Technical Challenges Encountered During Chromatographic Method Transfers to Pharmaceutical Manufacturing Sites

Drug substance development requires a range of analytical methods to be developed to generate process knowledge and to support in-process and release testing throughout a synthetic sequence. Analytical chemists are challenged to ensure these fit-for-purpose methods are reliably transferred and execu...

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Bibliographic Details
Published in:LCGC Asia pacific 2021-02, Vol.24 (1), p.5
Main Authors: Tattersall, Peter, Zang, Jia, Kleintop, Brent
Format: Article
Language:English
Subjects:
Chromatography
Methods
Pharmaceutical industry
Online Access:Get full text
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Summary:Drug substance development requires a range of analytical methods to be developed to generate process knowledge and to support in-process and release testing throughout a synthetic sequence. Analytical chemists are challenged to ensure these fit-for-purpose methods are reliably transferred and executed at external manufacturing sites. The performance and robustness will differ based on method complexity, experience, proximity to final drug substance, and by the clinical stage of development. Here, we share experiences with a wide variety of transfer challenges and our remediation strategy.
ISSN:1754-2715
1754-2715