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    MULTIPLEXED CHROMATOGRAPHY-IMMUNOASSAY METHOD FOR THE CHARACTERIZATION OF CIRCULATING IMMUNE COMPLEXES
    5.
    发明授权
    MULTIPLEXED CHROMATOGRAPHY-IMMUNOASSAY METHOD FOR THE CHARACTERIZATION OF CIRCULATING IMMUNE COMPLEXES 有权

    公开(公告)号：EP2823310B1

    公开(公告)日：2018-06-20

    申请号：EP13707879.6

    申请日：2013-03-07

    申请人： F. Hoffmann-La Roche AG

    发明人： DAHL, Uwe ,  JORDAN, Gregor ,  STAACK, Roland

    IPC分类号： G01N33/564 ,  G01N33/68 ,  G01N33/94

    CPC分类号： G01N33/564 ,  G01N33/686 ,  G01N33/94

    摘要： Thus, herein is reported a method for analyzing/characterizing circulating immune complexes (CICs) formed in vivo comprising a size-exclusion chromatography of a sample obtained from a mammal to which the drug had been administered at least once for determining the weight/size of the immune complexes, optionally a second non-SEC chromatography, and at least one immunoassay, whereby the immune complex is characterized by the correlation of the immune complex size and the immunoassay result/read-out. Also reported herein is the use of a method as reported herein for determining a correlation to altered pharmacokinetics, for determining loss or reduction of efficacy, for determining neutralization of natural counterparts of the drug, for determining immune and hypersensitivity reactions, including serum sickness/type III hypersensitivity reaction/immune complex-mediated disease.

    THREE-STEP ACID DISSOCIATION ENZYME LINKED IMMUNOSORBENT (TADELIS) ASSAY
    9.
    发明公开
    THREE-STEP ACID DISSOCIATION ENZYME LINKED IMMUNOSORBENT (TADELIS) ASSAY 审中-公开

    公开(公告)号：EP3391050A1

    公开(公告)日：2018-10-24

    申请号：EP16823180.1

    申请日：2016-12-14

    申请人： F. Hoffmann-La Roche AG

    发明人： JORDAN, Gregor ,  STAACK, Roland

    IPC分类号： G01N33/536 ,  G01N33/68 ,  G01N33/94

    摘要： Herein is reported a method for determining in a sample the (total, i.e. binding competent) amount of a ligand of a ligand-binding protein (therapeutic) comprising the following steps in the following order: subjecting the sample to an acid treatment, forming in solution a non-covalent complex comprising i) an anti-ligand antibody, ii) the ligand, and iii) labelled ligand-binding protein, by adding anti-ligand antibody and labelled ligand-binding protein to the sample, and determining the amount of the complex and thereby determining the amount of the ligand of the ligand-binding protein.