Dramatic advances in understanding somatic cell and tissue development, identification of numerous cytokines and genes, and sophisticated cell separation and culture methods have made it challenging for individual investigators and startup firms to develop novel cell-, tissue-, and gene-based therapies. Furthermore, FDA regulatory requirements necessitate that these investigational products be produced in accordance with current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP).
The University of Minnesota Academic Health Center (AHC), through resources and personnel at Molecular and Cellular Therapeutics, has demonstrated a commitment to ensure world class development and production of novel biotherapeutic products. Our comprehensive strategic quality process--composed of a cGMP/cGTP based Quality Assurance Program, Product Development Process, and Risk Management--helps to assure the implementation of a strategy consistent with clinical and development objectives.
MCT is supported by a complete set of administrative services and technical team skilled in the most advanced biotechnology methods. MCT's core competencies are illustrated below:
We have products at various stages of developmental maturity and complexity, supported by the most advanced biotechnology test methods. Examples of our current programs and capabilities include: