The Laboratory for Cell and Gene Medicine (LCGM) is designed to accommodate the cGMP-compliant production of biological materials for phase I/II clinical studies.
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. Sufficient space is provided to facilitate the orderly placement of equipment and supplies, cleaning, maintenance and production operations to prevent mix-ups or cross contamination.
Cell processing suites contain equipment for cell washing and fomulation, density separation, magnetic bead selection, flow cytometric cell sorting and culture. Each suite is a separate, ISA Class 7/EMA Grade D processing area, accessed by a dedicated gown room/pass-through. The suites are accessed through an ISO Class 8 general area, which includes a gowning airlock, material airlock, material staging/storage room, general storage room, media preparation room and irradiator room. Additional ISO CLass 8 space for media preparation, cryopreservation and released material storage is provided throughout the cell manufacturing area.
Specific areas have been designed for the receipt, identification, sampling and quarantine of incoming materials pending release or rejection, as well as the holding and testing of manufactured product intermediates and final formulated product. Adequate space is provided for packaging, labeling and retention of final products prior to distribution. General environmental conditions are specified to be adequate for the intended operations.
Laboratory Space Features:
- Cell processing devices
- Downstream purification equipment
- Tissue culture areas
- Viral vector and bacterial culture capabilities
- Molecular & Cellular Analytics
- Compendial Testing
- Environmental Monitoring
- Controlled Access