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1. 发明申请

US20130288346A1 LINEARLY SCALABLE SINGLE USE BIOREACTOR SYSTEM 有权
标题翻译：线性可扩展单一使用生物反应器系统
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
CPC分类号： C12M23/28 , C12M23/02 , C12M23/14 , C12M23/26 , C12M27/02
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。

2. 发明授权

US09969965B2 Linearly scalable single use bioreactor system 有权
公开(公告)号：US09969965B2
公开(公告)日：2018-05-15
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 , C12N1/06 , C12M1/06
CPC分类号： C12M23/28 , C12M23/02 , C12M23/14 , C12M23/26 , C12M27/02
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 10L 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.

3. 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。

4. 发明授权

US09499781B2 Disposable bioreactor condenser bag and filter heater 有权
标题翻译：一次性生物反应器冷凝器袋和过滤器加热器
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
IPC分类号： F25B21/02 , F25D17/06 , F25B5/00 , C12M1/00 , B01D5/00
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。

5. 发明申请

US20140349385A1 SINGLE-USE MIXING AND BIOREACTOR SYSTEMS 有权
标题翻译：单一混合和生物反应器系统
公开(公告)号：US20140349385A1
公开(公告)日：2014-11-27
申请号：US14345256
申请日：2012-09-13
申请人： Thomas Erdenberger , Richard L. Damren , Coln R. Tuohey , Michael Fisher , Parrish M. Galliher , Jonathan A. Kenney
发明人： Thomas Erdenberger , Richard L. Damren , Coln R. Tuohey , Michael Fisher , Parrish M. Galliher , Jonathan A. Kenney
IPC分类号： B01F13/08 , C12M1/00 , C12M1/06
CPC分类号： B01F13/0818 , B01F3/04106 , B01F3/04531 , B01F7/0025 , B01F7/00633 , B01F7/162 , B01F13/0872 , B01F15/00714 , B01F15/0085 , B01F2003/04673 , B01F2015/0011 , B01F2215/0073 , C12M23/14 , C12M23/26 , C12M27/02
摘要： Disclosed are magnetic agitation mixing systems for use with flexible container reaction vessels. In one aspect of the invention, the orientation of magnetic coupling between the impeller magnets and the external driver magnets is modified such that the coupling is neither strictly axial nor strictly radial. Also disclosed are “receiver-less” retainer configurations whereby the single-use container need not have a rigid base that defines a cup or post to engage of rotatable agitator.
摘要翻译：公开了用于柔性容器反应容器的磁力搅拌混合系统。在本发明的一个方面中，叶轮磁体和外部驱动磁体之间的磁耦合的取向被改变，使得联接器既不是严格的轴向也不是严格的径向。还公开了“无接收器”保持器构造，由此一次性容器不需要具有限定杯或柱以接合可旋转搅拌器的刚性基座。

6. 发明授权

US09550157B2 Single-use mixing and bioreactor systems 有权
标题翻译：一次性混合和生物反应器系统
公开(公告)号：US09550157B2
公开(公告)日：2017-01-24
申请号：US14345256
申请日：2012-09-13
申请人： Thomas Erdenberger , Richard L. Damren , Colin R. Tuohey , Michael Fisher , Parrish M. Galliher , Jonathan A. Kenney
发明人： Thomas Erdenberger , Richard L. Damren , Colin R. Tuohey , Michael Fisher , Parrish M. Galliher , Jonathan A. Kenney
IPC分类号： B01F13/08 , B01F7/00 , B01F7/16 , B01F15/00 , B01F3/04 , C12M1/06 , C12M1/00
CPC分类号： B01F13/0818 , B01F3/04106 , B01F3/04531 , B01F7/0025 , B01F7/00633 , B01F7/162 , B01F13/0872 , B01F15/00714 , B01F15/0085 , B01F2003/04673 , B01F2015/0011 , B01F2215/0073 , C12M23/14 , C12M23/26 , C12M27/02
摘要： Disclosed are magnetic agitation mixing systems for use with flexible container reaction vessels. In one aspect of the invention, the orientation of magnetic coupling between the impeller magnets and the external driver magnets is modified such that the coupling is neither strictly axial nor strictly radial. Also disclosed are “receiver-less” retainer configurations whereby the single-use container need not have a rigid base that defines a cup or post to engage of rotatable agitator.
摘要翻译：公开了用于柔性容器反应容器的磁力搅拌混合系统。在本发明的一个方面中，叶轮磁体和外部驱动磁体之间的磁耦合的取向被改变，使得联接器既不是严格的轴向也不是严格的径向。还公开了“无接收器”保持器构造，由此一次性容器不需要具有限定杯或柱以接合可旋转搅拌器的刚性基座。

7. 发明授权

US09109193B2 Continuous perfusion bioreactor system 有权
标题翻译：连续灌注生物反应器系统
公开(公告)号：US09109193B2
公开(公告)日：2015-08-18
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： C12N5/02 , C12M1/00 , C12M3/00 , C12M1/06
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。

8. 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。

9. 发明授权

US09127242B2 Tissue and organ graft bioreactor and method of operation 有权
标题翻译：组织和器官移植生物反应器及其操作方法
公开(公告)号：US09127242B2
公开(公告)日：2015-09-08
申请号：US13262155
申请日：2010-04-05
申请人： Patrick M. Guertin , Parrish M. Galliher , Michael Fisher , Joseph D. Crowell , Colin R. Tuohey , Laura A. Niklason , William E. Tente , Shannon M. Dahl , Juliana Blum , Justin Strader
发明人： Patrick M. Guertin , Parrish M. Galliher , Michael Fisher , Joseph D. Crowell , Colin R. Tuohey , Laura A. Niklason , William E. Tente , Shannon M. Dahl , Juliana Blum , Justin Strader
IPC分类号： C12M1/00 , C12M3/00 , A01N1/00 , C12M1/02 , C12M1/12
CPC分类号： C12M27/00 , C12M21/08 , C12M23/14 , C12M23/28 , C12M25/14 , C12M29/06
摘要： A single-use, single or multiple tissue, organ, and graft bioreactor and environmental control system is designed to replicate the necessary conditions for growth of tissues, organs, or grafts, while addressing problems in scaling up the tissue growth; adaptation to a single-use or disposable format; and operation as a stand-alone unit that provides full environmental control of cell culture conditions.
摘要翻译：单次使用，单次或多次组织，器官和移植物生物反应器和环境控制系统被设计为复制组织，器官或移植物生长所必需的条件，同时解决扩大组织生长的问题; 适应一次性或一次性格式; 作为提供细胞培养条件的全面环境控制的独立单元的操作。

10. 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。

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