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公开(公告)号：US09109193B2
公开(公告)日：2015-08-18
申请号：US12124039
申请日：2008-05-20
CPC分类号： C12M29/10 , B01D29/13 , C12M23/14 , C12M23/26 , C12M23/48 , C12M27/02 , C12M27/20 , C12M29/00 , C12M29/18 , C12M47/10
摘要： Systems and methods for containing and manipulating liquids, including vessels and unit operations or components of cell culture, cell containment, bioreactor, and/or pharmaceutical manufacturing systems, are provided. In certain embodiments, such vessels and unit operations are directed to continuous perfusion reactor or bioreactor systems and may include one or more disposable components. For instance, in one aspect, a system includes an apparatus in the form of a bioreactor for harvesting cells which produce one or more products. The apparatus may include a disposable, collapsible bag adapted for containing a liquid, the collapsible bag in fluid communication with a liquid-solids (e.g., cell) separation device. For example, an outlet of the collapsible bag may be connected to an inlet of the separation device, and an outlet of the separation device may be connected to an inlet of the collapsible bag for recycle. Accordingly, after separating the cells from the liquid in the separation device, the cells can be flowed back into the collapsible bag where they can be re-harvested. Meanwhile, product contained in the liquid can be collected in a separate container. The efficiency of product formation in such a system may be enhanced by using mixing systems described herein.
摘要翻译： 提供了用于容纳和操纵液体的系统和方法，包括容器和单元操作或细胞培养物，细胞容纳物，生物反应器和/或药物制造系统的组分。 在某些实施方案中，这样的容器和单元操作涉及连续灌注反应器或生物反应器系统，并且可以包括一个或多个一次性组件。 例如，一方面，系统包括生物反应器形式的装置，用于收集产生一种或多种产品的细胞。 该装置可以包括适于容纳液体的一次性可折叠袋，该可折叠袋与液体 - 固体（例如，池）分离装置流体连通。 例如，可折叠袋的出口可以连接到分离装置的入口，并且分离装置的出口可以连接到可折叠袋的入口以用于再循环。 因此，在分离装置中的液体分离细胞后，细胞可以流回到可收缩的袋子中，在那里它们可以被再次收获。 同时，包含在液体中的产品可以收集在单独的容器中。 通过使用本文所述的混合系统可以提高这种系统中产物形成的效率。
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公开(公告)号：US20090035856A1
公开(公告)日：2009-02-05
申请号：US12124039
申请日：2008-05-20
CPC分类号： C12M29/10 , B01D29/13 , C12M23/14 , C12M23/26 , C12M23/48 , C12M27/02 , C12M27/20 , C12M29/00 , C12M29/18 , C12M47/10
摘要： Systems and methods for containing and manipulating liquids, including vessels and unit operations or components of cell culture, cell containment, bioreactor, and/or pharmaceutical manufacturing systems, are provided. In certain embodiments, such vessels and unit operations are directed to continuous perfusion reactor or bioreactor systems and may include one or more disposable components. For instance, in one aspect, a system includes an apparatus in the form of a bioreactor for harvesting cells which produce one or more products. The apparatus may include a disposable, collapsible bag adapted for containing a liquid, the collapsible bag in fluid communication with a liquid-solids (e.g., cell) separation device. For example, an outlet of the collapsible bag may be connected to an inlet of the separation device, and an outlet of the separation device may be connected to an inlet of the collapsible bag for recycle. Accordingly, after separating the cells from the liquid in the separation device, the cells can be flowed back into the collapsible bag where they can be re-harvested. Meanwhile, product contained in the liquid can be collected in a separate container. The efficiency of product formation in such a system may be enhanced by using mixing systems described herein.
摘要翻译： 提供了用于容纳和操纵液体的系统和方法，包括容器和单元操作或细胞培养物，细胞容纳物，生物反应器和/或药物制造系统的组分。 在某些实施方案中，这样的容器和单元操作涉及连续灌注反应器或生物反应器系统，并且可以包括一个或多个一次性组件。 例如，一方面，系统包括生物反应器形式的装置，用于收集产生一种或多种产品的细胞。 该装置可以包括适于容纳液体的一次性可折叠袋，该可折叠袋与液体 - 固体（例如，池）分离装置流体连通。 例如，可折叠袋的出口可以连接到分离装置的入口，并且分离装置的出口可以连接到可折叠袋的入口以用于再循环。 因此，在分离装置中的液体分离细胞后，细胞可以流回到可收缩的袋子中，在那里它们可以被再次收获。 同时，包含在液体中的产品可以收集在单独的容器中。 通过使用本文所述的混合系统可以提高这种系统中产物形成的效率。
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3.发明申请GAS DELIVERY CONFIGURATIONS, FOAM CONTROL SYSTEMS, AND BAG MOLDING METHODS AND ARTICLES FOR COLLAPSIBLE BAG VESSELS AND BIOREACTORS 有权气体输送配置，泡沫控制系统和包装袋成型方法和可折叠包装袋和生物反应器的文章公开(公告)号：US20120132548A1
公开(公告)日：2012-05-31
申请号：US13276087
申请日：2011-10-18
IPC分类号： B65D77/00
CPC分类号： B65D33/02 , B01F3/04106 , B01F13/0827 , B01F15/00831 , B01F15/0085 , B01F2215/0073 , B29C45/16 , B29K2023/0633 , B29L2031/7128 , C12M23/14 , C12M29/06 , C12M41/02
摘要： Disclosed herein are fluid containment systems such as gas delivery configurations, foam control systems and bag molding methods and articles for supported collapsible bag vessels and bioreactors. A vessel may include a device which can reduce the foam produced or contained within the vessel. Sensors and/or controllers may optionally be used to monitor and/or control foaming.
摘要翻译： 本文公开了流体容纳系统，例如气体输送配置，泡沫控制系统和袋成型方法以及用于支撑的可折叠袋容器和生物反应器的制品。 容器可以包括可以减少容器内产生或容纳的泡沫的装置。 传感器和/或控制器可以可选地用于监测和/或控制发泡。
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4.发明申请Bag wrinkle remover, leak detection systems, and electromagnetic agitation for liquid containment systems 审中-公开袋式除皱剂，泄漏检测系统和液体容纳系统的电磁搅拌公开(公告)号：US20090188211A1
公开(公告)日：2009-07-30
申请号：US12011493
申请日：2008-01-25
CPC分类号： B01F15/00831 , B01F13/0827 , B01F13/0863 , B01F15/00318 , B01F15/0085 , C12M23/14 , C12M27/02
摘要： Systems and methods for containing and manipulating fluids, such as those involving collapsible bags and rigid containers that may be used as mixing systems, and as reactors for performing chemical, biochemical and/or biological reactions, are provided. A series of improvements and features for fluid containment systems such as containers including bag wrinkle removing systems, leak detection systems, and electromagnetic agitation systems are described.
摘要翻译： 提供了用于容纳和操纵流体的系统和方法，例如涉及可以用作混合系统的可折叠袋和刚性容器的流体，以及用于进行化学，生化和/或生物反应的反应器。 描述了流体容纳系统的一系列改进和特征，例如包括袋除皱系统，泄漏检测系统和电磁搅拌系统的容器。
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公开(公告)号：US09499781B2
公开(公告)日：2016-11-22
申请号：US13434345
申请日：2012-03-29
申请人： Richard Damren , Colin Touhey , Thomas Erdenberger , Michael Fisher , Geoffrey L. Hodge , Patrick M. Guertin , Parrish M. Galliher
发明人： Richard Damren , Colin Touhey , Thomas Erdenberger , Michael Fisher , Geoffrey L. Hodge , Patrick M. Guertin , Parrish M. Galliher
CPC分类号： C12M29/26 , B01D5/0042 , B01D5/0093 , B01D46/4263 , B01D53/265 , C12M23/28 , C12M29/04 , C12M41/12
摘要： Disclosed herein is a system and method for condensing moisture in a moist gas stream entering a bioreactor or leaving a bioreactor, forming a dry gas stream for entering or leaving the bioreactor.
摘要翻译： 本文公开了一种用于冷凝进入生物反应器或离开生物反应器的湿气流中的水分的系统和方法，形成用于进入或离开生物反应器的干燥气流。
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公开(公告)号：US07819934B2
公开(公告)日：2010-10-26
申请号：US11879033
申请日：2007-07-13
IPC分类号： B01D50/00
摘要： Environmental containment systems, and in certain embodiments, systems and methods involving vessels and unit operations or components of cell culture, cell containment, bioreactor, chemical manufacturing, or pharmaceutical manufacturing systems provided with environmental containment are provided. Certain vessels, unit operations, devices, and components may be used to perform all or part of biological, chemical, and/or pharmaceutical manufacturing processes therein. In some embodiments, an environmental containment system includes a multi-level containment apparatus. For instance, a first substantially closed environmental containment enclosure may be contained within a second substantially closed environmental containment enclosure; the first and second enclosures may be contained in a third substantially closed environmental containment enclosure, etc. Each of the environments within the substantially closed environmental containment enclosures may be controlled independently, and leakage of any materials from an inner system may be contained by an outer system.
摘要翻译： 提供环境容纳系统，并且在某些实施方案中，提供了涉及容器和单元操作的系统和方法或细胞培养物，细胞容纳物，生物反应器，化学制造或具有环境容纳物的药物制造系统。 某些容器，单元操作，装置和部件可用于执行其中的生物，化学和/或药物制造过程的全部或部分。 在一些实施例中，环境容纳系统包括多级容纳装置。 例如，第一基本封闭的环境容纳外壳可以包含在第二基本封闭的环境容纳外壳内; 第一和第二外壳可以包含在第三基本封闭的环境容纳外壳等中。基本封闭的环境容纳外壳内的每个环境可以独立地被控制，并且任何材料从内部系统的泄漏可以被外部 系统。
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公开(公告)号：US08894756B2
公开(公告)日：2014-11-25
申请号：US13276087
申请日：2011-10-18
CPC分类号： B65D33/02 , B01F3/04106 , B01F13/0827 , B01F15/00831 , B01F15/0085 , B01F2215/0073 , B29C45/16 , B29K2023/0633 , B29L2031/7128 , C12M23/14 , C12M29/06 , C12M41/02
摘要： Disclosed herein are fluid containment systems such as gas delivery configurations, foam control systems and bag molding methods and articles for supported collapsible bag vessels and bioreactors. A vessel may include a device which can reduce the foam produced or contained within the vessel. Sensors and/or controllers may optionally be used to monitor and/or control foaming.
摘要翻译： 本文公开了流体容纳系统，例如气体输送配置，泡沫控制系统和袋成型方法以及用于支撑的可折叠袋容器和生物反应器的制品。 容器可以包括可以减少容器内产生或容纳的泡沫的装置。 传感器和/或控制器可以可选地用于监测和/或控制发泡。
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公开(公告)号：US20120260671A1
公开(公告)日：2012-10-18
申请号：US13434345
申请日：2012-03-29
申请人： Richard L. DAMREN , Colin Tuohey , Thomas Erdenberger , Michael Fisher , Geoffrey L. Hodge , Patrick M. Guertin , Parrish M. Galliher
发明人： Richard L. DAMREN , Colin Tuohey , Thomas Erdenberger , Michael Fisher , Geoffrey L. Hodge , Patrick M. Guertin , Parrish M. Galliher
CPC分类号： C12M29/26 , B01D5/0042 , B01D5/0093 , B01D46/4263 , B01D53/265 , C12M23/28 , C12M29/04 , C12M41/12
摘要： Disclosed herein is a system and method for condensing moisture in a moist gas stream entering a bioreactor or leaving a bioretractor, forming a dry gas stream for entering or leaving the bioreactor.
摘要翻译： 本文公开了一种系统和方法，用于冷凝进入生物反应器或留下生物减馏器的湿气流中的水分，形成用于进入或离开生物反应器的干燥气流。
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公开(公告)号：US20080139865A1
公开(公告)日：2008-06-12
申请号：US11879033
申请日：2007-07-13
IPC分类号： B09B5/00
摘要： Environmental containment systems, and in certain embodiments, systems and methods involving vessels and unit operations or components of cell culture, cell containment, bioreactor, chemical manufacturing, or pharmaceutical manufacturing systems provided with environmental containment are provided. Certain vessels, unit operations, devices, and components may be used to perform all or part of biological, chemical, and/or pharmaceutical manufacturing processes therein. In some embodiments, an environmental containment system includes a multi-level containment apparatus. For instance, a first substantially closed environmental containment enclosure may be contained within a second substantially closed environmental containment enclosure; the first and second enclosures may be contained in a third substantially closed environmental containment enclosure, etc. Each of the environments within the substantially closed environmental containment enclosures may be controlled independently, and leakage of any materials from an inner system may be contained by an outer system.
摘要翻译： 提供环境容纳系统，并且在某些实施方案中，提供了涉及容器和单元操作的系统和方法或细胞培养物，细胞容纳物，生物反应器，化学制造或具有环境容纳物的药物制造系统。 某些容器，单元操作，装置和部件可用于执行其中的生物，化学和/或药物制造过程的全部或部分。 在一些实施例中，环境容纳系统包括多级容纳装置。 例如，第一基本封闭的环境容纳外壳可以包含在第二基本封闭的环境容纳外壳内; 第一和第二外壳可以包含在第三基本封闭的环境容纳外壳等中。基本封闭的环境容纳外壳内的每个环境可以独立地被控制，并且任何材料从内部系统的泄漏可以被外部 系统。
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公开(公告)号：US20130288346A1
公开(公告)日：2013-10-31
申请号：US13978726
申请日：2012-01-11
申请人： Colin Tuohey , Ted Deloggio , Thomas Erdenberger , Kenneth P. Clapp , Richard Damren , Parrish M. Galliher , Patrick Guertin , Jiyoung Lee , Michael Fisher
发明人： Colin Tuohey , Ted Deloggio , Thomas Erdenberger , Kenneth P. Clapp , Richard Damren , Parrish M. Galliher , Patrick Guertin , Jiyoung Lee , Michael Fisher
IPC分类号： C12M1/00
摘要： Disclosed is a single-use bioreactor bag design providing substantially equivalent maximum shear rate at the impeller tip and average or bulk shear rate over a range of power per unit working volume and rpm needed for bioculture processing. The uniformity in shear profile of the bag design providing a unique advantage when used as a scale-down or scale-up platform. Also disclosed is a linearly scalable, single-use, bioreactor system for use in carrying out a scalable biomanufacturing process, the system comprising two single-use bioreactor bags of different volumes, wherein the ratio H/D of the height of the working volume H to the diameter D of the tank, or of the bag is equal to about 1.5, and the bulk shear in each of the bags is substantially constant. The disclosed small scale system models larger scale systems from both a shear/scalability/performance basis and also from a validation and regulatory basis. In summary, the 10 L bioreactor system disclosed provides for “linear scalability” by using the same or substantially simulating the same vessel geometry, gas sparging system, impeller shape and type, polymer composition of the flexible bag/components, process control system, and shear rates as larger 50-5000 L systems.
摘要翻译： 公开了一种一次性生物反应器袋设计，其在叶轮尖端处提供基本上等效的最大剪切速率，并且在每单位工作体积和生物培养处理所需的rpm的功率范围内的平均或体积剪切速率。 袋子设计的剪切轮廓的均匀性在用作缩小或放大平台时提供了独特的优势。 还公开了一种线性可伸缩的一次性生物反应器系统，用于进行可扩展的生物制造过程，该系统包括两个不同体积的单次使用的生物反应器袋，其中工作体积H的高度比H / D 到罐的直径D或袋的直径D等于约1.5，并且每个袋中的体积剪切基本上是恒定的。 所披露的小规模系统从剪切/可扩展性/性能基础以及从验证和监管的角度来模拟更大规模的系统。 总之，所公开的10L生物反应器系统通过使用相同或基本上模拟相同的容器几何形状，气体喷射系统，叶轮形状和类型，柔性袋/部件的聚合物组成，过程控制系统和 剪切速率为较大的50-5000 L系统。
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