Archives: Articles

Enabling a sustainable and mutually beneficial CDMO partnership

The role of Contract Development Manufacturing Organizations (CDMOs) in the pharmaceutical and medical technology sectors is evolving, becoming essential for cost-effective and compliant solutions. Key considerations for selecting a CDMO include adherence to current Good Manufacturing Practice (cGMP) regulations and a clear understanding of project objectives. Companies need to conduct thorough research on CDMOs’ technical capabilities, quality management systems, and risk attitudes. Additionally, the focus needs to be on building a strong partnership based on transparency and communication, ensuring that the CDMO is integrated as an extension of the business to achieve shared goals in patient safety and quality.

Read More »

Portfolio Management for Generics: 40 Years of Evolution and Rising Complexity

The generic drug industry, now marking its 40th anniversary since the 1984 Hatch-Waxman Act, has expanded globally and is expected to reach $600 billion USD by 2030. However, the sector faces significant challenges, such as price erosion, global competition, and drug shortages, which threaten market sustainability. Additionally, emerging trends, including the rise of orphan drugs and the dominance of oncology, add complexity to portfolio decisions. In this evolving landscape, portfolio management plays a crucial role within the companies, requiring a strategic and holistic approach. To succeed, portfolio managers must balance strategic vision, technical expertise, and data-driven insights to optimize their companies’ portfolios. This article aims to guide portfolio managers in generic companies as they navigate the unique challenges of this industry.

Read More »

Launching Generic Pharmaceuticals with a Patient-Centric Approach

Launching generic pharmaceuticals is a complex process that requires balancing various factors such as patient needs, regulatory requirements, and market dynamics. The increasing demand for affordable medicines globally has positioned generic pharmaceuticals as essential in the healthcare ecosystem, especially in providing timely access to high-quality treatments at a fraction of the cost. In this article, we explore best practices for launching generic pharmaceuticals with patient-centricity at the core, using insights from experiences in the European and Australian markets.

Read More »

The five senses to the rescue of observance, utopia or next future?

Numerous innovations are retrieved on the era of drug forms where packaging can be seen as a real partner of the users. Materials and design evolved for offer the best usability, but the idea can be to going further with senses integration on product or on their packaging. An overview of some examples is proposed that integrate the taste, the touch, the vision, the Hearing or the Smell for a better uses/compliance for drug medication.

Read More »

System thinking: The untold story of sustainability in primary pharma packaging

In the discourse around sustainable packaging, the focus often narrows to recyclability and end-of-life considerations. While these aspects are crucial, they represent only a fraction of the complexities inherent in achieving truly sustainable packaging solutions, particularly in the pharmaceutical industry. This article explores the broader perspective necessary for sustainable innovation in pharma packaging, emphasizing the need for system thinking to navigate the multifaceted challenges and align with ambitious sustainability strategies.

Read More »

Liquid-Phase Peptide Synthesis (LPPS): A Sustainable Future for Peptide Therapeutics

Peptides, known for their specificity and therapeutic potential, have gained considerable interest in treating a variety of conditions, including cancer, metabolic diseases, and infections. Solid phase peptide synthesis has dominated peptide production due to its ease of use and automation. However, SPPS is inefficient, requiring excess reagents and huge volumes of solvent. Faced with the challenge of producing large volumes of peptide therapeutics, LPPS has emerged as an alternative manufacturing technology able to dramatically improve scalability and environmental sustainability while also reducing costs.

Read More »

Strategies for Enhancing Sustainability in Peptide Synthesis: Minimal-Protection and Minimal-Rinsing SPPS

Conventional SPPS involves extensive use of protecting groups and large volumes of trifluoroacetic acid (TFA) for deprotection and cleavage, contributing to inefficiencies and environmental concerns. The need for sustainable practices in peptide synthesis has led to the development of innovative approaches such as minimal-protection solid-phase peptide synthesis (MP-SPPS) and minimal-rinsing SPPS (MR-SPPS). This study explores MP-SPPS, which employs unprotected side-chain amino acids, specifically Fmoc-Arg-OH, Fmoc-His-OH, and Fmoc-Tyr-OH, to streamline the synthesis process. By reducing the need for protecting groups and TFA, MP-SPPS not only diminishes chemical waste but also enhances productivity, achieving a 5.3-fold increase in efficiency compared to traditional methods. Additionally, the integration of MR-SPPS further minimizes solvent usage, highlighting the potential of these sustainable strategies to improve peptide synthesis while addressing environmental impact.

Read More »

Antibody-Oligonucleotide Conjugation – Chemistry, Biology and Therapeutics

Nucleic acid therapeutics (NATs) have opened up novel therapeutic opportunities for treating diseases such as cancer, retinopathies and neurodegenerative disorders. However, there have been numerous reports of toxicity and potency-related concerns during the development of NATs. Antibody-oligonucleotide conjugates (AOCs) offer an innovative and highly promising approach to help deliver NATs, where precise targeting of disease-associated cell types and tissues can result in enhanced therapeutic efficacy. The use of advanced conjugation techniques to combine the oligonucleotide and antibody, such as click chemistry, provide safe and effective strategies for AOC synthesis. Importantly, more suitable preclinical models and early pre-clinical testing of AOCs are required to investigate their mechanistic behaviour and translational potential. In this review, we present an overview of the chemistry, biology and therapeutic applications of AOCs.

Read More »

Design to Refine for Homogeneous Catalysts

In this article, we explore the importance of metal extraction and refinement when using platinum group metal (PGM) catalysts in API synthesis. We detail the wide range of treatment options that R&D teams can integrate into their chemical processes, including metal scavenging and complex chemical treatments, and emphasise the challenges associated with each of them. We also discuss the importance and potential cost-savings involved in considering one’s waste stream early in process development. By embracing extraction and refinement, chemists can reduce their carbon emissions and capital expenditure, especially during scale-up, and forge a more sustainable pharmaceutical value chain.

Read More »

Login