highlights how numbering up combined with precise thermal control provides a robust and accelerated route from laboratory validation to industrial production.

How will the EU’s Critical Medicines Act influence supply-chain design, sourcing, and partnership decisions for essential APIs and finished products?

The proposed Critical Medicines Act aims to strengthen Europe’s ability to ensure the supply of essential medicines and APIs. The act’s main impact will likely come from the investment framework it introduces, which will support the expansion or modernization of manufacturing capacity for critical products within the EU. By providing tools for strategic projects, the act aims to reduce dependence on long, vulnerable global supply chains.

Although the exact implementation is still being developed, the act is expected to prompt companies to reevaluate the locations of key production steps and integrate more resilient regional capacity into their supply chain strategies. The act may also influence sourcing decisions by placing greater emphasis on supply security rather than lowest-cost procurement. Overall, the act provides a regulatory and financial environment designed to make Europe-based manufacturing a more viable option for essential medicines and APIs.

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Rajiv Khatau
Managing Director, Lodaat Pharma
Managing Director , Life Sciences Advisors LLC

How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

Great question, and one that we get asked all the time. We all understand that the pharmaceutical industry is facing significant increasing pressure given the growing instability around raw material supply chains. With rapid changes in raw materials costing, the industry has needed to prioritize establishing a robust supply chain with multiple qualified suppliers. This priority is particularly key for high risk or critical inputs and is being paired with strategic inventory management. We are seeing this shift especially in US-based manufacturers due to the volatility caused by changing tariff policies for materials coming from India and China.

Reshoring and regionalization are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

The US, like other global markets, is in the midst of a push for reshoring and localization of manufacturing with the implementation of the USFDA’s new ANDA Prioritization Pilot Program for generics developed in the US. The program shortens approval timelines for generics with US-based API and finished formulation manufacturing. While this certainly incentivizes manufacturing in the US, this significantly impacts cost of development and ultimately pricing and ROI.

How will the EU’s Critical Medicines Act influence supply-chain design, sourcing, and partnership decisions for essential APIs and finished products?

We have found that The EU’s Critical Medicines Act is similarly pushing efforts to bolster European manufacturing of essential medicines. An immediate and intended effect of the CMA will be further support for strategic projects – projects which create, increase, or modernize EU manufacturing capacity for these essential APIs and products – on financial, regulatory, and administrative levels. Given what we know and the intended purpose of the Act, the CMA will strengthen and secure supply chains, and from there sourcing and partnership decisions will be adapted to be more collaborative in nature and committed to prioritizing EU supply of medicines.

What defines a “strategic partner” today when quality, data access, and ESG transparency are intertwined?

At Lodaat and Life Sciences Advisors, strategic partnerships are paramount. Such partnerships are centered around robustness and reliability. Any potential strategic partner’s viability will be defined by their ability to maintain resilient quality supply chains. These general areas are where we will most likely see transparency, data access, and quality control converge into an intertwined network between partners.

In the race to accelerate CMC and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

The industry’s constant race for faster development requires front-load science combined with risk management to reduce the possibility of late-stage rework to maintain quality control. The principles of Quality by Design (QbD) as described in ICH Q8-9 are always applicable and effective to implement solid foundations to ensure manufacturing processes can be robust and flexible.

As manufacturing models evolve, how can digital tools, data integrity measures, and AI support continuous GMP compliance and faster audits?

Modernization of the pharmaceutical manufacturing infrastructure will also include implementation of AI models for streamlining and support. A study from Wang, et.al 2025 using an intelligent quality prediction and diagnostic (IQPD) framework proposed a novel path-enhanced double ensemble quality prediction model (PeDGAT) and found that it achieved an average improvement of 13.18% and 87.67% in prediction accuracy and stability, clearly showing how AI can be successfully implemented in manufacturing. Machine-learning frameworks can work best as a tool for predictive measures – in areas like maintenance, quality control, and data integrity – to ensure smoother and less delayed manufacturing. Implementation of machine-learning frameworks may be similar to the result of any successful application of AI, ML, or predictive data analytics – a self-healing supply chain that can automatically identify, predict, and resolve its own flaws and can use predictions to coordinate planning and reduce costs, achieve goals, and increase revenue.

References and notes

Wang, Kaiyi, et al. “AI-integrated IQPD framework of Quality Prediction and Diagnostics in small-sample multi-unit pharmaceutical manufacturing: Advancing from experience-driven to data-driven manufacturing.” Acta Pharmaceutica Sinica B, vol. 15, no. 8, Aug. 2025, pp. 4193–4209, https://doi.org/10.1016/j.apsb.2025.06.001.

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Julien Meissonnier
LifeScience Partner, MarketChemica & Associates, Zur Hadassah, Israel

How Gulf of Aden Turbulence Is Rewiring the Specialty Chemicals Supply Chain — and Why India and China May Look Twice at Europe for Reshoring

The global specialty chemicals industry has always lived with a certain level of geopolitical risk. Feedstocks move across continents, production is concentrated in a handful of Asian hubs, and the end markets—pharma, automotive, electronics, agriculture—are unforgiving when supply falters. But the disruptions that have unfolded since late 2023 in the Gulf of Aden and the Red Sea corridor represent a structural break, not a cyclical shock. The region, which carries roughly 12% of global trade via the Suez Canal, has been rattled by persistent attacks on commercial vessels, forcing shipping lines to reroute thousands of miles around the Cape of Good Hope. Insurance premiums have surged, transit times have doubled, and freight volatility has become the new normal.

For specialty chemicals—highvalue, lowvolume, timesensitive products—the consequences are profound. And the ripple effects are beginning to reshape strategic thinking in India and China, the world’s two largest producers of specialty chemicals. The question now is whether this disruption will accelerate a quiet but meaningful trend: Asian suppliers reshoring or nearshoring parts of their production into lowercost regions of Europe.

This is not as farfetched as it might have sounded five years ago. The Gulf of Aden crisis has exposed vulnerabilities that go beyond logistics. It has challenged assumptions about global production footprints, risk tolerance, and the balance between cost efficiency and supply security. And Europe—despite its higher labor costs—has pockets of competitive advantage that are becoming more attractive as the geopolitical calculus shifts.

The Gulf of Aden Crisis: A Structural Shock, Not a Temporary Disruption

The Red Sea/Gulf of Aden shipping crisis has been one of the most consequential supply chain disruptions since the pandemic. According to recent analyses, over 190 attacks on commercial vessels occurred between late 2023 and late 2024, prompting widespread rerouting and a collapse in Suez Canal traffic. The result has been:

Transit delays of 10–20 days for Asia–Europe shipments
Freight cost spikes and volatile insurance premiums
Reduced reliability of justintime supply chains
Inventory distortions across European manufacturers
Working capital strain for chemical distributors and converters

The specialty chemicals sector is particularly exposed. Unlike bulk petrochemicals, specialty chemicals often have:

Short shelf lives
Tight customer specifications
High valuetoweight ratios
Complex regulatory documentation
Limited substitutability

A delay of even a few days can disrupt downstream production in pharmaceuticals, coatings, electronics, and advanced materials. European buyers, already fatigued by pandemicera shortages, have begun demanding redundancy, dual sourcing, and regionalization.

This is where the strategic implications for India and China begin to take shape.

India and China: From Global Suppliers to Global Strategists

India and China dominate the specialty chemicals landscape. China alone accounts for more than 40% of global output in several categories, while India has become the world’s fastestgrowing exporter of intermediates, APIs, and performance chemicals. Both countries have benefited from scale, integrated ecosystems, and cost advantages.

But both are also grappling with new pressures:

Geopolitical scrutiny from Western buyers
Rising domestic labor and environmental compliance costs
Exportmarket diversification needs
Customer demands for supply chain resilience
Logistics fragility exposed by the Gulf of Aden crisis

The Gulf of Aden disruptions have forced Indian and Chinese suppliers to confront a simple truth: their competitive edge erodes when reliability collapses. A lowcost product loses its appeal if it arrives three weeks late.

This is why the idea of partial reshoring or nearshoring into Europe—once unthinkable—now sits on the strategic agenda of several Asian producers.

Why Europe Is Becoming More Attractive—Despite Higher Costs

Europe is not a monolith. While Western Europe has high labor costs and stringent regulations, Central and Eastern Europe (CEE) and parts of Southern Europe offer a different equation:

Lower labor costs (Romania, Bulgaria, Serbia, parts of Greece)
Strong chemical engineering talent
EU regulatory alignment
Proximity to end markets
Access to EU funding for green and strategic industries
Improved logistics connectivity

In addition, the EU’s push for strategic autonomy in chemicals, pharmaceuticals, and advanced materials creates a favorable policy environment for foreign investors willing to localize production.
For Indian and Chinese suppliers, establishing satellite production or finishing facilities in Europe offers several advantages:

Risk Diversification
By splitting production between Asia and Europe, suppliers reduce exposure to maritime chokepoints like the Gulf of Aden.
Customer Proximity
European buyers increasingly prefer suppliers with local or regional presence, especially for regulated sectors.
Faster Lead Times
A 2–5 day truck shipment beats a 30–40 day ocean route.
Regulatory Alignment
Producing within the EU simplifies REACH compliance and reduces administrative friction.
Brand Positioning
Local production enhances trust, especially in highpurity or highspecification segments.

The Gulf of Aden as a Catalyst for Strategic Rebalancing

The Gulf of Aden crisis has not created new trends—it has accelerated existing ones. Even before the disruptions, the Middle East’s chemical sector was investing heavily in downstream and specialty capabilities, with Saudi Arabia alone planning $367 billion in chemical expansion by 2035. This shift already threatened to alter global trade flows.

But the instability in the Red Sea has added urgency. The recent reports on GCC supply chain resilience emphasize the need for antifragile, diversified supply networks capable of withstanding geopolitical shocks. Asian suppliers are drawing similar conclusions.

The logic is straightforward:

If the Middle East becomes both a competitor and a chokepoint,
And if Europe becomes both a market and a potential production base,
Then the optimal strategy is to balance production across regions.

This is not a wholesale relocation. It is selective reshoring—focused on:

Highmargin specialty chemicals
Latestage finishing and formulation
Custom manufacturing
Highpurity intermediates
Products with high logistics sensitivity

In other words, the parts of the value chain where proximity matters most.

Will India and China Actually Move? The Strategic Calculus

India’s Position
India is wellpositioned to benefit from the crisis. Its shipping routes to Europe are equally affected, but Indian firms have:

Stronger political ties with Europe
Lower labor costs than China
A growing reputation for reliability
Government incentives for global expansion

Indian specialty chemical firms have already begun acquiring or partnering with European plants. The Gulf of Aden disruptions may accelerate this trend.

China’s Position
China faces more complex dynamics:

Higher geopolitical scrutiny
Rising domestic costs
Stronger capital resources
A desire to maintain global dominance

Chinese firms may pursue a “China + Europe” strategy, using European facilities to serve regulated markets while keeping bulk production at home.

Both countries share one motivation: protecting market share in Europe, which remains one of the world’s largest specialty chemicals consumers.

Conclusion: A New Geography of Specialty Chemicals

The Gulf of Aden crisis has done more than disrupt shipping lanes. It has forced a strategic reckoning across the specialty chemicals industry. For Indian and Chinese suppliers, the question is no longer whether they can afford to diversify production—but whether they can afford not to.

Europe, with its mix of lowercost regions, regulatory stability, and proximity to end markets, is emerging as a surprisingly viable destination for selective reshoring. The next decade may see a quiet but significant rebalancing of global specialty chemical production, driven not by cost alone but by resilience, reliability, and geopolitical pragmatism.

The Gulf of Aden may be thousands of miles from Europe’s chemical clusters, but its impact is being felt in boardrooms from Shanghai to Mumbai to Frankfurt. And the decisions made today will shape the industry’s geography for years to come.

References and notes

PSA BDP analysis of Middle East chemical industry resilience https://www.zawya.com/en/press-release/research-and-studies/transformationx-and-gpca-release-report-on-building-resilient-and-anti-fragile-supply-chains-feskmfe0
TransformationX & GPCA report on antifragile GCC supply chains https://psabdp.com/psa-bdp-blog/navigating-turbulence-supply-chain-resilience-in-the-middle-east-s-chemical-and-petrochemical-industry-amid-geopolitical-unrest
Atlas Institute report on Red Sea/Gulf of Aden shipping crisis https://atlasinstitute.org/the-red-sea-shipping-crisis-2024-2025-houthi-attacks-and-global-trade-disruption/

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Dr. Dirk Kirschneck
Strategic Director, Microinnova Engineering GmbH

How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

We see investment in modular and mobile plant systems as useful as a response strategy. Flexibility and process intensification are useful strategies for maintaining their agility to respond quickly to changing conditions and locations. Plug and produce helps to respond in uncertain times. AI tools will support this approach.

Reshoring and regionalisation are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

A high level of automation or even autonomous process plant operations open the door for regionalization of manufacturing tasks. Production will be executed by local sites and can respond to local conditions. Control, as well as data management, will be centralized. Local production could reduce logistics and increase sustainability.

How are you redefining agility in manufacturing — is it about modular capacity, accelerated tech transfer, digital batch release, or new contracting models?

Modular manufacturing strategies open new business models for process plant systems. Composing process plants out of existing modules instead of designing process-specific plant systems combines speed with process performance. Maybe plant rentals will become an option to reduce risks, CAPEX, and maximize flexibility. Plant usage can be increased, especially for plants using specific technologies.

In the race to accelerate CMC and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

We expect that standardized digital development milestones will enable the applicability of AI. Engineering seems to be ahead with the DEXPI standard, which covers the P&ID information within a digital readable standard. This makes the usage of AI agents easily applicable. Similar standards are expected for chemical development and process development in the near future.

What defines a “strategic partner” today when quality, data access, and ESG transparency are intertwined?

Strategies for cooperation will support the best possible result. Data exchange will help to get the best performance out of a system. For example, the interpretation of an in situ measured pump curve could result in predictive maintenance.
Deep process understanding, as well as the optimization of process details, could be a result of great cooperation based on data exchange.

What will “quality and supply-chain excellence” look like by 2030 — and what capabilities will differentiate the leaders?
Trustful partnerships with an open data exchange will differentiate between the leaders and followers. The focus on each organisation on its core competencies and executing them as well as possible will be a key success factor for the future. Side business will be reduced since specialists can typically do these tasks better. Generating value out of the data will be key for all partners.

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Sundar Narsimhan
Chief Procurement Officer, Neuland Labs

How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

Choppy supply markets: The global geopolitical landscape coupled with changing market dynamics has caused price and supply disruptions of all commodities and supplies. For instance, metal prices are rising from their all-time lows; while increased global capacity for basic chemicals and solvents is resulting in changing supply geographies and declining prices. In this environment, maintaining resilience and sound judgement is essential when seeking for the elusive supply assurance and price stability. See through the woods as they say.

Supply prospecting: The cardinal rule is to scour for the last bit of information on critical and vulnerable inputs from both structured and unstructured sources to aid decision-making. Either during negotiation or in contracting, the key to a successful outcome is a thorough preparation.

Inventory Strategy: An elementary but paramount input to the process is to get a fair idea on demand visibility. Break the demand complexity by having a runner-repeater-stranger stratification. Keep a hawk eye on the repeaters and strangers demand signals. Have an inventory strategy for these two categories based on value and shelf life of materials. Keep in mind the service level targets. A well-designed inventory protects from potential business losses and counteracts supply risk during the planning period.

CDMOs are faced with different realities depending on the stage of the product cycle. While contracts for early phases up to early Phase II come with a fair amount of uncertainty and newer materials, later phases are better grounded.

Early phases typically need quick lead times. The odds are stacked against and are very pronounced for a) specific materials needed for the projects and b) high-volume ones. To ensure procurement in a cost-effective manner, CDMOs can have a two-pronged approach. Develop / Scale-up the input in a dedicated external lab/plant or discover the price through a sourcing and procurement process/engine where all pre-qualified suppliers can quote at short notice. Meeting short term demands requires effective information gathering and supply network mobilisation. Here agility, flexibility and solution-orientation are crucial over all other considerations.

In the medium term, the winners have demonstrated consistent, cost-effective, risk-mapped and demonstrated performance. One must map deeper into the supply network and has understood all the vulnerabilities and built inventories or contracts for supply assurance. By negotiation and shared-risk approach, costs can be contained. Keeping an eye on all key risks and taking actions then makes up for any mid-way scare. Be it geographic or commodity risks, those that spread the risk and adopt a prudent business share for all key geographies and players win the war. While fixed-price contracts are the norm downstream, managers tend to build index based moving price contracts upstream and sometimes are able to ‘pass-through’ the variations beyond a threshold through pass-through clauses. However, such arrangements may offer little reassurance to supply managers.

Supply Continuity

Reshoring and regionalisation are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

Over the past 4 decades, the world economy has enjoyed growth owing largely to globalization, resultant demand and supply flows. Countries and economic blocs have revisited this approach and determined that self-reliance and onshore manufacturing is a recipe for future growth, employment and prosperity. Local demand to be met by local supplies! Nations are taking those actions as defending their own capacities and recently are protecting from dumping of foreign goods by deploying tariff and non-tariff barriers.

Self-reliance is an important economic necessity. If countries are able to produce those essential things that feed and sustain the populace and economy, they are protected from uncertainties. However, trade and exchange are probably as old as the planet itself and aim to provide both essential and fancy goods and services to the people at large. Hence it is important to pick those goods that one is need of while sustaining the economy.

Free trade is detrimental especially if there are motivated actions by economies to overproduce goods and services and dump it on others. A balanced approach for countries and enterprises then is to emphasize on self-reliance and encourage free trade only where the economy needs goods and services that are not locally available or in shortage. Another important thing is that self-reliance means there is enough demonstrated, active capacity to manufacture the country’s needs. If free trade results in these capacities going idle and resultant permanent loss, then it is meaningless. For corporations, therefore, it is essential that they are not fully reliant on a foreign geography or outside enterprises completely thereby increasing risk significantly.

A good strategy will be to have in-house capabilities wherever needed, use multiple geographical supply markets and seek to achieve best cost scenario in a balanced manner.

At a global level, this means that countries adopt a balanced mix of self-reliance and free trade and do not do such actions as to harm other countries through trade. I love the idea of digital transparency especially if it results in greater efficiency.

What will “quality and supply-chain excellence” look like by 2030 — and what capabilities will differentiate the leaders?

We are at a tipping point with the increasing adoption of robotics, maturing AI models and quantum computing moving closer to reality. While Supply chains are transitioning from forecasting models to predictive models, Quality function is increasingly relying on leveraging machine vision and automation to achieve true online control, minimize errors and improve accuracy.

Future Supply Chain excellence will

Increasingly adopt AI and Big Data Analysis to manage procurement, KPI tracking, performance management and improve sourcing ability
Adopt supply chain initiative across supplier tiers on ESG and sustainability for long-term competitiveness and value creation
Enhance customer experience through innovations like digital twins
Future focus on resilience, agility and sustainability in addition to the current fulfilment (OTIF), inventory and cost-efficiency.

Quality Excellence will see the strengthening of the current trend towards increasing focus on proactive compliance using

Lean tools, risk mapping and mitigation, digital batch reviews and robotic process automation including visual and tactile robotic monitoring
Automated and robotic sampling, testing and releasing both raw materials and in-process material
Sustainable quality management involving reduced testing, adaptability and reengineered processes to achieve near zero defects.

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Peter DeYoung
CEO, Piramal Global Pharma

Harmonizing the East-West Axis for a Patient-Centric Supply Chain

Unforeseen events that disrupt pharma supply chains can no longer be dismissed as isolated incidents. Having seen everything from geopolitical turmoil to volcanic eruptions affect their ability to get drugs to patients, companies are recognizing the need to move beyond reactive fire-fighting. In an era defined by disruption, a proactive, geographically diversified model is needed to ensure supply chain resilience.

The dangers of geographic concentration are now clear. Any supply chain that relies solely on a particular country, shipping route, or other potential bottleneck is vulnerable. Macro-level disruptions that expose supply chain vulnerabilities have dominated the headlines in recent years. Yet the impact of supply chain disruptions is felt most acutely at the micro-level. It is the patients waiting for potentially life-changing therapies who pay the highest cost when a shock event disrupts the supply chain.

Facing global instability, the industry has debated the merits of reshoring production to reverse decades of globalization and make their supply chains less vulnerable. Reshoring has its own problems, though.

A company that reshored all medicine manufacturing would face higher costs and potentially struggle to scale output, harming its ability to meet patients’ need for its products. Counterintuitively, the company may also make the supply chain less resilient. Creating a supply chain that relies exclusively on domestic plants would leave a manufacturer without alternative sources if local production was disrupted. Equally, supply chains with foreign single-source dependencies are now too vulnerable to be viable.

The limitations of dependence on a single country, whether domestic or foreign, show the path forward.

Building a Diversified Supply Chain

The lesson from the upheavals of recent years is not that supply chains that cross borders are inherently vulnerable. Any supply chain that lacks a fail-safe mechanism is inherently vulnerable. Viewed through that lens, it is clear that smarter global diversification is needed to create agile, efficient, and resilient supply chains that reliably deliver the medicines that patients need.

The ideal global supply network would combine the cost-efficiency and scale provided by some emerging markets with the proximity to patients and regulatory alignment associated with operations in the West. A supply network that stretches across India, the U.S., the U.K., and Canada is one highly effective way to achieve that ideal combination.

Spreading facilities across three continents can ensure that medicines continue reaching patients amid regional lockdowns, bottlenecked sea routes, and other disruptions to the supply chain. The East-West axis achieves those resiliency benefits without compromising on efficiency. With sites based in India, a country known as the “pharmacy of the world,” the network supports cost-efficient production at scale.

Integrating Indian facilities with sites in the U.S., the U.K., and Canada gives the network access to the capabilities and large patient populations of the key North American and European markets while providing the fail-safe mechanism that is essential to resilient supply chains. If a geopolitical or environmental event impacts one region, sites in other parts of the world can compensate to ensure the continuity of supply.

Digitizing the Network

The effectiveness of geographically diversified supply chains relies on the tight integration of facilities in different continents. Digitization is collapsing the distance between facilities by tying every node in the network, from raw material sourcing to delivery of the finished product, into a continuous digital loop. In doing so, companies are going beyond static planning and creating more dynamic, responsive systems.

Data is the fuel that powers digital systems. By collating real-time data, manufacturers can optimize the use of their facility networks and turn forecasts into efficient production plans. The data-driven systems continuously provide feedback at each node for continuous learning and improvement.

The best digital production systems extend beyond a manufacturer’s walls to encompass their suppliers and clients. Bringing best-in-class suppliers into the network ensures transparency, giving facilities timely access to critical information regardless of whether it emerges from an internal or external site.

Similarly, connecting with clients ensures that details of potential issues or delays are communicated as soon as possible. Timely, transparent communication is a key component of delivering a high quality and compliant service. Digitization is a key enabler of such communication.

The new, more turbulent world that has emerged in recent years has magnified the value of establishing digital systems that rapidly capture and respond to changes in the operating environment. When a shock event disrupts the supply chain, all the affected facilities need to know as soon as possible to guarantee a fast, effective response. Digital systems make that possible.

Accelerating ADC Programs

Antibody-drug conjugates (ADCs) are a perfect stress test for the geographically diversified supply chains that support resilience. Developing and making ADCs requires the tight integration of a range of distinct, specialized capabilities. Companies need deep expertise in manufacturing the targeting moiety and the cytotoxic payload, plus the ability to tightly link the two components together, to create effective ADCs.

With production requiring capabilities across key starting materials, mAbs, high-potency APIs, payload-linkers, finished dosage forms, and more, no single team can handle all the highly specialized tasks involved in ADC manufacturing. The need for multiple teams with distinct expertise to collaborate on ADCs makes the seamless orchestration of each element of the process vital to efficient production.

Each interaction and handoff between teams is a potential cause of delays and other setbacks. Working with a different vendor for each element amplifies that risk by bringing teams with different cultures and priorities together, and burdens the company outsourcing the work with responsibility for overseeing the interactions.

Companies can minimize those risks and burdens by working with service providers that have integrated, comprehensive ADC capabilities. Because each exchange involves internal teams, integrated ADC service providers can more consistently achieve smooth handoffs and unite each group behind the shared goal of accelerating the program.

Having a shared work culture and objectives will be particularly important as companies diversify supply chains. Integrated offerings allow companies to work with geographically distributed sites to mitigate the risk of regional disruptions without exposing themselves to the challenge of mobilizing those resources in support of their programs.

Conclusion

The East-West axis provided by a supply network that spans India, North America and the U.K. offers a strategic alternative to reliance on any single region, providing a diversified risk profile that is essential for modern security. Diversification delivers resilience alongside agility and efficiency. Companies can adapt quickly to whatever events occur, from volcanic eruptions to the recognition of emerging opportunities.

Yet while the East-West axis provides a solid foundation, leading companies recognize the need to keep innovating and refining their model. The long-term winners will be the businesses that harmonize agile, integrated networks with digital tools that support transparency and sustainability. Through such tools, companies are tracking and enforcing their supply and sustainability goals internally and at vendors.

The shifts in technology and strategy support an objective that has remained constant: reliably delivering high-quality, life-changing medicines to patients. Whether navigating a trade war, accelerating an ADC program, or digitizing a vendor audit, improving the lives of patients is the ultimate goal of every action taken to strengthen the supply chain.

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Stéphane Varray
Chief Commercial Officer, PolyPeptide

Transforming Peptide Production: Modularity, Digitalization, and the Road Ahead

As the industry moves toward 2030, those who invest in flexible, digital, and resilient manufacturing approaches have the opportunity to help shape the standard for excellence in a rapidly changing world.

Rethinking Construction: From Linear to Parallel

Traditional stick-built construction proceeds step by step—design, procurement, then site construction—each phase dependent on the last. Redesigns are common, timelines stretch, and years can pass before a facility is ready for qualification.

Modular manufacturing aims to change this paradigm. By enabling off-site module fabrication, procurement, equipment installation, and structural buildout could happen in parallel. In theory, completed units would arrive ready for rapid assembly, potentially compressing schedules by 20 to 50 percent. While these gains are compelling, the industry is still gathering real-world data to validate the full impact of this approach.

Quality and Speed: Aspirations for Improvement

In modular settings, the goal is for units to be standardized, equipped, and tested before reaching the operational site. This could minimize on-site labor, reduce disruptions, and increase the likelihood of smooth installation and commissioning. Prefabrication in controlled environments is expected to support consistent quality, while on-site assembly may become more streamlined. The aspiration is for faster startups and smoother transitions from installation to qualification, though broad-based evidence is still developing.

Building Resilience

Speed is just one aspect. Modular manufacturing is also seen as a way to enhance resilience in pharmaceutical and peptide production. Facilities built with modular methods could benefit from harmonized engineering, automation, and process-control systems. Standardized modules may reduce variability and improve predictability. Integrated control systems could help smooth out bottlenecks and stabilize production. The hope is that maintenance can be sequenced—allowing individual modules to be serviced without shutting down the entire facility. As demand fluctuates, uninterrupted production is a key aspiration for the future.

Risk Mitigation and Adaptability

Standardized units have the potential to simplify facility design, reducing engineering complexity and the risk of delays. Flexible layouts might allow for expansion, reconfiguration, or replication as program needs evolve. In therapeutic areas where demand can surge—such as metabolic, oncology, or rare diseases—modular adaptability could help manufacturing capacity keep pace with the market.

Redundancy is a design goal: distributed modular units may help isolate operational risks, preventing maintenance issues or equipment failures from cascading across the supply chain. In a world shaped by geopolitical uncertainty and regulatory divergence, this distributed resilience is an important aspiration. Global manufacturing networks could, in the future, spread capacity across regions, reducing exposure to localized disruptions and stabilizing supply.

Looking Toward 2030: Quality and Supply Chain Excellence

These structural changes align with broader shifts toward quality and supply-chain excellence anticipated by 2030. As value chains become more integrated, success will likely depend on the seamless flow of information—from market demand signals to development pipelines, CDMOs, and raw-material suppliers.

Key areas of focus include:

More accurate forecasting of peptide needs
Better coordination of inventory
Synchronized upstream and downstream activities

These are goals the industry is working toward. While fragment suppliers and lower-cost sourcing remain important, over-reliance on any single region or supplier creates new vulnerabilities. Diversification will be essential to buffer against tariff changes, export restrictions, and political tensions. Supply networks that balance cost, reliability, and flexibility are expected to outperform those focused on cost alone.

Collaboration and Digital Tools: The Next Frontier

Collaboration models are evolving. Partnerships that expand access to reliable raw materials, reduce bottlenecks, or distribute manufacturing load are becoming central to supply-chain strategy—especially as peptide demand accelerates into new therapeutic areas. CDMOs and pharmaceutical companies are increasingly exploring cooperative manufacturing ecosystems.

At the same time, AI is beginning to play a larger role in manufacturing and supply-chain operations. Organizations that deploy AI for forecasting, process optimization, deviation detection, and end-to-end visibility may gain a structural advantage. Predictive analytics could help identify risks earlier, optimize batch performance, and coordinate material flows with a precision manual systems can’t match.

Digital Transformation in Development

Digital tools are already influencing how development teams design and refine peptide manufacturing processes. Predictive platforms built on large internal datasets provide immediate insights into parameters like charge versus pH, mass spectra, hydrophobicity, conformation tendencies, solubility, and impurity profiles. These early assessments can reduce trial and error, allowing chemists to anticipate challenges before synthesis begins.

By organizing decades of experimental data into standardized formats, teams can compare new sequences with historical patterns and spot likely synthesis or purification pitfalls.
Simulation capabilities model peptide chemistry, offering a virtual environment to optimize conditions and evaluate design options before committing resources. Together, these tools are shifting development from empirical adjustment to more informed, model-supported decision making.

Compliance and Cybersecurity: Setting New Standards

Digital transformation extends to compliance. Virtual and hybrid audits, which grew during the Covid period, have set new expectations for transparency and readiness—even as most audits return to on-site formats. An audit-ready CDMO or manufacturer in 2026 is expected to maintain continuous compliance, not just prepare reactively. Updated documentation, alignment with regulatory expectations, and disciplined operational control are now essential. Teams must be able to retrieve documentation quickly and communicate openly and factually with auditors—demonstrating confidence in operational integrity.

Cybersecurity is following a similar path. As digital tools and interconnected systems become foundational, cybersecurity shifts from an IT concern to an operational requirement. Frameworks like ISO 27001:2022 provide a global standard for managing cyber risks. Adopting such frameworks reinforces trust among partners and regulators, ensuring that sensitive data and operational controls are governed, monitored, and continuously improved. In a manufacturing environment increasingly dependent on digital infrastructure, cybersecurity is essential for operational continuity and intellectual property protection.

The Road Ahead

Taken together, these developments point toward a vision of advanced manufacturing—built on speed, resilience, digital intelligence, and disciplined governance. While the full impact of modular manufacturing is still being realized, organizations that explore modular infrastructure, predictive tools, diversified sourcing, and strong compliance practices may be better positioned to adapt to emerging needs.

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Nicolò Rubino¹, Chiara Rigotti²
1. Chief Information Officer, Procos
2. Purchasing & Sourcing Manager, Procos

How are CDMOs and pharma manufacturers maintaining supply continuity in the context of rising cost pressure, geopolitical instability, and material shortages?

In today’s environment, supply continuity demands a versatile approach. CDMOs and pharmaceutical manufacturers are achieving this by proactively diversifying their supplier base, investing in flexible manufacturing processes and digital-monitoring tools, and strengthening upstream risk management. For example, digital transformation – including advanced traceability and information systems – has been shown to positively impact sustainable supply-chain performance in the pharmaceutical industry.

One of key tools is a comprehensive Business Continuity Plan (BCP), which is essential not only for regulatory compliance but for ensuring uninterrupted support to patients and partners. In the API field, business continuity has a direct impact on patient safety, operational reliability, and regulatory alignment. Any interruption in API production can trigger drug shortages, affecting public health and healthcare systems. For this reason, our BCP includes diversified supply chains, proactive risk-monitoring strategies, and emergency-preparedness protocols that allow us to adapt swiftly to evolving scenarios.
We also believe that continuity is rooted in strong and balanced partnerships. The traditional supplier–customer hierarchy is giving way to a more collaborative model, where shared accountability and open communication are fundamental. By cultivating long-term, trust-based relationships with our raw-material suppliers — much like the “customer of choice” mindset, but in reverse — we ensure mutual reliability and create an ecosystem capable of responding more effectively to complex challenges.

Reshoring and regionalization are gaining traction — do you see them as practical solutions or are smarter global diversification and digital transparency more realistic?

While reshoring and regionalization hold tangible benefits—such as shortening lead-times, reducing exposure to distant geopolitical risks and improving regulatory alignment, they are not panaceas. The more practical, scalable strategy is a hybrid model: a globally diversified footprint, augmented by digital transparency that enables oversight and agility across geographies. Industry reports highlight that successful supply chains rely on both geographic diversification and enhanced visibility through digital platforms. In this model, regional hubs (closer to demand markets) coexist with strategically located global sites. The differentiator becomes the ability to monitor, shift and optimize flows in real time—through data, traceability and transparency—rather than purely relying on proximity. In this way, companies like PROCOS can support global supply while offering regional responsiveness.

Cybersecurity has become a compliance and trust issue. How important are frameworks like CyberVadis or ISO 27001 certification for maintaining client confidence and regulatory alignment?

Cybersecurity is now integral to manufacturing, quality and supply-chain excellence in the pharmaceutical sector. Frameworks such as ISO 27001 and third-party trust assessments (e.g., CyberVadis) serve as formal evidence of robust information-security management, data integrity, and governance. These are increasing prerequisites for client confidence, regulatory scrutiny (especially when CMC, process data and intellectual property are involved) and partnership eligibility. Recent research also points toward the adoption of “zero trust” architectures in pharma supply chains to enhance resilience.

Therefore, for a CDMO or pharma manufacturer, obtaining and maintaining such certifications should be viewed not as cost burden but as strategic enabler: they underpin trust, reduce risk of reputational damage or regulatory non-compliance, and enhance partner attractiveness. In the case of PROCOS, the CyberVadis Bronze rating, for instance, reflects a structured commitment to evaluating and improving cyber risk management practices across several dimensions — from governance and access control to third-party monitoring. These certifications are not merely badges of compliance; they represent a company’s ability to protect sensitive scientific and operational information in line with evolving regulatory and client expectations. In an era of interconnected supply chains, cybersecurity maturity has become an indispensable component of quality assurance.

What defines a “strategic partner” today when quality, data access, and ESG transparency are intertwined?

A strategic partner today is more than a vendor: they are a collaborator who aligns on mission, offers visibility, shares data, upholds rigorous quality and integrates ESG commitments into their operations. From recent industry analyses: pharma companies are moving away from transactional, fee-for-service CDMO relationships toward long-term partnerships built on transparency, shared goals and risk-sharing.
In practical terms, this means a partner who:

upholds high standards of manufacturing and quality assurance (GMP, regulatory compliance);
provides meaningful data access (real-time KPIs, process transparency, supply-chain status);
demonstrates credible ESG performance (energy use, waste, sustainability, ethical sourcing);
is willing to integrate with clients’ supply-chain architecture rather than operate in isolation.

For PROCOS being a “strategic partner” means far more than delivering on-time and on-spec. It implies co-creation, transparent data sharing, and alignment on sustainability goals. Clients now seek CDMOs that integrate ESG accountability with scientific excellence — partners capable of managing complexity while remaining adaptable to evolving compliance frameworks. True strategic relationships are built on mutual visibility and shared values, where quality, digital trust, and environmental responsibility converge to drive innovation and long-term performance.

What will “quality and supply-chain excellence” look like by 2030 — and what capabilities will differentiate the leaders?

By 2030, quality and supply-chain excellence in the pharmaceutical/CDMO world will be characterized by end-to-end digital visibility, agile manufacturing models, resilient supply networks, proactive risk anticipation and embedded sustainability. Key capabilities that will differentiate the leaders include:

Traceability and digital continuity: full visibility of raw-material sources, manufacturing status, logistics, distribution – enabled by digital technologies such as IoT, blockchain, advanced analytics.

Flexible manufacturing platforms: ability to switch volumes, modalities (small molecules, biologics, advanced therapies), geography rapidly in response to market/regulatory shifts. As reports suggest, CDMOs will expand footprints, diversify capabilities and respond to new modalities.

Digital and cybersecurity maturity: robust data infrastructure, cyber-resilient operations, integration of “zero trust” principles, ensuring quality data, integrity and secure supply-chain flows.

Embedded ESG and sustainable operations: supply chains that minimize environmental footprint, manage Scope 3 emissions, ethical sourcing and transparent sustainability metrics will become baseline expectations.

Partnership ecosystems & data-driven collaboration: seamless integration of CDMO/pharma partnerships, real-time shared dashboards, collaborative risk-sharing models and insight-driven operations. The best will treat outsourced manufacturing as an extension of the client, rather than a service contract.

In this environment, leaders will be those who invest continuously in digital platforms and infrastructure, maintain transparency, diversify intelligently, and embed resilience and sustainability across the chain.

References and notes

MDPI – “The Effect of Digital Transformation on the Pharmaceutical Sustainable Supply Chain Performance” (Sustainability, 2023)
CPHI – Trend Report: “Outsourcing Trends and Strategies” (2024)
arXiv – “Zero Trust Architecture for the Pharmaceutical Supply Chain” (2025 preprint)
Pharmaceutical Manufacturer – “Pharma Outsourcing Trends 2025: Partnership, Precision and Resilience” (2024)
Alvarez & Marsal – “CDMO Predictions for 2030” (2023)
PCI Pharma Services – “The Role of CDMOs in Creating a More Sustainable Pharmaceutical Supply Chain” (2024)

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Joerg Ahlgrimm
CEO, SK pharmteco

Resilience by Design: The Next Evolution in Reliable ADC Manufacturing

Sustainable and Resilient Manufacturing

As we improve reliability, we must also do so sustainably and safely. High-potency manufacturing, like that for ADC payloads, has historically relied on harsh solvents and generated hazardous waste that must be carefully managed. The next step involves adopting greener and more efficient processes. For example, using solvent systems that cut down on volatile emissions or implementing closed-loop containment and waste treatment can significantly reduce the environmental impact of ADC production. Some ADC facilities are now installing solvent recycling systems and high-efficiency ventilation that captures and neutralizes toxins, instead of venting or disposing of them. These investments not only help protect the environment but also often enhance safety for workers and communities, which is essential for long-term operational reliability.
Energy efficiency remains a key focus. Containment suites and cleanrooms can consume a lot of energy due to constant air exchanges and specialized HVAC systems for potent compounds. As stewards of advanced therapeutic manufacturing, we have a duty to ensure our progress does not compromise environmental or worker safety. The future of modalities like ADCs, dual-payload conjugates, and others will rely not only on our ability to meet increasing demand but also on doing so in a way that protects the planet and upholds our safety ethics.
Another aspect of resilience is diversifying supply chains for raw materials. Recent global events have shown us that relying on one region for critical inputs is a vulnerabilities. Many ADC linker-payloads, for example, have been mainly sourced from a few specialized suppliers in Asia. Geopolitical tensions or export restrictions could threaten that supply. To ensure reliability throughout the value chain, the industry must also reconsider where and how critical components are produced. Overreliance on single-region suppliers has created vulnerabilities that became apparent during recent global disruptions.

At SK pharmteco, we address this not by seeking secondary sourcing but by being the diversified source. Our high-potency payload and linker manufacturing network spans North America, Europe, and Asia, providing customers with the geographic redundancy needed to protect against regional instability. This multi-continent infrastructure enables us to maintain business continuity even under stress, whether from logistical challenges, geopolitical shifts, or surges in global demand.
Resilience is integrated into our operating model, not added as an afterthought. That is the core of reliability in today’s global manufacturing environment.

Redefining Operational Excellence as Resilience

“Operational excellence” is a term often misunderstood to mean leaner, faster, cheaper. While efficiency is important, in the context of life-saving therapeutics excellence means resilience. A truly excellent operation is one that can perform under pressure, without deviations in quality or delivery, even when faced with challenges. Whether it’s an equipment failure, a quarantined shipment, or a surge of rush orders, the system should be robust enough to adapt and continue meeting patient needs. We must build this resilience not only within single sites, but across entire networks of sites and partners. This is why we emphasize common culture and communication in partnerships: a problem in one node should immediately concern all, and resources can be reallocated to prevent any impact on patients.

Resilience also means having zero tolerance for preventable risks. When we say we are designing systems so strong that nothing slips through the cracks, we imagine a future where: no therapy is delayed because two suppliers couldn’t align specifications; no batch is lost due to preventable contamination; and no patient is left waiting because a regulatory filing lacks consistency across the value chain. These are basic expectations we must meet. For example, aligning specifications may seem simple, but in reality, when one company makes the antibody and another makes the linker, even a slight difference in conjugation buffer specs could delay a campaign by weeks. In an integrated model, such misalignments are prevented by design, with the same team setting the specifications for all parts. Likewise, many contamination issues can be avoided with strict, harmonized protocols: if a single quality system oversees the entire process, the chance of errors or mix-ups decreases. And a unified data package means that when it’s time to file with regulators worldwide, the documentation is clear and complete, reducing questions that could delay approvals.

To put it simply, the strength of our industry depends on avoiding unnecessary errors and delays. Every weak link we can remove has the potential to save or extend a life. Strength, in this context, is not about muscle power, but about the integrity of the entire chain under pressure.

A New Era of Biopharma Reliability

If we collectively succeed in building an industry where each part of the supply chain functions as a unified, trusted, transparent, and technically flawless system, we will usher in a new era of reliability. In this era, complexity will no longer hinder progress. We will be able to deliver highly sophisticated therapies—such as ADCs with two different payloads, radioimmunoconjugates, or conjugates linked to RNA-based drugs—to patients without the long delays or setbacks that once slowed down new treatments. The foundation we establish now in integrating and strengthening ADC supply chains will yield benefits when the next wave of therapies appears. These emerging modalities, whether dual-payload ADCs, targeted radioconjugates, or other hybrid biologic–small molecule constructs, will likely present new challenges. Yet, the fundamental strategy will stay the same: making the supply chain as robust and seamless as the science is advanced.

Looking Forward

As the next generation of therapies develops, dual-payload ADCs, radioconjugates, and new biologic–small molecule hybrids will make manufacturing more complex. However, complexity should not lead to fragility. If we focus on resilience now, we can deliver even the most advanced therapies to patients confidently and quickly.

This is the future I believe in: a biopharma industry where reliability is not just an aspiration but a standard. Where harmonized systems, sustainable practices, and strong partnerships ensure the supply chain is as dependable as the science it supports.

For patients, reliability means trust; trust that innovation will arrive safely and on schedule. For those of us leading in this field, it is our duty to ensure that trust is never compromised. That is the standard I uphold for myself, my teams, and our industry every day.

–

Chris Neasham
Vice President of Global Procurement, Sterling Pharma Solutions

How are CDMOs and pharma manufacturers maintaining supply continuity in a context of rising cost pressure, geopolitical instability, and material shortages?

In today’s competitive pharmaceutical landscape, CDMOs must ensure that their supply chain strategies are tightly aligned with the needs of their clients, and fundamentally support the timely delivery of customers’ molecules. This alignment demands meticulous inventory management, and a proactive approach to vendor evaluation, to go as far as possible to guaranteeing consistent quality and reliability across a plethora of raw material requirements. To achieve this, CDMOs need to invest appropriately in their internal supply chain processes and their external vendor networks, as well as understand the dynamics of the uncontrollable and often changeable supply markets.

Clearly, there is much more to the role of supply chain management than that. In these times of rising raw material and energy costs, procurement teams need to manage material delivery programs alongside their supply chain partners, to ensure the most effective strategies are in place to offer both time and cost efficiency to their own manufacturing plants, whilst having awareness of all the other complexities of the program.

This approach should be multifaceted, delivering on both tactical and strategic procurement processes. Ensuring that raw materials are purchased at the most efficient scale locally, considering the site’s total chemical demand, involves examining production plans and schedules for future campaigns of the same product, in conjunction with other projects’ manufacturing needs. This allows the procurement team to consolidate large volume products for best value and ensure security of supply. By having good relationships with selected vendors, CDMOs can manage volume deliveries against internal schedule fluctuations as needed.

Globally, a more strategic process should be employed to govern and ensure consistent vendor networks are being adopted, deployed and qualified for use across the CDMO’s manufacturing network. Having aligned supply bases for critical materials with appropriately selected vendors, which are managed routinely, aids risk management and naturally inspires best value for top quality material supplies.

Best–in-class CDMO procurement teams can add value by supporting the initial customer RFP review, assessing if there are potential reductions in a molecule’s cost of goods (COGs) composition by challenging the intended starting point of the synthesis within the CDMO. Real value can be added by selecting a starting point later in the synthesis by sourcing a more advanced intermediate. This requires an understanding of the technical ability of suppliers, and selecting a vendor that would be able to deliver the later intermediate at necessary quality for the downstream process. Alternatively, backwardly integrating steps of the chemical synthesis to manufacture these in-house, can also potentially de-risk a program, and add commercial value to the project. With costs rising in traditional lower-cost countries such as India and China, the benefits of doing this, despite adding more internal process steps, can be economically beneficial. The strategic review of these opportunities should always be performed and discussed transparently with the customer prior to evaluation, to guarantee alignment with the enhanced raw material delivery strategy.

For CDMOs, deep partnerships with their customers are crucial as they allow for supply chain opportunities to be maximised, and these relationships permit greater engagement between the customers and the CDMO’s supply chain functions. An environment where existing or alternative material strategies are reviewed and deployed together, with mutual benefit, can create significant value that both the CDMO and sponsor can realise over time. Having a shared forward-looking view from customers on their demand, and a collaborative partnership that provides a forum for discussion, allows the CDMO’s procurement functions to plan ahead of time, work together to challenge current supply chains, and add cost value or negate the risk of supply shortages that can ultimately impact program timelines.

Reshoring and regionalisation are gaining traction — do you see them as practical solutions, or are smarter global diversification and digital transparency more realistic?

There is an ongoing trend of reshoring programs towards Western manufacturing companies, and the increased cost that this has for the customer has put greater pressure on procurement teams to find ways to lower the cost of goods, whilst maintaining compliance and meeting the program timelines. This trend is by no means new in the industry, however, the actual mobilisation of activities has significantly intensified in the last 12-24 months, as customers are now fulfilling these strategies by committing to, and moving forward with new work packages, in comparison to previous practices when many supply strategies had been executed as a paper-based, due diligence exercise only.

Global CDMOs can create significant value for customers by strategically leveraging their international network of facilities. This approach provides flexibility in manufacturing locations, and helps mitigate the impact of fluctuating tariffs on raw materials, intermediates, and finished APIs. By distributing synthesis steps across multiple regions, CDMOs can source raw materials where import duties are lower, perform initial chemical transformations at one site, and then transfer intermediates within their network for final API production. When executed effectively, this strategy not only reduces tariff exposure but also optimises capacity utilisation, strengthens supply chain resilience, and supports cost efficiency, which are all critical factors in today’s dynamic API market, shaped by geopolitical uncertainty and regulatory complexity.

Customers using CDMOs with multiple geographical facilities can also benefit from having a single company being able to offer both primary and secondary manufacturing options, validated in the same quality and process umbrella. This mitigates against the risk of having to use multiple suppliers, and works extremely well in practice when the region of supply appropriately aligns with the final drug’s distribution market.

In the race to accelerate CMC and scale-up, how do you maintain rigorous quality standards while reducing development timelines?

Multiple facilities with integrated systems, procedures and quality policies allow CDMOs to evolve traditional business models to suit customers’ needs. Development work can be carried out by multiple teams – potentially in different global locations – to accelerate the speed to manufacturing, and having flexible resources gives customers with multiple projects the flexibility and options to change priorities as necessary, and allocate resources accordingly. Some CDMOs now offer evolutionary reshoring FTE models, which do not confine resources to a single local site, and allow customers to leverage the experience and capabilities of an entire network.

For this to be successful, the CDMO must be truly integrated across its sites, but also have a culture within its workforce of both collaboration and flexibility. Such models rely upon a deep partnership between customer and CDMO and a combined philosophy of success. For the commitment of flexibility from a CDMO, trust and transparency must be offered by the customer, and when implemented correctly, can bring about the acceleration of projects towards developmental and manufacturing milestones.

Speed is of the essence in drug development, and customers are valuing more than just the cost of a project, which is in stark contrast to the early 2000s when much of the outsourced manufacturing went to India and China based on price alone. However, for CDMOs, this pressure means that it must be in a position to have assets, both in terms of workforce and reactor capacity, that are flexible and available at the right time for the customer. This balance is easier to achieve with various facilities with multifunctional capabilities, and alongside the advantages in terms of geography, tariff mitigation and the combined expertise of a global network, can offer customers the solutions that meet their time demands.

What will “quality and supply-chain excellence” look like by 2030 — and what capabilities will differentiate the leaders?

Whether from an innovator, or CDMO perspective, the key to future procurement and supply chain excellence is to be able to maximise the efficiency of both the systems and the workforce within an organisation. This can be achieved by automating many of the fundamental mundane tasks within the discipline, freeing up capacity to allow employees to utilise their expertise and add value to the operations in a strategic way. There are a number of systems such as SAP, that when optimised, can be used to integrate and coordinate fundamental supply and demand communications between companies without any human intervention. Using sophisticated enterprise resource planning (ERP) systems and AI has been a real enabler in freeing up resources to work on processes that can add value to a business.

Another key driver within refining and optimising supply chains is a focus on improving the ESG credentials of an organisation. Sustainability practices are a key metric that CDMOs are measured on by their customers, and there is an impetus to continue this down the supply chain, so there needs to be robust internal governance by CDMOs to manage and validate their suppliers. Whilst there are some standard certifications within the industry, such as EcoVadis, it will be the responsibility of the CDMOs to support key partners, enabling them to achieve these standards, so that the whole industry can move towards excellence.

CDMOs supplying into the pharmaceutical industry will need to continue to adopt these practices and processes. What will differentiate the leading organisations is having a flexible, adaptable and skilled network of global facilities to provide customers with various geographical and technical capabilities to match needs. The supply chain and procurement department will be a key ally in this process and when resourced correctly will be seen as a value-adding function that is fully integrated with the wider internal organisation and the customer’s supply chain.

–

Dr. Max Lauwiner
CEO, Valsynthese

As global pharmaceutical supply chains face cost inflation, geopolitical instability, and new frameworks such as the EU’s Critical Medicines Act, the industry is redefining what resilience means. Today, we speak with Dr. Max Lauwiner about how quality, supply chain security, and agility can coexist-not as trade-offs, but as mutually reinforcing pillars of a modern pharma ecosystem.

Quality has always been central in pharma. How is the definition of quality evolving today?

Quality remains our industry’s non-negotiable foundation, but its scope has expanded significantly. It is no longer enough to deliver a compliant product at the end of the process. Today, quality is evaluated across the entire value chain-raw-material traceability, supplier robustness, process reproducibility, digital documentation, and even sustainability expectations.

We now speak of “systemic quality”. If an API cannot be delivered reliably because a key starting material depends on a politically unstable region or because logistics networks lack resilience, then quality is compromised-no matter what the analytical results show.
At Valsynthese, we see quality emerging from three interconnected elements:

Process understanding and control, enabled by scientific development and digital tools.
People and culture, where every decision reflects responsibility toward patients.
Transparency across the supply chain, extending to suppliers, logistics partners, and customers.

This holistic view is essential as molecules grow more complex and regulatory expectations tighten.

Supply chain disruptions have become more visible since COVID-19. How should the industry rethink supply chain security?

For decades, global pharmaceutical supply chains prioritized cost and efficiency. The pandemic merely exposed vulnerabilities that had been accumulating for years. We now face geopolitical tensions, energy volatility, and heavy concentration of essential raw materials in a handful of regions. The key question has changed from “Can we afford resilient supply chains?” to “Can we afford not to have them?”.
The EU’s Critical Medicines Act highlights this shift toward strategic resilience. For CDMOs and fine chemical manufacturers, this means:

Expanding regional production capacity for critical intermediates and APIs.
Ensuring vertical traceability-including second-tier suppliers and their risk profiles.
Building redundancy into key steps and materials.
Strengthening energy resilience, especially for energy-intensive chemical processes.

At Valsynthese, being located in Switzerland gives us advantages in regulatory stability and energy reliability. But geography is only part of the puzzle. True security requires:

Strategic partnerships rather than transactional relationships
Early joint risk assessments with customers
Technology and knowledge sharing across supply networks

Security is not static-it is a dynamic ecosystem built on transparency, trust, and long-term collaboration.

Pharmaceutical pipelines are becoming more complex. Why is agility now such a critical differentiator?

Agility has moved from a “nice to have” to a competitive necessity. Companies expect their CDMOs to scale processes from grams to multi-ton volumes, navigate rapid demand fluctuations, and integrate new regulatory constraints and even mid-development. Agility directly influences time-to-market-and therefore patient access.

Infrastructure plays a key role. At Valsynthese, our “Vista” investment program-which includes new hydrogenation capabilities, debottlenecking measures, and modernization of multipurpose assets-was designed specifically to increase operational flexibility.

But agility is not simply about equipment. It is fundamentally a mindset, requiring:

Fast and empowered decision-making
An entrepreneurial culture
Highly skilled technical teams
Transparent risk-benefit discussions with partners

Agility must flow through the entire organization-from operators to senior management. In an environment where molecules evolve, regulations evolve, and customer priorities evolve, static systems are no longer viable.

Some believe that prioritizing agility, quality, and supply chain security simultaneously creates conflicts. Do you see these elements as competing or complementary?

They are absolutely complementary when approached intelligently. In fact, their interdependence strengthens the resilience of the whole system.

Quality reinforces security:
Deep process understanding reduces variability. Strong compliance builds trust with authorities and customers, which in turn stabilizes supply relationships.

Security reinforces quality:
Stable raw materials, reliable energy supply, and robust production networks prevent deviations and emergency interventions-two major sources of quality risk.

Agility reinforces both:
Agile organizations respond faster to deviations, market shifts, and regulatory changes. They prevent issues from escalating into disruptions and ensure continuous medication availability.

So rather than seeing these pillars as trade-offs, we need to treat them as a strategic triangle-each vertex strengthening the others.

What steps must the broader industry take to strengthen its resilience in the coming years?

The challenges we face-geopolitical shifts, climate-related disruptions, regulatory evolution-require systemic, not incremental, solutions. Several industry-wide actions are essential.

Regional diversification
We must reduce reliance on highly concentrated global sources for essential intermediates and key starting materials.
Investment in sustainable, energy-efficient production
Not only for environmental reasons, but to reduce vulnerability to volatile global energy markets.
Long-term partnerships instead of transactional procurement
Shared development models and transparent risk discussions lead to better and more resilient outcomes.
Regulatory harmonization
Diverging national frameworks slow development and increase compliance complexity. Streamlining them would strengthen global resilience.
Workforce development
We need chemists, engineers, and operators equipped for advanced processes, digitalization, and high-throughput technologies.
Adoption of digital tools
Predictive quality systems, demand forecasting, and supply-risk management tools can detect issues early and prevent disruptions.

Resilience should no longer be treated as a cost center-it is a strategic advantage.

How does the EU’s Critical Medicines Act influence future strategies for CDMOs and fine chemical producers?

The Act is a strong signal that access to essential medicines is becoming a matter of strategic autonomy. It pushes companies-and governments-to rethink supply chain structures and bring critical capabilities closer to home.
For CDMOs, this means:

Increased expectations for regional manufacturing capacity
Stricter requirements for supply transparency and documentation
Greater emphasis on dual sourcing and redundancy
More collaborative frameworks involving regulators, industry, and customers

Ultimately, it aligns with what many of us have been advocating for years: a shift from cost-optimized global supply chains to resilient, strategically diversified ecosystems.

Looking ahead, what does the future belong to? Which companies will thrive in this new environment?

The future belongs to companies that excel simultaneously in quality, security, and agility. These are no longer optional capabilities-they are the foundation of the industry’s license to operate.

At Valsynthese, our strategy and investments are guided by this conviction. We see our role not just as a supplier, but as a partner in ensuring medicine availability, patient safety, and technological progress. The companies that thrive will be those that understand resilience as a shared responsibility and act on it through innovation, collaboration, and long-term thinking.

Closing Statement

We are entering a new era for the pharmaceutical supply chain-one defined by rapid change, higher expectations, and greater strategic scrutiny. But these pressures also create opportunities. By aligning quality, supply chain security, and agility, we can build a stronger and more sustainable pharmaceutical ecosystem. For the sake of patients and society, coexistence of these pillars is not only possible-it is essential.

Panel discussion on Quality, Supply Chain Security & Agility in Pharma

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Panel discussion on Quality, Supply Chain Security & Agility in Pharma

COMMENTARY ARTICLE

Operations decide why quality, supply, and speed break together

The illusion of separation

Where friction accumulates in the value chain

The false trade-off between Speed, Quality, Costs

Technology alone is not the solution

Transformation fails without operational translation

People are the integrating force

Operations decide the outcome

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