Adenoassociated viral (AAV) vectors have become synonymous with gene therapy delivery. However, because they are produced in such small quantities and because their upstream processes carry comparatively large amounts of host-cell DNA and other impurities, AAV purification can be challenging. Several researchers have applied different chromatographic strategies, but no universal method has been adopted in the biopharmaceutical industry.
This eBook features a discussion among several industry experts that explores challenges specific to AAV purification, shedding light on whether current strategies and separation technologies are up to the task. The conversation traverses issues relating to material handling at the upstream–downstream interface, removal of host-cell DNA, chromatographic separation of empty and full capsids, and a lack of fast and robust in-process analytics for downstream processes. Participants also explore whether the rise of AAV-based treatments will require downstream scientists to shift away from the antibody-centered conceptions of chromatography that have grown alongside the biotherapeutics industry.
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