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1. 发明申请

US20190119354A1 CONTAMINANT REMOVAL METHOD 审中-公开
公开(公告)号：US20190119354A1
公开(公告)日：2019-04-25
申请号：US16041239
申请日：2018-07-20
申请人： CSL Limited
发明人： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC分类号： C07K14/775 , C07K1/34
摘要： A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

2. 发明授权

US10730927B2 Contaminant removal method 有权
公开(公告)号：US10730927B2
公开(公告)日：2020-08-04
申请号：US16041239
申请日：2018-07-20
申请人： CSL Limited
发明人： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC分类号： C07K1/34 , A61K38/00 , C07K14/775
摘要： A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

3. 发明授权

US10087235B2 Contaminant removal method 有权
公开(公告)号：US10087235B2
公开(公告)日：2018-10-02
申请号：US14910424
申请日：2014-08-08
申请人： CSL Limited
发明人： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC分类号： A61K38/00 , C07K14/775 , C07K1/34
摘要： A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nrn to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-f preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

4. 发明申请

US20210147509A1 CONTAMINANT REMOVAL METHOD 有权
公开(公告)号：US20210147509A1
公开(公告)日：2021-05-20
申请号：US16945312
申请日：2020-07-31
申请人： CSL Limited
发明人： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC分类号： C07K14/775 , C07K1/34
摘要： A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

5. 发明授权

US11732028B2 Contaminant removal method 有权
公开(公告)号：US11732028B2
公开(公告)日：2023-08-22
申请号：US16945312
申请日：2020-07-31
申请人： CSL Limited
发明人： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC分类号： C07K14/775 , C07K1/34 , A61K38/00
CPC分类号： C07K14/775 , C07K1/34 , A61K38/00
摘要： A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

6. 发明申请

US20160176947A1 CONTAMINANT REMOVAL METHOD 审中-公开
标题翻译：污染物去除方法
公开(公告)号：US20160176947A1
公开(公告)日：2016-06-23
申请号：US14910424
申请日：2014-08-08
申请人： CSL LIMITED
发明人： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC分类号： C07K14/775 , C07K1/34
CPC分类号： C07K14/775 , A61K38/00 , C07K1/34
摘要： A method for purifying Apo A-l is provided including the steps of providing a solution comprising Apo A-l and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nrn to 35 nm to thereby reduce viral contamination of the Apo A-l. An Apo A-f preparation is provided having at least a 12 LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-l and methods of treating diseases disorders or conditions.
摘要翻译：提供了用于纯化Apo A1的方法，包括以下步骤：提供包含Apo A1和盐酸胍的溶液，并通过孔径在15nm至35nm的滤光器过滤溶液，从而减少Apo A1的病毒污染。提供Apo A-f制剂，其对于细小病毒具有至少12个LRV（对数减少值）; 和/或至少9log LRV为非包膜病毒; 和/或至少8.5log LRV用于脂质包膜病毒。还提供了包含Apo A-1的药物组合物和重构高密度脂蛋白制剂以及治疗疾病障碍或病症的方法。

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