First cGMP feeder-independent pluripotent stem cell banks released for distribution

WiCell Research Institute and Waisman Clinical Biomanufacturing Facility offer new stem cell banks to support translational research through clinical applications

7.6.09

MADISON, Wis. – The WiCell™ Research Institute and the Waisman Clinical Biomanufacturing Facility (WCBF) announced today 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 Dr. 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,” states James Thomson, director of regenerative biology at the new private Morgridge Institute for Research on the UW-Madison campus 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,” states 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, states “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,” states Clive Svendsen, director of Cedars-Sinai Regenerative Medicine Institute, Los Angeles, California. “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.”

About the WiCell™ Research Institute

The WiCell Research Institute, founded in 1999, is dedicated to expanding the frontiers of science and medicine by unlocking the potential of stem cells. As a private, nonprofit supporting organization of the University of Wisconsin-Madison, WiCell conducts research, supports research at UW-Madison, hosts the National Stem Cell Bank and the WISC Bank, provides training for scientists, and offers educational outreach programs for K-12 students and the community. To date, WiCell has provided free human embryonic stem cell licenses to more than 500 researchers in 32 countries and 42 states, and since 2002 WiCell has trained more than 600 individuals in stem cell technologies and methodologies. Visit www.wicell.org for more information.

About the Waisman Clinical Biomanufacturing Facility

The Waisman Clinical Biomanufacturing Facility (WCBF), established in 2001, provides support for the translation of research therapeutics into human clinical trials. The WCBF is a state-of-the-art cleanroom facility located in the Waisman Center at the University of Wisconsin-Madison. The primary mission of the WCBF is to assist in the development of novel cell and gene therapeutics and to catalyze the advancement of therapies into human clinical trials. The WBCF is designed to manufacture cell and gene therapeutics for early stage (Phase I and II) human clinical trials according to the FDA's current Good Manufacturing Practice (cGMP) guidelines. Visit www.GMPBiomanufacturing.org for more information.