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公开(公告)号：US20170191101A1
公开(公告)日：2017-07-06
申请号：US15126790
申请日：2015-03-17
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Benjamin ADAMS , Andrew TUSTIAN , Hanne BAK
CPC classification number: C12P21/00 , C12N5/0081
Abstract: Disclosed is an improved method for clarifying a cell culture during the manufacture of a protein. The method includes the step of transiently reducing the pH of a cell culture, followed by a holding step for a period of time, followed by the neutralization of the cell culture prior to clarification by centrifugation.
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2.发明申请公开(公告)号：US20200055894A1
公开(公告)日：2020-02-20
申请号：US16542766
申请日：2019-08-16
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Michael PERRONE , Audrey RODRIGUEZ , Andrew TUSTIAN , Hanne BAK
Abstract: The invention relates to a chromatography system and method for assessing amount and/or purity of a multimeric protein in a sample, wherein the chromatography system comprises two different affinity chromatography matrices connected via a switch valve.
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公开(公告)号：US20160024147A1
公开(公告)日：2016-01-28
申请号：US14808171
申请日：2015-07-24
Applicant: REGENERON PHARMACEUTICALS, INC.
Inventor： Andrew TUSTIAN , Christine ENDICOTT , Benjamin ADAMS , John MATTILA , Hanne BAK
CPC classification number: C07K1/22 , B01D15/3819 , B01D15/3828 , B01J39/08 , B01J39/26 , C07K16/065 , C07K2317/14 , C07K2317/31 , C07K2317/526
Abstract: High resolution protein A chromatography employing a chaotropic agent and pH gradient or pH step elution buffer results in improved peak resolution between closely related molecular species. Bispecific antibodies containing a protein A-binding-ablating substitution CH3 domain paired with a protein A-binding CH3 domain are separated with high peak resolution from monospecific antibodies containing a protein A-binding-ablating substituted CH3 domain paired with the protein A-binding-ablating substituted CH3 domain and monospecific antibodies containing a protein A-binding CH3 domain paired with the protein A-binding CH3 domain. Useful chaotropic agents include magnesium chloride and calcium chloride.
Abstract translation: 使用离液剂和pH梯度或pH步骤洗脱缓冲液的高分辨率蛋白质A层析结果提高了密切相关的分子物质之间的峰分辨率。 将含有与蛋白质A结合的CH3结构域配对的蛋白质A结合消融的取代的CH3结构域的双特异性抗体与来自含有蛋白质A结合消融的取代的CH3结构域的单特异性抗体以高蛋白A-结合 - 消融取代的CH3结构域和含有与蛋白A结合CH3结构域配对的蛋白A结合CH3结构域的单特异性抗体。 有用的离液剂包括氯化镁和氯化钙。
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公开(公告)号：US20240415969A1
公开(公告)日：2024-12-19
申请号：US18757848
申请日：2024-06-28
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Hanne BAK , John MATTILA , Ning LI , Xiaolin TANG , Daniel B. DIX , Chen LI , William MARKIS
IPC: A61K47/22 , A61K39/395 , A61K47/26
Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.
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Patent Agency Ranking
公开(公告)号：US20230273163A1
公开(公告)日：2023-08-31
申请号：US18313745
申请日：2023-05-08
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Nathan L. MAO , Eric SHIERLY , Bernhard SCHILLING , Scott CARVER , Stefanie MCDERMOTT , John MATTILA , Hanne BAK
CPC classification number: G01N30/88 , G01N30/8617 , G01N30/8693 , G01N2030/889
Abstract: Embodiments of the present disclosure are directed to methods and systems for assessing integrity of chromatography columns, systems, and processes. The methods and systems can comprise one or more of extracting a block and signal combination for analysis, performing a transition analysis, performing one or more statistical process controls, and/or implementing in-process controls based on the statistical process controls.
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6.发明申请公开(公告)号：US20160101181A1
公开(公告)日：2016-04-14
申请号：US14878079
申请日：2015-10-08
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Hanne BAK , John MATTILA , Ning LI , Xiaolin TANG , Daniel DIX , Chen LI , William MARKIS
IPC: A61K47/22 , A61K39/395
CPC classification number: A61K47/22 , A61K39/39591 , A61K47/26
Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.
Abstract translation: 本公开内容提供了包含表面活性剂并且具有每个容器具有小于或等于10微米或更大直径的小于400个可隐形颗粒的稳定的蛋白质组合物，或每个容器具有小于10,000个2微米或更大的潜在颗粒。 公开了制备这种稳定蛋白质组合物的方法，其包括除去或降低降解表面活性剂的酯酶活性的操作单元。 操作单元可以是疏水相互作用层析或过滤，混合模式色谱法等。
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公开(公告)号：US20220308025A1
公开(公告)日：2022-09-29
申请号：US17659526
申请日：2022-04-18
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Nathan L. MAO , Eric SHIERLY , Bernhard SCHILLING , Scott CARVER , Stefanie MCDERMOTT , John MATTILA , Hanne BAK
Abstract: Embodiments of the present disclosure are directed to methods and systems for assessing integrity of chromatography columns, systems, and processes. The methods and systems can comprise one or more of extracting a block and signal combination for analysis, performing a transition analysis, performing one or more statistical process controls, and/or implementing in-process controls based on the statistical process controls.
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8.发明申请公开(公告)号：US20210382065A1
公开(公告)日：2021-12-09
申请号：US17268719
申请日：2019-08-16
Applicant: REGENERON PHARMACEUTICALS, INC.
Inventor： Michael PERRONE , Audrey RODRIGUEZ , Andrew TUSTINA , Hanne BAK
Abstract: The invention relates to a chromatography system and method for assessing amount and/or purity of a multimeric protein in a sample, wherein the chromatography system comprises two different affinity chromatography matrices connected via a switch valve.
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公开(公告)号：US20190231877A1
公开(公告)日：2019-08-01
申请号：US16377371
申请日：2019-04-08
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Hanne BAK , John MATTILA , Ning LI , Xiaolin TANG , Daniel DIX , Chen LI , William MARKIS
IPC: A61K47/22 , A61K39/395 , A61K47/26
CPC classification number: A61K47/22 , A61K39/39591 , A61K47/26
Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.
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