Method and kit for compounding radiolabeled antibodies for in vivo cancer diagnosis and therapy.

摘要

A method and an apparatus for selecting monoclonal antibodies or antibody fragments for use in preparing drugs for cancer detection or therapy, and a kit for compounding selected radiolabeled monoclonal antibodies or antibody fragments for in vivo cancer diagnosis and therapy. The kit provides reagents for: (1) the selection of monoclonal antibodies or antibody fragments which are specific to a tumor specimen; (2) compounding the selected antibodies with a radionuclide material; and (3) quality control testing of the resulting compound. In the method of the invention, multiple aliquots of tumor biopsy material are fixed onto separate test areas of an apparatus which permits reaction with a panel of various monoclonal antibodies or antibody fragments known to react with tumor associated antigens. If one or more of the antibodies or antibody fragments bind to the tumor specimen, the reagents and antibodies or antibody fragments contained in the kit may be combined with an appropriate, commercially available radionuclide. The resulting compounded radiopharmaceutical can then be administered to a patient for immunotherapy of the tumor or for cancer detection by diagnostic imaging of the tumor with an imaging devise to determine the extent and location of cancerous tumours. A quality control kit is used to assure that the radionuclide has been combined with the antibodies or antibody fragments to produce a formulation which will bind the radioactivity to the patient's tumor or tumor specimen.