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1. 发明授权

US11224643B2 Methods of treatment using alpha-1-antitrypsin compositions 有权
公开(公告)号：US11224643B2
公开(公告)日：2022-01-18
申请号：US16411627
申请日：2019-05-14
申请人： CSL Behring L.L.C.
发明人： Scott M. Kee , Paul I. Cook , James R. Smith , Robert Kling , Scott A. Fowler , David Weber
IPC分类号： A61K38/57 , B01D15/32 , B01D15/36 , C07K14/81 , A61K9/19 , G01N30/46
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitant. Separation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitable for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.

2. 发明申请

US20170042986A1 METHODS OF TREATMENT USING ALPHA-1-ANTITRYPSIN COMPOSITIONS 审中-公开
标题翻译：使用ALPHA-1-抗菌素组合物治疗的方法
公开(公告)号：US20170042986A1
公开(公告)日：2017-02-16
申请号：US15074266
申请日：2016-03-18
申请人： CSL Behring L.L.C.
发明人： Scott M. KEE , Paul I. COOK , James R. SMITH , Robert KLING , Scott A. FOWLER , David WEBER
IPC分类号： A61K38/57 , A61K9/19 , C07K14/81
CPC分类号： A61K38/57 , A61K9/19 , B01D15/327 , B01D15/363 , C07K14/8125 , G01N30/461
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Spearation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitable for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.
摘要翻译：提供了从含有AAT的蛋白质混合物（例如Coh级分IV沉淀）中纯化α-1-抗胰蛋白酶（AAT）的流线型方法。在本发明的方法中，通过用不影响AAT的还原剂如二硫醇裂解二硫键，污染蛋白质不稳定。然后将不稳定的蛋白质优先吸附在固体蛋白质吸附材料上，而不添加盐作为沉淀物。从溶液中吸取固体吸收剂留下直接适用于色谱纯化的纯化AAT溶液，而不需像现有技术方法那样进行广泛的脱盐。还描述了一种以商业规模提供高产量的药物级AAT的方法。

3. 发明授权

US10335467B2 Methods of treatment using alpha-1-antitrypsin compositions 有权
公开(公告)号：US10335467B2
公开(公告)日：2019-07-02
申请号：US15918614
申请日：2018-03-12
申请人： CSL Behring L.L.C.
发明人： Scott M. Kee , Paul I. Cook , James R. Smith , Robert Kling , Scott A. Fowler , David Weber
IPC分类号： A61K38/57 , A61K9/19 , B01D15/32 , B01D15/36 , C07K14/81 , G01N30/46
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Spearation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitabale for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.

4. 发明申请

US20200078451A1 METHODS OF TREATMENT USING ALPHA-1-ANTITRYPSIN COMPOSITIONS 审中-公开
公开(公告)号：US20200078451A1
公开(公告)日：2020-03-12
申请号：US16411627
申请日：2019-05-14
申请人： CSL Behring L.L.C.
发明人： Scott M. KEE , Paul I. COOK , James R. SMITH , Robert KLING , Scott A. FOWLER , David WEBER
IPC分类号： A61K38/57 , A61K9/19 , C07K14/81 , B01D15/36 , B01D15/32
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Spearation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitabale for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.

5. 发明申请

US20180200347A1 METHODS OF TREATMENT USING ALPHA-1-ANTITRYPSIN COMPOSITIONS 审中-公开
公开(公告)号：US20180200347A1
公开(公告)日：2018-07-19
申请号：US15918614
申请日：2018-03-12
申请人： CSL Behring L.L.C.
发明人： Scott M. KEE , Paul I. COOK , James R. SMITH , Robert KLING , Scott A. FOWLER , David WEBER
IPC分类号： A61K38/57 , B01D15/36 , C07K14/81 , A61K9/19 , B01D15/32 , G01N30/46
CPC分类号： A61K38/57 , A61K9/19 , B01D15/327 , B01D15/363 , C07K14/8125 , G01N30/461
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Spearation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitabale for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.

6. 发明授权

US09320783B2 Methods of treatment using alpha-1-antitrypsin compositions 有权
标题翻译：使用α-1-抗胰蛋白酶组合物的治疗方法
公开(公告)号：US09320783B2
公开(公告)日：2016-04-26
申请号：US14802885
申请日：2015-07-17
申请人： CSL Behring L.L.C.
发明人： Scott M. Kee , Paul I. Cook , James R. Smith , Robert Kling , Scott A. Fowler , David Weber
IPC分类号： A61K38/57 , B01D15/32 , B01D15/36 , C07K14/81 , G01N30/46
CPC分类号： A61K38/57 , A61K9/19 , B01D15/327 , B01D15/363 , C07K14/8125 , G01N30/461
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Separation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitable for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.
摘要翻译：提供了从含有AAT的蛋白质混合物（例如Coh级分IV沉淀）中纯化α-1-抗胰蛋白酶（AAT）的流线型方法。在本发明的方法中，通过用不影响AAT的还原剂如二硫醇裂解二硫键，污染蛋白质不稳定。然后将不稳定的蛋白质优先吸附在固体蛋白质吸附材料上，而不添加盐作为沉淀物。固体吸收剂与溶液的分离留下直接适用于色谱纯化的纯化的AAT溶液，而不需像现有技术方法一样进行广泛的脱盐。还描述了一种以商业规模提供高产量的药物级AAT的方法。

7. 发明申请

US20150320846A1 METHODS OF TREATMENT USING ALPHA-1-ANTITRYPSIN COMPOSITIONS 审中-公开
标题翻译：使用ALPHA-1-抗菌素组合物治疗的方法
公开(公告)号：US20150320846A1
公开(公告)日：2015-11-12
申请号：US14802885
申请日：2015-07-17
申请人： CSL Behring L.L.C.
发明人： Scott M. KEE , Paul I. COOK , James R. SMITH , Robert KLING , Scott A. FOWLER , David WEBER
IPC分类号： A61K38/57
CPC分类号： A61K38/57 , A61K9/19 , B01D15/327 , B01D15/363 , C07K14/8125 , G01N30/461
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Separation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitable for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.
摘要翻译：提供了从含有AAT的蛋白质混合物（例如Coh级分IV沉淀）中纯化α-1-抗胰蛋白酶（AAT）的流线型方法。在本发明的方法中，通过用不影响AAT的还原剂如二硫醇裂解二硫键，污染蛋白质不稳定。然后将不稳定的蛋白质优先吸附在固体蛋白质吸附材料上，而不添加盐作为沉淀物。固体吸收剂与溶液的分离留下直接适用于色谱纯化的纯化的AAT溶液，而不需像现有技术方法那样进行广泛的脱盐。还描述了一种以商业规模提供高产量的药物级AAT的方法。

8. 发明授权

US09950046B2 Methods of treatment using alpha-1-antitrypsin compositions 有权
公开(公告)号：US09950046B2
公开(公告)日：2018-04-24
申请号：US15074266
申请日：2016-03-18
申请人： CSL Behring L.L.C.
发明人： Scott M. Kee , Paul I. Cook , James R. Smith , Robert Kling , Scott A. Fowler , David Weber
IPC分类号： A61K38/57 , A61K9/19 , C07K14/81 , B01D15/36 , B01D15/32 , G01N30/46
CPC分类号： A61K38/57 , A61K9/19 , B01D15/327 , B01D15/363 , C07K14/8125 , G01N30/461
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Spearation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitable for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.

9. 发明申请

US20140323405A1 ALPHA-1-ANTITRYPSIN COMPOSITIONS 审中-公开
标题翻译： ALPHA-1-抗菌素组合物
公开(公告)号：US20140323405A1
公开(公告)日：2014-10-30
申请号：US14223010
申请日：2014-03-24
申请人： CSL Behring L.L.C.
发明人： Scott M. Kee , Paul I. Cook , James R. Smith , Robert Kling , Scott A. Fowler , David Weber
IPC分类号： C07K14/81
CPC分类号： A61K38/57 , A61K9/19 , B01D15/327 , B01D15/363 , C07K14/8125 , G01N30/461
摘要： A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as a Cohn fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as a dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitant. Separation of the solid adsorbent from the solution leaves a purified AAT solution that is directly suitable for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.
摘要翻译：提供了从含有AAT的蛋白质混合物如Cohn馏分IV沉淀物中纯化α-1-抗胰蛋白酶（AAT）的流线型方法。在本发明的方法中，污染蛋白质通过用不影响AAT的还原剂如二硫醇裂解二硫键而不稳定。然后将不稳定的蛋白质优先吸附在固体蛋白质吸附材料上，而不加入作为沉淀剂的盐。固体吸附剂与溶液的分离留下直接适用于色谱纯化的纯化AAT溶液，而不需像现有技术方法那样进行广泛的脱盐。还描述了一种以商业规模提供高产量的药物级AAT的方法。

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