QbD Pilot Program: Key Learnings

As part of an Alliance formed for the development and commercialization of an antibody product, Pfizer and Janssen participated together in the FDA QbD Pilot Program. This talk will review the key topics discussed and lessons learned during each of four meetings with the team from FDA. The four meetings covered the categories of General Approach to QbD, Critical Quality Attributes, Design Space, and Control Strategy, respectively. This talk will also review several general questions on the application of QbD principles that remain open after the Pilot Program experience.