Process optimization for AAV-based gene therapy: insights on downstream purification

In this article, Srivatsan Ramesh, Scientist, Downstream Process Development, BridgeBio discusses the critical challenges in downstream purification for AAV-based gene therapies, emerging technologies for viral vector characterization, in addition to methods for the robust translation of pre-clinical programs to clinical/commercial manufacturing. The importance of a holistic approach to process development—where both upstream and downstream processes are co-optimized—is highlighted.