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    ARTICLES AND METHODS INVOLVING DETECTION OF BINDING
    1.
    发明公开
    ARTICLES AND METHODS INVOLVING DETECTION OF BINDING 审中-实审

    公开(公告)号：EP4407317A2

    公开(公告)日：2024-07-31

    申请号：EP24181937.4

    申请日：2018-03-28

    申请人： Charles River Laboratories, Inc.

    发明人： SCHOLLE, Michael D. ,  SHERRILL, John

    IPC分类号： G01N33/68

    CPC分类号： C12Q1/6816 ,  C40B30/04 ,  G01N33/6851

    摘要： Articles and methods involving detection of binding between two or more species using MALDI are generally provided. In some embodiments, a method comprises exposing a first species to a composition comprising a second species, capturing the first species on a self-assembled monolayer, and performing MALDI on the self-assembled monolayer to generate a signal from the second species and a signal from a standard species present in the self-assembled monolayer. A ratio (first ratio) of the signal from the second species to the signal from the standard species may be compared to a cutoff value in order to determine if binding has occurred. This method may allow determination of a relative affinity of the second species for the first species.

    METHOD FOR DETERMINING THE IN VIVO COMPARABILITY OF BIOLOGIC DRUG AND A REFERENCE DRUG
    5.
    发明公开
    METHOD FOR DETERMINING THE IN VIVO COMPARABILITY OF BIOLOGIC DRUG AND A REFERENCE DRUG 审中-公开

    公开(公告)号：EP3353555A1

    公开(公告)日：2018-08-01

    申请号：EP16784612.0

    申请日：2016-09-23

    申请人： Bioanalytix, Inc.

    发明人： LI, Lily, Y.T ,  POSS, Kirtland, G. ,  WU, Shiaw-Lin ,  GARNICK, Robert

    IPC分类号： G01N33/68

    CPC分类号： G01N33/6848 ,  G01N33/6851

    摘要： The invention provides a mass-spectroscopic approach for assessing and determining the in vivo comparability of a candidate biologic molecule to a reference biologic molecule. The results can be presented in the form of an in vivo comparability profile, which can serve as a development tool, e.g., as a guide or target for the development of biologies, biosimilars,or gene therapy-based drugs. The invention further provides an approach using an in vivo comparability profile for measuring the similarity of two biologies, for example, a biosimilar and a reference approved biologic or manufacturing lots of the same biologic to confirm acceptable release criteria for a particular manufacturing lot.

    SECRETED PROTEIN ACIDIC AND RICH IN CYSTEINE (SPARC) PROTEIN SRM/MRM ASSAY
    8.
    发明公开
    SECRETED PROTEIN ACIDIC AND RICH IN CYSTEINE (SPARC) PROTEIN SRM/MRM ASSAY 审中-公开
    分泌型蛋白酸性和富含半胱氨酸（SPARC）蛋白SRM / MRM测定

    公开(公告)号：EP3267194A1

    公开(公告)日：2018-01-10

    申请号：EP17001229.8

    申请日：2010-12-22

    申请人： Expression Pathology, Inc.

    发明人： KRIZMAN, David B. ,  HEMBROUGH, Todd ,  THYPARAMBIL, Sheeno

    IPC分类号： G01N31/00 ,  A61K38/00

    CPC分类号： G01N33/68 ,  A61K38/08 ,  A61K38/10 ,  C07K7/06 ,  C07K7/08 ,  C07K14/47 ,  C07K16/18 ,  G01N33/6851 ,  G01N33/6887 ,  G01N2333/4727 ,  G01N2333/96433

    摘要： The present invention is related to a method for measuring the level of the Secreted Protein Acidic and Rich in Cysteine (SPARC) protein in a human biological sample of formalin fixed tissue, comprising detecting and quantifying the amount of a SPARC fragment peptide in a liquid, soluble, dilutable protein digest prepared from said human biological sample by heating and proteolysis, wherein said detecting and/or quantifying is carried out using mass spectrometry; and calculating the level of SPARC protein in said sample; wherein the SPARC fragment peptide is selected from the group consisting of SEQ ID NO:4, SEQ ID NO:5 and SEQ ID NO:6; wherein said level is a relative level or an absolute level; and wherein the method further comprises selecting for the subject from which said biological sample was obtained a treatment based on the presence, absence, or amount of one or more SPARC fragment peptides or the level of SPARC protein.

    摘要翻译： 本发明涉及测量福尔马林固定组织的人生物样品中半胱氨酸分泌蛋白（SPARC）蛋白水平的方法，包括检测和定量液体中SPARC片段肽的量， 通过加热和蛋白水解从所述人类生物样品制备的可溶的，可稀释的蛋白质消化物，其中所述检测和/或定量使用质谱进行; 并计算所述样品中SPARC蛋白的水平; 其中所述SPARC片段肽选自由SEQ ID NO：4，SEQ ID NO：5和SEQ ID NO：6组成的组; 其中所述级别是相对级别或绝对级别; 并且其中所述方法进一步包括基于一种或多种SPARC片段肽的存在或不存在或量或SPARC蛋白质的水平来选择从其获得所述生物样品的受试者的治疗。