CLINICAL PRODUCTION

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The responsibility of Core C, Clinical Production, is to manufacture recombinant antibodies, antibody fragments and immunocytokines of sufficient quantity and purity for the Phase I therapy studies that are the focus of this Program Project. To achieve these goals, Core C has three support functions: 1) Production for clinical trials, 2) Purification for clinical trials and 3) Conjugation and Vialing for clinical trials. The City of Hope has built a $12 million, 20,000 sq. ft., Center for Biomedicine and Genetics (CBG), which houses a pilot Biological Manufacturing Facility operating under current Good Manufacturing Practice (cGMP). The CBG provides Quality Assurance, Quality Control as well as maintenance of the facility. Core C operates within the CBG and has previously produced clinical lots of the chimeric T84.66 antibody, T84.66 minibody, T84.66 diabody and humanized hT84.66-M5A antibody. Standard operating procedures are in place for pilot scale manufacturing at the one to two gram scale. This manufacturing includes generation of a master cell bank, large scale bioreactor production, purification, conjugation if required, and vialing. During this project period, the antibodies proposed for manufacture include the hT84.66-M5A antibody, T84.66-IL2 immunocytokine, and a humanized antibody for pretargeting. In addition the commercial antibodies, Herceptin and Avastin and a hapten for pretargeting will be conjugated with the chelate DOTA. Quality Assurance biosafety release tests of cells, purified bulk and final products are according to the safety guidelines set forth in the FDA