Evaluation and performance of an AAV affinity resin: a CDMO case study

Cell & Gene Therapy Insights 2024; 10(3), 397–413

DOI: 10.18609/cgti.2024.053

Published: 3 May
Innovator Insight
Spyros Gerontas, Buzz Lobbezoo

Often referred to as the gold standard for in vivo gene therapy, the adeno-associated virus (AAV) has seen a huge increase in its use in clinical trials over the last few years, with various serotypes used depending on the target tissues and cells. There are now six AAV-based gene therapy products on the market, with many more in the R&D pipeline. This has led to an increased demand for the development of efficient and robust downstream purification processes to ensure the production of high-quality AAV vectors for clinical applications. The performance of the affinity capture step of AAV as a scalable unit operation is of particular importance to deliver high purity and recovery.This article introduces POROS™ CaptureSelect™ AAVX affinity resins for the scalable downstream purification of a range of AAV serotypes for gene therapy applications. A case study from Pharmaron, a leading CRO/CDMO, provides an analysis of the performance of the resin under varying conditions at both small and large scales, from early development runs to assess the resin capabilities to the affinity capture of 22 L of AAV harvest material.