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    METHODS FOR THE DETECTION OF JC POLYOMA VIRUS
    62.
    发明申请
    METHODS FOR THE DETECTION OF JC POLYOMA VIRUS 有权
    检测JC多聚病毒的方法

    公开(公告)号：US20150219651A1

    公开(公告)日：2015-08-06

    申请号：US14603002

    申请日：2015-01-22

    Applicant: Biogen Idec MA Inc.

    Inventor： Leonid Gorelik ,  Alexey Lugovskoy

    IPC: G01N33/569

    CPC classification number: G01N33/56983 ,  C07K16/081 ,  C07K2317/33 ,  G01N2333/025 ,  G01N2469/20 ,  G01N2800/28 ,  G01N2800/50 ,  G01N2800/52

    Abstract: Methods and compositions for determining whether a subject is at risk for PML, including subjects being treated with immunosuppressants, by determining whether the subject harbors a JCV variant with reduced binding for sialic acid relative to a normal JCV, are presented. Furthermore, combinations of JCV-VP1 sequence variations that are associated with PML and that can be used as a basis of an assay for identifying subjects susceptible to PML, subjects with PML (e.g., early stage PML), or subjects at risk of developing PML in response to an immunosuppressive treatment are provided.

    Abstract translation: 呈现用于确定受试者是否处于PML风险中的方法和组合物，包括用免疫抑制剂治疗的受试者，通过确定受试者是否携带具有减少的唾液酸相对于正常JCV的结合的JCV变体。 此外，与PML相关的JCV-VP1序列变异的组合可用作用于鉴定易受PML影响的受试者（例如早期PML）或具有发展PML风险的受试者的测定的基础 响应于免疫抑制治疗。

    METHODS OF DETECTING GLYCOSAMINOGLYCANS
    69.
    发明申请
    METHODS OF DETECTING GLYCOSAMINOGLYCANS 审中-公开
    检测糖蛋白酶的方法

    公开(公告)号：US20150075261A1

    公开(公告)日：2015-03-19

    申请号：US14391775

    申请日：2013-04-11

    Applicant: Biogen Idec MA Inc.

    Inventor： Zoran Sosic ,  Andrew Blum ,  Bing Guan ,  Boris Boumajny

    IPC: G01N30/60

    CPC classification number: G01N30/60 ,  C08B37/0003 ,  C08B37/0021 ,  C08B37/0063 ,  G01N33/6842 ,  G01N2030/027 ,  G01N2400/40

    Abstract: In one aspect, the disclosure provides methods of distinguishing a glycosaminoglycan from one or more other components in a sample by subjecting the sample to size-exclusion chromatography using a mobile phase having a pH of 6.8 or lower. A mobile phase having a pH of 6.8 or lower is found to improve the separation of glycosaminoglycans from proteins during size exclusion chromatography. In some embodiments, improved separation is due to the low pH of the mobile phase causing elution of less dispersed fractions of the protein and/or glycosaminoglycan. In some embodiments, the overlap between protein and/or glycosaminoglycan fractions is reduced.

    Abstract translation: 一方面，本公开提供了通过使用pH为6.8或更低的流动相对样品进行尺寸排阻色谱法来区分糖胺聚糖与样品中一种或多种其它组分的方法。 发现pH为6.8或更低的流动相可改善在尺寸排阻层析期间糖胺聚糖与蛋白质的分离。 在一些实施方案中，改进的分离是由于流动相的低pH导致较少分散的蛋白质和/或糖胺聚糖部分的洗脱。 在一些实施方案中，蛋白质和/或糖胺聚糖级分之间的重叠减少。

    METHODS AND PRODUCTS FOR EVALUATING AN IMMUNE RESPONSE TO A THERAPEUTIC PROTEIN
    70.
    发明申请
    METHODS AND PRODUCTS FOR EVALUATING AN IMMUNE RESPONSE TO A THERAPEUTIC PROTEIN 有权
    用于评估对治疗性蛋白质的免疫应答的方法和产品

    公开(公告)号：US20150071917A1

    公开(公告)日：2015-03-12

    申请号：US14330619

    申请日：2014-07-14

    Applicant: Biogen Idec MA Inc.

    Inventor： Meena Subramanyam ,  Lakshmi Amaravadi ,  Eric Wakshull ,  Frances Lynn ,  Michael Panzara ,  Robin McDaid Barbour ,  Julie Elizabeth Taylor

    IPC: G01N33/68 ,  C07K16/28

    CPC classification number: G01N33/6854 ,  C07K16/2839 ,  G01N33/686 ,  G01N2333/70546 ,  G01N2800/065 ,  G01N2800/102 ,  G01N2800/285 ,  G01N2800/52

    Abstract: The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. A first aspect of the invention relates to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titre of antibodies against the therapeutic protein, e.g. the collection of at least two samples at two different time points. A third aspect of the invention relates to the selection of the critical threshold level, which corresponds to the antibody titre of untreated patients increased by the double of the standard deviation of this control antibody titre.

    Abstract translation: 本发明涉及用治疗性蛋白质治疗的受试者鉴定临床显着免疫应答的方法和产品。 本发明的第一方面涉及用治疗量的VLA4结合抗体（例如那他珠单抗）治疗的患者中鉴定临床显着免疫应答的方法和组合物。 本发明的第二方面涉及用于确定针对治疗性蛋白质的抗体滴度的样品收集的时间顺序细节，例如。 在两个不同的时间点收集至少两个样本。 本发明的第三方面涉及临床阈值水平的选择，其对应于未经治疗的患者的抗体滴度增加了该对照抗体滴度的两倍的标准偏差。

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