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公开(公告)号：US20250095773A1
公开(公告)日：2025-03-20
申请号：US18887534
申请日：2024-09-17
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Nimish GUPTA , Christopher COWAN , John MATTILA
Abstract: A method of purifying a target molecule may include introducing a load including a high molecular weight species concentration (% HMW) to a chromatography apparatus comprising sartobind phenyl chromatography media. A method of generating a chromatography protocol, may include identifying chromatography loading parameters, identifying chromatography performance criteria. The method of generating the chromatography protocol may include selecting combinations of test values of the loading parameters, and conducting a chromatography run for each combination of the set of test values combinations, thereby generating actual performance criteria values corresponding to each combination of the set of test value combinations.
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公开(公告)号：US20250161457A1
公开(公告)日：2025-05-22
申请号：US19029726
申请日：2025-01-17
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Hanne BAK , John MATTILA , Ning LI , Xiaolin TANG , Daniel B. DIX , Chen LI , William MARKIS , Mayank PATEL
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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公开(公告)号：US20200002373A1
公开(公告)日：2020-01-02
申请号：US16459187
申请日：2019-07-01
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Isabelle LIVIGINI , Stefanie MCDERMOTT , James REILLY , John MATTILA
Abstract: Embodiments of the present disclosure are directed to methods for preparing a target polypeptide from a mixture including the target polypeptide. The method may include contacting the mixture to a hydrophobic interaction chromatography (HIC) apparatus including multiple chromatographic zones. The method may further include passing the target polypeptide through the outlets of at least a first zone and a second zone of the HIC apparatus. A residence time for the mixture including the target polypeptide in a first zone may be approximately the same as a residence time of one or more mobile phases in the second zone.
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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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公开(公告)号：US20220259261A1
公开(公告)日：2022-08-18
申请号：US17630695
申请日：2020-04-23
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： John MATTILA , Andrew BARMASSE , Mark CHIBOROSKI
Abstract: Embodiments of the present disclosure are directed to systems and methods for modulating pH in a mixture containing a polypeptide. The pH may be modulated for any suitable purpose, e.g., inactivating virus in the mixture. Methods may include eluting, from a chromatography column, a mixture (e.g., an eluate) having a pH greater than, e.g., 3.9 and less than, e.g., 8.5. Methods may further include one or more of measuring a protein concentration of the mixture and measuring a pH of the mixture. An amount of acid necessary to reduce the pH of the mixture to a target pH may then be calculated based on the protein concentration of the mixture, the pH of the mixture, or both. After an acid addition amount is calculated, a portion of acid may be added to the mixture, wherein the portion of acid is sufficient to achieve the target pH.
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8.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：US20220323937A1
公开(公告)日：2022-10-13
申请号：US17753915
申请日：2020-09-23
Applicant: Regeneron Pharmaceuticals, Inc.
Inventor： Robert STAIRS , James REILLY , John MATTILA , Samantha WADSWORTH
Abstract: Aspects of the present disclosure relate to a method of regenerating a hydrophobic interaction chromatography column to which a load mass has been applied, the method comprising passing one or more column volumes of an alkaline solution through hydrophobic interaction media within the column, wherein the alkaline solution exhibits a pH of between about 10 and about 14, and a conductivity of between 0.5 mS/cm and about 10 mS/cm, wherein material bound to the hydrophobic interaction media is removed. In some cases, the alkaline solution may include sodium hydroxide at a concentration of between, e.g., about 0.1 mM and 10 mM.
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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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