Webinar: Islet Viability and Potency Testing
Thursday, March 31, 2022 | 11 AM ET
Klearchos K Papas
Institute for Cellular Transplantation, University of Arizona, Cell Transplant and Regenerative Medicine Society
The US Food & Drug Administration (FDA) Guidance for Industry for Potency Tests for Cellular and Gene Therapy Products published in 2011 states that “No lot of any licensed product shall be released by the manufacturer prior to completion of the tests for conformity with standards applicable to such product (21CFR 610.1), which include tests for potency, sterility, purity, and identity (21 CFR Part 610, Subpart B).” The challenge for all laboratories manufacturing islets for potential transplantation is what menu of the tests available to assess islet viability and potency. Can they meet the standards specified by the FDA regulations above? Where do these methods fall short? The webinar will review the current state of the art and note areas for future development.
About the Presenter
Klearchos K Papas
Professor of Surgery, Director of the Institute for Cellular Transplantation, University of Arizona, President of Cell Transplant and Regenerative Medicine Society (CTRMS)
Klearchos devoted his research career to the application of engineering principles and development of enabling technologies in fields of cell therapy and tissue engineering with a focus on diabetes. Before joining the University of Arizona in 2011, he was a member of the Schultze Diabetes Institute at the University of Minnesota (2003-2011) where he was the Associate Director of the Islet Transplant Program. Before that he held joint positions in the Department of Chemical Engineering at MIT and the JDRF sponsored Center for Islet Transplantation at Harvard Medical School (1999-2003). Currently he is President of the Cell Transplant and Regenerative Medicine Society and serves on the Editorial Boards of Cell Transplantation, Cell Medicine, Xenotransplantation, and Cell R4.