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    Concentrated protein lyophilates, methods, and uses
    1.
    发明授权
    Concentrated protein lyophilates, methods, and uses 有权
    浓缩蛋白冻干物，方法和用途

    公开(公告)号：US07956160B2

    公开(公告)日：2011-06-07

    申请号：US11996420

    申请日：2006-07-20

    申请人： Sampathkumar Krishnan ,  Monica Pallitto ,  Margaret Ricci ,  Wenjin Cao ,  Hong Lin ,  Yong Xie ,  Samantha Nagle ,  Shon Lee Crampton

    发明人： Sampathkumar Krishnan ,  Monica Pallitto ,  Margaret Ricci ,  Wenjin Cao ,  Hong Lin ,  Yong Xie ,  Samantha Nagle ,  Shon Lee Crampton

    IPC分类号： A61K38/16 ,  A61K39/395 ,  C07K14/00 ,  C07K16/00 ,  C07K19/00

    CPC分类号： A61K38/17 ,  F26B5/06

    摘要： The invention provides, among other things, lyophilized compositions of high surface area that comprise a protein and that reconstitute quickly and efficiently to solution of high protein concentration with minimal formation, if any, of foam, effervescence, bubbles, turbidity, or particulates that might be deleterious. The invention also provides, among other things, methods for making the lyophilized compositions. The invention in additional aspects also provides Raman Imaging Spectrographic methods for real time analyses of polymorphs in a sample using PLS algorithms. By way of particular example, the use of the method for the analysis of mannitol polymorphs is described, and the use of the analysis to determine optimum compositions and lyophilization methods for producing lyophilates of pharmaceutical proteins having a predefined distribution of mannitol polymorphs and having the aforementioned reconstitution properties is also described.

    摘要翻译： 本发明尤其提供了包含蛋白质的高表面积的冻干组合物，并且可以快速且有效地重构高蛋白质浓度溶液，同时发生泡沫，泡腾，气泡，混浊或微粒的形成 有害 本发明还提供了用于制备冻干组合物的方法。 本发明的其它方面还提供拉曼成像光谱方法，用于使用PLS算法实时分析样品中的多晶型物。 作为具体实例，描述了用于分析甘露醇多晶型物的方法的使用，并且使用分析来确定用于制备具有预定分布的甘露醇多晶型物并具有前述物质的药物蛋白质的冷冻干燥剂的最佳组合物和冻干方法 还描述了重构性质。

    Concentrated Protein Lyophilates, Methods, and Uses
    2.
    发明申请
    Concentrated Protein Lyophilates, Methods, and Uses 有权
    浓缩蛋白冻干细胞，方法和用途

    公开(公告)号：US20080213215A1

    公开(公告)日：2008-09-04

    申请号：US11996420

    申请日：2006-07-20

    申请人： Sampathkumar Krishnan ,  Monica Pallitto ,  Margaret Ricci ,  Wenjin Cao ,  Hong Lin ,  Yong Xie ,  Samantha Nagle ,  Shon Lee Crampton

    发明人： Sampathkumar Krishnan ,  Monica Pallitto ,  Margaret Ricci ,  Wenjin Cao ,  Hong Lin ,  Yong Xie ,  Samantha Nagle ,  Shon Lee Crampton

    IPC分类号： A61K38/20 ,  A61K38/17 ,  A61K39/395 ,  G01J3/44

    CPC分类号： A61K38/17 ,  F26B5/06

    摘要： The invention provides, among other things, lyophilized compositions of high surface area that comprise a protein and that reconstitute quickly and efficiently to solution of high protein concentration with minimal formation, if any, of foam, effervescence, bubbles, turbidity, or particulates that might be deleterious. The invention also provides, among other things, methods for making the lyophilized compositions. The invention in additional aspects also provides Raman Imaging Spectrographic methods for real time analyses of polymorphs in a sample using PLS algorithms. By way of particular example, the use of the method for the analysis of mannitol polymorphs is described, and the use of the analysis to determine optimum compositions and lyophilization methods for producing lyophilates of pharmaceutical proteins having a predefined distribution of mannitol polymorphs and having the aforementioned reconstitution properties is also described.

    摘要翻译： 本发明尤其提供了包含蛋白质的高表面积的冻干组合物，并且可以快速且有效地重构高蛋白质浓度溶液，同时发生泡沫，泡腾，气泡，混浊或微粒的形成 有害 本发明还提供了用于制备冻干组合物的方法。 本发明的其它方面还提供拉曼成像光谱方法，用于使用PLS算法实时分析样品中的多晶型物。 作为具体实例，描述了用于分析甘露醇多晶型物的方法的使用，并且使用分析来确定用于制备具有预定分布的甘露醇多晶型物并具有前述物质的药物蛋白质的冷冻干燥剂的最佳组合物和冻干方法 还描述了重构性质。

    CONCENTRATED PROTEIN LYOPHILATES, METHODS, AND USES
    3.
    发明申请
    CONCENTRATED PROTEIN LYOPHILATES, METHODS, AND USES 审中-公开
    浓缩蛋白柠檬酸盐，方法和用途

    公开(公告)号：US20120116054A1

    公开(公告)日：2012-05-10

    申请号：US13102733

    申请日：2011-05-06

    申请人： Sampathkumar Krishnan ,  Monica Pallitto ,  Margaret Ricci ,  Wenjin Cao ,  Hong Lin ,  Yong Xie ,  Samantha Nagle ,  Shon Lee Crampton

    发明人： Sampathkumar Krishnan ,  Monica Pallitto ,  Margaret Ricci ,  Wenjin Cao ,  Hong Lin ,  Yong Xie ,  Samantha Nagle ,  Shon Lee Crampton

    IPC分类号： C07K19/00 ,  C07K16/18

    CPC分类号： A61K38/17 ,  F26B5/06

    摘要： The invention provides, among other things, lyophilized compositions of high surface area that comprise a protein and that reconstitute quickly and efficiently to solution of high protein concentration with minimal formation, if any, of foam, effervescence, bubbles, turbidity, or particulates that might be deleterious. The invention also provides, among other things, methods for making the lyophilized compositions. The invention in additional aspects also provides Raman Imaging Spectrographic methods for real time analyses of polymorphs in a sample using PLS algorithms. By way of particular example, the use of the method for the analysis of mannitol polymorphs is described, and the use of the analysis to determine optimum compositions and lyophilization methods for producing lyophilates of pharmaceutical proteins having a predefined distribution of mannitol polymorphs and having the aforementioned reconstitution properties is also described.

    摘要翻译： 本发明尤其提供了包含蛋白质的高表面积的冻干组合物，并且可以快速且有效地重构高蛋白质浓度溶液，同时发生泡沫，泡腾，气泡，混浊或微粒的形成 有害 本发明还提供了用于制备冻干组合物的方法。 本发明的其它方面还提供拉曼成像光谱方法，用于使用PLS算法实时分析样品中的多晶型物。 作为具体实例，描述了用于分析甘露醇多晶型物的方法的使用，并且使用分析来确定用于制备具有预定分布的甘露醇多晶型物并具有前述物质的药物蛋白质的冷冻干燥剂的最佳组合物和冻干方法 还描述了重构性质。