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


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.

Laboratory technician operating in one of the Exothera's cleanrooms
Attendees will learn about:
      • Criteria and data to support correct selection of AAV affinity capture resin as part of an off-the shelf AAV production system for various serotypes
      • Characteristics of the resin that enable platformability and process efficiencies
      • Expertise and results of DoE optimization of the affinity capture step and its effect on AAV CQAs
      • Considerations for the efficient, cost-effective development and scale-up of recombinant AAV-based gene therapies
Tiago Albano

Tiago Albano

Senior Bioprocess Engineer

Skilled scientist with 7 years’ experience in developing effective production processes for biologics. I am curious, persistent, meticulous and passionate about science innovation.