Molecular and Cellular Therapeutics Facility

Academic Health Center
University of Minnesota

1900 Fitch Ave.
University of Minnesota
St. Paul, MN 55108
Phone: (612) 624-0765
FAX: (612) 624-1777
Contact: Randall Tlachac, Program Director

MCT Facility Homepage

Biomedical/Bioscience Field

Biological materials
Biotherapeutics
Clinical trials scale-up
Good Manufacturing Practices (cGMP)

The MCT's primary mission is to ensure that biological materials produced at the University of Minnesota for human clinical trials are of the highest quality and meet the current Good Manufacturing Practices (cGMP) regulations enforced by the Federal Food and Drug Administration (FDA). Its secondary mission is to partner with biotechnology industries in providing a facility to produce clinical materials necessary for phase I and II clinical trials.

Business

Services
Contract research

Services

  • On-campus cGMP process space for biologicals needed for clinical trials
  • Assistance with cGMP process documentation
  • Assistance with IND preparation
  • Regulatory consultation
  • Assistance with cGMP process design and implementation
  • Support with Quality Assurance requirements
  • Support for calibration, maintenance, and validation of equipment and processes.
  • cGMP training for process operators.

    Technical Support Contact