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公开(公告)号：US10570367B2
公开(公告)日：2020-02-25
申请号：US14733630
申请日：2015-06-08
申请人： Genzyme Corporation
摘要： Provided herein are seed train processes and methods of producing a recombinant protein that include the use of these seed train processes.
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公开(公告)号：US20150353896A1
公开(公告)日：2015-12-10
申请号：US14733630
申请日：2015-06-08
申请人： Genzyme Corporation
摘要： Provided herein are seed train processes and methods of producing a recombinant protein that include the use of these seed train processes.
摘要翻译： 本文提供了种子培育方法和生产重组蛋白的方法，其包括使用这些种子培育过程。
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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
申请人： Genzyme Corporation
发明人： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala , Mahsa Rohani
IPC分类号： C07K1/16
CPC分类号： C07K1/16 , A61L2/081 , B01D15/1807 , B01D15/1864 , B01D15/20 , B01D15/363 , B01D15/3809 , B01D15/426 , C07K1/165 , C07K1/22 , C12N9/2465 , C12Y302/01022
摘要： 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.
摘要翻译： 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：US11912739B2
公开(公告)日：2024-02-27
申请号：US16993654
申请日：2020-08-14
申请人： Genzyme Corporation
发明人： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala , Mahsa Rohani
IPC分类号： C07K1/16 , A61L2/08 , B01D15/18 , B01D15/20 , B01D15/36 , B01D15/38 , B01D15/42 , C07K1/22 , C12N9/40
CPC分类号： C07K1/16 , A61L2/081 , B01D15/1864 , B01D15/20 , B01D15/363 , B01D15/3809 , B01D15/426 , C07K1/165 , C07K1/22 , C12N9/2465 , B01D15/1807 , C12Y302/01022
摘要： 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：US11839861B2
公开(公告)日：2023-12-12
申请号：US17149613
申请日：2021-01-14
申请人： Genzyme Corporation
IPC分类号： B01J20/281 , B01J20/34 , B01D15/18 , B01D15/20 , B01D15/32 , B01D15/34 , B01D15/36 , B01J39/26 , B01D15/38 , B01J20/26 , B01J41/12 , B01J41/20 , C07K1/16 , C07K1/22 , A61L2/08 , C07K1/18
CPC分类号： 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
摘要： 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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26.发明申请公开(公告)号：US20210171572A1
公开(公告)日：2021-06-10
申请号：US17180272
申请日：2021-02-19
申请人： Genzyme Corporation
摘要： Provided herein are methods of processing a fluid that include the use of one or both of a circuit system including a tangential flow filtration (TFF) unit and a circuit system including a tangential flow virus filtration (TFVF) unit. Also provided are integrated and continuous processes for manufacturing a therapeutic protein drug substance that include a step of processing a fluid including the recombinant therapeutic protein using any of the methods provided herein.
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公开(公告)号：US10919021B2
公开(公告)日：2021-02-16
申请号：US16107110
申请日：2018-08-21
申请人： Genzyme Corporation
IPC分类号： 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
摘要： 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：US20200369718A1
公开(公告)日：2020-11-26
申请号：US16993654
申请日：2020-08-14
申请人： Genzyme Corporation
发明人： Rahul Godawat , Veena Warikoo , Rohan Patil , Konstantin Konstantinov , Venkat Kishore Ryakala , Mahsa Rohani
IPC分类号： C07K1/16 , A61L2/08 , B01D15/18 , B01D15/20 , B01D15/36 , B01D15/38 , B01D15/42 , C07K1/22 , C12N9/40
摘要： 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：US20200317726A1
公开(公告)日：2020-10-08
申请号：US16908401
申请日：2020-06-22
申请人： Genzyme Corporation
IPC分类号： C07K1/22 , C12P21/00 , C07K16/00 , C12N9/00 , C07K1/36 , C12M1/00 , B01D15/18 , B01D15/32 , B01D15/36 , B01D15/38 , C07K1/16 , C07K1/18 , C12N9/24 , C12N9/40 , B01D15/34 , B01D15/42
摘要： 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：US09657056B2
公开(公告)日：2017-05-23
申请号：US14645138
申请日：2015-03-11
申请人： Genzyme Corporation
IPC分类号： C07K1/22 , C07K16/00 , C12P21/00 , C12N9/00 , C07K1/36 , B01D15/18 , B01D15/32 , B01D15/36 , C07K1/16 , C07K1/18 , C12N9/24 , C12N9/36 , B01D15/38 , C12N9/40 , C12M1/00
CPC分类号： 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
摘要： 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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