About Our Facility
CBG’s two-story, 20,000 square-foot, state-of-the-art secured building features:
 
  • 10,000 square feet of biologics manufacturing space (clean rooms) in three specialized zones:
     
  • Viral vector zone – processes in development include adenovirus, retrovirus, adeno-associated virus, lentivirus
  • DNA and protein production zone – 13 production and purification suites served by dedicated aseptic fill-and-finish with air-handling system for class 100/1000 sterile materials, equipment, glassware autoclave/glasswasher and quarantine areas
  • Cell engineering zone – processes in development include ex vivo T-cell and islet cell manipulation

These zones have separate entries, gowning, air-handling and exits to ensure complete isolation of simultaneous production processes.
  • Water facilities: clinical-grade water generator system (2,000 gallon/day capacity); water for injection steam generator for sterilization
  • Cryogenics storage rooms
  • Irradiator facilities
  • Four-gas storage system
  • Quality Control, Quality Assurance and product release storage and management

In addition, this facility supports phase I and II clinical trials at City of Hope through pilot-scale cGMP (current Good Manufacturing Practices) production of:
 
  • Biologics
  • Viral and nonviral gene therapeutics
  • Modified patient cell populations

The design of the facility allows for these three processes to be performed simultaneously, under cGMP, in functionally isolated areas of the building. Further important features include:
 
  • WFI clean stream
  • BL-3 containment capability
  • Key-card-restricted access
  • Provisions for CO2, medical grade air, N2 or other gases
  • Validated monitoring of all equipment, including HVAC and pressurization equipment

Technological Expertise
While CBG is designed to accommodate a wide variety of biological production and purification processes, specific expertise exists in the following areas:
 
  • AAV/adenovirus and retrovirus production 
  • Plasmid DNA production
  • Monoclonal antibody production
  • Hematopoietic cell purification, transduction and propagation