The WHCC cGMP facility occupies 11,000 square feet in the Diabetes Research Institute (DRI) on the medical campus of the University of Miami and is co-shared with the DRI. The space was designed to meet the demands of investigators whose endeavors in translational research require compliance with current Good Manufacturing or Good Tissue Practice (cGMP or cGTP) regulations.
The facility is equipped with cGMP/cGTP compliant human cell processing laboratories that are staffed with dedicated personnel who undergo continuous training. A Quality Assurance program is in place to monitor and verify compliance with regulations and to ensure consistent product quality. The laboratories are equipped to process human cells and tissues, including cadaveric pancreata (to harvest islets) and hematopoietic cells (vertebral body marrow, mobilized peripheral blood, cord blood, iliac crest aspirates, and mesenchymal stem cells). A renovation of the WHCC cGMP/cGTP Cell Processing Facility (cGMP/cGTP Facility) has been completed, thereby providing space for the performance of 4 cell based procedures at any given time.
Procedure rooms are class 10,000, positive pressure, laminar flow, temperature regulated clean rooms designed for human tissue processing and equipped for cell separation, purification, culture and cryopreservation.
Access to the facility can be gained by 1) having a project that has officially entered the WHCC or 2) fee for service or other cooperative arrangements with WHCC (for information, contact: 305-243-8091). |