Use of Enzymes in the Manufacture of Active Pharmaceutical Ingredients鈥擜 Science and Safety-Based Approach To Ensure Patient Safety and Drug Quality

详细信息    查看全文

• 作者：Andrew S. Wells ; Gregory L. Finch ; Peter C. Michels ; John W. Wong
• 刊名：Organic Process Research & Development
• 出版年：2012
• 出版时间：December 21, 2012
• 年：2012
• 卷：16
• 期：12
• 页码：1986-1993
• 全文大小：237K
• 年卷期：v.16,no.12(December 21, 2012)
• ISSN：1520-586X

文摘

A significant number of marketed pharmaceuticals contain active pharmaceutical ingredients that are manufactured in part using biocatalysis as a key enabling technology. The utilization of biocatalysis is growing due to significant advances in technologies for enzyme discovery, supply, and improvement, as well as an increased focus on applications for chiral drugs and green chemistry. Nevertheless, there still remains a lack of clarity around quality and regulatory expectations when using biotransformations in research and manufacturing, and this lack of clarity can be a barrier to the uptake and adoption of biocatalysis. This commentary will explore and offer some rational, coherent, and achievable strategies for the use of biocatalysis in the manufacture of small molecule active pharmaceutical ingredients (APIs) based on a scientific, risk-based approach to drug quality and patient safety. We also seek to invite other interested parties to contact us with their views to add to the topics discussed here with the goal of expanding these thoughts into an industry-based white paper.