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 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.