Development Of A Serotype-Agnostic AAV Platform For Suspension Cell Culture

By Andrew Detzel, Kaitlyn Krewson, Annie Daniels, Christopher Cultrara, Matthew Tomaneng, Yeti Nepal, Kieran White, Sheik Salma, Maryam Rahimian, Upul Halambage, Ph.D., Chris Nieder, and Tatiana Nanda, Ph.D.

The manufacture of adeno-associated virus (AAV)-based gene therapies typically relies on either adherent or suspension-based processes. While each approach carries distinct advantages and challenges, suspension-based processes are increasingly favored for large-scale production due to their scalability and ability to deliver higher upstream yields.

To evaluate performance, we compared our suspension process with an adherent iCELLis (200 m²) system, assessing upstream and downstream recovery, as well as a comprehensive analytical panel using our AAV testing platform. This included potency, titer, Empty:Full ratio, aggregation, and process-related impurities.

Our results demonstrate that Pfizer’s serotype-agnostic suspension platform provides significantly increased upstream productivity, with downstream recoveries and critical quality attributes equivalent to those achieved with a well-established adherent platform. Taken together, these findings highlight the suspension platform as a robust and scalable solution for AAV manufacturing, capable of meeting the demands of both clinical and commercial production.