Navigating evolving regulatory CMC guidance in the AAV gene therapy field

Cell & Gene Therapy Insights 2023; 9(7), 1015


Published: 24 August 2023
Michael Brewer, Alexis Cockroft, Christina Fuentes, Christine Le Bec, Yan Zhi

Cell & Gene Therapy Insights brought together a panel of regulatory, analytical, and process experts to examine some of the key developments in the CMC landscape for AAV-based gene therapy. The panel dissected current and future regulatory guidance, offering advice to those seeking to avoid the setbacks that have recently hindered products in late-stage development. Here are some of the highlights…