Viral vector production guide part 2: considerations of scaling up GMP

Abstract

Key topics:Early consideration on high yield cell lines and IPImportance of effective starting material strategy to de-risk viral vector scalability and commercializationAligning DOE effectively with unit operations and data insights to drive streamlined robust, high-yield scaling Optimizing scalability for low cost of goodsFollowing the acquisition of Cobra Biologics/Cognate BioServices by Charles River Laboratories (CRL) in April 2021, Professor Smith was appointed Executive Director, Global Cell & Gene Therapy Portfolio within the CRL Corporate Development & Strategy function. Prior to acquisition, Professor Smith was the Chief Scientific Officer across the Cognate/Cobra C> CDMO portfolio (2020–2021), and Cobra Biologics (2014–2020), driving CDMO innovations and partnerships across plasmid DNA, viral vectors, and latterly, (gene-modified) Cell Therapies, with respect to development and production. Previously he was Knowledge Transfer Manager and Senior Technologist for the BioProcessUK team. Daniel spent five years (2005–2010) at Cobra in roles including Senior Scientist, QC Team Leader, Head of Process Technology Transfer and Commercial Scientific Development Manager. He has over eight years academic research experience, 30+ research publications to his name and a PhD in Molecular Cell Biology, and a BSc (Hons) in Biochemistry. Daniel holds Honorary Industry Professor positions at both the University of Kent, UK and at the University of Warwick, UK.