Large-Scale AAV Manufacturing: The Road From Concept To Ready-To-Use Platform

The success of Adeno Associated Vector (AAV)-based gene therapies rely on production platforms that can ensure high quality, large scale, and cost-effective manufacturing. In the context of clinical studies or the commercial phase, an important manufacturing challenge is the availability of an efficient and scalable AAV production process.

To address this goal, two production platforms are being developed for the large-scale production of AAVs:

• The first platform is adherent-based using the leading fixed-bed disposable bioreactor iCELLis^® for clinical and commercial manufacturing.
• The second platform is suspension-based to meet higher scale-up demands and take full advantage of an animal-free culture system to improve safety, performance, and consistency.

In this webinar, Margherita Neri, Upstream Vector Process Development Manager, AGC Biologics, and Claire Wartel, Director of Quality and Compliance, Polyplus-Transfection, focus on critical parameters for scalable production during both upstream and downstream process development, with details on achieving scalable transfection in both adherent and suspension platforms. We further discuss the flexibility that these new platforms will offer, in terms of AAV serotypes and Gene of Interest, and their availability as ready-to-use platforms for large-scale production of 200L and beyond.