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公开(公告)号：US11464828B2
公开(公告)日：2022-10-11
申请号：US16826585
申请日：2020-03-23
Applicant: CSL Limited
Inventor： Yvonne Vucica , Gary Lee Warren
Abstract: The present invention relates to reconstituted high density lipoprotein (rHDL) formulations comprising an apolipoprotein, a lipid and a lyophilization stabilizer. Said formulations have reduced renal toxicity and good long-term stability, especially in lyophilized form.
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公开(公告)号：US10730927B2
公开(公告)日：2020-08-04
申请号：US16041239
申请日：2018-07-20
Applicant: CSL Limited
Inventor： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: C07K1/34 , A61K38/00 , C07K14/775
Abstract: 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.
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公开(公告)号：US20190015476A1
公开(公告)日：2019-01-17
申请号：US15894397
申请日：2018-02-12
Applicant: CSL Limited
Inventor： Yvonne Vucica , Gary Lee Warren
IPC: A61K38/17 , C07K14/775 , A61K9/00 , A61K9/19
Abstract: The present invention relates to reconstituted high density lipoprotein (rHDL) formulations comprising an apolipoprotein, a lipid and a lyophilization stabilizer. Said formulations have reduced renal toxicity and good long-term stability, especially in lyophilized form.
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公开(公告)号：US10087235B2
公开(公告)日：2018-10-02
申请号：US14910424
申请日：2014-08-08
Applicant: CSL Limited
Inventor： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: A61K38/00 , C07K14/775 , C07K1/34
Abstract: 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.
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公开(公告)号：US11732028B2
公开(公告)日：2023-08-22
申请号：US16945312
申请日：2020-07-31
Applicant: CSL Limited
Inventor： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: C07K14/775 , C07K1/34 , A61K38/00
CPC classification number: C07K14/775 , C07K1/34 , A61K38/00
Abstract: 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.
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Patent Agency Ranking
公开(公告)号：US20200223902A1
公开(公告)日：2020-07-16
申请号：US16575105
申请日：2019-09-18
Applicant: CSL LIMITED
Inventor： Yvonne Vucica , Gary Lee Warren
IPC: C07K14/775 , C07K1/30
Abstract: The present invention relates to processes of obtaining Apo A-1 from an Apo A-1 containing protein fraction (A), comprising suspending—the Apo A-1 containing protein fraction (A) in a buffer solution (B), removing impurities from the suspension while keeping the Apo A-1 proteins solubilized, followed by precipitating Apo A˜I from the suspension and collecting the Apo A-1 precipitate. Apo A-I obtained by such processes, reconstituted HDL obtained from such Apo A-1, and pharmaceutical compositions comprising such Apo A-I and/or reconstituted HDL also are provided.
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公开(公告)号：US10603355B2
公开(公告)日：2020-03-31
申请号：US15894397
申请日：2018-02-12
Applicant: CSL Limited
Inventor： Yvonne Vucica , Gary Lee Warren
Abstract: The present invention relates to reconstituted high density lipoprotein (rHDL) formulations comprising an apolipoprotein, a lipid and a lyophilization stabilizer. Said formulations have reduced renal toxicity and good long-term stability, especially in lyophilized form.
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公开(公告)号：US20160176947A1
公开(公告)日：2016-06-23
申请号：US14910424
申请日：2014-08-08
Applicant: CSL LIMITED
Inventor： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: C07K14/775 , C07K1/34
CPC classification number: C07K14/775 , A61K38/00 , C07K1/34
Abstract: 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.
Abstract translation: 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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公开(公告)号：US20210147509A1
公开(公告)日：2021-05-20
申请号：US16945312
申请日：2020-07-31
Applicant: CSL Limited
Inventor： Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: C07K14/775 , C07K1/34
Abstract: 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.
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公开(公告)号：US10421799B2
公开(公告)日：2019-09-24
申请号：US15870203
申请日：2018-01-12
Applicant: CSL LIMITED
Inventor： Yvonne Vucica , Gary Lee Warren
IPC: C07K14/775 , C07K1/30 , A61K38/17 , A61K38/00
Abstract: The present invention relates to processes of obtaining Apo A-1 from an Apo A-1 containing protein fraction (A), comprising suspending the Apo A-1 containing protein fraction (A) in a buffer solution (B), removing impurities from the suspension while keeping the Apo A-1 proteins solubilized, followed by precipitating Apo A˜I from the suspension and collecting the Apo A-1 precipitate. Apo A-I obtained by such processes, reconstituted HDL obtained from such Apo A-1, and pharmaceutical compositions comprising such Apo A-I and/or reconstituted HDL also are provided.
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