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1. 发明申请

US20140325868A1 LYOPHILIZATION SYSTEM AND METHOD 有权
标题翻译： LYOPHILIZATION系统和方法
公开(公告)号：US20140325868A1
公开(公告)日：2014-11-06
申请号：US14334722
申请日：2014-07-18
申请人： Theodore Hall Gasteyer, III , Robert Rex Sever , Balazs Hunek , Nigel Grinter , Melinda Lee Verdone
发明人： Theodore Hall Gasteyer, III , Robert Rex Sever , Balazs Hunek , Nigel Grinter , Melinda Lee Verdone
IPC分类号： F26B5/06
CPC分类号： F26B5/06
摘要： System and method for lyophilization or freeze-drying is provided. During the freezing step, the material or solution to be frozen is initially brought to a temperature near or below its freezing temperature after which the pressure in the freeze-dryer chamber is reduced to induce nucleation of the material.
摘要翻译：提供了用于冻干或冷冻干燥的系统和方法。在冷冻步骤期间，待冷冻的材料或溶液最初达到接近或低于其冷冻温度的温度，之后冷冻干燥室中的压力降低以引起材料成核。

2. 发明授权

US09181521B2 Bioreactor with upward flowing impeller system for use in a mammalian cell culture process 有权
标题翻译：具有向上流动的叶轮系统的生物反应器用于哺乳动物细胞培养过程
公开(公告)号：US09181521B2
公开(公告)日：2015-11-10
申请号：US13559957
申请日：2012-07-27
申请人： Alan T. Y. Cheng , Ying Zhou , Amitabh Gupta , Balazs Hunek , Nigel Grinter
发明人： Alan T. Y. Cheng , Ying Zhou , Amitabh Gupta , Balazs Hunek , Nigel Grinter
IPC分类号： C12M1/06 , C12M1/00 , C12N1/38 , C12M1/08 , C12M1/34 , C12M1/36
CPC分类号： C12M27/20 , C12M27/02 , C12M27/24 , C12M29/06 , C12M41/12 , C12M41/26 , C12M41/32 , C12M41/48 , C12N1/38
摘要： A bioreactor with an upward flowing impeller system for controlling a mammalian cell culture process is provided. The disclosed system enables control of the cell culture process by controlling the level of dissolved carbon dioxide in the cell culture media and prevent increases in the osmolality level is achieved by enhanced stripping of carbon dioxide via surface gas exchange with little or no damage to the mammalian cells. The use of an upward flow impeller combined with vertical baffles converts the swirling motions of the cell culture media into a largely vertical flow and promotes the removal of dissolved carbon dioxide via surface gas exchange with a sweep gas flowing over the top surface of the cell culture media within the bioreactor vessel.
摘要翻译：提供了一种具有向上流动的叶轮系统用于控制哺乳动物细胞培养过程的生物反应器。所公开的系统能够通过控制细胞培养基中溶解的二氧化碳的水平来控制细胞培养过程，并且通过经由表面气体交换增强汽提二氧化碳来实现渗透压浓度的增加，对哺乳动物几乎没有或没有损伤细胞。使用与垂直挡板结合的向上流动叶轮将细胞培养基的旋转运动转化为大体垂直的流动，并通过与流过细胞培养物顶表面的吹扫气体的表面气体交换促进去除溶解的二氧化碳生物反应器容器内的介质。

3. 发明申请

US20130236358A1 SYSTEM AND METHOD FOR VIRUS INACTIVATION 有权
标题翻译：用于病毒灭活的系统和方法
公开(公告)号：US20130236358A1
公开(公告)日：2013-09-12
申请号：US13796848
申请日：2013-03-12
申请人： Peter W. Latham , Nigel Grinter , Robert Sever
发明人： Peter W. Latham , Nigel Grinter , Robert Sever
IPC分类号： A61L2/00
CPC分类号： A61L2/0094 , A61L2/18
摘要： Methods and systems for virus inactivation in the production or processing of biological or other sensitive substances are provided. The disclosed methods and systems for virus inactivation involve the key steps of dissolving carbon dioxide into biological or other sensitive substances; and treating the substance with the dissolved carbon dioxide at conditions which are less than critical pressure and temperature for a prescribed treatment time to inactivate at least 80% of the target virus or viruses contained within the biological or other sensitive substances. The disclosed carbon dioxide treatments for virus inactivation may optionally include concurrently or sequentially subjecting the substances with an acid treatment to lower the pH of the substance and inactivate viruses contained within the biological or other sensitive substance. Operating conditions for the disclosed carbon dioxide treatments preferably involve sparging carbon dioxide gas into the substance until the composition is saturated with carbon dioxide and is conducted at pressures below about 5 MPa; at temperatures of less than or equal to 30° C.; and for a treatment time of between about one minute and about 2000 minutes.
摘要翻译：提供了生物或其他敏感物质生产或加工中病毒灭活的方法和系统。公开的用于病毒灭活的方法和系统涉及将二氧化碳溶解到生物或其他敏感物质中的关键步骤; 并且在规定的处理时间内，在小于临界压力和温度的条件下用溶解的二氧化碳处理物质，使至少80％的生物或其他敏感物质中所含的靶病毒或病毒灭活。公开的用于病毒灭活的二氧化碳处理可以任选地包括同时或依次经受酸处理的物质以降低物质的pH并灭活生物或其它敏感物质中所含的病毒。所公开的二氧化碳处理的操作条件优选包括将二氧化碳气体喷射到物质中，直到组合物用二氧化碳饱和并在低于约5MPa的压力下进行; 在小于或等于30℃的温度下。并且治疗时间在约1分钟至约2000分钟之间。

4. 发明授权

US09453675B2 Method of inducing nucleation of a material 有权
标题翻译：诱导材料成核的方法
公开(公告)号：US09453675B2
公开(公告)日：2016-09-27
申请号：US11702472
申请日：2007-02-05
申请人： Theodore Hall Gasteyer, III , Robert Rex Sever , Balazs Hunek , Nigel Grinter , Melinda Lee Verdone
发明人： Theodore Hall Gasteyer, III , Robert Rex Sever , Balazs Hunek , Nigel Grinter , Melinda Lee Verdone
IPC分类号： F25C1/00 , F26B5/06
CPC分类号： F26B5/06
摘要： Methods of inducing nucleation of a material is provided. The disclosed methods comprise the steps of bringing the material to a temperature near or below a phase transition temperature and altering the pressure to induce nucleation of the material. The disclosed methods are useful in freeze-drying processes, particularly pharmaceutical freeze-drying processes.
摘要翻译：提供了诱导材料成核的方法。所公开的方法包括使材料达到接近或低于相变温度的温度并改变压力以诱导材料成核的步骤。所公开的方法在冷冻干燥方法，特别是药物冷冻干燥方法中是有用的。

5. 发明授权

US09200836B2 Lyophilization system and method 有权
标题翻译：冻干系统和方法
公开(公告)号：US09200836B2
公开(公告)日：2015-12-01
申请号：US14334722
申请日：2014-07-18
申请人： Theodore Hall Gasteyer, III , Robert Rex Sever , Balazs Hunek , Nigel Grinter , Melinda Lee Verdone
发明人： Theodore Hall Gasteyer, III , Robert Rex Sever , Balazs Hunek , Nigel Grinter , Melinda Lee Verdone
IPC分类号： F26B5/06
CPC分类号： F26B5/06
摘要： System and method for lyophilization or freeze-drying is provided. During the freezing step, the material or solution to be frozen is initially brought to a temperature near or below its freezing temperature after which the pressure in the freeze-dryer chamber is reduced to induce nucleation of the material.
摘要翻译：提供了用于冻干或冷冻干燥的系统和方法。在冷冻步骤期间，待冷冻的材料或溶液最初达到接近或低于其冷冻温度的温度，之后冷冻干燥室中的压力降低以引起材料成核。

6. 发明授权

US08956566B2 System and method for virus inactivation 有权
标题翻译：用于病毒灭活的系统和方法
公开(公告)号：US08956566B2
公开(公告)日：2015-02-17
申请号：US13796848
申请日：2013-03-12
申请人： Peter W. Latham , Nigel Grinter , Robert Sever
发明人： Peter W. Latham , Nigel Grinter , Robert Sever
IPC分类号： A61L9/00 , A61L2/00 , B08B7/00 , B08B9/00 , A61L2/18
CPC分类号： A61L2/0094 , A61L2/18
摘要： Methods and systems for virus inactivation in the production or processing of biological or other sensitive substances are provided. The disclosed methods and systems for virus inactivation involve the key steps of dissolving carbon dioxide into biological or other sensitive substances; and treating the substance with the dissolved carbon dioxide at conditions which are less than critical pressure and temperature for a prescribed treatment time to inactivate at least 80% of the target virus or viruses contained within the biological or other sensitive substances. The disclosed carbon dioxide treatments for virus inactivation may optionally include concurrently or sequentially subjecting the substances with an acid treatment to lower the pH of the substance and inactivate viruses contained within the biological or other sensitive substance. Operating conditions for the disclosed carbon dioxide treatments preferably involve sparging carbon dioxide gas into the substance until the composition is saturated with carbon dioxide and is conducted at pressures below about 5 MPa; at temperatures of less than or equal to 30° C.; and for a treatment time of between about one minute and about 2000 minutes.
摘要翻译：提供了生物或其他敏感物质生产或加工中病毒灭活的方法和系统。公开的用于病毒灭活的方法和系统涉及将二氧化碳溶解到生物或其他敏感物质中的关键步骤; 并且在规定的处理时间内，在小于临界压力和温度的条件下用溶解的二氧化碳处理物质，使至少80％的生物或其他敏感物质中所含的靶病毒或病毒灭活。公开的用于病毒灭活的二氧化碳处理可以任选地包括同时或依次经受酸处理的物质以降低物质的pH并灭活生物或其它敏感物质中所含的病毒。所公开的二氧化碳处理的操作条件优选包括将二氧化碳气体喷射到物质中，直到组合物用二氧化碳饱和并在低于约5MPa的压力下进行; 在小于或等于30℃的温度下。并且治疗时间在约1分钟至约2000分钟之间。

7. 发明申请

US20140047851A1 BULK FREEZING OF BIOPHARMACEUTICALS 审中-公开
标题翻译：生物吸收的大容量冷冻
公开(公告)号：US20140047851A1
公开(公告)日：2014-02-20
申请号：US14008455
申请日：2012-03-27
申请人： Ying Zhou , Alan Cheng , Nigel Grinter , Zachary Fowler , Robert Sever , Ranko Bursac
发明人： Ying Zhou , Alan Cheng , Nigel Grinter , Zachary Fowler , Robert Sever , Ranko Bursac
IPC分类号： F25D3/10
CPC分类号： F25D3/10 , A01N1/0252 , A23L3/364 , F25D15/00 , F25D17/06 , F25D2400/38
摘要： A system and method for bulk freezing is provided. In one embodiment, the system and method for bulk freezing includes a bulk freezing container adapted to hold at least one and preferably a plurality of bags holding a biopharmaceutical liquid. The bulk freezing container includes at least a first and second shelf having corrugations wherein the second shelf is vertically arranged above the first shelf with the bags disposed between the shelves. The bags and the corrugations of the first and second shelves define a plurality of substantially parallel flow channels through which a cryogenic cold fluid or a warming fluid is passed to freeze and/or thaw the biopharmaceutical fluid. In another embodiment, the bulk freezing system and method includes a bulk freezing container with a plurality of adjacent elongated chambers adapted for holding the biopharmaceutical fluid. The adjacent elongated chambers have side walls defining a plurality of substantially parallel flow channels between the plurality of adjacent elongated chambers through which a heat transfer medium is passed for heat exchange through the side walls of the elongated chambers to the fluid within the elongated chambers.
摘要翻译：提供一种用于大容量冷冻的系统和方法。在一个实施例中，用于体积冷冻的系统和方法包括适于容纳至少一个并且优选地多个保持生物药物液体的袋的体积冷冻容器。散装冷冻容器至少包括具有波纹的第一和第二搁架，其中第二搁板垂直地布置在第一搁板的上方，袋子设置在搁架之间。第一和第二搁架的袋和波纹限定了多个基本平行的流动通道，低温冷流体或加温流体通过该流动通道冷冻和/或解冻生物药物流体。在另一个实施方案中，本体冷冻系统和方法包括具有适于保持生物药物流体的多个相邻细长室的体积冷冻容器。相邻的细长室具有在多个相邻的细长室之间限定多个基本平行的流动通道的侧壁，通过该多个相邻的细长室之间传热介质通过细长室的侧壁进行热交换，使其在细长室内的流体。

8. 发明申请

US20090001042A1 CONTAINER-CLOSURE SYSTEM FOR USE IN LYOPHILIZATION APPLICATIONS 审中-公开
标题翻译：用于LYOPHILIZATION应用的集装箱封闭系统
公开(公告)号：US20090001042A1
公开(公告)日：2009-01-01
申请号：US12144872
申请日：2008-06-24
申请人： Robert Sever , Balazs Hunek , Nigel Grinter , Gurjit Baring
发明人： Robert Sever , Balazs Hunek , Nigel Grinter , Gurjit Baring
IPC分类号： B65D51/16 , B65D41/50
CPC分类号： B65D51/241 , A61J1/1468 , B65D41/28 , B65D51/002 , B65D2251/0015 , B65D2251/0075 , B65D2539/005
摘要： A container closure system for use in lyophilization processes employing depressurization to initiate nucleation is provided. The present container closure system includes a container and a closure element disposed proximate to and adapted for sealing the opening of the container. The closure element includes a first sealing surface adapted for sealably contacting an interior surface of the container and a second sealing surface adapted for sealably contacting the top surface of the container when the container closure system is in a closed position. The closure element also includes a plurality of closure legs extending from the second sealing surface that define a plurality of side vents between each of the closure legs when the container closure system is in the open position. The length, thickness, number, and shape of the legs are chosen to produce an effective total side vent area that is at least 50% of the area of the container opening. Alternatively, the length, thickness, number, and shape of the legs are chosen to produce an effective total side vent area that is greater than the cumulative surface area of the outwardly facing surface of the closure legs.
摘要翻译：提供了一种用于使用减压引发成核的冻干方法的容器封闭系统。本发明的容器封闭系统包括容器和靠近并适于密封容器开口的封闭元件。闭合元件包括适于密封地接触容器的内表面的第一密封表面和适于在容器封闭系统处于关闭位置时密封地接触容器的顶表面的第二密封表面。闭合元件还包括从第二密封表面延伸的多个封闭柱，当容器封闭系统处于打开位置时，封闭件在每个封闭支柱之间限定多个侧通风口。选择腿的长度，厚度，数量和形状以产生至少占容器开口面积的50％的有效总侧排气面积。或者，选择腿的长度，厚度，数量和形状以产生大于闭合腿的面向外的表面的累积表面积的有效总侧排气面积。

9. 发明授权

US08793895B2 Lyophilization system and method 有权
标题翻译：冻干系统和方法
公开(公告)号：US08793895B2
公开(公告)日：2014-08-05
申请号：US11702479
申请日：2007-02-05
申请人： Theodore Hall Gasteyer, III , Robert Rex Sever , Balazs Hunek , Nigel Grinter , Melinda Lee Verdone
发明人： Theodore Hall Gasteyer, III , Robert Rex Sever , Balazs Hunek , Nigel Grinter , Melinda Lee Verdone
IPC分类号： F26B5/06
CPC分类号： F26B5/06
摘要： System and method for lyophilization or freeze-drying is provided. During the freezing step, the material or solution to be frozen is initially brought to a temperature near or below its freezing temperature after which the pressure in the freeze-dryer chamber is reduced to induce nucleation of the material.
摘要翻译：提供了用于冻干或冷冻干燥的系统和方法。在冷冻步骤期间，待冷冻的材料或溶液最初达到接近或低于其冷冻温度的温度，之后冷冻干燥室中的压力降低以引起材料成核。

10. 发明申请

US20130189767A1 BIOREACTOR WITH UPWARD FLOWING IMPELLER SYSTEM FOR USE IN A MAMMALIAN CELL CULTURE PROCESS 有权
标题翻译：具有向上流动的叶轮系统的生物反应器在马马里细胞培养过程中使用
公开(公告)号：US20130189767A1
公开(公告)日：2013-07-25
申请号：US13559957
申请日：2012-07-27
申请人： Alan T. Y. Cheng , Ying Zhou , Amitabh Gupta , Balazs Hunek , Nigel Grinter
发明人： Alan T. Y. Cheng , Ying Zhou , Amitabh Gupta , Balazs Hunek , Nigel Grinter
IPC分类号： C12M1/00
CPC分类号： C12M27/20 , C12M27/02 , C12M27/24 , C12M29/06 , C12M41/12 , C12M41/26 , C12M41/32 , C12M41/48 , C12N1/38
摘要： A bioreactor with an upward flowing impeller system for controlling a mammalian cell culture process is provided. The disclosed system enables control of the cell culture process by controlling the level of dissolved carbon dioxide in the cell culture media and prevent increases in the osmolality level is achieved by enhanced stripping of carbon dioxide via surface gas exchange with little or no damage to the mammalian cells. The use of an upward flow impeller combined with vertical baffles converts the swirling motions of the cell culture media into a largely vertical flow and promotes the removal of dissolved carbon dioxide via surface gas exchange with a sweep gas flowing over the top surface of the cell culture media within the bioreactor vessel.
摘要翻译：提供了一种具有向上流动的叶轮系统用于控制哺乳动物细胞培养过程的生物反应器。所公开的系统能够通过控制细胞培养基中溶解的二氧化碳的水平来控制细胞培养过程，并且通过经由表面气体交换增强汽提二氧化碳来实现渗透压浓度的增加，对哺乳动物几乎没有或没有损伤细胞。使用与垂直挡板结合的向上流动叶轮将细胞培养基的旋转运动转化为大体垂直的流动，并通过与流过细胞培养物顶表面的吹扫气体的表面气体交换促进去除溶解的二氧化碳生物反应器容器内的介质。

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