The goal of this Program Project is to demonstrate that bioengineered antibodies can be effectively used for the imaging and therapy of human cancer. The responsibility of Core C, Clinical Production, is to produce bioengineered antibodies of sufficient quantity and purity for the human imaging and Phase I/II therapy studies that are the focus of this program. To achieve these goals, Core C has two support functions: 1) Production for clinical trials and 2) Purification for clinical trials. The City of Hope has recently built a $12 million, 20,000 ft2, Center for Biomedicine and Genetics (CBG). The CBG houses a Biological Manufacturing Facility in which all Core C operations for clinical production will be conducted under current Good Manufacturing Procedures. In addition, the CBG will provide regulatory assistance, process development, Quality Control and Product Release services. Based on the previous clinical productions of the chimeric T84.66 antibody and T84.66 minibody, standard operating procedures have been established. A Master Cell Bank, and Working Cell Bank will be made and large scale production is expected to produce 3-4 grams of the T84.66 diabody, the T84.66 minibody, a humanized T84.66 antibody and a Prostate Stem Cell Antigen antibody. These bioengineered antibodies will be produced in a medium scale hollow fiber bioreactor, which produces a concentrated and reasonably pure harvest. The bioengineered antibodies will be purified by a combination of ceramic hydroxyapatite chromatography and ion exchange chromatography. The cell lines and purified products will be tested according to the Quality Assurance safety guidelines set forth in the FDA """"""""Points to consider in the manufacture and testing of monoclonal antibody products for human use."""""""" Achieving these production goals will provide the Program Project with the current and future generations of radiolabeled imaging and therapeutic agents.
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