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Synthetic depth filters are a suitable option to provide a high-performance and scalable single-step clarification process.
Viral gene therapy has gained momentum after recent approvals and commercial successes with novel therapies based on chimeric antigen receptor T cell (CAR-T) or direct virus-mediated gene modification. Viral vectors such as adeno-associated viruses (AAV) and lentiviruses are the foundation of such therapies, and their manufacture is not without challenges. With the growing demand for these vectors and the desire to target large organs, higher virus titers are required; higher titers enable the number of batches to be minimized and reduces the cost of manufacturing. The authors here describe the results of a collaboration which focused on identifying best practices during clarification of bulk harvest to ensure maximum virus vector yield.
João Marques is senior scientist, and Paul Carter is scientific leader, Downstream Vector; both are at Downstream Process Development at the Cell & Gene Therapy Platform CMC, Medicinal Science and Technology, R&D at GlaxoSmithKline. Matthew Dillingham is a senior process development scientist, Paul Beckett is senior technology manager, Purification Technologies, Adina Paun is account manager pharma processing, Youness Cherradi is senior process development scientist, and Anissa Boumlic*, firstname.lastname@example.org, is associate director Vaccines and Viral Therapies Segment, all at MilliporeSigma.
*To whom all correspondence should be addressed.
eBook: Biologics and Sterile Drug Manufacturing, May 2020
When referring to this article, please cite it as J. Marques et al., “Optimizing Viral Vector Manufacturing for Gene Therapy," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2020).