Industry Perspective on the Selection of Regulatory Starting Materials for Synthetic Peptides

IF 3.1 3区化学 Q2 CHEMISTRY, APPLIED

Organic Process Research & Development Pub Date : 2025-02-26 DOI:10.1021/acs.oprd.4c0042610.1021/acs.oprd.4c00426

Subha Mukherjee*, David A. Thaisrivongs*, Paridhi Agrawal, Mark R. Berglund, Alec Fettes, Zack Guo, Martin N. Kenworthy, Rasmus Lewinsky, John Lopez, Ogonna Nwajiobi, Yasuhiro Sawai and Kevin D. Seibert,

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Abstract

This Perspective from the Synthetic Peptide Working Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium or IQ) Drug Substance Leadership Group discusses the selection of regulatory starting materials (RSMs) for peptide manufacture. Given the ubiquity of solid-phase peptide synthesis (SPPS), it has been common practice to simply default to individual amino acids or dipeptides as RSMs. However, as the field of synthetic peptide research has grown and new synthesis technologies have been more widely adopted, this team proposes that there are cases where significant scientific and technical justification exists to consider larger peptide fragments as RSMs that remain consistent with ICH Q11. This framework would provide greater flexibility and support for the adoption of new and superior peptide synthesis technologies, increasing manufacturing process and supply chain robustness and offering opportunities for industry to address sustainability challenges inherent to current practices in synthetic peptide manufacture.

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合成多肽起始原料选择的行业展望

国际药物开发创新和质量联盟（IQ Consortium或IQ）药物物质领导小组合成多肽工作组的观点讨论了多肽生产的监管起始材料（rsm）的选择。考虑到固相肽合成（SPPS）的普遍性，通常的做法是简单地默认为单个氨基酸或二肽作为rsm。然而，随着合成肽研究领域的发展和新合成技术的广泛采用，该团队提出，在某些情况下，存在重大的科学和技术理由，可以将较大的肽片段视为rsm，这与ICH Q11保持一致。该框架将为采用新的和优质的肽合成技术提供更大的灵活性和支持，增加制造过程和供应链的稳健性，并为行业提供机会，以解决合成肽生产中当前实践中固有的可持续性挑战。

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来源期刊

Organic Process Research & Development 化学-应用化学

CiteScore

6.90

自引率

14.70%

发文量

251

审稿时长

2 months

期刊介绍： The journal Organic Process Research & Development serves as a communication tool between industrial chemists and chemists working in universities and research institutes. As such, it reports original work from the broad field of industrial process chemistry but also presents academic results that are relevant, or potentially relevant, to industrial applications. Process chemistry is the science that enables the safe, environmentally benign and ultimately economical manufacturing of organic compounds that are required in larger amounts to help address the needs of society. Consequently, the Journal encompasses every aspect of organic chemistry, including all aspects of catalysis, synthetic methodology development and synthetic strategy exploration, but also includes aspects from analytical and solid-state chemistry and chemical engineering, such as work-up tools，process safety, or flow-chemistry. The goal of development and optimization of chemical reactions and processes is their transfer to a larger scale; original work describing such studies and the actual implementation on scale is highly relevant to the journal. However, studies on new developments from either industry, research institutes or academia that have not yet been demonstrated on scale, but where an industrial utility can be expected and where the study has addressed important prerequisites for a scale-up and has given confidence into the reliability and practicality of the chemistry, also serve the mission of OPR&D as a communication tool between the different contributors to the field.