On June 26, 2017, the National Academies of Sciences, Engineering and Medicine organized a workshop hosted by the Regenerative Medicine Forum afocused on manufacturing and quality aspects in cell therapies.
Akron’s CEO, Dr. Claudia Zylberberg, co-chaired the workshop. This was a public event with the aim of discussing challenges and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. Titled Navigating the Manufacturing Process and Assuring the Quality of Regenerative Medicine Therapies, speakers from industry and academia included Dr. Adrian Ghee (Baylor College of Medicine), Dr. Laura Niklason (Yale University), Dr. Linda Kelley (Moffitt Cancer Center), Dr. Anne Plant (NIST) and more.
This week, the National Academies released the proceedings from the workshop, which includes a summary of the discussions that have taken place at the event. The Proceedings provides a summary of the workshop which includes all talks and panels, and is a handy guide for those who have not managed to attend, of the important issues that were discussed.
To remind, the objectives of the workshop included:
- To explore how unique cell populations are defined and evaluated for quality and purity.
- To highlight the importance of establishing a strong scientific understanding of source cells, as well as the characteristics of regenerative cellular and tissue products.
- To learn about the logistical challenges and successes associated with identifying and measuring critical quality attributes and developing effective regulatory and manufacturing standards.
- To examine possible mechanisms and technologies to improve the ability of researchers, manufacturers, and regulators to ensure that new therapies are safe, effective, and can be produced efficiently.
The PDF of the proceedings is available here.