Core C core Director Yazaki, Paul Principal investigator: Raubitschek. AndrewDESCRIPTION:The responsibility of Core C, Clinical Production, is to manufacture recombinant antibodies, antibodyfragments and immunocytokines of sufficient quantity and purity for the Phase I therapy studies that are thefocus of this Program Project. To achieve these goals, Core C has three support functions: 1) Production forclinical 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), whichhouses 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 Coperates within the CBG and has previously produced clinical lots of the chimeric T84.66 antibody, T84.66minibody, T84.66 diabody and humanized hT84.66-M5A antibody. Standard operating procedures are inplace for pilot scale manufacturing at the one to two gram scale. This manufacturing includes generation of amaster cell bank, large scale bioreactor production, purification, conjugation if required, and vialing. Duringthis project period, the antibodies proposed for manufacture include the hT84.66-M5A antibody, T84.66-IL2immunocytokine, 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. QualityAssurance biosafety release tests of cells, purified bulk and final products are according to the safetyguidelines set forth in the FDA 'Points to consider in the manufacture and testing of monoclonal antibodyproducts for human use' and US Federal Code of Regulations. Achieving these production goals will providethe Program Project with the current and future generations of radiation and immunotherapy agents for thetreatment of solid tumors.
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