Case Studies in the Applicability of Drug Substance Design Spaces Developed on the Laboratory Scale to Commercial Manufacturing

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• 作者：Nicholas M. Thomson ; Kevin D. Seibert ; Srinivas Tummala ; Shailendra Bordawekar ; William F. Kiesman ; Erwin A. Irdam ; Brian Phenix ; Daniel Kumke
• 刊名：Organic Process Research & Development
• 出版年：2015
• 出版时间：August 21, 2015
• 年：2015
• 卷：19
• 期：8
• 页码：925-934
• 全文大小：282K
• ISSN：1520-586X

文摘

A number of strategies have been employed within the pharmaceutical industry in order to mitigate the risk of applying design space boundaries developed on the laboratory scale to commercial drug substance manufacturing. The following communication presents a number of case histories from members of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), with the aim of exemplifying strategies used to confirm applicability of design spaces developed on the laboratory scale. The strategies presented have a common aim of ensuring that appropriate quality standards are developed, maintained, and enhanced during the product lifecycle whilst delivering rapid and cost-effective mechanisms for drug substance commercialization.