Patents by Inventor Rahul Godawat
Rahul Godawat 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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Patent number: 11912739Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.Type: GrantFiled: August 14, 2020Date of Patent: February 27, 2024Assignee: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala, Mahsa Rohani
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Patent number: 11913039Abstract: A method of producing recombinant alkaline phosphatase comprising control of production parameters, particularly harvest clarified culture fluid (HCCF) and filtration pool (UFDF), to provide a defined total sialic acid content.Type: GrantFiled: March 13, 2019Date of Patent: February 27, 2024Assignee: Alexion Pharmaceuticals, Inc.Inventors: Rahul Godawat, Meghan Dewitt, Siguang Sui, Saravanamoorthy Rajendran
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Publication number: 20240052327Abstract: Featured are methods of manufacturing recombinant alkaline phosphatases, such as asfotase alfa, that provide more precise quality control over total sialic acid content (TSAC) concentration in the final product by measuring TSAC concentration during fermentation and adjusting downstream production steps in response.Type: ApplicationFiled: October 21, 2021Publication date: February 15, 2024Applicant: Alexion Pharmaceuticals, Inc.Inventors: Meghan DeWitt, Siguang Sui, Rahul Godawat, Sarah Berendes
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Patent number: 11839861Abstract: Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.Type: GrantFiled: January 14, 2021Date of Patent: December 12, 2023Assignee: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala
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Publication number: 20230143163Abstract: Disclosed are methods for purifying antibodies using a Protein A Chromatography Column and an arginine wash, resulting in decreased host cell protein (HCP) contamination. The method may comprise loading a composition comprising an antibody on a Protein A Chromatography column and washing the column with a wash solution. In an embodiment, the wash is repeated.Type: ApplicationFiled: April 26, 2021Publication date: May 11, 2023Applicant: Alexion Pharmaceuticals, Inc.Inventors: Rahul Godawat, Abraham Friedman
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Publication number: 20220154155Abstract: A method of producing recombinant alkaline phosphatase comprising control of production parameters, particularly harvest clarified culture fluid (HCCF) and filtration pool (UFDF), to provide a defined total sialic acid content.Type: ApplicationFiled: January 24, 2022Publication date: May 19, 2022Inventors: Rahul GODAWAT, Meghan DEWITT, Siguang SUI, Saravanamoorthy RAJENDRAN
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Patent number: 11203747Abstract: The present invention relates to methods for purifying or enriching a biomolecule using multimodal resins and an elution buffer containing a Good's buffer.Type: GrantFiled: December 23, 2019Date of Patent: December 21, 2021Assignee: Genzyme CorporationInventors: Rahul Godawat, Daniel Cummings, Veena Warikoo
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Publication number: 20210317425Abstract: A method of producing recombinant alkaline phosphatase comprising control of production parameters, particularly harvest clarified culture fluid (HCCF) and filtration pool (UFDF), to provide a defined total sialic acid content.Type: ApplicationFiled: March 13, 2019Publication date: October 14, 2021Inventors: Rahul GODAWAT, Meghan DEWITT, Siguang SUI, Saravanamoorthy RAJENDRAN
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Publication number: 20210268477Abstract: Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.Type: ApplicationFiled: January 14, 2021Publication date: September 2, 2021Applicant: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala
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Publication number: 20210122806Abstract: The present application relates to a method of producing an anti-C5 antibody (ravulizumab).Type: ApplicationFiled: June 27, 2019Publication date: April 29, 2021Inventors: Hunter F. MALANSON, Kyle A. ZINGARO, Anjil GIRI, Justin WEAVER, Abraham FRIEDMAN, Jeffrey William HUNTER, Saranya SIVANANDAM, Jeffrey ZUGATES, Rahul GODAWAT
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Patent number: 10919021Abstract: Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.Type: GrantFiled: August 21, 2018Date of Patent: February 16, 2021Assignee: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala
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Publication number: 20200369718Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.Type: ApplicationFiled: August 14, 2020Publication date: November 26, 2020Applicant: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala, Mahsa Rohani
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Publication number: 20200317726Abstract: Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.Type: ApplicationFiled: June 22, 2020Publication date: October 8, 2020Applicant: Genzyme CorporationInventors: Konstantin Konstantinov, Rahul Godawat, Veena Warikoo, Sujit Jain
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Patent number: 10711034Abstract: Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.Type: GrantFiled: April 21, 2017Date of Patent: July 14, 2020Assignee: Genzyme CorporationInventors: Konstantin Konstantinov, Rahul Godawat, Veena Warikoo, Sujit Jain
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Publication number: 20200131493Abstract: The present invention relates to methods for purifying or enriching a biomolecule using multimodal resins and an elution buffer containing a Good's buffer.Type: ApplicationFiled: December 23, 2019Publication date: April 30, 2020Applicant: Genzyme CorporationInventors: Rahul Godawat, Daniel Cummings, Veena Warikoo
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Publication number: 20180369786Abstract: Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.Type: ApplicationFiled: August 21, 2018Publication date: December 27, 2018Applicant: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala
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Publication number: 20180354986Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.Type: ApplicationFiled: August 21, 2018Publication date: December 13, 2018Applicant: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala, Mahsa Rohani
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Patent number: 10087214Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.Type: GrantFiled: January 16, 2015Date of Patent: October 2, 2018Assignee: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala, Mahsa Rohani
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Patent number: 10071364Abstract: Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.Type: GrantFiled: January 16, 2015Date of Patent: September 11, 2018Assignee: Genzyme CorporationInventors: Rahul Godawat, Veena Warikoo, Rohan Patil, Konstantin Konstantinov, Venkat Kishore Ryakala
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Publication number: 20170218012Abstract: Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.Type: ApplicationFiled: April 21, 2017Publication date: August 3, 2017Applicant: Genzyme CorporationInventors: Konstantin Konstantinov, Rahul Godawat, Veena Warikoo, Sujit Jain