GMP Services
CBC provides a full range of cGMP-compliant biomanufacturing services for academic and industry-based companies, to support IND-enabling clinical trials. Following FDA Guidelines and current Industry Standards, the CBC has a comprehensive range of systems and procedures in place to ensure the highest product quality is produced under the purview of a robust Quality Management System (QMS):
- Inventory Management
- Equipment Validation and Routine
PM Activities - 24-7 Facility and Equipment Monitoring
- Environmental Monitoring
- Standard Operating Procedures
- Vendor Management and Quality Audits
The CBC houses About 6,600 Square Feet of Cleanroom Space including:
- Seven cGMP cleanroom (ISO 7) cell production
suites - One media preparation suite
- One vial fill room
- Staging room
- Freezer and liquid nitrogen storage room
- Receiving and storage
- Specialized bioreactors and CliniMACS Prodigy
instruments - Custom QC Method Development and Validation
GMP manufacturing capabilities include, but are not limited to:
- Manufacturing cGMP Master Cell Banks (MCBs) and
Working Cell Banks (WCBs) - Autologous Cell Products
- Allogeneic Cell Products
- iPSC Reprogramming
- iPSC-Derived Cells
- Gene-edited Cell Therapies
- Retinal Cells
- Cellular Immunotherapies
- NK Cell Therapies
- CAR T and TCR Cell Therapies
GMP Quality Control capabilities include:
- Comprehensive Cell Bank Characterization Testing
- Identity, Viability, Composition, Activity, Stability
- Sterility, Mycoplasma, Endotoxin
- Flow Cytometry
- Droplet digital PCR (ddPCR)
- Custom QC Method Development and Validation
