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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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Lentiviral vector manufacturing process enhancement utilizing TFDF technology

Viral vector bioprocessing & analytics: today’s key tools and innovation requirements to meet future demand

Thomas Williams, Oliver Goodyear, Lee Davies, Carol Knevelman, Michael Bransby, Kyriacos Mitrophanous & James Miskin

Oxford Biomedica (OXB) is a leading gene and cell therapy company that focusses on Lentiviral Vector (LV) technology innovation, with over 22 years of experience in process development and manufacturing. To address increased LV supply demand, OXB transitioned a GMP LV cell culture manufacturing platform from a cell factory-based adherent cell process to a more scalable, serum-free suspension process performed in single use bioreactors, scaled-up to 200 L in volume at the current time. The relative sensitivity of lentiviral vectors to environmental pH, salt concentration and shear stress during vector harvest and downstream processing continues to present a challenge for the development of efficient manufacturing processes [1]. This work evaluates the TFDF (Tangential Flow Depth Filtration) technology developed by Repligen Corporation (Repligen) for the harvest of lentiviral vectors from cell culture supernatant from the bioreactor. The TFDF technology effectively separated cells and cell debris from vector particles. Harvest yields typically exceeded 90% with flux rates between 700–750 liters/m2/hour (LMH) at both 5 and 50 L scales. The tangential mode of TFDF was found to be sufficiently gentle on the cells to support multiple harvests, opening the possibility of greatly increasing LV vector production in a perfusion mode

DOI: 10.18609/cgti.2020.053
Citation: Cell & Gene Therapy Insights 2020; 6(3), 455– 467
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