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    IMMUNOGENIC COMPOSITION
    3.
    发明申请
    IMMUNOGENIC COMPOSITION 有权
    免疫组化

    公开(公告)号：US20140377302A1

    公开(公告)日：2014-12-25

    申请号：US14375385

    申请日：2013-01-29

    Applicant: Serum Institute of India Ltd.

    Inventor： Subhash Vinayak Kapre ,  Sambhaji Shankar Pisal

    IPC: A61K47/48 ,  A61K39/095

    CPC classification number: A61K47/4833 ,  A61K39/095 ,  A61K47/646 ,  A61K2039/6037 ,  A61K2039/627 ,  A61K2039/70

    Abstract: The invention provides immunogenic polysaccharide protein conjugates comprising capsular polysaccharides from N. Meningitidis serogroup X and methods for preparation thereof. The present invention relates to N. meningitidis X saccharide-carrier protein conjugates prepared by a conjugation reaction. Accordingly, the instant invention relates to multivalent meningococcal polysaccharide protein conjugate composition comprising capsular saccharide from serogroups X and at least one capsular saccharide from A, C, W135 and Y wherein, i) polysaccharides A C W135 X are sized mechanically whereas polysaccharide Y is sized chemically, ii) all saccharide are conjugated to carrier protein via a linker with a cyanylation conjugation chemistry iii) all saccharide to protein ratios in final conjugates are between 0.2-0.6 and iv) at least two different carrier proteins selected from the group consisting of TT, DT and CRM197 are utilized.

    Abstract translation: 本发明提供包含脑膜炎奈瑟氏球菌血清群X的荚膜多糖的免疫原性多糖蛋白质缀合物及其制备方法。 本发明涉及通过共轭反应制备的脑膜炎奈瑟球菌X糖蛋白结合物。 因此，本发明涉及包含来自血清群X的荚膜糖和来自A，C，W135和Y的至少一种荚膜糖的多价脑膜炎球菌多糖蛋白质结合组合物，其中i）多糖AC W135X的大小是机械尺寸的，而多糖Y的大小是化学的 ，ii）所有糖通过具有氰基化缀合化学化合物的接头与载体蛋白质缀合; iii）最终缀合物中所有糖与蛋白质比例在0.2-0.6之间，iv）至少两种不同的载体蛋白，其选自TT， 使用DT和CRM197。

    HIGHLY SENSITIVE IMMUNOASSAY FOR RAPID QUANTIFICATION OF MENINGOCOCCAL CAPSULAR POLYSACCHARIDE ANTIGENS
    4.
    发明申请
    HIGHLY SENSITIVE IMMUNOASSAY FOR RAPID QUANTIFICATION OF MENINGOCOCCAL CAPSULAR POLYSACCHARIDE ANTIGENS 审中-公开
    高敏感性免疫球蛋白快速定量分析多糖多糖抗体

    公开(公告)号：US20160025719A1

    公开(公告)日：2016-01-28

    申请号：US14808352

    申请日：2015-07-24

    Applicant: SERUM INSTITUTE OF INDIA LTD.

    Inventor： Kale Sameer MANOHAR ,  Sharma Pankaj KESHAV ,  Gairola Sunil JAGDISHPRASAD

    IPC: G01N33/543

    CPC classification number: G01N33/54306 ,  G01N33/56911 ,  G01N2333/22 ,  G01N2400/00

    Abstract: The present disclosure relates to the field of immunoassays for Gram negative bacteria, in particular N. meningitidis. The disclosure provides a simple and affordable immunoassay to quantitate polysaccharides in meningococcal vaccines for the evaluation of antigen content and lot-to-lot manufacturing consistency. The inventors have found a Sandwich ELISA that can be applicable for the quantitation and identification of N. meningitidis serogroup X polysaccharide in a multivalent meningococcal polysaccharide-protein conjugate vaccine as well as in a multivalent meningococcal plain polysaccharide vaccine. Said assay employs a polyclonal antibody as capture antibody and a novel monoclonal antibody against serogroup X polysaccharide as detection antibody. Further the assay is rapid, robust and reproducible.

    Abstract translation: 本公开涉及革兰氏阴性细菌，特别是脑膜炎奈瑟氏球菌的免疫测定领域。 本公开提供了一种简单且经济的免疫测定法，用于定量脑膜炎球菌疫苗中的多糖，用于评估抗原含量和批次生产一致性。 发明人已经发现可以应用于多价脑膜炎球菌多糖 - 蛋白质结合疫苗以及多价脑膜炎球菌纯多糖疫苗中脑膜炎奈瑟氏球菌血清群X多糖的定量和鉴定的夹心ELISA。 所述测定使用多克隆抗体作为捕获抗体和抗血清群X多糖作为检测抗体的新型单克隆抗体。 此外，该测定是快速，鲁棒和可重复的。

    Immunogenic composition
    8.
    发明授权
    Immunogenic composition 有权
    免疫原性组成

    公开(公告)号：US09198977B2

    公开(公告)日：2015-12-01

    申请号：US14375385

    申请日：2013-01-29

    Applicant: Serum Institute of India Ltd.

    Inventor： Subhash Vinayak Kapre ,  Sambhaji Shankar Pisal

    IPC: A61K39/00 ,  A61K39/02 ,  A61K39/095 ,  A61K39/385 ,  A61K47/48

    CPC classification number: A61K47/4833 ,  A61K39/095 ,  A61K47/646 ,  A61K2039/6037 ,  A61K2039/627 ,  A61K2039/70

    Abstract: The invention provides immunogenic polysaccharide protein conjugates comprising capsular polysaccharides from N. Meningitidis serogroup X and methods for preparation thereof. The present invention relates to N. meningitidis X saccharide-carrier protein conjugates prepared by a conjugation reaction. Accordingly, the instant invention relates to multivalent meningococcal polysaccharide protein conjugate composition comprising capsular saccharide from serogroups X and at least one capsular saccharide from A, C, W135 and Y wherein, i) polysaccharides A C W135 X are sized mechanically whereas polysaccharide Y is sized chemically, ii) all saccharide are conjugated to carrier protein via a linker with a cyanylation conjugation chemistry iii) all saccharide to protein ratios in final conjugates are between 0.2-0.6 and iv) at least two different carrier proteins selected from the group consisting of TT, DT and CRM197 are utilized.

    Abstract translation: 本发明提供包含脑膜炎奈瑟氏球菌血清群X的荚膜多糖的免疫原性多糖蛋白质缀合物及其制备方法。 本发明涉及通过共轭反应制备的脑膜炎奈瑟球菌X糖蛋白结合物。 因此，本发明涉及包含来自血清群X的荚膜糖和来自A，C，W135和Y的至少一种荚膜糖的多价脑膜炎球菌多糖蛋白质结合组合物，其中i）多糖AC W135X的大小是机械尺寸的，而多糖Y的大小是化学的 ，ii）所有糖通过具有氰基化缀合化学化合物的接头与载体蛋白质缀合; iii）最终缀合物中所有糖与蛋白质比例在0.2-0.6之间，iv）至少两种不同的载体蛋白，其选自TT， 使用DT和CRM197。

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