The primary objective of Core 9001 (Radiopharmacy) is to provide support to Project 0005, Human Radioimmunotherapy Studies. Yttrium-90 radiolabeled chimeric T84.66 anti-CEA antibody will be used in Phase I and Phase II clinical trials for colon cancer patients at the City of Hope National Medical Center. Radiopharmacy will support Project 0005 by providing expertise and facilities to prepare radiolabeled antibodies and to provide quality control for these reagents. A protocol for large- scale preparation of IN-111 or Y-90 labeled monoclonal antibodies will be developed and their biochemical and radiological stabilities will be studied. IND applications for these antibody preparations will be filed for human studies. The quality assurance mechanisms include the maintenance of all NRC and FDA requirements for the radiopharmaceutical preparations and the optimization of radiopharmacy practices, such as safe handling of radioactive materials and documentation of procedures, records and compliance failures and solutions. This Core will also play a central role in regard to troubleshooting preclinical and clinical problems involving radiolabeled antibody preparations in other projects and cores of the program.
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