cGMP Cellular Therapy Manufacturing Facility

 

The Human Islet and Cellular Transplant Facility (HICTF) - GMP Facility has 4,500 sq. feet of manufacturing cleanrooms and support areas designed and managed specifically for the production of innovative cellular therapy (CT) products under the standards of both current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP). The CT products are used in the treatment of human diseases in approved early phase IND (Investigation New Drug application) clinical trials.

The GMP Facility has a three-fold mission in service, research, and education. The GMP Facility is FDA Registered (FEI 3005404215) and serves primarily UCSF investigators and collaborators. The Facility applies a robust quality program to ensure safe and pure cellular products.

The GMP Facility and teams from the UCSF Diabetes Center, UCSF Transplant Surgery Research Lab, and UCSF Department of Transplant Surgery are actively engaged in cell and tissue therapy research. UCSF teams have published a number of publications and participate in CT conferences and meetings.

The GMP Facility provides training opportunities involving CMC and IND compliance specific to cell manufacturing, cleanroom lab operations, environmental monitoring (EM) and HVAC management. 

For more information on the autologous and allogeneic pancreatic islet program, please see the islet program website.

University of California, San Francisco – HICTF and GMP Facility
Mission Center Building – Rooms M640 - 650,
1855 Folsom Street, San Francisco, CA 94103

Phone: (415) 502-7711
Fax: (415) 502-7712