The Minnesota Molecular and Cellular Therapeutics Facility: A State-of-the-Art Biotherapeutics Engineering Laboratory

• Published in: Transfusion medicine reviews Vol. 19; no. 3; pp. 217 - 228
• Main Authors: McKenna, David H., Kadidlo, Diane M., Miller, Jeffrey S., Orchard, Paul J., Wagner, John E., McCullough, Jeffrey
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-07-2005
• Subjects: Academic Medical Centers; Biological Products - chemistry; Biological Products - isolation & purification; Bone Marrow Transplantation; Cancer Vaccines - metabolism; Clinical Trials as Topic; Engineering; Graft vs Host Disease - prevention & control; Hematopoietic Stem Cells - cytology; Humans; Killer Cells, Natural - cytology; Laboratories - organization & administration; Lymphocyte Activation; Minnesota; Minnesota
• ISSN: 0887-7963; 1532-9496
• DOI: 10.1016/j.tmrv.2005.02.007

Molecular-, gene-, cellular-, and tissue-based therapies have become increasingly acceptable modes of clinical therapy. Regulatory requirements and oversight have increased, and the need for facilities suited for production of such therapies has become more apparent. The Minnesota Molecular and Cellular Therapeutics Facility is a state-of-the-art laboratory at the University of Minnesota, Saint Paul, Minn, that was designed to support production of biologic products for use in clinical trials. A talented staff experienced in the medical, scientific, technical, and regulatory aspects of the development, production, and administration of such products complements the special design and construction of the facility. Hematopoietic stem cells (HSCs) are manipulated for transplant, and current clinical trials involving novel therapies include the use of allogeneic natural killer (NK) cells and tumor vaccines for the treatment of various malignancies and suicide gene-transduced T cells for the prevention of graft-vs-host disease (GVHD) after bone marrow transplantation. Other therapies, including marrow-derived multipotent adult progenitor cells (MAPCs), umbilical cord blood (UCB) stem cells, regulatory T cells, skeletal myoblasts, and monoclonal antibodies, will be used to treat a spectrum of disease and are in various phases of development. Here we provide an overview of the Minnesota Molecular and Cellular Therapeutics (MMCT) Facility, detailing our approach to the manufacture of novel therapeutics and highlighting current and future activities.