The mission of the UMBI GMP Training and Biomanufacturing Program is to provide contract manufacturing capability to the biotech industry and training to both the biotech industry and to University of Maryland students. The contract manufacturing will be performed under CGMP (Current Good Manufacturing Practice) as regulated by the FDA. Material produced there will be appropriate for use in Phase I/II clinical trials and/or to facilitate research in scale up production processes in partnership with other CGMP production companies. Additionally, training in GMP operations will be offered.

The GMP Training and Biomanufacturing Program is located on the 4th floor of a recently completed 140,000 sf building at the Shady Grove campus of the University System. Space available to the program includes 6000 sf of clean rooms, 1100 sf of QC labs, 2000 sf of general lab space, and support space (office and storage). A description of the facility and its capabilities in manufacturing and training will be presented.