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Quantitation of AAV-Based Gene Therapy Products; Public Workshop

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Silver Spring

10903 New Hampshire Avenue

Building 31 Conference Center, The Great Room

Silver Spring, MD 20993-0002

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The goals of the workshop are to discuss best practices for quantitating the concentration of AAV vectors, and to educate sponsors on FDA expectations for such assays. AAV vectors are remarkably promising for treating a variety of genetic diseases. The development of safe, high quality AAV vectors requires robust assay methods. The strength of AAV products is most commonly measured in terms of viral genomes. For many manufacturers, qPCR is the assay of choice to measure AAV vector concentration. More recently, manufacturers are also developing innovative methods to quantitate the titer of AAV vectors based on chromatography, capsid detection, light absorption or other methods.

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Silver Spring

10903 New Hampshire Avenue

Building 31 Conference Center, The Great Room

Silver Spring, MD 20993-0002

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