Capabilities

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 an ISO-based Quality Assurance Program, Product Development Process, and Regulatory Support--helps to assure the implementation of a strategy consistent with clinical and development objectives.

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:

• Isolation and expansion of the multipotent adult progenitor cell (MAPC)
• Isolation and expansion of CD4/CD25 regulatory T cells
• Ex vivo expansion of umbilical cord blood (UCB) hematopoietic stem cells (HSC)
• Development of tumor vaccines
• Isolation and expansion of allogeneic natural killer (NK) cells
• Isolation and expansion of MFG-TKiNG engineered T cells.
• Full capability for quality control testing of products
• Full equipment change control, supported by IQ/OQ/PQ
• Purification of IgM monoclonal antibodies
• Development of bioanalytical methods
• Master Cell Bank and Working Cell Bank manufacturing, testing and storage
• Quality Control assay development, qualification and validation
• Full 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 and reports to support the need to transport products worldwide