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37 条记录 (耗时 0.063 秒)

    High Pressure Treatment of Aggregated Interferons
    8.
    发明申请
    High Pressure Treatment of Aggregated Interferons 审中-公开
    聚合干扰素的高压处理

    公开(公告)号：US20130058895A1

    公开(公告)日：2013-03-07

    申请号：US13560979

    申请日：2012-07-27

    申请人： Jeffrey L. Cleland ,  Stephen P. Eisenberg ,  Mary S. Rosendahl ,  Matthew B. Seefeldt

    发明人： Jeffrey L. Cleland ,  Stephen P. Eisenberg ,  Mary S. Rosendahl ,  Matthew B. Seefeldt

    IPC分类号： C07K14/555 ,  A61K38/21 ,  C07K14/57 ,  C07K14/56 ,  C07K14/565

    CPC分类号： C07K14/555 ,  A61K38/212 ,  A61K38/215 ,  A61K38/217 ,  C07K14/565

    摘要： Methods are provided using high pressure to treat aggregated interferons, to reduce the aggregate content of interferon material. In particular, recombinant human interferon-β may be so treated. Multiple strategies may be used in combination to make nonglycosylated IFN-β more amenable to high pressure treatment. When coupled with purification techniques, these strategies singly or in combination provide a low aggregate or substantially aggregate free, biologically active solution. In certain aspects, pharmaceutical compositions containing nonglycosylated interferon having less than about 5 weight percent of protein aggregation are provided.

    摘要翻译： 提供使用高压处理聚集的干扰素的方法，以减少干扰素材料的总含量。 特别是重组人干扰素 可能会如此对待 可以组合使用多种策略以制备非糖基化IFN-和bgr; 更适合高压处理。 当与纯化技术结合时，这些策略单独或组合提供了低聚集体或基本上聚集的游离的生物活性溶液。 在某些方面，提供了含有小于约5重量％蛋白质聚集的非糖基化干扰素的药物组合物。

    High pressure treatment of aggregated interferons
    9.
    发明授权
    High pressure treatment of aggregated interferons 失效
    聚合干扰素的高压治疗

    公开(公告)号：US08273561B2

    公开(公告)日：2012-09-25

    申请号：US12287262

    申请日：2008-10-06

    申请人： Jeffrey L. Cleland ,  Stephen P. Eisenberg ,  Mary S. Rosendahl ,  Matthew B. Seefeldt

    发明人： Jeffrey L. Cleland ,  Stephen P. Eisenberg ,  Mary S. Rosendahl ,  Matthew B. Seefeldt

    IPC分类号： C07K1/02 ,  C07K14/00 ,  C12N9/00

    CPC分类号： C07K14/555 ,  A61K38/212 ,  A61K38/215 ,  A61K38/217 ,  C07K14/565

    摘要： High pressure to treat aggregated interferons, particularly recombinant human interferon-β, to reduce the aggregate content of interferon material. Highly pure, soluble monomeric recombinant interferon-β is prepared in representative embodiments. Multiple strategies may be used in combination that make nonglycosylated IFN-β more amenable to high pressure treatment. It has been found that refolding yields of high pressure treatment can be significantly improved by use of a combination of strategies, including, or example a pre-treatment of the IFN-β that involves solubilizing and then precipitating the protein. This pre-treatment is particularly effective with respect to recombinant IFN-β inclusion bodies recovered from host cells such as E. coli cells. According to another strategy, refolding under high pressure is much more effective when the refolding reagent incorporating the IFN-β incorporates a zwitterionic surfactant and/or a cholate salt. When a solubilization and precipitation pre-treatment is used, the effectiveness of the high pressure treatment is further enhanced when the refolding reagent incorporating the protein incorporates a disulfide shuffling chemistry such as cysteine/cystine. According to still yet another strategy, high pressure treatment is more effective when using atypically high treatment pressures. When coupled with purification techniques, these strategies singly or in combination provide a low aggregate or substantially aggregate free, biologically active solution. Biologically active solutions comprising nonglycosylated interferon, said interferon comprising less than about 5 weight percent of protein aggregation has been found to exhibit improved PK/PD characteristics.

    摘要翻译： 高压处理聚集的干扰素，特别是重组人类干扰素，以减少干扰素材料的总含量。 高纯度，可溶性单体重组干扰素 在代表性的实施方案中制备。 可以组合使用多种策略，使得非糖基化IFN-和bgr 更适合高压处理。 已经发现，通过使用策略的组合（包括或例如IFN-α的预处理）可以显着改善高压治疗的重折叠产率。 这涉及使蛋白质溶解并沉淀。 该预处理对于重组IFN-和bgr是特别有效的; 从宿主细胞如大肠杆菌细胞中回收的包涵体。 根据另一种策略，当加入IFN-和bgr的重折叠试剂时，在高压下重折叠更有效。 加入两性离子表面活性剂和/或胆酸盐。 当使用溶解和沉淀预处理时，当掺入蛋白质的重折叠剂包含二硫化物改组化学物质如半胱氨酸/胱氨酸时，高压处理的有效性进一步增强。 根据还有另一个策略，当使用非常高的处理压力时，高压处理更有效。 当与纯化技术结合时，这些策略单独或组合提供了低聚集体或基本上聚集的游离的生物活性溶液。 已经发现包含非糖基化干扰素的生物活性溶液，所述干扰素包含小于约5重量％的蛋白质聚集体已经表现出改善的PK / PD特征。

    Sustained release formulation
    10.
    发明授权
    Sustained release formulation 有权
    持续释放制剂

    公开(公告)号：US08067020B2

    公开(公告)日：2011-11-29

    申请号：US11954608

    申请日：2007-12-12

    申请人： Franklin Okumu ,  Jeffrey L. Cleland

    发明人： Franklin Okumu ,  Jeffrey L. Cleland

    IPC分类号： A61K9/14 ,  A61K38/00 ,  A61F2/00 ,  A61F13/00

    CPC分类号： A61K38/27 ,  A61K9/0019 ,  A61K33/30 ,  A61K47/26 ,  A61K2300/00

    摘要： A composition comprises a protein, a polyol, and a metal. The protein is stabilized by the polyol and the metal, and is protected from denaturing when in contact with an organic solvent. The polyol may be a hydrocarbon containing two or more hydroxyl groups (—OH) bonded to carbon. The metal may be divalent.

    摘要翻译： 组合物包含蛋白质，多元醇和金属。 蛋白质被多元醇和金属稳定，并且当与有机溶剂接触时，蛋白质被保护而不变性。 所述多元醇可以是含有两个以上与碳结合的羟基（-OH）的烃。 金属可以是二价的。