With the first AAV vector-driven gene therapy product approvals has come significant evolution in regulators’ guidance and expectations, particularly in the area of product characterization and quality control (QC). Analytical tool innovation is delivering a new depth of understanding of AAV vectors and the impact of elements such as full-empty capsid ratio. But with this new knowledge comes uncertainty, as regulators and developers alike struggle to keep pace with the speed of progress in what is a still nascent and relatively unstandardized field.
This roundtable discussion will feature regulatory, analytical and process experts who will examine some of the key developments in the CMC landscape for AAV-based gene therapy. The panel will dissect current, and likely future, regulatory guidance, offering advice to those seeking to avoid the setbacks that have hindered a number of products in late-stage development over recent times.
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