Supporting clinical trial manufacturing
The UCLA Human Gene and Cell Therapy Facility (HGCTF) supports manufacturing of gene and cell therapy products for UCLA investigators as well as other academic and industry partners conducting clinical trials in which a cell or gene therapy product is manufactured under an FDA IND. This facility is a joint effort of the David Geffen School of Medicine, the Human Gene and Cell Therapy Program (HGCTP), the Jonsson Comprehensive Cancer Center, and the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research.
The HGCTF is a 2,395 square foot Biosafety level 2 contained area with seven HEPA-filtered rooms (ISO 7/Class 10,000). Four positive pressure rooms are designed for ex vivo manipulation of cells to minimize the possibility of outside pathogen contamination. Three negative pressure rooms for gene transfer procedures, and ensure that the recombinant vectors do not contaminate the surrounding environment. Aseptic processing is carried out in biosafety cabinets (ISO 5/Class 100).
The overall operational plan for the facility includes: controlled access, facility cleaning, continuous monitoring of environment, air pressure and equipment, scheduled routine preventive maintenance and calibration of equipment. The quality system for the facility includes the appropriate management of out-of-specification (OOS) lab results and investigations, non-conforming materials and products, equipment and process deviations, change control, corrective and preventive actions (CAPA), product review/release, and internal audits.
Examples of clinical trials supported by HGCTF
- 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
- Miltenyi Biotec CliniMACS cell selection device
- Miltenyi Biotec CliniMACS Prodigy cell selection and culturing device
- Controlled rate freezer (CRF) for cryopreservation of cells
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, including costs for inclusion in grant budgets, please email the HGCTF staff at firstname.lastname@example.org.
To download the HGCTF Application Form, click here.
Donald B. Kohn, M.D.
Sujna Raval-Fernandes, Ph.D.