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。
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:
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:
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:
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:
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:
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:
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:
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:
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.