Issue: Vol. 43

Preparing for an AI future that’s already here

Few foresaw the impact OpenAI’s ChatGPT would have just 2.5 years ago. Yet GenAI has already begun disrupting entire industries and new technology breakthroughs are emerging at pace. As new iterations push the boundaries of deep research and insight generation, the implications for life sciences are both profound and uncertain. ArisGlobal’s Jason Bryant considers how the biopharma industry can best prepare for an undefined future that is already unfolding.

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Artificial Intelligence for Life Science and Materials Science Innovations

Artificial Intelligence (AI) and Machine Learning (ML) are transforming various scientific disciplines by enabling novel insights and accelerating research and development processes. This review focuses on the application of AI/ML in life sciences (biotechnology, pharmaceuticals), and materials science. Each section explores the current status, potential challenges, and future prospects of AI/ML in these domains.

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YMC – The Future of Gene Therapy Manufacturing: Focus on Innovative Purification Solutions

In the world of biotechnology and pharmaceutical industry, the effective and reliable purification of complex biomolecules used for gene therapy is of crucial importance. In particular, the isolation of adeno-associated viruses (AAVs), virus-like particles (VLPs), and also plasmid DNA (pDNA) places high demands on the chromatography technologies used. As the demand for gene therapies grows, so does the need for highly specialised solutions which provide the precise purification of native and intact molecules ensuring the safety and efficacy of such therapeutics.

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Investigating the synthesis of dodeca oligomers of Sarcosine using Fmoc-Sar-OH, Fmoc-(Sar)2-OH and Fmoc-(Sar)4-OH

In recent years, pharmaceutical research has increasingly utilized the conjugation of two molecules (typically an antibody or peptide and a small molecule) as a key strategy for drug development. This technique is based on the use of a linker to bind the two moieties. Although monomers of oligoethylene glycol (OEG) are most widely used in this context, there is interest in repeated amino acid oligomers. Monodisperse polysarcosine (PSar) emerges as an excellent option. Dodeca oligomer peptides of Sarcosine (Sar) were synthesized using Fmoc-Sar-OH, Fmoc-(Sar)2-OH, and Fmoc-(Sar)4-OH, respectively, as building blocks, applying DIC and OxymaPure as coupling reagents. The dodeca target peptide was obtained in all three cases; however, small impurities accompanying the main product peak precluded its direct use as linker for conjugation chemistry in drug discovery. Previous studies by our group indicated that ETT works well in combination with DIC for the coupling of steric-hindered amino acids. We therefore proceeded to prepare (Sar)12 using DIC/ETT as coupling reagents. We observed that the use of Fmoc-Sar-OH and Fmoc-(Sar)2-OH to grow the peptide chain led to a mixture containing the desired dodeca peptide along with an additional Sar attachment, i.e., one extra Sar residue in the case of Fmoc-Sar-OH and two extra ones for Fmoc-(Sar)2-OH, detectable only by MS. However, Fmoc-(Sar)4-OH yielded the desired peptide without any additional Sar attachments.

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Securing supply chain certainty: strategies for resilience and risk management

The current global climate is making it increasingly difficult for pharmaceutical companies to ensure the reliable supply of their products. Recent disruptions have underscored the critical need for robust strategies to de-risk supply chains and ensure the continuous delivery of essential therapies. In this article, Jim Donovan, Vice President of Pfizer CentreOne, provides his unique insights on supply chain security and explores the approaches drug manufacturers must employ to safeguard integrity and build resilience.

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Wuxi Tides – Accelerating Complex Oligonucleotide Therapies

The FDA approval of the first siRNA drug in 2018 marked a key milestone for RNAi therapeutics, confirming the potential of gene-silencing oligonucleotides (1). Small interfering RNAs (siRNAs) selectively silence disease-related genes, enabling targeted treatments for genetic and metabolic diseases.

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30 Years of Transforming the CDMO Industry – A Chemist’s Perspective

Being part of today’s Contract Development and Manufacturing Organization (CDMO) industry feels significantly different to two decades ago, when I began my professional career as a chemist. Back then, CDMOs were referred to as Contract Manufacturing Organizations (CMOs), and the concept of contract manufacturing as a business model was just starting to take shape…

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Supplier relationship management – The crucial role of strategic supplier partnerships in building a resilient supply chain

The aim of this article is to explore the principles of Supplier Relationship Management (SRM) and its crucial role in building strong supplier partnerships within the Biopharma industry. It highlights the importance of strategic supplier partnerships in creating a resilient supply chain and achieving operational excellence. The article discusses the need for a Governance Framework to manage supplier relationships effectively, emphasizing the significance of governance, transparency, and clear expectations. It also addresses the impact of effective supplier management on cost reduction, efficiency, and risk mitigation. The findings are based on a survey of nearly 200 Biopharma professionals, revealing that only a small percentage view their supplier relationships as highly effective. The article concludes by underscoring the benefits of collaborative engagement, continuous improvement, and aligned expectations in streamlining development and operational timelines to meet patient needs sooner.

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Without aligned improvements, R&D processes will never be optimal

Across core late-stage pharma R&D functions including Regulatory Affairs, Quality and Pharmacovigilance/Drug Safety, current process rigour and performance is linked primarily to SOPs. Yet these snapshot definitions of processes do not, of themselves, ensure efficiency. Indeed, the deliverables of those processes have too often become hazy and forgotten. MAIN5’s Tobias Hitziger reflects on the barriers preventing true end-to-end process transformation, and what is being lost as a result.

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