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Center for Biomedicine and Genetics

Center for Biomedicine and Genetics
City of Hope established the Center for Biomedicine and Genetics (CBG) to ensure that its technological innovations are efficiently translated from the research lab to the clinical setting in a cost-effective and expeditious manner.  The center also allows scientific and clinical investigators the freedom to test and refine the most promising new therapeutics. 
 
  • CBG is recognized as the nation's premier academic biologic manufacturing facility (the “gold standard” for such facilities, according to the Food and Drug Administration), and has been lauded by The New York Times for its leading role in devising innovative methods of rapid drug development.
     
  • CBG was founded with generous support from City of Hope’s  National Office Products Industry (NOPI), and is licensed by the state and federal government to produce pharmaceutical-grade therapeutic compounds.
     
  • CBG provides investigators with the isolation, environmental control and security needed for the manufacture of products for human use. It functions as a centralized facility and shared resource, available for multiple investigators both on and off campus.
  • CBG is a founding member of the Association of Academic Biologics Manufacturers (AABM), whose mission is to establish a cooperative network of nonprofit, academic-based biologics manufacturers. The association serves as a national resource that brings together clinical investigators with manufacturing capacity and expertise, develops and shares facility operations knowledge among members, provides quality, manufacturing and regulatory training opportunities, and holds annual meetings.
 
GMP-grade Biologics Production
CBG is designed specifically to accommodate small scale (bench-top) production of GMP-grade biologics, viral and nonviral gene therapeutics and modified patient cell populations to support phase I and II clinical trials at City of Hope.  Adherence to cGMP (current Good Manufacturing Practices) is essential in ensuring the quality and integrity of manufactured biologics.
 
Islet Cell Production
The islet cell production facility at CBG provides isolated islet cells for the islet cell resource centers, which are accelerating the study of islet cell transplantation as a potential cure for type 1 diabetes.
 
Partnership Opportunities
An important component of CBG is our Production Partnership Program, which facilitates the development of innovative biologics created by City of Hope investigators, colleagues and partners to treat patients with cancer, diabetes, viral disease and other life-threatening illnesses, and establishes working relationships with regional biopharmaceutical and academic organizations.

The regulatory expertise and manufacturing skill consistently demonstrated by CBG, coupled with leading-edge bioinformatics and clinical trials groups, makes City of Hope an attractive partner for companies looking to streamline drug development and bring exciting new therapeutic technologies to our patients.
 

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
 

Meet our Staff

Contact Us
For inquiries concerning the CBG manufacturing facility and collaborative opportunities please contact:
 
Larry A. Couture, Ph.D. or
David Hsu, Ph.D.
Center for Applied Technology Development
City of Hope
1500 E. Duarte Road
Duarte, CA 91010
626-256-8728
Center for Applied Technology Development (CATD)
The Sylvia R. and Isador A. Deutch Center for Applied Technology Development (CATD) offers broad expertise in technology transfer and licensing, biologics manufacturing, quality assurance and regulatory affairs.

Beckman Research Institute of City of Hope is internationally  recognized for its innovative biomedical research.
City of Hope is one of only 41 Comprehensive Cancer Centers in the country, the highest designation awarded by the National Cancer Institute to institutions that lead the way in cancer research, treatment, prevention and professional education.
Support Our Research
By giving to City of Hope, you support breakthrough discoveries in laboratory research that translate into lifesaving treatments for patients with cancer and other serious diseases.
 
 
 
 
Learn more about City of Hope's institutional distinctions, breakthrough innovations and collaborations.
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