Agenda Details

This session will provide a CMC comparability playbook that can be utilized by CGT developers to support the incorporation of manufacturing changes throughout the stages of drug product development. Specifically, the symposium will consider case studies of comparability for both AAV and cell therapy products and industry best practices, as well as a review of FDA’s draft guidance on comparability. The symposium will provide attendees insights into overcoming the challenges associated with CMC comparability for cell and gene therapy drug products.