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1.发明授权REMOVAL OF SERINE PROTEASES BY TREATMENT WITH FINELY DIVIDED SILICON DIOXIDE 有权丝氨酸蛋白酶的距离。通过与二氧化硅细粉处理
公开(公告)号：EP2575762B1
公开(公告)日：2014-07-09
申请号：EP11729200.3
申请日：2011-05-26
发明人： TESCHNER, Wolfgang , SCHWARZ, Hans-Peter , MADLENER, Ruth , SVATOS, Sonja , PLJEVLJAKOVIC, Azra , WEBER, Alfred
CPC分类号： C07K1/36 , A61K9/0019 , A61K9/08 , A61K35/16 , A61K38/1709 , A61K47/183 , C07K1/14 , C07K1/18 , C07K1/30 , C07K1/34 , C07K16/065
摘要： The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.
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2.发明公开FRACTION I-IV-1 PRECIPITATION OF IMMUNOGLOBINS FROM PLASMA 审中-公开FRAKTION-I-IV-1FÄLLUNGVON IMMUNGLOBULINEN AUS等离子体
公开(公告)号：EP2817334A1
公开(公告)日：2014-12-31
申请号：EP13708051.1
申请日：2013-02-25
发明人： BRUCKSCHWAIGER, Leopold , GUNDINGER, Thomas , NUERNBERGER, Julia , TESCHNER, Wolfgang , SCHWARZ, Hans-Peter
IPC分类号： C07K16/06 , A61K39/395 , A61K35/16 , C07K1/30
CPC分类号： A61K39/395 , A61K35/16 , A61K39/39591 , C07K1/145 , C07K1/30 , C07K16/065
摘要： Among other aspects, the present invention provides methods for the manufacture of blood protein compositions from pooled plasma. In one embodiment, the invention provides an alcohol fractionation scheme that allows for significant increases in the yield of blood proteins purified from the starting plasma sample. In a specific embodiment, a method for fractionating pooled plasma is provided, the method comprising an initial low pH, high alcohol precipitation step. The present invention also provides pharmaceutical compositions of therapeutic blood proteins.
摘要翻译： 在其它方面中，本发明提供了从合并血浆制造血液蛋白质组合物的方法。 在一个实施方案中，本发明提供了允许从起始血浆样品纯化的血液蛋白的产量的显着增加的醇分馏方案。 在一个具体实施方案中，提供了用于分级汇集的等离子体的方法，该方法包括初始低pH，高醇沉淀步骤。 本发明还提供治疗性血液蛋白质的药物组合物。
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公开(公告)号：EP2445482B1
公开(公告)日：2014-08-27
申请号：EP10727539.8
申请日：2010-05-27
发明人： BRUCKSCHWAIGER, Leopold , SVATOS, Sonja , NÜRNBERGER, Julia , TESCHNER, Wolfgang , BUTTERWECK, Harald Arno , SCHWARZ, Hans-Peter , GUNDINGER, Thomas , KOELBL, Bernhard , GRAUSENBURGER, Reinhard , PLJEVLJAKOVIC, Azra
CPC分类号： C07K1/36 , A61K9/0019 , A61K9/08 , A61K35/16 , A61K38/1709 , A61K47/183 , C07K1/14 , C07K1/18 , C07K1/30 , C07K1/34 , C07K16/065
摘要： The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.
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4.发明公开A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use 审中-公开一种生产用于皮下使用高度浓缩的免疫球蛋白制剂过程
公开(公告)号：EP2762492A2
公开(公告)日：2014-08-06
申请号：EP14162703.4
申请日：2010-05-27
发明人： TESCHNER, Wolfgang , BUTTERWECK, Harald Arno , PLJEVLJAKOVIC, Azra , BAUER, Theresa Friederike , KOELBL, Bernhard , SCHWARZ, Hans-Peter , NIKOLIC, Nebojsa , POELSLER, Gerhard , KINDERMANN, Johanna
IPC分类号： C07K16/06
CPC分类号： C07K16/18 , A61K39/39591 , A61K2039/505 , A61K2039/54 , B01D61/142 , B01D61/145 , B01D2315/16 , C07K16/00 , C07K16/065 , C07K2317/10 , C07K2317/21
摘要： The present invention relates to a new and improved method for preparing a highly concentrated immunoglobulin composition from pooled plasma for subcutaneous injection. A composition comprising 20% or more immunoglobulin suitable for subcutaneous use is also described.
摘要翻译： 本发明涉及一种用于从用于皮下注射混合血浆制备高度浓缩的免疫球蛋白组合物的新的改进方法。 由此描述了包含20％或适用于皮下使用多种免疫球蛋白的组合物。
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5.发明公开STABILIZATION OF IMMUNOGLOBULINS THROUGH AQUEOUS FORMULATION WITH HISTIDINE AT WEAK ACIDIC TO NEUTRAL PH 审中-公开稳定价格在弱酸基于的水性制剂，免疫球蛋白组氨酸pH至中性
公开(公告)号：EP2616090A1
公开(公告)日：2013-07-24
申请号：EP11764040.9
申请日：2011-09-16
发明人： BUTTERWECK, Harald, Arno , KÖLBL, Bernhard , HOFBAUER, Lucia , TESCHNER, Wolfgang , SCHWARZ, Hans-Peter
CPC分类号： A61K39/39591 , A61K9/0019 , A61K47/02 , A61K47/183
摘要： The present invention provides, among other aspects, storage stabile aqueous formulations of labile proteins at a mildly acidic to neutral pH. The present invention also provides methods for stabilizing a labile therapeutic protein composition at a mildly acidic to neutral pH. Advantageously, the methods and formulations provided herein allow stabile aqueous compositions of labile proteins at mildly acidic to neutral pH useful for parenteral administration.
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6.发明公开REMOVAL OF SERINE PROTEASES BY TREATMENT WITH FINELY DIVIDED SILICON DIOXIDE 有权丝氨酸蛋白酶的距离。通过与二氧化硅细粉处理
公开(公告)号：EP2575762A2
公开(公告)日：2013-04-10
申请号：EP11729200.3
申请日：2011-05-26
发明人： TESCHNER, Wolfgang , SCHWARZ, Hans-Peter , MADLENER, Ruth , SVATOS, Sonja , PLJEVLJAKOVIC, Azra , WEBER, Alfred
CPC分类号： C07K1/36 , A61K9/0019 , A61K9/08 , A61K35/16 , A61K38/1709 , A61K47/183 , C07K1/14 , C07K1/18 , C07K1/30 , C07K1/34 , C07K16/065
摘要： The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.
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7.发明公开STABLE CO-FORMULATION OF HYALURONIDASE AND IMMUNOGLOBULIN, AND METHODS OF USE THEREOF 有权稳定共表达透明质酸酶及免疫球蛋白的制造方法及其使用
公开(公告)号：EP2477603A2
公开(公告)日：2012-07-25
申请号：EP10760140.3
申请日：2010-09-16
发明人： TESCHNER, Wolfgang , SVATOS, Sonja , BRUCKSCHWAIGER, Leopold , WEBER, Alfred , SCHWARZ, Hans-Peter , LEI, Laura
IPC分类号： A61K9/00 , A61K47/36 , A61K47/42 , A61K39/00 , A61K39/395 , C07K16/00 , C07K16/06 , C12N9/24
CPC分类号： A61K39/00 , A61K9/0021 , A61K39/39591 , A61K47/42 , A61K2039/505 , C07K16/00 , C07K16/06 , C07K2317/21 , C12N9/2474 , C12Y302/01035 , Y02A50/464
摘要： Provided herein are stable co-formulations of immunoglobulin and hyaluronidase that are stable to storage in liquid form at room temperature for at least 6 months and at standard refrigerator temperatures for 1-2 years. Such co-formulations can be used in methods of treating IG-treatable diseases or conditions by subcutaneous administration.
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8.发明公开STABILIZATION OF IMMUNOGLOBULINS AND OTHER PROTEINS THROUGH AQUEOUS FORMULATIONS WITH SODIUM CHLORIDE AT WEAK ACIDIC TO NEUTRAL PH 审中-公开稳定价格在弱酸性免疫球蛋白和其它蛋白BY含水配方氯化钠pH至中性
公开(公告)号：EP2616091A1
公开(公告)日：2013-07-24
申请号：EP11764394.0
申请日：2011-09-16
发明人： BUTTERWECK, Harald,Arno , BAUER, Theresa, Friederike , HOFBAUER, Lucia , TESCHNER, Wolfgang , ZOCHLING, Oliver , SCHWARZ, Hans-Peter , MAYER, Christa , HASSLACHER, Meinhard
CPC分类号： A61K39/39591 , A61K9/0019 , A61K47/02 , A61K47/183
摘要： The present invention provides, among other aspects, storage stabile aqueous formulations of labile proteins at a mildly acidic to neutral pH. The present invention also provides methods for stabilizing a labile therapeutic protein composition at a mildly acidic to neutral pH. Advantageously, the methods and formulations provided herein allow stabile aqueous compositions of labile proteins at mildly acidic to neutral pH useful for parenteral administration.
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公开(公告)号：EP2445482A1
公开(公告)日：2012-05-02
申请号：EP10727539.8
申请日：2010-05-27
发明人： BRUCKSCHWAIGER, Leopold , SVATOS, Sonja , NÜRNBERGER, Julia , TESCHNER, Wolfgang , BUTTERWECK, Harald Arno , SCHWARZ, Hans-Peter , GUNDINGER, Thomas , KOELBL, Bernhard , GRAUSENBURGER, Reinhard , PLJEVLJAKOVIC, Azra
CPC分类号： C07K1/36 , A61K9/0019 , A61K9/08 , A61K35/16 , A61K38/1709 , A61K47/183 , C07K1/14 , C07K1/18 , C07K1/30 , C07K1/34 , C07K16/065
摘要： The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.
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10.发明公开METHOD FOR REDUCING THE THROMBOEMBOLIC POTENTIAL OF A PLASMA-DERIVED IMMUNOGLOBULIN COMPOSITION 有权对于血浆的血栓栓塞减轻潜在方法获得的免疫球蛋白组合物
公开(公告)号：EP2748193A1
公开(公告)日：2014-07-02
申请号：EP12768938.8
申请日：2012-08-27
发明人： TESCHNER, Wolfgang , BUTTERWECK, Harald, Arno , KOELBL, Bernhard , HOFBAUER, Lucia , SCHWARZ, Hans-Peter
IPC分类号： C07K16/06
CPC分类号： C07K16/065
摘要： The present invention provides methods for reducing the amidolytic and anti-complement activity (ACA) content of an immunoglobulin composition through the use of cation exchange chromatography. In a specific embodiment, the invention provides methods for reducing the Factor XI and/or Factor XIa and/or ACA content of an immunoglobulin composition by collecting the leading portion of a cation exchange eluate. The present invention also provides immunoglobulin composition having reduced levels of amidolytic activity, Factor XI, and/or Factor XIa, and/or ACA content.
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