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.
MCT's overall design, architectural systems and finishes meet regulatory requirements and are consistent with the ability to integrate process equipment and process utilities (Figures 1 and 2).
Figure 1-MCT Lower Level: Cancer Center/Regenerative Medicine Program (yellow) for developmental work (preclinical testing, large scale development, pre-validation runs-Room 40) and clinical production (Rooms 33, 35, 38). All clinical products are manufactured by the UMMC Fairview Cell Therapy Clinical Laboratory staff. As shown in orange, additional space (Rooms 49, 51, and 54) is available should activities justify the need.
Figure 2-MCT Upper Level: The upper level is occupied by the Pancreatic Islet Transplant Program and Active Pharmaceutical Ingredient Synthesis/Biotherapeutic Protein Program.
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.
Current Core Activities
- Quality and Compliance
- Operations/Quality/Materials Management
- Control of Critical Systems
- Program Budgets/Forecasts/Cost Accounting
- Business Plan Development
- Project Management
- Equipment Management
- Document Change Control
- Process Development/Qualification/Validation
Facility FDA Registration
The MCT Facility's Drug Master File (DMF) was submitted to the FDA originally on September 7, 2004. The DMF provides confidential detailed information about the MCT Facility, processes, and articles used in the manufacturing,processing, packaging, and storing of biotherapeutics and drugs. While the submission of a DMP is not required by law or FDA regulation, it is submitted solely at the discretion of the holder in support of IND or New Drug Applications.