- March 14, 2023
- 9:00 AM - 4:45 PM ET
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) will host a virtual workshop for FDA staff and cell and gene therapy stakeholders to obtain specialized knowledge from experts in the field of advanced manufacturing and analytical technologies (AMAT) for regenerative medicine therapies (RMT), discuss innovative manufacturing technologies and alternative testing methods, and share experiences, challenges, and best practices critical for chemistry, manufacturing, and controls (CMC) of cellular and gene therapies and tissue engineered medical products.
This workshop will be comprised of external speakers, presentations, and panel discussions with experts in the AMAT field from academia, government, and industry.
Keynote speakers include Dr. Krishnendu Roy, Regents Professor, Director, NSF ERC for Cell Manufacturing Technologies and Marcus Center for Cell Manufacturing, Georgia Institute of Technology; and Dr. Jude Samulski, Director, Gene Therapy Center, University of North Carolina.
This workshop will include presentations and discussions on the current and future advanced manufacturing processes and analytical technologies used in the manufacturing of cellular therapies, gene therapies and tissue engineered medical products. Topics for discussion include but are not limited to:
- Advances in Adeno-Associated Virus (AAV) development and manufacturing. Novel analytical methods for AAV product characterization.
- Tissue engineered medical product manufacturing, including biomaterials and 4D bioprinting.
- Advances in iPSC and MSC-extracellular vesicle manufacturing.
- Manufacturing scaling technologies, including integration and implementation of artificial intelligence and digital twins to support process modelling and cell therapy manufacturing.
To register for the workshop and submit questions or comments related to this event, please visit the registration page. Following registration, a link will be delivered containing the Zoom session’s information.
Recordings for this workshop are linked below and can also be found on the registration page.
- Cellular Therapy and Tissue Engineering Session Recording
- Gene Therapy: Viral Vectors Session Recording