eChalk Talk: CMC Bioanalytical Control for ATMPs-Challenges and Strategies

Sr. Director of CMC Bioanalytical Services, Jeff Patrick, PhD, and Scientific Officer, Michelle Miller, PhD, provide an overview of considerations in the development and lifecycle of assays for CMC control strategies for ATMPs. Watch as they discuss case studies that highlight the development and phase-appropriate validation of tests for potency, purity/impurity, quantity, and identity of ATMP drug products.