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公开(公告)号：US20150203529A1
公开(公告)日：2015-07-23
申请号：US14598450
申请日：2015-01-16
Applicant: Genzyme Corporation
Inventor： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala , Mahsa Rohani
IPC: C07K1/16
CPC classification number: C07K1/16 , A61L2/081 , B01D15/1807 , B01D15/1864 , B01D15/20 , B01D15/363 , B01D15/3809 , B01D15/426 , C07K1/165 , C07K1/22 , C12N9/2465 , C12Y302/01022
Abstract: 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.
Abstract translation: 本文提供了使用γ-辐射色谱树脂进行色谱法的方法，其包括提供包含γ-辐射色谱树脂的色谱柱; 通过色谱柱进行第一次色谱循环，其中循环包括将色谱树脂暴露于变性缓冲液; 并通过柱进行至少一个附加的色谱循环。 还提供了整合的，封闭的或基本上封闭的，连续的制备重组蛋白质的方法，其包括使用至少一个色谱柱，包括γ-照射的色谱树脂，其中在每个过程中将γ-辐照色谱树脂暴露于变性缓冲液 在该过程中循环，并且在该过程中使用减少的生物负载缓冲液。
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公开(公告)号：US20240417427A1
公开(公告)日：2024-12-19
申请号：US18817164
申请日：2024-08-27
Applicant: Genzyme Corporation
Inventor： Konstantin Konstantinov , Rahul Godawat , Veena Warikoo , Sujit Jain
IPC: C07K1/22 , B01D15/18 , B01D15/32 , B01D15/34 , B01D15/36 , B01D15/38 , B01D15/42 , C07K1/16 , C07K1/18 , C07K1/36 , C07K16/00 , C12M1/00 , C12N9/00 , C12N9/24 , C12N9/40 , C12P21/00
Abstract: 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.
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公开(公告)号：US10087214B2
公开(公告)日：2018-10-02
申请号：US14598450
申请日：2015-01-16
Applicant: Genzyme Corporation
Inventor： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala , Mahsa Rohani
IPC: A61L2/08 , B01D15/18 , B01D15/20 , B01D15/36 , B01D15/38 , B01D15/42 , C07K1/16 , C07K1/22 , C12N9/40
Abstract: 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.
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公开(公告)号：US20170218012A1
公开(公告)日：2017-08-03
申请号：US15493523
申请日：2017-04-21
Applicant: Genzyme Corporation
Inventor： Konstantin Konstantinov , Rahul Godawat , Veena Warikoo , Sujit Jain
IPC: C07K1/16 , C07K1/18 , C07K16/00 , C12N9/40 , C12N9/24 , B01D15/42 , C07K1/36 , C12M1/00 , B01D15/18 , B01D15/36 , B01D15/34 , B01D15/38 , C07K1/22 , C12P21/00
Abstract: 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.
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公开(公告)号：US20210268477A1
公开(公告)日：2021-09-02
申请号：US17149613
申请日：2021-01-14
Applicant: Genzyme Corporation
Inventor： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala
IPC: B01J20/34 , B01D15/18 , B01D15/20 , B01D15/32 , B01D15/34 , B01D15/36 , B01J39/26 , B01D15/38 , B01J20/26 , B01J20/281 , B01J41/12 , B01J41/20 , C07K1/16 , C07K1/22 , A61L2/08 , C07K1/18
Abstract: 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.
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Patent Agency Ranking
公开(公告)号：US20180369786A1
公开(公告)日：2018-12-27
申请号：US16107110
申请日：2018-08-21
Applicant: Genzyme Corporation
Inventor： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala
IPC: B01J20/34 , B01D15/36 , B01D15/34 , B01D15/32 , B01D15/20 , B01D15/18 , C07K1/18 , A61L2/08 , B01D15/38 , B01J20/26 , B01J20/281 , C07K1/22 , B01J41/12 , B01J41/20 , C07K1/16 , B01J39/26
Abstract: 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.
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公开(公告)号：US10071364B2
公开(公告)日：2018-09-11
申请号：US14598401
申请日：2015-01-16
Applicant: Genzyme Corporation
Inventor： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala
IPC: A61L2/08 , B01J20/34 , B01D15/36 , B01D15/38 , B01J20/26 , B01J20/281 , B01J41/12 , B01J41/20 , C07K1/16 , C07K1/22 , C07K1/18 , B01D15/18 , B01D15/20 , B01D15/32 , B01D15/34 , B01J39/26
CPC classification number: B01J20/3441 , A61L2/081 , B01D15/1864 , B01D15/20 , B01D15/327 , B01D15/34 , B01D15/362 , B01D15/363 , B01D15/3804 , B01J20/265 , B01J20/281 , B01J39/26 , B01J41/12 , B01J41/20 , C07K1/16 , C07K1/18 , C07K1/22 , Y10T29/49826
Abstract: 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.
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公开(公告)号：US09650413B2
公开(公告)日：2017-05-16
申请号：US14627559
申请日：2015-02-20
Applicant: Genzyme Corporation
Inventor： Konstantin Konstantinov , Rahul Godawat , Veena Warikoo , Sujit Jain
CPC classification number: C07K1/16 , B01D15/1807 , B01D15/1864 , B01D15/1871 , B01D15/327 , B01D15/34 , B01D15/362 , B01D15/363 , B01D15/3809 , B01D15/3814 , B01D15/422 , C07K1/18 , C07K1/22 , C07K1/36 , C07K16/00 , C07K2317/14 , C12M23/52 , C12M47/10 , C12M47/12 , C12N9/00 , C12N9/2402 , C12N9/2465 , C12P21/00 , C12P21/005 , C12Y302/01022 , C12Y302/01045
Abstract: 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.
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公开(公告)号：US20150203532A1
公开(公告)日：2015-07-23
申请号：US14629356
申请日：2015-02-23
Applicant: Genzyme Corporation
Inventor： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala , Mahsa Rohani
CPC classification number: C07K1/16 , A61L2/081 , B01D15/1807 , B01D15/1864 , B01D15/20 , B01D15/363 , B01D15/3809 , B01D15/426 , C07K1/165 , C07K1/22 , C12N9/2465 , C12Y302/01022
Abstract: 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.
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公开(公告)号：US20150203531A1
公开(公告)日：2015-07-23
申请号：US14629315
申请日：2015-02-23
Applicant: Genzyme Corporation
Inventor： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala
CPC classification number: B01J20/3441 , A61L2/081 , B01D15/1864 , B01D15/20 , B01D15/327 , B01D15/34 , B01D15/362 , B01D15/363 , B01D15/3804 , B01J20/265 , B01J20/281 , B01J39/26 , B01J41/12 , B01J41/20 , C07K1/16 , C07K1/18 , C07K1/22 , Y10T29/49826
Abstract: 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.
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