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    Production and Purification of Recombinant Arylsulftase
    3.
    发明申请
    Production and Purification of Recombinant Arylsulftase 有权
    重组芳烃聚糖酶的生产和纯化

    公开(公告)号：US20080003211A1

    公开(公告)日：2008-01-03

    申请号：US10588082

    申请日：2005-01-30

    申请人： Jens Fogh ,  Claes Andersson ,  Cecilia Weigelt ,  Christer Moller ,  Pia Hyden

    发明人： Jens Fogh ,  Claes Andersson ,  Cecilia Weigelt ,  Christer Moller ,  Pia Hyden

    IPC分类号： A61K38/46 ,  A61P25/00 ,  C12N9/16

    CPC分类号： C12N9/16 ,  A61K38/00 ,  C12Y301/06008

    摘要： The present invention pertains to a process for production of recombinant arylsulfatase A in a cell culture system, the process comprising culturing a mammalian cell capable of producing rASA in liquid medium in a system comprising one or more bio-reactors; and concentrating, purifying and formulating the rASA by a purification process comprising one or more steps of chromatography. Other aspects of the invention provides a pharmaceutical composition comprising rASA, which is efficiently endocytosed via the mannose-6-phosphate receptor pathway in vivo as well as a rhASA a medicament and use of a rhASA for the manufacture of a medicament for reducing the galactosyl sulphatide levels within target cells in the peripheral nervous system and/or within the central nervous system in a subject. A final aspect of the invention provides a method of treating a subject in need thereof, said method comprising administering to said subject a pharmaceutical composition comprising a rhASA and thereby obtaining a reduction in the galactosyl sulphatide levels in target cells within said subject.

    摘要翻译： 本发明涉及在细胞培养系统中生产重组芳基硫酸酯酶A的方法，该方法包括在包含一个或多个生物反应器的系统中培养能够在液体培养基中产生rASA的哺乳动物细胞; 并通过包括一个或多个色谱步骤的纯化方法浓缩，纯化和配制rASA。 本发明的其它方面提供了包含rASA的药物组合物，其通过体内甘露糖-6-磷酸受体途径有效内吞，以及rhASA药物和使用rhASA来制备用于还原半乳糖基硫酰胺的药物 受试者周围神经系统和/或中枢神经系统内靶细胞内的水平。 本发明的最后方面提供了治疗有需要的受试者的方法，所述方法包括向所述受试者施用包含rhASA的药物组合物，从而获得所述受试者内的靶细胞中半乳糖基硫苷脂水平的降低。

    Production and purification of recombinant arylsulftase
    4.
    发明授权
    Production and purification of recombinant arylsulftase 有权
    重组芳基水解酶的生产和纯化

    公开(公告)号：US08536315B2

    公开(公告)日：2013-09-17

    申请号：US10588082

    申请日：2005-01-30

    申请人： Jens Fogh ,  Claes Andersson ,  Cecilia Weigelt ,  Christer Moller ,  Pia Hyden

    发明人： Jens Fogh ,  Claes Andersson ,  Cecilia Weigelt ,  Christer Moller ,  Pia Hyden

    IPC分类号： A23J1/00 ,  C12N9/16 ,  C12N15/00 ,  C12N1/20 ,  C12P21/06 ,  C12P21/04 ,  C07H21/04

    CPC分类号： C12N9/16 ,  A61K38/00 ,  C12Y301/06008

    摘要： The present invention pertains to a process for production of recombinant arylsulfatase A in a cell culture system, the process comprising culturing a mammalian cell capable of producing rASA in liquid medium in a system comprising one or more bio-reactors; and concentrating, purifying and formulating the rASA by a purification process comprising one or more steps of chromatography. Other aspects of the invention provides a pharmaceutical composition comprising rASA, which is efficiently endocytosed via the mannose-6-phosphate receptor pathway in vivo as well as a rhASA a medicament and use of a rhASA for the manufacture of a medicament for reducing the galactosyl sulphatide levels within target cells in the peripheral nervous system and/or within the central nervous system in a subject. A final aspect of the invention provides a method of treating a subject in need thereof, said method comprising administering to said subject a pharmaceutical composition comprising a rhASA and thereby obtaining a reduction in the galactosyl sulphatide levels in target cells within said subject.

    摘要翻译： 本发明涉及在细胞培养系统中生产重组芳基硫酸酯酶A的方法，该方法包括在包含一个或多个生物反应器的系统中培养能够在液体培养基中产生rASA的哺乳动物细胞; 并通过包括一个或多个色谱步骤的纯化方法浓缩，纯化和配制rASA。 本发明的其它方面提供了包含rASA的药物组合物，其通过体内甘露糖-6-磷酸受体途径有效内吞，以及rhASA药物和使用rhASA来制备用于还原半乳糖基硫酰胺的药物 受试者周围神经系统和/或中枢神经系统内靶细胞内的水平。 本发明的最后方面提供了治疗有需要的受试者的方法，所述方法包括向所述受试者施用包含rhASA的药物组合物，从而获得所述受试者内的靶细胞中半乳糖基硫苷脂水平的降低。