About Us

Cellular therapies have gained significant momentum and have developed into an exciting and promising field that offers great therapeutic potential to treat disorders of virtually every organ and tissue system. Lack of cost-effective infrastructure solutions complicate translation of these invaluable treatment options from reaching the clinic, where they’re desperately needed.

The cGMP Advanced Cell and Biologic Products Manufacturing Facility was established in 1994 to develop novel advanced cellular therapies and regenerative medicine products compliant with Federal and other applicable regulations, for research and clinical applications. Since it’s inspection, the Facility has served as a technical and regulatory resource for translational applications that include product development, process scale-up and optimization operations to ensure maximum throughput. The facility manufactures, stores and distributes human cells, tissue and cellular products for clinical applications and research. The facility and manufactured products meet rigorous standards put forth by the FDA (Food and Drug Administration) to ensure product safety, quality, purity, potency and effectiveness. The facility is registered with the FDA, and is accredited by FACT (Foundation for Accreditation of Cellular Therapies) and AABB, and is the NIH Cell Distribution Center which serves investigators at UM, in the US, Europe and the Middle East.