Core B Preclinical Therapeutics will provide purified antibodies for conjugation and use in Projects 1 and 2 to generate novel caveolae-targeting imaging and therapeutic agents. The Core will also provide analytical services to ensure quality control of reagents that will be used for preclinical animal testing. Antibodies generated in Core B will be conjugated to radionuclides in Core D for use in Project 1. Antibodies will be provided to Project 2 for conjugation to various chemotherapies, and testing in preclinical metastatic models of disease. Reagents developed in Projects 1 and 2 will be rigorously evaluated for quality control using analytical services provided by Core B prior to use in any animal studies. Core B will also provide support services and guidance for the cGMP production of the humanized antibody and therapeutic agents destined for clinical trials, including scale-up, process development, validation, batch testing, compliance, and providing technical expertise as needed to ensure successful technology transfer and quality manufacturing of finished goods.
The purpose of the Antibody Therapeutics Core is to provide antibodies, reagents, and services to support research activities in Projects 1, 2, and 3. Analytical services provided by Core B, are to ensure quality control of antibody-derived reagents produced in the projects and in other cores intended for use in preclinical animal studies. In addition to these services, the core will support technology transfer of production and analytical protocols to outside organizations providing cGMP services, and analyze cGMP-produced antibody-derived reagents intended for use in animal studies, and eventual clinical imaging and therapeutic testing.
