GMP Facility & Cellular Therapy Services

Description

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 products under the standards of both current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP). The cellular therapy products are used in the treatment of human diseases in approved early phase clinical trials under IND.

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 facility was renovated in 2017-2018.

Cellular Therapy Services

We have capacity to partner with UCSF investigators and outside biotech or pharma partners to manufacture cellular therapy products. Our model is unique since we require manufacturing staff and QA staff from our collaborators to work alongside us on site. If you are interested in learning more about the services that we offer, please email facility medical director Jonathan Esensten MD, PhD.

Current partners/users

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

UCSF Diabetes Center. For more information, see the regulatory T cell program website.

Novo Nordisk

 

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

Inquiries: Dean Parent, HICTF Operations Manager

Jonathan Esensten, MD, PhD, HICTF Medical Director