Patents by Inventor John MATTILA
John MATTILA has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Publication number: 20250214062Abstract: 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.Type: ApplicationFiled: February 12, 2025Publication date: July 3, 2025Applicant: Regeneron Pharmaceuticals, Inc.Inventors: Robert STAIRS, James REILLY, John MATTILA, Samantha WADSWORTH
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Publication number: 20250161457Abstract: 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.Type: ApplicationFiled: January 17, 2025Publication date: May 22, 2025Applicant: Regeneron Pharmaceuticals, Inc.Inventors: Hanne BAK, John MATTILA, Ning LI, Xiaolin TANG, Daniel B. DIX, Chen LI, William MARKIS, Mayank PATEL
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Publication number: 20250095773Abstract: 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.Type: ApplicationFiled: September 17, 2024Publication date: March 20, 2025Applicant: Regeneron Pharmaceuticals, Inc.Inventors: Nimish GUPTA, Christopher COWAN, John MATTILA
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Patent number: 12246305Abstract: 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.Type: GrantFiled: September 23, 2020Date of Patent: March 11, 2025Assignee: Regeneron Pharmaceuticals, Inc.Inventors: Robert Stairs, James Reilly, John Mattila, Samantha Wadsworth
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Patent number: 12234277Abstract: The present application provides a method for characterizing and/or determining viral clearance capacity of hydrophobic interaction chromatography (HIC) including experimental design for multivariate analysis of viral clearance of HIC. The method provides understanding of the mechanism of the viral clearance using HIC by running a D-Optimal design of experiment including evaluations of multiple factors, such as pH, buffer concentration, column loading concentration, flow rate of column, or hydrophobic strength of the HIC column.Type: GrantFiled: January 15, 2021Date of Patent: February 25, 2025Assignee: Regeneron Pharmaceuticals, Inc.Inventors: John Ruppino, John Mattila, Robert Stairs
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Publication number: 20240415969Abstract: 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.Type: ApplicationFiled: June 28, 2024Publication date: December 19, 2024Applicant: Regeneron Pharmaceuticals, Inc.Inventors: Hanne BAK, John MATTILA, Ning LI, Xiaolin TANG, Daniel B. DIX, Chen LI, William MARKIS
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Publication number: 20240384243Abstract: Methods for viral clearance using low pH hold based on a statistical design of experiment are provided. Several factors are evaluated to characterize the impacts of a low pH hold step for virus inactivation, including the factors of pH conditions, conductivity conditions, protein type, temperature, acid titrant, spike timing, and post-spike filtration. In addition to the effect of pH on virus inactivation, an increase in ionic strength through manipulating the conductivity can be a key component that influences virus inactivation kinetics.Type: ApplicationFiled: July 19, 2024Publication date: November 21, 2024Applicant: Regeneron Pharmaceuticals, Inc.Inventors: Jena Daya, Valerie Ann Cusick, John Mattila
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Patent number: 12077782Abstract: Methods for viral clearance using low pH hold based on a statistical design of experiment are provided. Several factors are evaluated to characterize the impacts of a low pH hold step for virus inactivation, including the factors of pH conditions, conductivity conditions, protein type, temperature, acid titrant, spike timing, and post-spike filtration. In addition to the effect of pH on virus inactivation, an increase in ionic strength through manipulating the conductivity can be a key component that influences virus inactivation kinetics.Type: GrantFiled: May 11, 2021Date of Patent: September 3, 2024Assignee: Regeneron Pharmaceuticals, Inc.Inventors: Jena Daya, Valerie Ann Cusick, John Mattila
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Patent number: 12070502Abstract: 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.Type: GrantFiled: April 8, 2019Date of Patent: August 27, 2024Assignee: Regeneron Pharmaceuticals, Inc.Inventors: Hanne Bak, John Mattila, Ning Li, Xiaolin Tang, Daniel B. Dix, Chen Li, William Markis
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Publication number: 20240209021Abstract: 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.Type: ApplicationFiled: December 15, 2023Publication date: June 27, 2024Applicant: Regeneron Pharmaceuticals, Inc.Inventors: Isabelle LIVIGNI, Stefanie MCDERMOTT, James REILLY, John MATTILA
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Publication number: 20240199688Abstract: Pharmaceutical formulations comprising an antibody that specifically binds to human interleukin-4 receptor alpha (hIL-4R?) are provided. The formulations may contain, in addition to an anti-IL-4R? antibody, one or more buffers, at least one amino acid, at least one sugar, and a surfactant comprising a polysorbate, polyethylene glycol or a poloxamer. Methods for producing pharmaceutical formulations with reduced lipase activity are also provided, which may include subjecting a drug substance to anion exchange chromatography in acidic conditions, agitation stress, heat stress, and additional ion exchange or size exclusion chromatography. In one aspect, the pharmaceutical formulations do not have appreciable subvisible particle formation in the presence of lipase, and exhibit a substantial degree of antibody stability during storage and after being subjected to thermal and other physical stresses.Type: ApplicationFiled: May 2, 2023Publication date: June 20, 2024Inventors: Xiaolin Tang, Leonid Breydo, John Mattila
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Patent number: 11884698Abstract: 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.Type: GrantFiled: July 1, 2019Date of Patent: January 30, 2024Assignee: Regeneron Pharmaceuticals, Inc.Inventors: Isabelle Livigni, Stefanie McDermott, James Reilly, John Mattila
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Publication number: 20240010737Abstract: The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.Type: ApplicationFiled: February 28, 2023Publication date: January 11, 2024Inventors: John Mattila, Xiaolin Tang, Hanne Bak, Shawn M. Lawrence, Amy S. Johnson, Meghan Casey, Michelle LaFond, Andrew Tustian, Philip Mellors, John Hourihan, John Crowley, Laura Callinan, Shadia Abike Oshodi, Ashley Witmer, Daniel Corbett, James Reilly, Ankit Vartak, Mark Chiboroski, Alessandra Starling, Robert Stairs, Hai-Yuan Goh, Liam Nicholl, Aishling Conlon
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Publication number: 20230348532Abstract: The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.Type: ApplicationFiled: February 28, 2023Publication date: November 2, 2023Inventors: John Mattila, Xiaolin Tang, Hanne Bak, Shawn M. Lawrence, Amy S. Johnson, Meghan Casey, Michelle LaFond, Andrew Tustian, Philip Mellors, John Hourihan, John Crowley, Laura Callinan, Shadia Abike Oshodi, Ashley Witmer, Daniel Corbett, James Reilly, Ankit Vartak, Mark Chiboroski, Alessandra Starling, Robert Stairs, Hai-Yuan Goh, Liam Nicholl, Aishling Conlon
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Publication number: 20230332201Abstract: The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.Type: ApplicationFiled: February 28, 2023Publication date: October 19, 2023Inventors: John Mattila, Xiaolin Tang, Hanne Bak, Shawn M. Lawrence, Amy S. Johnson, Meghan Casey, Michelle LaFond, Andrew Tustian, Philip Mellors, John Hourihan, John Crowley, Laura Callinan, Shadia Abike Oshodi, Ashley Witmer, Daniel Corbett, James Reilly, Ankit Vartak, Mark Chiboroski, Alessandra Starling, Robert Stairs, Hai-Yuan Goh, Liam Nicholl, Aishling Conlon
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Publication number: 20230331776Abstract: The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.Type: ApplicationFiled: February 28, 2023Publication date: October 19, 2023Inventors: John Mattila, Xiaolin Tang, Hanne Bak, Shawn M. Lawrence, Amy S. Johnson, Meghan Casey, Michelle LaFond, Andrew Tustian, Philip Mellors, John Hourihan, John Crowley, Laura Callinan, Shadia Abike Oshodi, Ashley Witmer, Daniel Corbett, James Reilly, Ankit Vartak, Mark Chiboroski, Alessandra Starling, Robert Stairs, Hai-Yuan Goh, Liam Nicholl, Aishling Conlon
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Publication number: 20230332084Abstract: The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.Type: ApplicationFiled: February 28, 2023Publication date: October 19, 2023Inventors: John Mattila, Xiaolin Tang, Hanne Bak, Shawn M. Lawrence, Amy Johnson, Meghan Casey, Michelle LaFond, Andrew Tustian, Philip Mellors, John Hourihan, John Crowley, Laura Callinan, Shadia Abike Oshodi, Ashley Witmer, Daniel Corbett, James Reilly, Ankit Vartak, Mark Chiboroski, Alessandra Starling, Robert Stairs, Hai-Yuan Goh, Liam Nicholl, Aishling Conlon
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Publication number: 20230287043Abstract: The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.Type: ApplicationFiled: February 28, 2023Publication date: September 14, 2023Inventors: John Mattila, Xiaolin Tang, Hanne Bak, Shawn M. Lawrence, Amy S. Johnson, Meghan Casey, Michelle LaFond, Andrew Tustian, Philip Mellors, John Hourihan, John Crowley, Laura Callinan, Shadia Abike Oshodi, Ashley Witmer, Daniel Corbett, James Reilly, Ankit Vartak, Mark Chiboroski, Alessandra Starling, Robert Stairs, Hai-Yuan Goh, Liam Nicholl, Aishling Conlon
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Publication number: 20230273163Abstract: 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.Type: ApplicationFiled: May 8, 2023Publication date: August 31, 2023Applicant: Regeneron Pharmaceuticals, Inc.Inventors: Nathan L. MAO, Eric SHIERLY, Bernhard SCHILLING, Scott CARVER, Stefanie MCDERMOTT, John MATTILA, Hanne BAK
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Patent number: 11680930Abstract: 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.Type: GrantFiled: April 18, 2022Date of Patent: June 20, 2023Assignee: Regeneron Pharmaceuticals, Inc.Inventors: Nathan L. Mao, Eric Shierly, Bernhard Schilling, Scott Carver, Stefanie McDermott, John Mattila, Hanne Bak