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1. 发明授权

US08298054B2 System and method for manufacturing 有权
标题翻译：系统和制造方法
公开(公告)号：US08298054B2
公开(公告)日：2012-10-30
申请号：US11050133
申请日：2005-02-03
申请人： Geoffrey Hodge , Parrish Galliher , Michael Fisher
发明人： Geoffrey Hodge , Parrish Galliher , Michael Fisher
IPC分类号： F24F7/00 , B01L1/04
CPC分类号： G05D27/02 , G05B15/02 , G05B19/41865 , G05B2219/31075 , G05B2219/32287 , Y02P90/04 , Y02P90/14 , Y02P90/16 , Y02P90/185 , Y02P90/20
摘要： Embodiments of the present invention are directed to a customizable bio-manufacturing system which includes a manufacturing space having a first air handling system for providing supply air and a second air handling system for handling exhaust air, the supply air system being optionally provided with at least one of filtration, heating, cooling and or humidity control and a plurality of portable modules provided within the manufacturing space. At least one module having an interior capable of being interconnected with another module interior and each module's interior includes one or more components to perform at least one specific task of a biological, chemical, and/or pharmaceutical manufacturing process. At least one module includes an on-board environmental control system for controlling an environment within the module and a connection means for interconnecting the module interior with another module interior. The system also includes a central controller operating to at least perform one or more of operation and information collection for the operation of at least one of the system and one or more modules.
摘要翻译：本发明的实施例涉及一种可定制的生物制造系统，其包括具有用于提供供应空气的第一空气处理系统和用于处理排气的第二空气处理系统的制造空间，供应空气系统可选地至少设置过滤，加热，冷却和/或湿度控制之一以及设置在制造空间内的多个便携式模块。至少一个模块具有能够与另一个模块内部互连的内部，并且每个模块的内部包括执行生物，化学和/或药物制造过程的至少一个特定任务的一个或多个组件。至少一个模块包括用于控制模块内的环境的车载环境控制系统和用于将模块内部与另一个模块内部互连的连接装置。该系统还包括中央控制器，其操作以至少执行用于系统和一个或多个模块中的至少一个的操作的操作和信息收集中的一个或多个。

2. 发明申请

US20150025685A1 BATCH AUTHORING TOOL AND BIOREACTOR CONTROL SYSTEM 有权
标题翻译：批量作业工具和生物反应器控制系统
公开(公告)号：US20150025685A1
公开(公告)日：2015-01-22
申请号：US13807033
申请日：2011-06-30
申请人： David R. Mills
发明人： David R. Mills
IPC分类号： G05D21/02 , G05B15/02
CPC分类号： G05D21/02 , G05B15/02 , G05B19/41865 , G05B2219/32096 , G05B2219/32287 , Y02P90/18 , Y02P90/20
摘要： A bioreactor control system comprises a batch server for controlling a bioreactor system in response to a recipe, a batch software system for generating a control sequence for the bioreactor system via the batch server for implementing the recipe, and a recipe conversion system that inputs the recipe into the batch software system. Preferably, the recipe conversion system reads a word processor file containing the recipe and interprets styles applied to text in the word processor file as indicating equipment and phases of the recipe to the recipe conversion system. Generally, the bioreactor system includes one or more bioreactors and additional hardware to perform the upstream and downstream processing. The document properties of the word processor file containing the recipe are applied as header information for the recipe input into the batch software system. This system solves a problem associated with traditional batching software systems, in which the authoring of recipes on the systems can be relatively arcane. Here, the recipe can be authored on a common word processor.
摘要翻译：生物反应器控制系统包括用于响应于配方控制生物反应器系统的批量服务器，用于通过批量服务器生成生物反应器系统的用于实施配方的控制顺序的批量软件系统，以及输入配方的配方转换系统进入批量软件系统。优选地，配方转换系统读取包含配方的文字处理器文件，并将应用于文字处理器文件中的文本的样式解释为配方转换系统的配方的指示设备和阶段。通常，生物反应器系统包括一个或多个生物反应器和用于执行上游和下游处理的附加硬件。包含配方的文字处理程序文件的文档属性作为用于配方输入到批处理软件系统的标题信息。该系统解决了与传统批处理软件系统相关的问题，其中在系统上创建配方可能相当神秘。在这里，配方可以在一个通用的文字处理器上创作。

3. 发明申请

US20130200005A1 LARGE VOLUME DISPOSABLE ULTRAFILTRATION SYSTEMS AND METHODS 有权
标题翻译：大容量废弃超声波系统和方法
公开(公告)号：US20130200005A1
公开(公告)日：2013-08-08
申请号：US13879354
申请日：2011-10-14
申请人： Scott A. Mangiacotti , Parrish M. Galliher , Joseph J. Arduino , Michael Fisher , John J. Vicalvi, JR. , Joseph Makowiecki
发明人： Scott A. Mangiacotti , Parrish M. Galliher , Joseph J. Arduino , Michael Fisher , John J. Vicalvi, JR. , Joseph Makowiecki
IPC分类号： B01D61/22
CPC分类号： B01D61/22 , B01D61/145 , B01D2311/08 , B01D2311/25 , B01D2313/18 , B01D2313/20 , B01D2313/243 , B01D2313/58 , B01D2315/16 , B01D2317/08 , B01D2319/06 , C02F1/444 , C02F2209/005 , C02F2209/02 , C02F2209/03 , C02F2209/05 , C02F2209/11 , C02F2209/40 , B01D2311/04
摘要： A disposable filtration system can include a disposable filter housing having an ultrafiltration filter contained therein. The disposable filtration system can further include a feed inlet and retentate outlet in fluid communication on one side of the filter and a permeate conduit on the other side of the filter for withdrawing permeate that passes through the filter. The system can include at least one disposable pressure control valve in fluid communication with either the retentate outlet or the permeate conduit and configured to regulate the pressure within the housing.
摘要翻译：一次性过滤系统可以包括其中包含超滤过滤器的一次性过滤器壳体。一次性过滤系统还可以包括在过滤器的一侧处流体连通的进料入口和滞留物出口，以及在过滤器的另一侧的渗透管道，用于抽出通过过滤器的渗透物。该系统可以包括至少一个一次性压力控制阀，其与渗余物出口或渗透物导管流体连通，并被配置成调节壳体内的压力。

4. 发明申请

US20090035856A1 CONTINUOUS PERFUSION BIOREACTOR SYSTEM 有权
标题翻译：连续曝光生物反应器系统
公开(公告)号：US20090035856A1
公开(公告)日：2009-02-05
申请号：US12124039
申请日：2008-05-20
申请人： Parrish M. Galliher , Geoffrey L. Hodge , Michael Fisher , Patrick Guertin , Dan Mardirosian
发明人： Parrish M. Galliher , Geoffrey L. Hodge , Michael Fisher , Patrick Guertin , Dan Mardirosian
IPC分类号： C12N5/06 , C12M1/00
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。

5. 发明申请

US20130017131A1 SINGLE-USE CONTROLLED ENVIRONMENT MODULE 审中-公开
标题翻译：单一使用控制环境模块
公开(公告)号：US20130017131A1
公开(公告)日：2013-01-17
申请号：US13623584
申请日：2012-09-20
申请人： XCELLEREX, INC.
发明人： Parrish M. GALLIHER , Michael Fisher , Geoffrey L. Hodge
IPC分类号： A61L2/20 , A61L2/28 , B01L3/00
CPC分类号： C12M37/00 , B01L1/025 , B01L2300/123 , B01L2400/0487
摘要： Disclosed herein is a single use, controlled environment manufacturing module in the form of a sterile sealed bag formed of a substantially flexible material, such that the bag can be inflated and deflated for transport and/or disposal. The flexible bag has one or more access ports and connectors to accommodate a variety of biochemical or pharmaceutical manufacturing processes to be carried out within the flexible bag. The interiors of one or more disclosed modules can be connected, forming a module train.
摘要翻译：本文公开了一种单一使用的受控环境制造模块，其形式为由基本上柔性的材料形成的无菌密封袋，使得袋可以被充气和放气以便运输和/或处理。柔性袋具有一个或多个入口和连接器，以适应在柔性袋内进行的各种生物化学或药物制造过程。可以连接一个或多个所公开的模块的内部，形成模块列。

6. 发明申请

US20120260671A1 DISPOSABLE BIOREACTOR CONDENSER BAG AND FILTER HEATER 有权
标题翻译：可处理的生物反应器冷凝器袋和过滤器加热器
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
IPC分类号： F28D15/00 , F24F7/00 , F25B21/02
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。

7. 发明申请

US20120118828A1 SYSTEM AND METHOD FOR VARIABLE SPEED FEEDBACK CONTROL CHROMATOGRAPHY LOADING 有权
标题翻译：用于变速反馈控制色谱装载的系统和方法
公开(公告)号：US20120118828A1
公开(公告)日：2012-05-17
申请号：US13277888
申请日：2011-10-20
申请人： Geoffrey L. HODGE
发明人： Geoffrey L. HODGE
IPC分类号： B01D15/08
CPC分类号： G01N30/32 , G01N30/461 , G01N30/74 , G01N30/8658 , G01N2030/324 , G01N2030/326
摘要： Disclosed herein is a chromatography system wherein a sensor, for example, a UV sensor, is tied to a continuously variable load pump in a feedback control loop, with an option to divert the feed stream back to the load vessel or reservoir or onto a second chromatography column, the disclosed chromatography system allowing a true feedback control across variable load rates, thereby adjusting chromatographic operating parameters, for example, variable load rates, to process conditions, while maximizing throughput.
摘要翻译：本文公开了一种色谱系统，其中传感器例如UV传感器连接到反馈控制回路中的连续可变负载泵，具有将进料流转回加载容器或储存器或第二个色谱柱，所公开的色谱系统允许跨可变负载率的真实反馈控制，从而将色谱操作参数（例如，可变负载率）调节到处理条件，同时最大化产量。

8. 发明申请

US20090191542A1 Multi-variant cell indication technique 审中-公开
标题翻译：多变细胞指示技术
公开(公告)号：US20090191542A1
公开(公告)日：2009-07-30
申请号：US11895057
申请日：2007-08-23
申请人： Geoffrey L. Hodge , Shari Brezinsky
发明人： Geoffrey L. Hodge , Shari Brezinsky
IPC分类号： C12Q1/68 , C12Q1/02 , C12Q1/26 , G01N33/53 , C12N5/06 , G06Q90/00
CPC分类号： G01N33/5023 , G01N2333/906 , G06Q99/00
摘要： The invention provides methods for identifying and isolating cells that express high levels of protein. A method is described for identifying a cell or cell line expressing a desired protein comprising determining in a cell or cell line that has been transfected with a vector comprising a nucleotide sequence encoding the desired protein the intracellular expression levels of elements of the vector and also determining expression of the desired protein on the surface of the cell or cell line, in certain cases in a single assay.
摘要翻译：本发明提供用于鉴定和分离表达高水平蛋白质的细胞的方法。描述了用于鉴定表达所需蛋白质的细胞或细胞系的方法，包括在已经用包含编码所需蛋白质的核苷酸序列的载体转染的细胞或细胞系中测定载体元件的细胞内表达水平，并确定在单个测定中，在某些情况下，在细胞或细胞系的表面上表达所需的蛋白质。

9. 发明申请

US20080213874A1 WEIGHT MEASUREMENTS OF LIQUIDS IN FLEXIBLE CONTAINERS 审中-公开
标题翻译：液体在柔性容器中的重量测量
公开(公告)号：US20080213874A1
公开(公告)日：2008-09-04
申请号：US12039052
申请日：2008-02-28
申请人： Peter A. Mitchell , Michael Fisher
发明人： Peter A. Mitchell , Michael Fisher
IPC分类号： C12M1/34 , G01F22/00
CPC分类号： G01F23/14 , G01F23/18 , G01F23/20 , G01G17/04
摘要： Articles and methods for measuring weight of a liquid in a disposable bag bioreactor are presented. In certain embodiments, bioreactor systems described herein include a supported container (e.g., a flexible bag in a reusable housing) for containing a liquid, and at least two pressure indicating sensors operatively associated with the container. A first pressure indicating sensor can be placed near the bottom of the container to measure the total downward force within the container, including the liquid head in the container and the gas pressure above the liquid. The second pressure indicating sensor can be placed near the top of the container to measure only the pressure at the top of or above the liquid. Signals from the pressure indicating sensors can be directed to a control system that receives the signals and calculates a difference between the signals. This difference can be used to determine a volume or a weight of the liquid in the container. Advantageously, real-time weight measurements can be obtained while the system is in operation and continuous flow processes can be monitored. Moreover, in some embodiments, the pressure indicating sensors are isolated from contact with any fluid (e.g., liquid) in the container and, therefore, do not require cleaning after processing of each batch of reactants. Contamination of the process fluid by contact with the pressure indicating sensors can also be avoided.
摘要翻译：提出了一次性袋式生物反应器中液体重量测量的物品和方法。在某些实施方案中，本文所述的生物反应器系统包括用于容纳液体的支撑容器（例如，可重复使用的壳体中的柔性袋）和与容器可操作地相关联的至少两个压力指示传感器。第一压力指示传感器可以放置在容器的底部附近，以测量容器内的总的向下的力，包括容器中的液体头和液体上方的气体压力。第二压力指示传感器可以放置在容器顶部附近，以仅测量液体顶部或上方的压力。来自压力指示传感器的信号可以被引导到接收信号并计算信号之间的差异的控制系统。该差异可用于确定容器中液体的体积或重量。有利的是，可以在系统运行时获得实时重量测量，并且可以监视连续的流程。此外，在一些实施例中，压力指示传感器与容器中的任何流体（例如液体）接触隔离，因此在处理每批反应物之后不需要清洁。也可以避免通过与压力指示传感器的接触对工艺流体的污染。

10. 发明申请

US20080139865A1 Environmental containment systems 有权
标题翻译：环境遏制系统
公开(公告)号：US20080139865A1
公开(公告)日：2008-06-12
申请号：US11879033
申请日：2007-07-13
申请人： Parrish M. Galliher , Geoffrey L. Hodge , Michael Fisher
发明人： Parrish M. Galliher , Geoffrey L. Hodge , Michael Fisher
IPC分类号： B09B5/00
CPC分类号： C12M41/14 , B08B15/02 , C12M23/52 , C12M37/02 , C12M41/00 , C12M41/40 , Y10S55/18
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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