LINEARLY SCALABLE SINGLE USE BIOREACTOR SYSTEM
    11.
    发明申请
    LINEARLY SCALABLE SINGLE USE BIOREACTOR SYSTEM 有权
    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

    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。

    SINGLE USE SLURRYING AND CHROMATOGRAPHY SYSTEMS
    12.
    发明申请
    SINGLE USE SLURRYING AND CHROMATOGRAPHY SYSTEMS 审中-公开
    单一使用浆料和色谱系统

    公开(公告)号:US20130186834A1

    公开(公告)日:2013-07-25

    申请号:US13825829

    申请日:2011-09-23

    IPC分类号: B01D15/22

    摘要: Methods and systems for chromatography are disclosed that employ a flexible container configured to fit within a support structure and adapted to receive a filtration or absorptive medium, such as a chromatography resin. The flexible container can include at least one inlet, at least one outlet, and a separation barrier peripherally sealed within the container to separate the container into a resin containing portion and a drainage portion. The barrier can be configured to exclude the resin material from the drainage portion during use while allowing fluids to pass therethrough. The disposable chromatography system can further include one or more agitators disposed within the flexible container and adjustably configured to be raised or lowered in the flexible container. When the agitator is in the raised position, the resin packing material can operate in a settled, packed-bed configuration. Alternatively, the agitator in the lowered position permits the chromatography resin packing material to operate in a mixed, slurry configuration.

    摘要翻译: 公开了用于层析的方法和系统,其采用配置成装配在支撑结构内并适于接收过滤或吸收介质如色谱树脂的柔性容器。 柔性容器可以包括至少一个入口,至少一个出口和周边地密封在容器内的分离屏障,以将容器分离成树脂容纳部分和排出部分。 挡板可以构造成在使用期间将树脂材料从排水部分排除,同时允许流体通过。 一次性色谱系统还可以包括设置在柔性容器内的一个或多个搅拌器,并可调节地构造成在柔性容器中升高或降低。 当搅拌器处于升起位置时,树脂包装材料可以以沉降的填充床构型运行。 或者,处于降低位置的搅拌器允许色谱树脂包装材料以混合的浆料配置运行。

    Lift and support assemblies and methods for collapsible bag containers of vessels and bioreactors
    13.
    发明授权
    Lift and support assemblies and methods for collapsible bag containers of vessels and bioreactors 有权
    用于容器和生物反应器的可折叠袋容器的提升和支撑组件和方法

    公开(公告)号:US08381780B2

    公开(公告)日:2013-02-26

    申请号:US12469469

    申请日:2009-05-20

    IPC分类号: B65B3/04

    摘要: Disclosed are a lift assembly and methods that may be used to raise a component of a system, a component such as a collapsible bag to be used as a reactor for performing chemical or biological reactions, and/or to position the collapsible bag for use. Use of the lift assembly may allow for the automated assembly of the systems described herein. In some cases, trauma to the system components is minimized.

    摘要翻译: 公开了一种电梯组件和方法,其可用于升高系统的部件,诸如可用作进行化学或生物反应的反应器的可折叠袋的部件和/或定位可折叠袋以供使用。 提升组件的使用可以允许本文所述的系统的自动组装。 在某些情况下,系统组件的创伤最小化。

    Environmental containment systems
    20.
    发明授权
    Environmental containment systems 有权
    环境遏制系统

    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。