Advancing AAV Product Quality Through Use of In-line PAT in Downstream Processing
Poster Authors:
Pharmaron Gene Therapy l Estuary Commerce Park, Speke, Liverpool, L24 8RB, UK
AAV Product Quality Through Adaptive Downstream Purification
AAV product quality depends on more than hitting a vector genome number. It’s the combined outcome of purity, capsid integrity, full/empty content, and consistency from batch to batch. Pharmaron’s downstream approach is built around an adaptive “toolbox” designed to handle the reality that different serotypes (and different products) don’t behave the same during purification.
Using High Throughput Process Development (HTPD), Pharmaron runs scale-down experiments to quickly check platform fit, screen buffers and resins, and optimize affinity and ion exchange (IEX) chromatography using robocolumns®. This multi-platform strategy helps teams choose the best purification path—rather than forcing a one-size-fits-all process—while pairing manufacturing with highly sensitive in-process analytics to support the right titre and the right quality, including monitoring full/empty distribution.
Capabilities