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    Methods of interferon-β purification and recovery
    1.
    发明授权
    Methods of interferon-β purification and recovery 有权
    干扰素的方法 净化和回收

    公开(公告)号：US08388942B2

    公开(公告)日：2013-03-05

    申请号：US12150530

    申请日：2008-04-29

    申请人： Sidney N Wolfe ,  Bret A Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

    发明人： Sidney N Wolfe ,  Bret A Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

    IPC分类号： A61K38/21 ,  C07K14/565

    CPC分类号： C07K14/565

    摘要： Improved methods for purification and recovery of interferon-beta (IFN-β) and compositions comprising substantially monomeric IFN-β are provided. In one purification method, substantially purified IFN-β or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-β, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-β.

    摘要翻译： 用于纯化和回收干扰素-β（IFN-和bgr）的改进方法和包含基本上单体的IFN- 被提供。 在一种纯化方法中，基本纯化的IFN- 或其变体沉淀，然后溶解在盐酸胍（HCl）溶液中。 蛋白质的复性通过用合适的缓冲液稀释而发生。 还提供了没有沉淀步骤的类似的纯化方法。 经IFN-α的复性后，通过渗滤或用药学上可接受的缓冲液进行透析来除去残余的胍盐，以制备基本上含有单体IFN-β的药物组合物。

    IGF-I composition and its use
    4.
    发明授权
    IGF-I composition and its use 失效
    IGF-I组成及其用途

    公开(公告)号：US07067485B2

    公开(公告)日：2006-06-27

    申请号：US09187661

    申请日：1998-11-06

    申请人： Bret A. Shirley ,  Maninder S. Hora

    发明人： Bret A. Shirley ,  Maninder S. Hora

    IPC分类号： A61K38/00 ,  A61K38/30 ,  C07K14/00

    CPC分类号： A61K38/30 ,  A61K9/0024 ,  A61K9/1647 ,  A61K9/1694

    摘要： A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.

    摘要翻译： 提供了高浓度，低含盐，生物活性糖浆形式的IGF-I或其变体及其制备方法。 IGF-I的这种新型糖浆形式具有至少约250mg / ml的IGF-I浓度，约1.0g / ml至约1.2g / ml的密度，约13,000厘泊（cps）至约 在环境温度（23℃）下测量的19,000cps。 IGF-I糖浆通过从溶液中沉淀或分配IGF-I来制备，优选通过调节溶液pH或通过使用溶解度增强剂将IGF-I浓缩在溶液中，然后除去溶解度增强剂。 沉淀的糖浆可用作以稳定形式存储IGF-I的手段，并且作为制备包含生物活性IGF-I的组合物的手段。 提供了包含该浓缩的IGF-1糖浆的药物组合物和试剂盒。 从IGF-I糖浆重建的沉淀的IGF-1糖浆，IGF-I，药物组合物和试剂盒可用于针对IGF-1反应性条件的IGF-1治疗。

    Methods of protein purification and recovery
    7.
    发明申请
    Methods of protein purification and recovery 有权
    蛋白质纯化和回收方法

    公开(公告)号：US20090123424A1

    公开(公告)日：2009-05-14

    申请号：US12150530

    申请日：2008-04-29

    申请人： Sidney N. Wolfe ,  Bret A. Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

    发明人： Sidney N. Wolfe ,  Bret A. Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

    IPC分类号： A61K38/21

    CPC分类号： C07K14/565

    摘要： Improved methods for purification and recovery of interferon-beta (IFN-β) and compositions comprising substantially monomeric IFN-β are provided. In one purification method, substantially purified IFN-β or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-β residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-β.

    摘要翻译： 提供了用于纯化和回收干扰素-β（IFN-β）和包含基本上单体IFN-β的组​​合物的改进方法。 在一种纯化方法中，将基本上纯化的IFN-β或其变体沉淀，然后溶解在盐酸胍（HCl）溶液中。 蛋白质的复性通过用合适的缓冲液稀释而发生。 还提供了没有沉淀步骤的类似的纯化方法。 经IFN-β复性后，通过用药学上可接受的缓冲液进行渗滤或透析来除去HCl，以制备包含基本上单体的IFN-β的药物组合物。

    Novel IGF-1 composition and its use
    9.
    发明申请
    Novel IGF-1 composition and its use 审中-公开
    新型IGF-1组合物及其用途

    公开(公告)号：US20080171071A1

    公开(公告)日：2008-07-17

    申请号：US12002513

    申请日：2007-12-17

    申请人： Bret A. Shirley ,  Maninder S. Hora

    发明人： Bret A. Shirley ,  Maninder S. Hora

    IPC分类号： A61K38/18 ,  A61K9/00

    CPC分类号： A61K38/30 ,  A61K9/0024 ,  A61K9/1647 ,  A61K9/1694

    摘要： A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.

    摘要翻译： 提供了高浓度，低含盐，生物活性糖浆形式的IGF-I或其变体及其制备方法。 IGF-I的这种新型糖浆形式具有至少约250mg / ml的IGF-I浓度，约1.0g / ml至约1.2g / ml的密度，约13,000厘泊（cps）至约 在环境温度（23℃）下测量的19,000cps。 IGF-I糖浆通过从溶液中沉淀或分配IGF-I来制备，优选通过调节溶液pH或通过使用溶解度增强剂将IGF-I浓缩在溶液中，然后除去溶解度增强剂。 沉淀的糖浆可用作以稳定形式存储IGF-I的手段，并且作为制备包含生物活性IGF-I的组合物的手段。 提供了包含该浓缩的IGF-1糖浆的药物组合物和试剂盒。 从IGF-I糖浆重建的沉淀的IGF-1糖浆，IGF-I，药物组合物和试剂盒可用于针对IGF-1反应性条件的IGF-1治疗。