The Institute's Cell Processing Facility
Class 10,000 Clean-Room for Therapeutic Cell Processing Facility: This facility is dedicated to the processing of bone marrow, human pancreatic tissue, and islet cells for clinical transplantation. The general facilities have been established under Foundation for the Accreditation of Cell Therapy (FACT) guidelines. The area designated for clinical processing encompasses 2,000 square feet and can accommodate two simultaneous cell-processing procedures for two separate patients. Approximately 1,200 square feet of the facility is a controlled clean room environment. Vertebral columns and mobilized peripheral blood will be processed in this facility to support the clinical trials sponsored by the ICT.
Tissue will be processed in a manner that is compliant with current Good Manufacturing Practice (cGMP), as defined by the US Food and Drug Administration. Cell processing, quality control and quality assurance activities will be conducted. We also have a separate room within the cell processing facility (also with filtered air handling) dedicated to sorting of cells for clinical transplantation. A Becton-Dickinson FACS Vantage, with up to eight parameter sorting capability, turbo sorting, and enhanced electronics and fluidics has been installed and is dedicated to the clinical program.
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