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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。

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