Resource Statement

The current Good Manufacturing Practices (cGMP) facility at the Center for Human Therapeutics (CHT), University of Virginia (UVA) is designed in accordance with U.S. Food and Drug Administration (FDA) as well as other relevant requirements for controlled clean room manufacturing environments and aseptic processing.  The facility includes 6 manufacturing rooms (All six rooms are ISO 7) controlled access corridor, office, and support space. The CHT cGMP is a dedicated multi-use clean room complex for the manufacturing and processing of cellular products, preparation of islet cells for transplantation, production of monoclonal and bispecific antibodies, manufacturing of viral vectors, and production of solution phase nanoparticles for human clinical use. The appropriate cell processing and harvesting equipment and protein purification equipment have been acquired to produce biologics.