> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# AAV Gene Product Quantitation Workshop
- URL: https://www.fdaweb.com/aav-gene-product-quantitation-workshop/
- Published: 2018-09-04T12:00:00.000Z
- Updated: 2026-09-15T00:29:45.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5142251

CBER has scheduled a 12/7 public workshop on Quantitation of AAV-Based Gene Therapy Products. A workshop [announcement](https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm618876.htm?ref=fdaweb.com) says it is to discuss best practices when measuring the concentration of AAV (adeno-associated virus) vectors and to provide FDA perspective on qualifying such assays. Workshop topics are to include **(1)** overview of AAV concentration-determining assays; **(2)** critical elements for assay optimization and qualification; **(3)** FDA perspective on qualification and validation of AAV concentration assays; and **(4)** development of AAV concentration assays: case studies.