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    BULK FREEZING OF BIOPHARMACEUTICALS
    14.
    发明申请
    BULK FREEZING OF BIOPHARMACEUTICALS 审中-公开
    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。

    SYSTEM AND METHOD FOR VIRUS INACTIVATION
    15.
    发明申请
    SYSTEM AND METHOD FOR VIRUS INACTIVATION 有权
    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。

    System and method for virus inactivation
    16.
    发明授权
    System and method for virus inactivation 有权
    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。