Brent Kleintop

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. This article describes practical examples of a wide variety of transfer challenges and our remediation strategy.

Drug substance development requires a complex range of analytical methods, presenting a challenge to analytical chemists to reliably transfer and execute these fit-for-purpose methods to external manufacturing sites. Here, we provide guidelines to follow, and share examples of realworld problems and the strategies used to remedy them.