OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual town hall to answer stakeholder questions related to cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTAT. This event is part of a series to answer questions from stakeholders about a variety of topics on which OTAT has regulatory oversight.

Focus For This Town Hall: What Are Chemistry, Manufacturing, and Controls for Cell Therapy and Tissue-engineered Products?

The FDA requires sponsors to provide CMC information as part of an investigational new drug application. The CMC information should describe product manufacturing and testing to assure safety, identity, quality, purity, and strength (including potency) of the investigational product. Please see this FDA guidance document for more information.

Note: On September 29, 2022, OTAT held a town hall about gene therapy CMC. View the town hall announcement page for the meeting recording and other meeting materials.

Meeting Logistics

Submit a Question

The period to submit questions in advance of this event has closed. Attendees will be able to submit questions during the live event.

Please note, the FDA is not able to comment on or answer questions regarding specific investigational products or drug applications during the town hall. Further, questions considered inappropriate or out of scope for the event will not be addressed.

About the OTAT Town Hall Series

OTAT launched its virtual town hall series to engage with product development stakeholders and discuss topics related to OTAT-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 OTAT and view our available resources.

Article shared from FDA’s website: OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – 12/07/2022 | FDA