Lessons Learned from Registrational Analytical Methods Transfer and Validation at External CMOs in Support of Drug Substance Processes

Specific analytical methods are developed and optimized for process quality control requirements in small molecule drug substance commercial manufacture. The goals of these methods are simplicity (user friendliness and routine instruments), robustness and the ability to meet validation criteria. The operating conditions and parameters are optimized in alignment with the Analytical Target Profile (ATP, as described in ICHQ14, Draft) ahead of formal validation (meeting ICHQ2) and transfer. Here we will review method development requirements, workflows and transfer approaches. Specific consideration will be given for more challenging methods, varying vendor needs and timelines.