Analytical Tools to Improve Production of Full Capsids in Initial Stages of AAV Process Development

This webcast features: Ivana Petrović Koshmak, PhD, Head of Upstream Process Development, BIA Separations, now a Sartorius company.

Empty AAV capsids are known contributors of immunogenicity in gene therapy products. Reducing them below 10% during downstream process is difficult if they constitute the vast majority of total AAV produced in harvest – the solution is a further optimization of harvest.

Determining the factors that improve production of full AAVs is possible at the initial stages of upstream process development, with utilization of at-line HPLC system that measures E/F ratio directly in harvest samples. The same tool can be used for in-process control, to track the AAV production in samples collected during manufacturing runs.

Described HPLC analytics is suitable for a wide variety of samples which allows easy link-up of upstream with downstream process development, and overall, a more holistic approach to AAV bioprocessing.

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