Facility

Molecular and Cellular Therapeutics, built in 1992 and renovated in 1998, is a 36,000-square-foot, free-standing, state-of-the-art facility located on the University of Minnesota St. Paul campus. In accordance with the FDA regulations, the facility meets current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) standards for production and testing of biotherapeutic products. 

A total of 11,000 square feet of dedicated ISO Class 7 Controlled Environment Areas and ISO Class 5 areas are available for the development and production of advanced cell-, tissue-, and gene-based therapies. There are 19 clean rooms, with the space divided into five production areas, several with negative pressure, Biosafety Level 2 capabilities.

The flexible, compliant design of the facility accommodates investigator-specific needs regarding bio-safety levels, bio-containment requirements, and project-specific gowning areas.

 As part of the University of Minnesota Academic Health Center, Molecular and Cellular Therapeutics has developed extensive, highly effective relationships with many departments and centers at the University, including the Stem Cell Institute, the Diabetes Institute for Immunology and Transplantation, the Cancer Center, and University of Minnesota Medical Center, Fairview.

The facility is also an excellent resource for investigators from other research institutions and commercial firms, such as start-up biotherapeutic firms, that need development services, quality management, and regulatory services for testing novel biological therapeutic products.