Advancing Gene Therapy 2022

AAV Manufacturing and In-Process Controls

Speaker: Ivana Petrović Koshmak

Date & Time: Tuesday, March 29 at 10:50am

Abstract:

One of the key challenges of AAV manufacturing is obtaining a final product exclusively composed of AAV particles with full-length genome of interest. Upstream process commonly delivers harvests that contain a mixture of empty, partially full and full capsids. In harvests that contain rather low percent of full AAVs, downstream is often unable to reduce empty capsids below 10% in the final product. In these cases, further optimization of upstream is a necessity.

Conditions that affect empty/full ratio can addressed already in early stages of process development with the help of fast at-line HPLC methods. HPLC analytics is a multi-use tool that allows quality control screening of components, recording background profile from media and cells, as well as in-process control for upstream and downstream samples.

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