Scaling Good Manufacturing Practice (GMP) Cell Manufacturing
Pioneering Closed Manufacturing Systems
The Center for Cancer Cell Therapy (CCT) manufacturing team is focused on expanding Stanford's cell manufacturing capacity and innovating cost-effective enhancements to improve the availability and performance of CAR-T cells.
We launched the first CCT investigator-initiated clinical trial using an automated, fully closed manufacturing platform. The CCT was also the first to adapt this system for retroviral transduction of CAR-T cells, and we have now successfully generated GD2 CAR-T cells using this process that are under study in a clinical trial for childhood brain tumors.
CCT is explores novel, automated cell manufacturing approaches that have the capacity for cell selection, product monitoring during manufacturing, and scaling. These platforms hold promise for enhancing cell potency as well as manufacturing efficiency.
Our Partners
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).