Transfer and scale-up from 10 L BioBLU®️ to Allegro™ STR 50 and STR 200 Bioreactors

Abstract

Adeno-associated viruses (AAV) are established vectors for delivering gene-therapy payloads, however the cost of goods for the transfection reagents and DNA, along with challenges to scaling-up the transfection process, presents obstacles for industrialization of recombinant adeno-associated virus (rAAV) therapeutic products to overcome. The ELEVECTA® platform from CEVEC is a stable cell line with inducible AAV production which removes the need for costly transfection reagents and the need for transient transfection. In this work we show that vector production from an AAV producer cell line is scalable from the bench-scale 10 L production bioreactors to 50 L and 200 L using Pall AllegroTM STR 50 and STR 200 bioreactors and paves the way for production up to 2000 L using Pall Allegro STR 2000 bioreactor. We also demonstrate good capacity, yield and scalability for the initial unit operations of the downstream process, harvest clarification and tangential flow filtration.