Lauren Coyle (Editor, BioInsights) speaks with Lonza's Laura Sands (Head of Regulatory Affairs), Ramesh Koukuntla (Director of R&D), Wenling Dong (Head of Upstream Process Development), and Vijetha Bhat (Subject Expert of Platform Technologies) about:
- Key regulatory considerations when transitioning to AAV producer cell lines
- Comparability and bridging strategies to support a successful transition
- Approaches to managing manufacturing and regulatory risk
- Considerations for enabling scalable AAV production