Center for Biomedicine and Genetics

The Center for Biomedicine & Genetics (CBG) is a California-licensed, 20, 000 square foot, multi-product biologics manufacturing facility. With twelve ISO 7 production rooms in three product type “zones”, a dedicated aseptic fill suite and a staff with extensive biopharmaceutical experience, the CBG is capable of producing virtually any type of biologic at scales suitable for Phase I through Phase II clinical trials.           

 


Capabilities

  • Aseptic fills
  • Cell therapeutics
  • Plasmid DNA
  • Viral vectors
  • Therapeutic vaccines
  • Recombinant proteins
  • iPSC & hESC products

 

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:

  • Adenovirus, modified vaccinia, and retrovirus production
  • Plasmid DNA production
  • Monoclonal antibody production
  • Hematopoietic cell purification, transduction and propagation