This Core is the biologic materials production (manufacturing) core. Core activities, the production of plasmid DNA, ex-vivo genetic modification and expansion of T-cell products and production and conjugation of monoclonal antibodies will be performed in The Center for Biomedicine and Genetics (CBG) on the campus of The City of Hope National Medical Center. The CBG is a fully licensed biologics manufacturing facility operated under the principles of current Good Manufacturing Practices (cGMP) and Good Tissue Practices (cGTP) commensurate with Phase 1/11clinical trials. The facility consists of controlled access Class 10,000 manufacturing suites, quarantined and released material areas, Quality Control laboratory, continuous process monitoring, USP purified water production, USP process gas farm, fully validated preparative equipment (autoclave, glasswash, depyrogenation oven) and biologics production equipment as required (incubators, centrifuges, bioreactors, chromatography equipment, etc.) The CBG is staffed with fully trained professionals who perform manufacturing, quality assurance and quality control functions as well as management staff with extensive biotechnology and pharmaceutical industry experience. The purpose of the CBG is to provide cGMP/cGTP quality clinical trials material for the SPORE. All manufacturing and release testing is performed according to standard operating procedures using materials that are inspected and released by the Quality Assurance Department. Manufacturing staff produces batch records of production that are reviewed by Quality Assurance prior to the release of any clinical materials. The Quality Control department performs raw material and (certain) release testing on drug intermediates and final products. Some testing (i.e. sterility, endotoxin) is performed by qualified third party providers including the City of Hope Microbiology and General Clinical Research Center laboratories. The CBG is also a National Gene Vector Laboratory for plasmid DNA production and has experience with the manufacturing of monoclonal antibodies and T-cell products. The staff of the CBG manages all support services such as equipment maintenance and calibration, cleaning, gowning, environmental monitoring and other facility-related activities.
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