Human Gene and Cell Therapy Facility
Broad Stem Cell Research Center (BSCRC)
Overview
The UCLA Human Gene and Cell Therapy Facility provides comprehensive support for the manufacturing of cell and gene therapy products intended for early-phase clinical trials conducted under FDA Investigational New Drug (IND) applications led by our members, as well as academic and industry collaborators.
Like all pharmaceuticals, cell and gene therapies must be produced under conditions that meet rigorous FDA safety standards before they can be tested in humans.These standards, known as current Good Manufacturing Practices, or cGMPs, require strict operational controls to ensure the identity, strength, quality and purity of drug and cell products.
The facility’s highly-trained staff, specialized equipment and state-of-the-art laboratories provide the expertise and resources to manufacture GMP-compliant products for first-in-human clinical trials.
The close proximity between the center’s research laboratories, the Translational Cell Therapy Laboratory and this facility removes barriers and increases access for our researchers, enabling the transformation of discoveries into life-saving therapies.
Our center funds this vital resource in partnership with the UCLA David Geffen School of Medicine, the Human Gene and Cell Therapy Program and the UCLA Health Jonsson Comprehensive Cancer Center.
Visit David Geffen School of Medicine’s Research Cores to learn more about the Human Gene and Cell Therapy Facility, including equipment and pricing.
Members
Services
The facility’s team of expert staff provide the knowledge and experience needed to accelerate the development, regulatory approval and manufacturing of these cutting-edge therapeutic candidates.
Its services cover all aspects of production including:
- Materials
- Equipment
- Personnel
- Processes
- Premises
- Procedures