12.13.21 -- Scalable AAV Manufacturing Process

This infographic guides you through the adeno-associated virus (AAV) workflow — from buffer and media prep through upstream, downstream, analytics, and storage. Take a step-by-step tour of the objectives, things to consider, and key strategies that will help you achieve a process that’s both efficient and scalable.

Making small amounts of AAV is one thing; manufacturing it under GMP is another. Here we adapted adherent HEK293 cells to suspension culture. Then, we developed an optimized transient transfection protocol that’s suitable for different serotypes — and scales.

Unlocking the full potential of viral vector-based therapies requires an understanding of existing challenges in viral vector production and which technologies are now available in upstream and downstream processing to help address them.

Processes to produce a common viral vector for gene therapy — AAV — are in place, but there’s room to improve them. In this article, we focus on optimizing AAV purification to achieve high overall yields and efficiently remove empty capsids and other impurities.

The recent pandemic revealed that, with the proper framework, a drug product can be developed, clinically tested, and produced for hundreds of millions of patients in less than a year. What lessons can we apply from this effort for AAV development and production? And why does the cell and gene therapy arena so urgently need these learnings?