Method for compounding and testing patient specific monoclonal a

Details Method for compounding and testing patient specific monoclonal a Method for compounding and testing patient specific monoclonal a

1986-04-09

1990-07-10

Rosen, Sam

Chemistry: analytical and immunological testing

Involving production or treatment of antibody

Monoclonal antibody

424 11, 424 858, 424 8591, 435 7, 436512, 436813, 935107, A61K 39395, G01N 33574, G01N 33577

Patent

active

049406701

ABSTRACT:
A kit for compounding radiolabeled monoclonal antibodies or antibody fragments for in vivo cancer diagnosis and therapy, which 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 are 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 imaging of the tumor with an imaging device to determine the extent and location of cancerous tumors. 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.

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