City of Hope established the Center for Biomedicine & Genetics (CBG) in 2001 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 allowed scientific and clinical investigators the freedom to test and refine the most promising new therapeutics. 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 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 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.