Optimizing Scale-Up Of AAV Gene Therapy In Upstream Processing

By Rafal Garus, Director of Manufacturing Science and Technology (MSAT) Department

Viralgen takes pride in its expertise in manufacturing Adeno-Associated Virus (AAV) gene therapy vectors. Our proprietary platform leverages a unique combination of elements: a suspension cell line derived from Human Embryonic Kidney (HEK) 293 cells, a scalable upstream process, and a robust purification downstream. This comprehensive approach extends to supporting every stage of vector production, from Drug Product Fill and Finish to Quality Control testing. We also provide regulatory guidance throughout the development process, from pre-clinical studies to commercialization.

Viralgen's commitment to continuous improvement is evident in our recent successful scale-up to 2000L production. This achievement involved a combination of process characterization and experimentation to optimize critical steps like mixing dynamics and transfection cocktail maturation kinetics. These insights are then meticulously incorporated back into the overall process, ensuring both increased yield and recovery of AAV vectors while maintaining the highest quality standards.

This poster also helps to answer these questions:

• How can you find the best scale up conditions?
• Does the time of transfection matter?