Downstream purification of adeno-associated virus for large-scale manufacturing of gene therapies

As the growth of the gene therapy field continues apace, it is crucial that the production of high yield, high quality viral vectors is achievable at a larger scale to meet the industry’s growing needs. Validated viral clearance approaches are a key step in the manufacture of safe gene therapy products, and Thermo Fisher Scientific’s combined CaptureSelect™ and POROS™ technologies offer an affinity chromatography platform that can simplify the vector purification process while also maintaining yield. A series of viral clearance studies conducted by REGENXBIO using the POROS™ CaptureSelect™ AAVX affinity resin demonstrated that the resin provided robust viral clearance, even under ‘worst case’ processing parameters outside of typical manufacturing conditions, as demonstrated using typical model viruses expanded to include human viruses. Additionally, minimal to no non-specific interactions were observed between the viruses and the AAV capsid, as well as between the viruses and POROS™ beads or V_HH ligand.

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