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公开(公告)号：US20240150395A1
公开(公告)日：2024-05-09
申请号：US18416145
申请日：2024-01-18
Applicant: Genzyme Corporation
Inventor： Michael Coolbaugh , Tarl Vetter , Chad Varner , Kevin Brower
Abstract: The present disclosure relates to methods and systems for the continuous production of recombinant proteins. In particular embodiments, the disclosure relates to methods and systems using capture chromatography, post-capture chromatography, virus filtration, and ultrafiltration/diafiltration for the continuous production of recombinant proteins.
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公开(公告)号：US12157873B2
公开(公告)日：2024-12-03
申请号：US18374435
申请日：2023-09-28
Applicant: Genzyme Corporation
Inventor： Kevin Brower , Michael Coolbaugh , Xhorxhi Gjoka , Chad Varner , Jason Walther
Abstract: Systems and devices for producing biological products and methods of using the same are provided. An example universal skid includes a rigid support and a plurality of flow-channel hardware sets. Each flow-channel hardware set couples with a respective flow channel of a plurality of flow channels for unit operations. The flow-channel hardware sets allow the flow channels to operate in parallel or in series for continuous processing over the unit operations. An example modular assembly includes one or more single-use kits for one or more unit operations and a universal skid coupled with the one or more single-use kits. An example manufacturing system includes multiple modular assemblies coupled with each other allowing continuous processing within each modular assembly, in between the modular assemblies, fully continuous processing across multiple unit operations.
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公开(公告)号：US20200069822A1
公开(公告)日：2020-03-05
申请号：US16543247
申请日：2019-08-16
Applicant: Genzyme Corporation
Inventor： Rohan Patil , Chad Varner
IPC: A61L2/08 , B01J20/26 , B01J20/28 , B01J20/286 , B01J20/30 , B01J41/04 , B01J41/12 , B01J49/60 , B01J47/02 , B01J47/014 , C07K1/18 , B01D15/36 , B01D15/38
Abstract: Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol 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 a liquid including at least one alcohol, 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.
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Patent Agency Ranking
公开(公告)号：US11912741B2
公开(公告)日：2024-02-27
申请号：US16837126
申请日：2020-04-01
Applicant: Genzyme Corporation
Inventor： Michael Coolbaugh , Tarl Vetter , Chad Varner , Kevin Brower
Abstract: The present disclosure relates to methods and systems for the continuous production of recombinant proteins. In particular embodiments, the disclosure relates to methods and systems using capture chromatography, post-capture chromatography, virus filtration, and ultrafiltration/diafiltration for the continuous production of recombinant proteins.
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公开(公告)号：US20200317728A1
公开(公告)日：2020-10-08
申请号：US16837126
申请日：2020-04-01
Applicant: Genzyme Corporation
Inventor： Michael Coolbaugh , Tarl Vetter , Chad Varner , Kevin Brower
Abstract: The present disclosure relates to methods and systems for the continuous production of recombinant proteins. In particular embodiments, the disclosure relates to methods and systems using capture chromatography, post-capture chromatography, virus filtration, and ultrafiltration/diafiltration for the continuous production of recombinant proteins.
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公开(公告)号：US20250051705A1
公开(公告)日：2025-02-13
申请号：US18930067
申请日：2024-10-29
Applicant: Genzyme Corporation
Inventor： Kevin Brower , Michael Coolbaugh , Xhorxhi Gjoka , Chad Varner , Jason Walther
Abstract: Systems and devices for producing biological products and methods of using the same are provided. An example universal skid includes a rigid support and a plurality of flow-channel hardware sets. Each flow-channel hardware set couples with a respective flow channel of a plurality of flow channels for unit operations. The flow-channel hardware sets allow the flow channels to operate in parallel or in series for continuous processing over the unit operations. An example modular assembly includes one or more single-use kits for one or more unit operations and a universal skid coupled with the one or more single-use kits. An example manufacturing system includes multiple modular assemblies coupled with each other allowing continuous processing within each modular assembly, in between the modular assemblies, fully continuous processing across multiple unit operations.
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公开(公告)号：US20240101945A1
公开(公告)日：2024-03-28
申请号：US18374435
申请日：2023-09-28
Applicant: Genzyme Corporation
Inventor： Kevin Brower , Michael Coolbaugh , Xhorxhi Gjoka , Chad Varner , Jason Walther
CPC classification number: C12M23/44 , B01D15/1821 , B01D15/3804 , C12M47/10 , C12M47/12
Abstract: Systems and devices for producing biological products and methods of using the same are provided. An example universal skid includes a rigid support and a plurality of flow-channel hardware sets. Each flow-channel hardware set couples with a respective flow channel of a plurality of flow channels for unit operations. The flow-channel hardware sets allow the flow channels to operate in parallel or in series for continuous processing over the unit operations. An example modular assembly includes one or more single-use kits for one or more unit operations and a universal skid coupled with the one or more single-use kits. An example manufacturing system includes multiple modular assemblies coupled with each other allowing continuous processing within each modular assembly, in between the modular assemblies, fully continuous processing across multiple unit operations.
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公开(公告)号：US11369703B2
公开(公告)日：2022-06-28
申请号：US16543247
申请日：2019-08-16
Applicant: Genzyme Corporation
Inventor： Rohan Patil , Chad Varner
IPC: A61L2/08 , B01J20/26 , B01J20/28 , B01J20/286 , B01J20/30 , B01J41/04 , B01J49/60 , B01J47/02 , B01J47/014 , C07K1/18 , B01D15/36 , B01D15/38 , B01J41/12
Abstract: Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol 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 a liquid including at least one alcohol, 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.
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