City of Hope's Center for Biomedicine and Genetics (CBG), a purpose-built 20,000-sq.-ft., two-story facility, was designed to allow investigators on and off campus to efficiently translate research from the lab into the clinical sett ing by giving them the freedom to test and refine the most promising new therapies quickly.

Licensed by the California Food and Drug Branch as a multi-product biologic manufacturing facility, the CBG is desi gned to accommodate Phase I/II-scale production of plasmid DNA, recombinant proteins, viral-based biologics, and engin eered cells. These very different processes may be performed simultaneously within nearly 10,000 square feet of classi fied biologics manufacturing space in three specialized zones: the Viral Vector zone, capable of adenovirus, retrovir us, adeno-associated virus and lentivirus production; the DNA and Recombinant Protein zone, where plasmid DNA for the NGVL and monoclonal antibody production takes place; and the Cell Engineering zone, which can handle various cell mani pulation and expansion and islet cell isolation. Product isolation in each zone is maintained by separate entries, gow ning, air-handling, and exits to ensure compliance with current Good Manufacturing Practices. In addition, the Center offers a class 100/1000 fill and finish, 2000 gallons/day pure water and WFI clean steam for steam-in-place processes , complete facility and systems monitoring and total security and access control.

The Center's management team was recruited from the biopharmaceutical sector and has considerable collectively expe rtise in regulatory affairs, product and process development, cGMP compliance as well as specific expertise in plasmid , adenovirus, retrovirus, monoclonal antibody, cell processing and other related technologies.

For more information: http://www.cityofhope.org/CBG