Navigating evolving regulatory CMC guidance in the AAV gene therapy field

Cell & Gene Therapy Insights 2023; 9(4), 417–432

DOI: 10.18609/cgti.2023.062

Published: 15 May 2023
Expert Roundtable
Michael Brewer, Alexis Cockroft, Christina Fuentes, Christine Le Bec, Yan Zhi

Elisa Manzotti, CEO of BioInsights, speaks to (pictured left to right) Michael Brewer, Director, Global Principal Consultant, Regulatory, Bioproduction Group, Thermo Fisher Scientific, Alexis Cockroft, Director & Regulatory Consultant, Lex Regulatory Ltd, Christina Fuentes, Senior Consultant, Dark Horse Consulting Group, Christine Le Bec, Head of CMC Gene Therapy, Sensorion Pharma & Yan Zhi, Director and Cell and Gene Therapy Product Owner, Process Engineering, CSL Behring