UCLA Human Gene and Cell Therapy Facility

Scientist in personal protective equipment holds petri dishes

The UCLA Human Gene and Cell Therapy Facility supports manufacturing of gene and cell therapy products for UCLA investigators as well as other academic and industry partners conducting clinical trials under an U.S. Food and Drug Administration Investigational New Drug application. 

This Good Manufacturing Practice Facility is jointly supported by the UCLA David Geffen School of Medicine, the Human Gene and Cell Therapy Program, the Jonsson Comprehensive Cancer Center and the Broad Stem Cell Research Center.

The HGCTF is a 2,395 square foot Biosafety level 2-contained area with 7 ISO 7/Class 10,000 HEPA-filtered rooms, including:

  • 4 positive pressure rooms designed for ex vivo manipulation of cells. Positive pressure minimizes the possibility of outside pathogen contamination of cell products.
  • 3 negative pressure rooms for gene transfer procedures. Negative pressure ensures that the recombinant vectors used in these procedures do not contaminate the surrounding environment.
  • ISO 5/Class 100 biosafety cabinets for carrying out aseptic processing of gene and cell products for use in humans.

Operational Plan
The overall operational plan for the facility includes: controlled access, facility sterilization, continuous monitoring of environment, air pressure and equipment, scheduled routine preventive maintenance and calibration of equipment. 

Quality Control
The quality control system for the facility includes the appropriate management of out-of-specification lab results and investigations, non-conforming materials and products, equipment and process deviations, change control, corrective and preventive actions, product review/release and internal audits.

Pricing
Pricing varies and is based on the scope of work. Investigators planning to utilize the HGCTF for future research studies should include anticipated HGCTF costs in new grant application budgets.

For further information on pricing, please email gmp@mednet.ucla.edu.

Clinical Trials
Examples of clinical trials supported by the UCLA Human Gene and Cell Therapy Facility include:

  • Immunotherapy of melanoma and sarcoma with TCR-modified T cells.
  • Immunotherapy of advanced malignancies with TCR-engineered PBMC.
  • Immunotherapy of glioblastoma with tumor antigen-pulsed dendritic cells (DC).
  • Immunotherapy of glioblastoma with allogeneic cytotoxic T lymphocytes (CTL).
  • Immunotherapy of renal cell carcinoma with Ad-CAIX/DC.
  • Gene therapy for ADA-deficient SCID, XSCID, XALD.
  • Retinal pigment epithelial cells for Stargardt and age-related macular degeneration.