Scaling Up The Learning Curve For Large-Scale AAV Manufacturing

By David Bohonak and Ratish Krishnan, MilliporeSigma

Even companies with experience with more well-characterized products, such as mAbs, at large scale, or with AAV at small scales, face a steep learning curve when moving to large-scale AAV production. Transitioning to large-scale production requires manufacturers to decide whether to scale up or scale out AAV production, and is more challenging than choosing to add more manufacturing lines to a process., in turn creating higher capital costs, the need for more personnel and dedicated space, and increasing the cost of goods. Consequently, manufacturers are highly incentivized to scale up and optimize their AAV process when demand is high.

The AAV therapies of the future will require the AAV manufacturing processes of the future. As the industry sees more AAV programs targeting high-dose indications or larger patient populations, demand will continue to grow for processes that can manufacture more material more efficiently while reducing the costs of goods. These demands can be met with advancements in process technologies to improve productivity and drive down costs.

Opportunities exist within every unit operation that makes up these processes to increase upstream titers, improve downstream recovery, reduce batch failures, and more efficiently utilize materials and equipment.