AAV production and purification: key steps from design to GMP readiness

AAV manufacturing presents challenges across both upstream and downstream processes, each requiring optimization to facilitate robust and scalable production. The following studies focus on AAV production workflow and how different steps within the upstream and downstream processes were optimized. Namely, cell expansion, plasmid transfection, and vector production in the upstream process, and purification and analytics in the downstream process. Case studies highlight how critical raw materials and process parameters were chosen to enable productivity and scalability as well as how to meet the quality target product profile of the AAV produced.