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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