SIALYLATED GLYCOPROTEINS
    61.
    发明申请

    公开(公告)号:WO2020215021A1

    公开(公告)日:2020-10-22

    申请号:PCT/US2020/028863

    申请日:2020-04-17

    Inventor: PATIL, Siddhesh

    Abstract: Pharmaceutical preparations containing hypersialylated immunoglobulins are described. The preparations are stable to shear stress. The pharmaceutical compositions described herein provide pharmaceutically acceptable hslgG compositions that are stable against shear stress (e.g., a significant a number of subvisible particles do not form when the formulation is subjected to shear stress, such as agitation, for example, durin shippin and thus can be shipped and handled in liquid form.

    VARIANT-SPECIFIC ALIGNMENT OF NUCLEIC ACID SEQUENCING DATA

    公开(公告)号:WO2018156872A1

    公开(公告)日:2018-08-30

    申请号:PCT/US2018/019383

    申请日:2018-02-23

    Inventor: DUFFNER, Jay

    Abstract: Techniques and systems for determining a correct alignment of nucleic acid sequences are described. Determining the correct alignment may include generating multiple reference sequences that include one or more variants and aligning the nucleic acid sequences to the multiple reference sequences. The correct alignment may include performing an alignment of the nucleic acid sequences using the multiple reference sequences and determining the correct alignment for the nucleic acid sequences based at least in part on a result of the alignment using the multiple reference sequences.

    GLYCAN OXONIUM ION PROFILING OF GLYCOSYLATED PROTEINS
    64.
    发明申请
    GLYCAN OXONIUM ION PROFILING OF GLYCOSYLATED PROTEINS 审中-公开
    糖基化蛋白质的甘氨酸氧离子特性

    公开(公告)号:WO2018035350A1

    公开(公告)日:2018-02-22

    申请号:PCT/US2017/047395

    申请日:2017-08-17

    CPC classification number: C12P21/005 G01N33/6848 G01N33/6854

    Abstract: Methods disclosed herein include an improved technique for comparing a glycosylation profile of a first protein (e.g., an innovator protein drug) with a glycosylation profile of a second protein (e.g., a corresponding biogeneric/biosimilar). For example, a method of manufacture can include providing or obtaining a batch of a test glycoprotein drug substance, using mass spectrometry to acquire a test oxonium ion profile from a sample of the test glycoprotein drug substance batch, comparing the test oxonium ion profile to a corresponding target oxonium ion profile of a target glycoprotein drug product, and processing the batch of the test glycoprotein drug substance as a drug product if the difference between the test oxonium ion profile and the corresponding target oxonium ion profile is tolerable, or taking an alternative action if the difference between the test oxonium ion profile and the target oxonium ion profile is not tolerable.

    Abstract translation: 本文公开的方法包括用于比较第一蛋白(例如,创新蛋白药物)的糖基化分布与第二蛋白(例如,相应的生物基因/生物仿制药)的糖基化分布的改进技术。 例如,制造方法可包括提供或获得一批测试糖蛋白药物物质,使用质谱法从测试糖蛋白药物物质批次的样品获得测试氧鎓离子特征,将测试氧鎓离子特征与 如果测试氧鎓离子分布图和相应的目标氧鎓离子分布图之间的差异是可容忍的,或者采取替代动作,则将目标糖蛋白药物产品的相应目标氧鎓离子分布图,以及处理该批测试糖蛋白药物物质作为药品 如果测试的氧鎓离子分布和目标氧鎓离子分布之间的差异是不可容忍的。

    THERAPEUTIC AND DIAGNOSTIC METHODS FOR AUTOIMMUNE DISEASES AND/OR INFLAMMATION
    65.
    发明申请
    THERAPEUTIC AND DIAGNOSTIC METHODS FOR AUTOIMMUNE DISEASES AND/OR INFLAMMATION 审中-公开
    自发性疾病和/或炎症的治疗和诊断方法

    公开(公告)号:WO2017059276A2

    公开(公告)日:2017-04-06

    申请号:PCT/US2016/054833

    申请日:2016-09-30

    CPC classification number: C12Q1/68 C12Q1/6886 C12Q2600/106 C12Q2600/156

    Abstract: The present invention features methods of treating a subject having an autoimmune disease and/or inflammation including determining the genotype, and/or the glycophenotype of the subject and administering to the subject an Fc-activity modulating agent or an anti-TNFα agent based on the genotype and/or the glycophenotype of the subject. The invention also features methods of predicting the responsiveness of a patient to an anti-TNFα treatment by identifying a patient having inflammation or an autoimmune disease, determining the genotype, or glycophenotype of the subject, and selecting the patient for treatment with an Fc-activity modulating agent or an anti-TNFα agent based on the genotype and/or the glycophenotype of the subject.

    Abstract translation: 本发明的特征在于治疗患有自身免疫疾病和/或炎症的受试者的方法,包括确定受试者的基因型和/或糖基型,并且基于该受试者施用Fc-活性调节剂或抗TNFα剂 基因型和/或受试者的糖表型。 本发明还具有通过鉴定患有炎症或自身免疫疾病,确定受试者的基因型或糖基型,并选择患者用Fc活性治疗的患者来预测患者对抗TNFα治疗的反应性的方法 基于受试者的基因型和/或糖表型的调节剂或抗TNFα剂。

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