Along with the commercialization of already-approved gene therapies, and reports of clinical success in products still in the pipeline, have come concerns about the vector supply chain. Future gene therapies may require significantly more vector and/or the ability to treat much larger numbers of patients than currently approved products. Current production capacity for clinical-grade vector is relatively low and there is a clear requirement for additional cGMP grade vector production capacity. Continuous manufacturing is one approach to achieving higher productivity, increased product quality, and, potentially, better utilization of production infrastructure. However, it is still in the early stages of being applied to viral vector manufacturing.
To help address this gap, we are developing and demonstrating a continuous upstream viral vector manufacturing platform by developing a first principles mathematical model for continuous viral vector cell culture unit operation process design; developing and demonstrating novel analytics for the in-line measurement of vector production parameters; and leveraging these learnings to demonstrate the continuous cell culture production of viral vectors.
- FDA Center for Biologics Evaluation & Research