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," says Erik Forsberg, executive director of WiCell. "Using matched research/cGMP stem cell banks early in development will greatly reduce the time and cost associated with transitioning research projects from bench to bedside."
The collaboration between two leading organizations in the stem cell field, the WiCell Research Institute and the Waisman Clinical Biomanufacturing Facility, is key to the successful production of cGMP stem cell products. Human embryonic stem cells cultured and propagated at WiCell serve as the source of the well-characterized research cell banks. Production of clinical master cell banks then is carried out in the WCBF cleanrooms with complete cGMP testing and documentation. Cell banks are offered as research banks derived from the cGMP master cell bank for screening cell properties, as well as cGMP working cell banks, derived from the same fully tested master cell bank under cGMP conditions.
Derek Hei, director of the WCBF, says, "It is a priority of our partnership with WiCell to pursue cGMP feeder-independent production of both human ES and iPS cells. We need to continue work with both cell types until we more thoroughly understand their characteristics and how these characteristics may affect their potential use in therapies."
"cGMP stem cell banks represent the key in today's research market with respect to therapeutics, clinical applications and human clinical trials," says Clive Svendsen, director of Cedars-Sinai Regenerative Medicine Institute, Los Angeles. "For scientists poised to take their research to new levels and explore the reality of using pluripotent stem cells to cure human disease, the tools now provided through this partnership between WiCell and the WCBF signal the beginning of a new era in regenerative medicine."
|Contact: Janet L. Kelly|
University of Wisconsin-Madison