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# CBER to Host Gene Therapy Manufacturing Town Hall
- URL: https://www.fdaweb.com/cber-to-host-gene-therapy-manufacturing-town-hall/
- Published: 2025-09-12T12:00:00.000Z
- Updated: 2026-09-14T15:21:35.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159857

CBER is hosting a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes. The Office of Therapeutic Products event brings together experts from the Office of Gene Therapy and the Division of Manufacturing and Product Quality. FDA officials will address questions related to chemistry, manufacturing, and controls and facility readiness, an [agency notice](https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-gene-therapy-manufacturing-cmc-and-facility-readiness-blas-and-post-licensure-changes?ref=fdaweb.com) says.

As part of the review process, FDA inspects facilities where gene therapy products, drug substances, or critical components are produced and tested. The agency emphasizes that facility preparedness is essential for licensure. The discussion will also cover challenges sponsors face after approval, when changes to production processes, quality controls, equipment, or facilities are often necessary, it says