Making the move from antibody therapeutics to gene therapy: applicability of monoclonal antibody learnings to adeno-associated virus vector bioprocessing

Published: 29 April 2021
Commentary
Andrew D Tustian
Andrew D Tustian
Regeneron Pharmaceuticals Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA andrew.tustian@regeneron.com

The surge of interest in gene therapy in the past few years has led many companies to build process development groups to drive these therapies into the clinic. It can be hard to recruit bioprocess scientists with gene therapy backgrounds, therefore many bioprocess scientists from the monoclonal antibody field have moved to gene therapy development. Here we discuss, with specific focus on adeno-associated virus (AAV) based viral vectors, how knowledge of bioprocess manufacturing steps, regulatory expectations, disposable technologies, viral clearance and quality by design approaches make these scientists invaluable for the gene therapy industry. However, the larger size and mass of the AAV product, lower process productivity, and lack of molecular biology and virology knowledge can be pitfalls for those making the transfer.

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