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首页> 外文期刊>Organic process research & development >Case Studies Illustrating a Science and Risk-Based Approach to Ensuring Drug Quality When Using Enzymes in the Manufacture of Active Pharmaceuticals Ingredients for Oral Dosage Form
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Case Studies Illustrating a Science and Risk-Based Approach to Ensuring Drug Quality When Using Enzymes in the Manufacture of Active Pharmaceuticals Ingredients for Oral Dosage Form

机译：案例研究说明了在生产口服活性剂型活性药物成分中使用酶时确保药物质量的科学方法和基于风险的方法

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摘要

Biocatalysis is essentially the use of enzymes to perform chemical transformations on organic compounds and has been exploited for applications in various industries including food, fine chemicals, agrochemicals, and pharmaceuticals. Due to their selectivity and ability to operate under mild conditions, enzymes offer clear advantages for efficient sustainable manufacturing processes. Rapid development of enabling technologies including gene mining, molecular biology, biocatalyst evolution, and bioprocess engineering, has created opportunities to use biocatalysis more broadly for the manufacture of small molecule intermediates and APIs (active pharmaceutical ingredients). To facilitate the adoption of biocatalysis for API manufacture and address a perceived lack of regulatory clarity, several of the current authors published a science and risk based approach to ensuring patient safety and drug quality when using biocatalysis (Org. Process Res. Dev. 2012, 16, 1986-1993). Since this publication, consultation of multiple users and stakeholders in the biocatalysis community has expanded on key guidance and specific approaches, as well as providing real examples of regulatory review and approval in this article. Our ultimate goal as highlighted in this publication is to provide a clear path and knowledge base to enable a robust and sound science and risk-based approach for utilizing biocatalysis whenever appropriate for the manufacture of small molecule pharmaceuticals.
机译：生物催化本质上是利用酶对有机化合物进行化学转化，并已被广泛用于食品，精细化学品，农用化学品和制药等行业。由于其选择性和在温和条件下运行的能力，酶为有效的可持续生产过程提供了明显的优势。包括基因挖掘，分子生物学，生物催化剂进化和生物过程工程在内的使能技术的迅速发展，创造了将生物催化更广泛地用于生产小分子中间体和API（活性药物成分）的机会。为了促进在原料药生产中采用生物催化方法并解决人们认为缺乏法规清晰性的问题，目前有几位作者发表了一种基于科学和风险的方法，以确保使用生物催化法时患者的安全性和药物质量（Org。Process Res。Dev。2012， 16（1986-1993）。自发布以来，生物催化界的多个用户和利益相关者的咨询已经扩展了关键指导和特定方法，并在本文中提供了监管审查和批准的真实示例。如本出版物所强调的，我们的最终目标是提供一条清晰的道路和知识基础，以使每一种适合用于生产小分子药物的生物催化方法都能够采用稳健，可靠的科学方法和基于风险的方法。

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