The BioInsights Podcast

← The BioInsights Podcast6. Okt. · 29 Min.

Making the Move to AAV producer cell lines: comparability, bridging studies and regulatory considerations

Making the Move to AAV producer cell lines: comparability, bridging studies and regulatory considerations6. Okt.29 Min.

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 e...