Flexible & scalable solutions for AAV viral vector production using a templated platform

Abstract

Adeno-associated virus (AAV) has become an increasingly popular viral vector for gene therapy. Currently, there are two approved AAV-based gene therapies, and the number of clinical trials is steadily increasing. As with most viral vector-based therapies, production is labor-intensive and expensive due to the use of adherent cell culture production processes. Consequently, for process intensification, the industry has begun to utilize bioreactors. This article explores the development of a suspension-based AAV upstream process to provide a more efficient and cost-effective bioprocessing solution for large-scale production. The use of template tools for upstream process development will be examined, as will development of the clarification and tangential flow filtration unit operations immediately following harvest.