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  4. OTP Town Hall: Gene Therapy Manufacturing CMC and Facility Readiness for BLAs and Post-licensure Changes - 10/22/2025
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Town Hall | Virtual

Event Title
OTP Town Hall: Gene Therapy Manufacturing CMC and Facility Readiness for BLAs and Post-licensure Changes
October 22, 2025

Date:
October 22, 2025
Time:
12:00 p.m. - 1:30 p.m. ET

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual town hall on October 22, 2025. During this town hall, OTP’s Office of Gene Therapy partnered with experts from CBER’s Office of Compliance and Biologics Quality’s Division of Manufacturing and Product Quality (DMPQ) to answer questions regarding CMC and facility readiness for BLA submissions and post-licensure changes for gene therapy manufacturing facilities.

Focus for This Town Hall
CMC and facility readiness are integral parts of a CGT BLA submission. Facility inspections are performed as part of the BLA review process and are necessary for licensure. FDA typically inspects the sites where critical components, drug substances, or drug products are being produced and where tests are being performed.

Additionally, for a variety of reasons, changes are often implemented to the product, production process, quality controls, equipment, or facilities post-licensure.  As described in the FDA Guidance for Industry, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products, an integral component in successfully implementing any manufacturing change is an effectively-designed and effectively-managed change management process. An effective change management system assesses risks to product quality and can enable the applicant to make informed decisions regarding manufacturing changes and inform the necessary data to support the change.

About the OTP Town Hall Series
OTP launched its virtual town hall series to engage with product developers and researchers and discuss topics related to OTP-regulated products. The town halls have a question-and-answer format with the goal of providing regulatory information to advance drug development. Learn more about OTP and view recordings from our previous town hall events.

Stay Connected
Sign up for the CBER listserv to stay up to date on all FDA CBER news and events. For questions about this event, please email OTPPublicEventsandWorkshops@fda.hhs.gov.

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