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).

  • Publication number: 20250214062
    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.
    Type: Application
    Filed: February 12, 2025
    Publication date: July 3, 2025
    Applicant: Regeneron Pharmaceuticals, Inc.
    Inventors: Robert STAIRS, James REILLY, John MATTILA, Samantha WADSWORTH
  • Publication number: 20250161457
    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.
    Type: Application
    Filed: January 17, 2025
    Publication date: May 22, 2025
    Applicant: Regeneron Pharmaceuticals, Inc.
    Inventors: Hanne BAK, John MATTILA, Ning LI, Xiaolin TANG, Daniel B. DIX, Chen LI, William MARKIS, Mayank PATEL
  • Publication number: 20250095773
    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.
    Type: Application
    Filed: September 17, 2024
    Publication date: March 20, 2025
    Applicant: Regeneron Pharmaceuticals, Inc.
    Inventors: Nimish GUPTA, Christopher COWAN, John MATTILA
  • Patent number: 12246305
    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.
    Type: Grant
    Filed: September 23, 2020
    Date of Patent: March 11, 2025
    Assignee: Regeneron Pharmaceuticals, Inc.
    Inventors: Robert Stairs, James Reilly, John Mattila, Samantha Wadsworth
  • Patent number: 12234277
    Abstract: 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: Grant
    Filed: January 15, 2021
    Date of Patent: February 25, 2025
    Assignee: Regeneron Pharmaceuticals, Inc.
    Inventors: John Ruppino, John Mattila, Robert Stairs
  • Publication number: 20240415969
    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.
    Type: Application
    Filed: June 28, 2024
    Publication date: December 19, 2024
    Applicant: Regeneron Pharmaceuticals, Inc.
    Inventors: Hanne BAK, John MATTILA, Ning LI, Xiaolin TANG, Daniel B. DIX, Chen LI, William MARKIS
  • Publication number: 20240384243
    Abstract: 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: Application
    Filed: July 19, 2024
    Publication date: November 21, 2024
    Applicant: Regeneron Pharmaceuticals, Inc.
    Inventors: Jena Daya, Valerie Ann Cusick, John Mattila
  • Patent number: 12077782
    Abstract: 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: Grant
    Filed: May 11, 2021
    Date of Patent: September 3, 2024
    Assignee: Regeneron Pharmaceuticals, Inc.
    Inventors: Jena Daya, Valerie Ann Cusick, John Mattila
  • Patent number: 12070502
    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.
    Type: Grant
    Filed: April 8, 2019
    Date of Patent: August 27, 2024
    Assignee: Regeneron Pharmaceuticals, Inc.
    Inventors: Hanne Bak, John Mattila, Ning Li, Xiaolin Tang, Daniel B. Dix, Chen Li, William Markis
  • Publication number: 20240209021
    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.
    Type: Application
    Filed: December 15, 2023
    Publication date: June 27, 2024
    Applicant: Regeneron Pharmaceuticals, Inc.
    Inventors: Isabelle LIVIGNI, Stefanie MCDERMOTT, James REILLY, John MATTILA
  • Publication number: 20240199688
    Abstract: 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: Application
    Filed: May 2, 2023
    Publication date: June 20, 2024
    Inventors: Xiaolin Tang, Leonid Breydo, John Mattila
  • Patent number: 11884698
    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.
    Type: Grant
    Filed: July 1, 2019
    Date of Patent: January 30, 2024
    Assignee: Regeneron Pharmaceuticals, Inc.
    Inventors: Isabelle Livigni, Stefanie McDermott, James Reilly, John Mattila
  • Publication number: 20240010737
    Abstract: 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: Application
    Filed: February 28, 2023
    Publication date: January 11, 2024
    Inventors: 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
  • Publication number: 20230348532
    Abstract: 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: Application
    Filed: February 28, 2023
    Publication date: November 2, 2023
    Inventors: 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
  • Publication number: 20230332201
    Abstract: 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: Application
    Filed: February 28, 2023
    Publication date: October 19, 2023
    Inventors: 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
  • Publication number: 20230331776
    Abstract: 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: Application
    Filed: February 28, 2023
    Publication date: October 19, 2023
    Inventors: 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
  • Publication number: 20230332084
    Abstract: 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: Application
    Filed: February 28, 2023
    Publication date: October 19, 2023
    Inventors: 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
  • Publication number: 20230287043
    Abstract: 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: Application
    Filed: February 28, 2023
    Publication date: September 14, 2023
    Inventors: 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
  • Publication number: 20230273163
    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.
    Type: Application
    Filed: May 8, 2023
    Publication date: August 31, 2023
    Applicant: Regeneron Pharmaceuticals, Inc.
    Inventors: Nathan L. MAO, Eric SHIERLY, Bernhard SCHILLING, Scott CARVER, Stefanie MCDERMOTT, John MATTILA, Hanne BAK
  • Patent number: 11680930
    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.
    Type: Grant
    Filed: April 18, 2022
    Date of Patent: June 20, 2023
    Assignee: Regeneron Pharmaceuticals, Inc.
    Inventors: Nathan L. Mao, Eric Shierly, Bernhard Schilling, Scott Carver, Stefanie McDermott, John Mattila, Hanne Bak