The LCGM is an innovative, cutting-edge facility staffed by world class professionals extensively trained in development of cGMP compliant manufacturing processes and manufacturing of innovative cell and gene therapies. LCGM is a translational laboratory and cGMP manufacturing facility 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) and European Medicines Agency (EMA) regulations for clinical stage investigational products. The 23,000 square foot LCGM facility was designed as a multi-product facility and has sufficient space, equipment, and qualified staff to develop cGMP compliant manufacturing and analytics, manufacture, release and store cell and viral vector products intended for phase I/II clinical investigations. The facility contains separate spaces for the production of cell and viral vector products with mechanical systems and operating procedures designed to prevent the adulteration of raw materials or products.
The LCGM at Stanford was created to expand development of innovative cell and gene therapies for Stanford Medicine. In particular, this facility focuses on process development, the science of creating qualified manufacturing and analytical processes for reliable and efficient production of these therapies. Given the complexity of cell and gene therapies, development of efficient, effective and scalable processes for manufacturing of therapies at the LCGM, is a critical component of the value proposition of these therapies, both in terms of attaining regulatory approval and in terms of enhancing the therapies' appeal to eventual commercial partners. A focus on best-in-class process development for each therapy in the pipeline translates into therapies manufactured with efficiency and scale, both of which are crucial for eventual wide distribution to patients. LCGM has a developed quality system to ensure cGMP compliance of the facility.
Currently, there are 6 investigator-initiated projects, 2 clinical stage and 4 preclinical stage, which are being developed or manufactured at LCGM. These 6 projects represent therapeutic modalities as diverse as induced pluripotent stem cell-derived therapies for urinary incontinence and RDEB patients, engineered immune cells for autoimmune diseases, regulatory T cells for GvHD and CRISPR gene correction for sickle cell disease. LCGM initiated first industry partnership, which will entail manufacturing of novel pluripotent stem cell-derived neuronal cell product for neurodegeneration. This level of breadth is nearly unheard of, even for extremely well-funded contract manufacturing organizations and in-house manufacturing facilities of the biggest pharmaceutical companies in the world. The combination of nimbleness, breadth, and depth of expertise makes the LCGM a truly key piece of the CDCM and is a testament to the expertise of the LCGM team.
The Stanford LCGM's commitment to best-in-class process development, manufacturing, quality control and quality assurance, across a wide range of treatment modalities (including both cell and vector production), sets it apart from most other GMP facilities. This breadth, combined with the deep expertise of its leadership and staff, is a key success factor for the CDCM. The investment in this expertise allows for a Stanford-branded process, both for regulatory and manufacturing methods, which engender trusted working relationships, both with regulators and industry partners. The CDCM has often been approached by leading biotech companies and industry entities to be a manufacturing partner for their therapies. While this presents potential challenges for balancing Stanford investigator-initiated projects, the CDCM leadership has maintained that internal projects will be prioritized over external projects.