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).
Programs and Capability Examples
Manufactured products
- Manufacturing of hematopoietic stem cells derived from peripheral blood (PB), umbilical cord blood (UCB), and bone marrow (BM)
- Isolation and purification of allogeneic and autologous pancreatic islet cells
- Isolation and expansion of CD4/CD25 regulatory T cells (UCB and PB)
- Ex vivo expansion of UCB hematopoietic stem cells (HSCs)
- Isolation and expansion of mesenchymal stromal cells (MSCs)
- Development of tumor vaccines
- Isolation and expansion of allogeneic natural killer (NK) cells
- Monoclonal antibody production/Targeted immunotoxins
- Synthesis of active pharmaceutical ingredients (API)
- Master cell bank and working cell bank manufacturing
Processes
- Full equipment change control, supported by IQ/OQ/PQ
- Quality control assay development, qualification, and validation
- Materials requirements planning and materials qualification
- Stability testing for products and manufacturing
- Process validation from design to implementation
- Cryopreservation program development and qualification
- Development of shipping validation protocols
- Translational product development from pre-clinical/scale up studies through process validation and clinical production
The University of Minnesota Office of Academic Clinical Affairs (OACA), through resources and personnel at Molecular and Cellular Therapeutics (MCT), 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.