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Baylor College of Medicine Center for Cell & Gene Therapy
GMP/GTP Cell Processing Facilities
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Baylor College of Medicine Center for Cell & Gene Therapy
GMP/GTP Cell Processing Facilities
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Activity•
Processes cells for adult & pediatric transplant & immunotherapy units
•
HPC, CTL, DC, Vaccines, Islet, Tissues•
~20 INDs
and 500 products annually
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Location11th Floor
Feigin Center
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Cell Processing FacilityClass 10,000 cleanroom facility
9 Production Rooms
Flow Cytometry Laboratory
Centralized Cryobank
Central Supply Management
Fermenter (30 liter) for plasmids
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Flow Patterns
No clean & dirty corridorsTwo-way trafficIn-process stocking of roomsMultiple products per room
2
Materials flowpath
CAGT CELL PROCESSING FACILITY Traffic Patterns
Materials Staff Waste (Plasmid Production) (Plasmid Production)
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1616thth
FloorFloorFeigin CenterFeigin Center
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Cell Processing MainCell Processing Main
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Vector Production FacilityVector Production Facility
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Special ProcessingSpecial Processing
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Receiving & Receiving & StorageStorage
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Cell Cell BanksBanks
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Quality Assurance Quality Assurance & Control& Control
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Offices &Administration
Offices &Offices &AdministrationAdministration
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Cell Processing Facility
60 air changes per hour
Recirculated
air
HVAC Systems
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Cell Processing Facility
Single corridor design
CPF Flowpath
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Vector Production Facility
60 air changes per hour
100% exhausted air
HVAC Systems
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Vector Production Facility
Clean & dirty
corridors
VPF Flowpath
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Cell Processing Facility
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Gowning & Degowning
Room
Gowning / Degowning
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Freezer Room
Gowning & Degowning
Room
Product Storage
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Pass through toLonger Term Freezer Room Product Storage
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Freezer Room
10 Processing Suites of ~165sq ft
Gowning & Degowning
Room
Processing Suites
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Cell Processing Suite
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Freezer Room 10 Processing Suites of ~165sq ft
3 Processing Suites of ~165sq ft
Gowning & Degowning
Room
Larger Suites
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Larger Suite
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Freezer Room 10 Processing Suites of ~165sq ft
3 Processing Suites of ~165sq ft
3 Unidirectional Processing Suites of 150-200sq ft
(Cells/Vectors)
Gowning & Degowning
Room
Unidirectional Suites
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Freezer Room 10 Processing Suites of ~165sq ft
3 Processing Suites of ~165sq ft
3 Unidirectional Processing Suites of 150-200sq ft
(Cells/Vectors)
Staff FlowpathMain Facility
Gowning & Degowning
Room
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Gowning & Degowning
Room
Freezer Room
3 Processing Suites of ~165sq ft
3 Unidirectional Processing Suites of 150-200sq ft
(Cells/Vectors)
10 Processing Suites of ~165sq ft
Staff FlowpathSpecial Processing
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Flow CytometryLinked via Pass-through
FlowCytometry
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Receiving & Initial StorageShared between CPF & VPF
MaterialsManagement
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Pass-through to Released Supply Room(s)
Released MaterialsStorage
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Finishes
•
Epoxy painted walls•
Sealed vinyl coved flooring
•
Clean room tiles•
Removable cabinetry
•
Epoxy countertops
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Major Decisions•
Single corridor design
•
Increased capacity: 16 Processing Rooms•
Larger Rooms >165 sq ft + 6 double rooms
•
3 unidirectional rooms•
Recirculated
Air + 3 100% exhaust rooms
•
Improved gowning areas•
Separate room for irradiator
•
Similar design for each suite•
Wireless alarm system
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Thank you