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