Adeno-associated virus (AAV) vector products offer great potential for gene therapy applications however, current yields are very low, and the production process is costly in both time and consumables.<br/>To investigate the use of continuous processing methodologies in the production of viral vectors, a consortium was set up in the UK. The goal of this work was to advance the AAV purification process by targeting the losses from several aspects and in turn affecting a combined 25% improvement in yield. The project aimed to do so by a) improving recovery of initial filtration steps b) improving recovery of downstream manufacturing by establishing a continuous chromatography process and c) using and automating novel next generation analytical techniques to enhance accuracy of process optimisation prior to scale up.<br/>The data presented here will provide an overview of the work performed by Pall to develop a robust process for AAV viral vector production in the Pall iCELLis® Nano bioreactor, show the benefit of using SPTFF methodologies and demonstrate how up to 50 x concentration of viral vector can be achieved for multiple serotypes of AAV.

Purification of adeno-associated virus by single-pass tangential flow filtration (SPTFF)

ACS Fall 2021

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