Transfer of an AAV production platform from bench-scale to 50 L: experiences, challenges and learnings.

A key challenge for Adeno-Associated Virus (AAV) process development teams working at bench-scale (15 mL to 2 L) is to ensure the process is suitable for scale-up (50 L and beyond) and transfer to GMP to support clinical studies and commercial supply. Cell and Gene Therapy Catapult have recently transferred an AAV production platform from 2 L process development to 50 L MSAT and then to GMP manufacturing. An overview of the experiences and insights gained during the optimisation and scale-up work, highlighting the complexities faced during the most challenging steps of the upstream and downstream processes, will be discussed. Furthermore, the valuable lessons learned, and the solutions being implemented to address the remaining challenges effectively, will be shared.