The Good Manufacturing Practice (GMP) Facility Core is responsible for:

• Developing and manufacturing novel biologic, cellular and other state-of-the-art therapeutics for human administration under controlled conditions in accordance with the U.S. Food and Drug Administration and other regulations.
• Providing support for translational medicine (from bench to bedside) in the field of cellular therapy, gene therapy and other treatment modalities.
• Providing support and help in the administrative process of getting a therapeutic approved by regulatory agencies and finally applied clinically.
• Helping with the production of other therapeutics and products (pharmaceuticals) administered to humans that need to be manufactured in a controlled environment.
• Routine tissue processing and cryopreservation (e.g. cryopreservation of parathyroid tissue).

The GMP Core also provides consulting services for Siteman Cancer Center members, Washington University faculty and interested academic and nonacademic entities in compliance issues with Good Manufacturing Practice rules and regulations, and with issues regarding the new Good Tissue Practice Act, which became effective in May 2005.

STAFF:
John DiPersio, MD, PhD, interim scientific director
Gerald Linette, MD, PhD, medical director
Mary Kay Belota, laboratory director

LOCATION: GMP facility: Southwest Tower, Room 717; Office: Southwest Tower, Room 719

TO ACCESS: Contact Mary Kay Belota at 314-362-9011 or e-mail belotam@wustl.edu

DOCUMENT USAGE: If research supported by the GMP Core results in publication, please acknowledge this support by including the following in your publication(s): We would like to thank the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Mo., for the use of the GMP Core, which provided __________ service. The Siteman Cancer Center is supported in part by an NCI Cancer Center Support Grant #P30 CA91842.