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.
Inquiries and consultation can be directed to the facility Medical Director, Dr. Phyllis Warkentin, or Operations Manager, Charles Branson 402-559-6009.