FDA AMAT for Regenerative Medicine Therapies Workshop Recap

This podcast episode provides a short recap of the day long workshop hosted by the FDA’s Office of Therapeutic Products (OTP) a new office within CBER. The goal of the workshop was to share knowledge and best practices from experts in the field of advanced manufacturing and analytical technologies (AMAT) for regenerative medicine therapies. Innovative manufacturing technologies and alternative testing methods were discussed along with, challenges and best practices critical for chemistry, manufacturing, and controls (CMC) of cellular and gene therapies and tissue engineered medical products.