The Biologics Production Facility provides an environment that is compliant with Good Manufacturing Practices (GMP) regulations, and is intended for the manufacture, processing, cryopreservation, and/or storage of cells, tissues, and cellular and tissue derived products for administration to humans, such as bone marrow, peripheral blood stem cells, cord blood cells, and vaccines. Certain non-cellular products may also be appropriate for manufacture within the facility. A comprehensive Quality System is in place that applies to all projects within the facility, including controlled access, personnel, and training; documents, production, and process controls; environmental monitoring; and management of occurrences, deviations, adverse events, and corrective action. The space is appropriately divided into controlled access areas capable of achieving Class 100,000 to Class 100 (ISO 8-5) air quality.
Research projects that have reached translational or clinical phase of development are reviewed and approved by a multidisciplinary Scientific Advisory Committee. Technical and scientific assistance is provided to advance these projects and to interface as needed with applicable regulatory agencies or Institutional Review Board.