Development of Monoclonal Antibody Based Products for Medical Research and Diagnostic Imaging

摘要

Two major areas of application of monoclonal antibodies were examined: the development of products to support the 'Antibody Delivery System', a parent-specific and variable antibody formula drug system for use in imaging and treatment of cancer, and the development of an antibody-based radiopharmaceutical for imaging occult abscesses and other conditions involving high concentrations of white blood cells. In development of the Antibody Delivery System components, methods for characterization and purification of monoclonal antibodies were developed and validated; a dot immunoassay test, under the name RhoDot (TM) Immunoassay, was developed for matching antibodies to putative tumor specimen: a radioimmunoassay, under the name PhoChek (TM) Quality Control Test Kit for Radiolabeled Antibodies, was developed and commercialized for measuring the immunoreactive fraction of radiolabeled antibodies specific to colorecal cancer; and a patient-specific quality control test was developed. In development of the antibody-based radiopharmaceutical for imaging occult abscesses, a candidate antibody was identified and produced under U.S. Food and Drug Administration standards preparatory to human clinical trials.