Stanford’s Good Manufacturing Practice (GMP) facility, the Laboratory for Cell and Gene Medicine (LCGM), is a cutting-edge 23,000 sqft facility 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 committed to providing best-in-class services and technology across a wide range of applications. The facility features highly skilled and trained professionals, a dedicated development space, six ISO-7 manufacturing suites and three ISO-7 viral vector manufacturing and fill-and-finish suites. LCGM’s investment in high quality processes, operations, workforce talent and expertise creates a Stanford-branded process in regulatory and manufacturing, while fostering trusted working relationships with our partners and affiliates.  

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).