A Differentiated End-To-End Process Suspension-Based Platform For The Manufacturing Of AAVs

By A. Youssef, M. Langhauser, A. Schulze, A. Schoberth, M. Hoerer, and K. Heller

Recombinant adeno-associated virus (rAAV) is one of the most widely used viral vectors for gene therapy, yet maintaining high quality and consistent productivity across different manufacturing scales remains a challenge. Additionally, process variability between AAV serotypes can extend development timelines, delaying clinical supply.

To address these challenges, we have developed a robust suspension platform process based on our proprietary HEK293 cell line, designed to minimize batch variability and integrate quality by design. This platform simplifies manufacturing, enhances scalability, and reduces costs while maintaining flexibility for diverse production needs.

Our end-to-end solution incorporates proprietary technologies, including a 2-split plasmid system, to optimize yield and quality while meeting evolving regulatory standards. Fully scalable across multiple capsid serotypes, our platform accelerates clinical-grade AAV production. We continuously refine our process to support the broader application of AAV gene therapies, ensuring the development of safer, high-quality products for our clients and their patients.