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METHOD FOR DETERMINING ANTIBODIES TO MEDICINES AGAINST HUMAN OR HUMANIZED MEDICINE ANTIBODIES WITH SUPPRESSED EFFECTIVE FUNCTION
METHOD FOR DETERMINING ANTIBODIES TO MEDICINES AGAINST HUMAN OR HUMANIZED MEDICINE ANTIBODIES WITH SUPPRESSED EFFECTIVE FUNCTION
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机译:确定具有有效功能的抗人或人为药用药物的药物的方法
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摘要
Herein is reported an anti-drug antibody immunoassay for the determination of the presence of an anti-drug antibody against an effector function suppressed human or humanized drug antibody in a sample comprising the incubation of a sample comprising mammalian blood serum with full length human Fcgamma receptor I or an Fc-region binding fragment thereof so that a complex between the anti-drug antibody against the effector function suppressed human or humanized drug antibody present in the sample and the human Fcgamma receptor I or the Fc-region binding fragment thereof forms, whereby the full length human Fcgamma receptor I or the Fc-region binding fragment thereof is conjugated to a detectable label, and the determination of the formed complex by the detectable label.
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