GMP

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.

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.

 

LCGM Products and Services

Process Development

  • Scale up/scale out/technology development
  • Raw materials/vendors sourcing, qualification
  • In process/release test development
  • Process and reagent qualification

Clinical Materials Production

  • Cell Selection (Phenotype, cytokine expression, size)
  • Cell expansion (flasks, static bags, bioreactor)
  • Genetic modification (Viral Tdx, CRISPR, etc.)
  • Cell/Device Preparation (Skin grafts, iPSC-derived grafts)
  • Viral Vector Production (AAV, Lentivirus)

LCGM Functional Managers