Stanford Laboratory for Cell & Gene Medicine
Stanford’s Good Manufacturing Practice (GMP) Facility: Laboratory for Cell & Gene Medicine’s (LCGM) mission is to develop innovative platforms for manufacturing cell and gene therapy products enabling Stanford investigators and Industry partners to bridge the bench to bedside gap for treating patients with large unmet medical needs. LCGM's end-to-end services and diverse team of experts enables high quality solutions. The LCGM is an innovative, cutting-edge 23,000 sqft facility staffed by world class professionals extensively trained in development of cGMP compliant manufacturing processes and manufacturing of innovative cell and gene therapies.
The facility is designed for manufacturing Biosafety level I/II biologicals with separate controlled spaces for cell and vector production. LCGM provides cGMP services such as the development of cGMP compliant processes and methods, manufacturing, release and storage of CGT and viral vector products intended for phase I/II clinical trials.
LCGM is FACT accredited and compliant with US FDA current Good Manufacturing Practices (cGMP - 21 CFR Parts 210, 211), Human Cells, Tissues, and Cellular and Tissue-Based Products (21 CFR Part 1271).