MADISON The WiCell Research Institute and the Waisman Clinical Biomanufacturing Facility (WCBF) announced today (July 6) the release of the first current Good Manufacturing Practices (cGMP) feeder-independent pluripotent stem cell banks available for sale and distribution to researchers worldwide.
These cGMP banks of human embryonic stem (ES) cells are produced using H9 (WA09), one of the original lines derived by stem cell pioneer James Thomson at the University of Wisconsin-Madison and the most frequently used and cited human ES cell line in stem cell research today. Release of this material demonstrates the successful execution of the production, quality-control testing and documentation required for cGMP banks.
Through the new partnership between WiCell and the WCBF, researchers now can purchase matched cGMP and research cell banks, allowing them the opportunity to seamlessly advance their programs from research through clinical application. In the future, WiCell and the WCBF plan to make available a wide variety of other cGMP lines, including lines produced from newly derived, fully compliant human ES cells and induced pluripotent stem (iPS) cells. These clinical-grade cell banks will help advance the field of regenerative medicine.
"The effective development of stem cell-based therapeutics requires cell banks that have been characterized and produced under conditions suitable for human clinical trials," says Thomson, director of regenerative biology at the new private Morgridge Institute for Research at UW-Madison and the scientific director of WiCell. "The availability of these cGMP stem cell banks and matched research cell lines should open the door to more rigorous, reliable and successful clinical applications."
"The availability of stem cell banks that have been produced and tested under cGMP is a critical component of any program that intends to advance a stem cell-based therapy into human clinical trials," sa
|Contact: Janet L. Kelly|
University of Wisconsin-Madison