Platform optimization for efficient AAV purification: insights from a CDMO
Cell & Gene Therapy Insights 2022; 8(1), 145–158
10.18609/cgti.2022.001
Over the last decade, the number of clinical trials involving recombinant adeno-associated viral (AAV) vectors has dramatically increased, the diversity of serotypes has expanded, and the demand for larger quantities of highly purified material manufactured to cGMP standards has rocketed. For contract development and manufacturing organizations (CDMOs) like Yposkesi, the manufacturing challenges are centered around flexibility, robustness, and productivity, especially with regards to purification. Universal tools able to address any serotype with minimal process adjustments are critical. In this article, we describe how POROS™ CaptureSelect™ AAVX resin can be used as a pan-affinity tool for the universal capture of AAV vectors, and how Yposkesi optimized the operational parameters to make the resin an efficient, robust, and productive purification platform that fits within the constraints faced by CDMOs.