Platform Optimization for Efficient AAV Purification: Insights from a CDMO

The number of clinical studies continues to increase for candidate gene therapies based on adenoassociated virus (AAV) vectors. Application of different AAV serotypes has enabled drug developers to target a large panel of tissues and to address a breadth of diseases — but with the drawback that each serotype necessitates a distinctive purification process. Such development work requires considerable resources and results in long process-development timelines, which can cause significant delays to entering clinical trials. Thus, gene-therapy companies and contract development and manufacturing organizations (CDMOs) are working to establish platform purification processes that require minimal adjustments between batches.

In this article, writers from Thermo Fisher Scientific and Yposkesi (an SK Pharmteco company) describe their companies’ efforts to develop a platform process for AAV purification based on Poros CaptureSelect AAVX chromatography resin. Scientists from both companies collaborated to study the influence of critical operational parameters on binding capacity, vector recovery, and product purity using different AAV serotypes. The team also compared the Poros CaptureSelect AAVX medium’s performance with that of other affinity sorbents, with results demonstrating the value of Poros CaptureSelect AAVX resin as a versatile, scalable, and easy-to-implement tool for purification of different AAV serotypes.

Download the article now to learn about important considerations for AAV purification, critical operating parameters for AAV chromatography media, and advantages that the Poros CaptureSelect AAVX resin can raise for process economics and downstream operations.