INDIRECT HOMOGENEOUS MOBILITY SHIFT ASSAYS FOR THE DETECTION OF BIOLOGICS IN PATIENT SAMPLES
    2.
    发明申请
    INDIRECT HOMOGENEOUS MOBILITY SHIFT ASSAYS FOR THE DETECTION OF BIOLOGICS IN PATIENT SAMPLES 审中-公开
    用于检测患者样本中生物制剂的间接齐性移动换档测定

    公开(公告)号:WO2016088104A2

    公开(公告)日:2016-06-09

    申请号:PCT/IB2015/059381

    申请日:2015-12-04

    Applicant: NESTEC S.A.

    Abstract: The present invention provides a sensitive and specific indirect homogeneous mobility shift assay using size exclusion chromatography to measure biologics such as vedolizumab and ustekinumab in a patient sample. The assays of the present invention are particularly advantageous for detecting the presence or level of biologics that target complex or large antigens including cell surface proteins, transmembrane proteins, heavily glycosylated proteins, and multimeric proteins, as well as antigens that cannot be purified, impure antigens, and partially or substantially purified antigens. The present invention also provides isolated soluble α4β7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.

    Abstract translation: 本发明提供了使用尺寸排阻色谱法来测量患者样品中的生物制剂如维多珠单抗和ustekinumab的敏感且特异性的间接均质迁移率变动测定。 本发明的测定法对于检测靶向包括细胞表面蛋白质,跨膜蛋白质,重度糖基化蛋白质和多聚体蛋白质的复合或大抗原的生物制剂的存在或水平是特别有利的,以及不能纯化的抗原,不纯的抗原 和部分或基本上纯化的抗原。 本发明还提供了适用于本文所述间接测定的分离的可溶性α4β7整联蛋白异二聚体和分离的可溶性IL-12p40单体。

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