OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023
April 25, 2023
- April 25, 2023
- 11:30 AM - 1:00 PM ET
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual town hall on Tuesday, April 25, 2023. This event focused on gene therapy chemistry, manufacturing, and controls.
View the April 2023 recording for the OTP Town Hall on Gene Therapy CMC.
What Are Gene Therapy Chemistry, Manufacturing, and Controls?
Gene therapy-related research and development continues to grow rapidly, resulting in an increasing number of products being evaluated in late-stage clinical studies in support of product licensure. The FDA requires sponsors to provide information about chemistry, manufacturing, and controls (CMC) as part of investigational new drug, biologics license, and new drug applications. For gene therapies and other biologic products, the CMC information should describe the sponsor’s commitment to perform manufacturing and testing to assure product safety, identity, quality, purity, and strength (including potency). For more information, see the FDA gene therapy CMC guidance document or view materials from the September 2022 gene therapy CMC town hall event.
About the OTP Town Hall Series
OTP, formerly OTAT, launched its virtual town hall series to engage with product development stakeholders 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 stakeholders to advance drug development. Learn more about OTP and view recordings from our previous town hall events.
View previous OTP Town Halls
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