Post on 17-Jul-2020
Baylor College of Medicine Center for Cell & Gene Therapy
GMP/GTP Cell Processing Facilities
Baylor College of Medicine Center for Cell & Gene Therapy
GMP/GTP Cell Processing Facilities
Activity•
Processes cells for adult & pediatric transplant & immunotherapy units
•
HPC, CTL, DC, Vaccines, Islet, Tissues•
~20 INDs
and 500 products annually
Location11th Floor
Feigin Center
Cell Processing FacilityClass 10,000 cleanroom facility
9 Production Rooms
Flow Cytometry Laboratory
Centralized Cryobank
Central Supply Management
Fermenter (30 liter) for plasmids
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)
1616thth
FloorFloorFeigin CenterFeigin Center
Cell Processing MainCell Processing Main
Vector Production FacilityVector Production Facility
Special ProcessingSpecial Processing
Receiving & Receiving & StorageStorage
Cell Cell BanksBanks
Quality Assurance Quality Assurance & Control& Control
Offices &Administration
Offices &Offices &AdministrationAdministration
Cell Processing Facility
60 air changes per hour
Recirculated
air
HVAC Systems
Cell Processing Facility
Single corridor design
CPF Flowpath
Vector Production Facility
60 air changes per hour
100% exhausted air
HVAC Systems
Vector Production Facility
Clean & dirty
corridors
VPF Flowpath
Cell Processing Facility
Gowning & Degowning
Room
Gowning / Degowning
Freezer Room
Gowning & Degowning
Room
Product Storage
Pass through toLonger Term Freezer Room Product Storage
Freezer Room
10 Processing Suites of ~165sq ft
Gowning & Degowning
Room
Processing Suites
Cell Processing Suite
Freezer Room 10 Processing Suites of ~165sq ft
3 Processing Suites of ~165sq ft
Gowning & Degowning
Room
Larger Suites
Larger Suite
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
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
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
Flow CytometryLinked via Pass-through
FlowCytometry
Receiving & Initial StorageShared between CPF & VPF
MaterialsManagement
Pass-through to Released Supply Room(s)
Released MaterialsStorage
Finishes
•
Epoxy painted walls•
Sealed vinyl coved flooring
•
Clean room tiles•
Removable cabinetry
•
Epoxy countertops
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
Thank you