Increasing efficiency in AAV-based gene therapy production: platform optimization with multiserotype AAV affinity capture

Abstract:

As the gene therapy field is advancing, faster development and speed-to-market timelines are possible by leveraging platform-based tools and technical expertise. This presentation introduces an off-the-shelf solution for adeno-associated virus (AAV) production developed by a CDMO, and focuses particularly on the AAV capture steps of the downstream process. Experimental data is shown for the evaluation and comparison of two different resin performance.

Design of experiment elution optimization studies were performed and resulted in gains in recovery to over 90% for multiple AAV serotypes. The employment of rapid, cost-effective analytical tools demonstrate the importance of affinity capture optimization on AAV critical quality attributes, including empty / full ratio, impurity clearance, and aggregation reduction. Resin reuse studies demonstrate higher than 90% recovery, supporting reduced cost of goods. Other productivity and cost consideration are discussed for effective scale-up.