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
  •  One media preparation suite
  • One vial fill room
  • Staging room
  • Freezer and liquid nitrogen storage room
  • Receiving and storage
  • Specialized bioreactors and CliniMACS Prodigy
  • 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

Contact Us

Click here to contact the iPSC Core and Biomanufacturing Center.