Molecular and Cellular Therapeutics Facility
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Molecular and Cellular Therapeutics Facility

University of MinnesotaFacility DesignDiane Kadidlo MT(ASCP), SBBOperations ManagerUniversity of MinnesotaMolecular and Cellular Therapeutics Facility

Molecular and Cellular Therapeutics FacilityUniversity of Minnesota

Molecular and Cellular TherapeuticsFacility• Multi-use facility capable of developing andproducing biotherapeutic agents for humanuse, including cellular- and tissue-basedproducts• Provides expertise to bridge the gap betweenresearch and investigational cell and tissuebasedtherapies for human use.

Molecular and Cellular Therapeutics(MCT) Facility Est.1992• Manufactures cell-, tissue-, and gene-basedproducts for Phase I/II clinical trials of U of MNresearchers and external contracts.• Responsibility producing investigationalbiological products using current GoodManufacturing Practices (cGMPs) and currentGood Tissue Practices (cGTPs)• Includes two laboratories – the Cell TherapyClinical Laboratory and Pancreatic Islet CellLaboratory

Upper Level (10,000 sq ft.)5500 sq ft Clean Space

LOWER LEVEL7,000 Sq ft Clean Space

MCT Facility• Limited Access – Electronic Card Key• Controlled Environment Areas◦ HVAC System◦ 4 Air Handling Units• Central Alarm Monitoring Critical Systems• Materials and Inventory Management• Equipment Management◦ Calibration◦ Preventative Maintenance◦ Equipment IQ/OQ/PQ

MCT Staff•Facility Director•Managers◦Operations◦Facility & Materials Management•3 staff◦Finance & HR◦Quality Assurance•2 Staff

Facility QA Activities• Document Change Control◦Batch Records, Forms, SOPs, Cell Processing Records◦Materials Specifications• Lot Review and Release◦CMC Quality Indices• Equipment◦Calibration, Maintenance, IQ/OQ/PQ• Product Development Process◦Process Validation• Environmental Monitoring• Facility (Type V) Master File• Deviations & CAPA System◦Risk Management Plan• Audits

University of Minnesota Medical Center, FairviewClinical Cell Therapy Laboratory• Established 1979 in support of the Blood and MarrowTransplant Program at the University of Minnesota. Moved toMCT Facility 1996• Processes more than 1500 human bone marrow, peripheralblood, umbilical cord blood and tissues annually• Provide translational development expertise for bringing novelcell engineering techniques from research to clinicalapplications

LOWER LEVEL7,000 Sq ft Clean Space

UMMC Cell Therapy LabClinical Operations -GTP Production• 3300 sq ft, separate air handling system• Clinical production not requiring extensivemanipulation.• Processes: cryopreservation, positive andnegative selection.◦Auto/Allo PB, CB & Bone Marrow• Closed system processes – products in bags;biological safety cabinets

Translational Cell Therapy Laboratory

Production Area Characteristics•Class 10,000 Clean Suite•Single pass, isolated differential air pressurerooms, negative pressure capabilities•Terminal HEPA Filtration, 20-70 AirChanges/Hr•Clean Room surfaces, epoxy liquid flooringcoved base, reinforced resinous wall surfacing,and epoxy painted veneer plaster ceilings

Products Manufactured at UMN underIND• Immunoadoptive Therapies◦Allogeneic Natural Killer Cells (CB & PB)◦T Regulatory Cells (CB & PB)◦Mesenchymal Stem Cells◦Tumor Vaccine (Breast Ca, Renal, Melanoma)•Master Cell Banks• Cardiac◦Bone Marrow Mononuclear Cells◦Skeletal Myoblasts• HSC◦Multiadult Progenitor Cells (MAPC)

UMMC Cell Therapy ClinicalLaboratory Staff•Medical Directorship◦Dr. Jeffrey McCullough MD◦Dr. David McKenna MD•Technical Supervisor◦MT(ASCP), SBB•2 Lead Technologists◦Translational & Development◦Clinical Operations•8 Staff Technologists◦MT(ASCP) 1-15 years•1 IT Specialist

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