university of minnesota facility design - pact...
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University of Minnesota Facility Design
Diane Kadidlo MT(ASCP) Facility DirectorUniversity of MinnesotaMolecular and Cellular Therapeutics
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Molecular and Cellular Therapeutics University of Minnesota
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OverviewFacility – 40,000 square feet
ISO Class Production Clean Rooms – 20
Total Operational Staff – 37
Therapeutic Product Classes Supported – 4
18 INDs (14 internal; 4 external)
Over 900 products produced annually
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Molecular and Cellular Therapeutics (MCT) Est.1992
Translate basic discovery to clinical trials, across a wide array or therapeutic classes
Develop and manufacture therapeutic products meeting Good Manufacturing Practices (cGMPs) and current Good Tissue Practices (cGTPs)
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Molecular and Cellular Therapeutics (MCT) Est.1992
Support Phase I/II/III clinical trials of molecular and advanced cell-, tissue-, gene-based, protein, drug therapies for researchers and external contracts
Manufacturing Units
Cell Therapy Laboratory
Protein Production
Pancreatic Islet Transplant
Pharmaceutical SynthesisSlide 5
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Production Capabilities
Hematopoietic TransplantBone Marrow, Peripheral Blood, Cord Blood
Pancreatic Islet TransplantImmunoadoptive Therapies
Natural Killer CellsT Regulatory CellsMesenchymal Stem CellTumor Vaccine
Cardiac RepairBone Marrow MononuclearCardiac Derived Cells
Monoclonal Antibodies/ProteinsActive Pharmaceutical Ingredients (API
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Upper Level (10,000 Sq feet)
5500 Sq ft Clean Space
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MCT Renovation
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Lower Level
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Core Activities
Quality and ComplianceFacility
Control of Critical SystemsEquipment Management
OperationsProduct Development
FinanceProgram Budgets/Forecasts/Cost Accounting
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MCT Organizational Structure
Scientific Director Dr. Mark Paller, MD
Facility Medical DirectorDr. David McKenna, MD
Facility DirectorDiane Kadidlo
Director of IND/IDE Assistance ProgramHarvey Arbit, PhD
ManagersQuality AssuranceFacility & MaterialsOperationsFinance
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Quality Assurance
All 4 Programs (Cell, Islet, Mono aby, API) comply with one Quality Program
Common Quality PlanType V Drug Master File
Centralized QA SystemsDocument Control SystemEquipment ManagementRecord KeepingLot ReleaseAudits
StaffingQuality Manger2 QA Staff
Quality Steering Committee
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Facilities and Services
o Security• Limited Access – Electronic Card Key
o Facility Design• Controlled Environment Areas (ISO Class 5 and 7)• Single pass, isolated differential air pressure rooms,
negative pressure capabilitieso Central Alarm Monitoring
o Equipmento Critical Systems – Heating, Ventilation & Air Conditioning
o Materials and Inventory Managemento Equipment
• Calibration & Preventative maintenance• IQ/OQ/PQ
o Product Development• Project Management
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LOWER LEVEL LOWER LEVEL 7,000 Sq ft Clean Space7,000 Sq ft Clean Space
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University of Minnesota Medical Center, Fairview Clinical Cell Therapy Laboratory
Established 1979 in support of the Blood and Marrow Transplant Program at the University of Minnesota. Moved to MCT Facility 1996
Processes more than 1500 human bone marrow, peripheral blood, umbilical cord blood and tissues annually
Provide translational development expertise for bringing novel cell engineering techniques from research to clinical applications
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UMMC Cell Therapy Lab Clinical Operations - GTP Production
3300 sq ft, separate air handling systemUnclassified space meets the requirements for Class 100,000Clinical production not requiring extensive manipulation. Processes: cryopreservation, positive and negative selection.
Auto/Allo PB, CB & Bone Marrow
Closed system processes – products in bags; biological safety cabinets
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GMP Production
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Production Area Characteristics
Class 10,000 (ISO 7) Clean Suite ISO 5 Biological Safety CabinetsSingle pass, isolated differential air pressure rooms, negative pressure capabilitiesTerminal HEPA Filtration, 20-70 Air Changes/Hr Clean Room surfaces, epoxy liquid flooring coved base, reinforced resinous wall surfacing, and epoxy painted veneer plaster ceilings
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PersonnelMaterialsProductWaste
•Uni-directional workflow
•Production in biosafety cabinets or within closed systems.
•Personnel and product exit through the degowning rooms.
Process Flow
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Environmental Controls
SanitizationContract for janitorial services (non Class 10,000)Programs cleans production suites
Environmental MonitoringWeekly surface testingMonthly viable particlesQuarterly mold and non-viable particles
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