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:
Accordingly, in one embodiment of the invention, a bioreactor system is presented and includes a disposable container for housing biomaterials for processing, the disposable container including at least one input port, at least one exhaust port, at least one harvest port, and the integrity of the sterile environment is protected with sterile filters attached to all external open ports a structure for supporting the disposable container, one or more sensors for sensing one or more parameters of the biomaterials in the container, a heater for heating the contents of the container, the heater having a thermostat and mixing system arranged with the system such that biomaterials contained in the disposable container are mixed.
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:
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:
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:
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:
The present invention relates in certain aspects to systems and methods involving the identification, tracking, determination of location of, determination of material consumption by, waste removal from, component positioning in or on, and assembly of vessels and unit operations or components of cell culture, cell containment, bioreactor, chemical manufacturing, or pharmaceutical manufacturing systems. Certain vessels, unit operations, devices, or other components of the invention may be used to perform all or part of a biological, chemical, or pharmaceutical manufacturing process therein. In some embodiments, the inventive method may be used to assemble system components, verify that the system components are correctly assembled, protect against the use of counterfeit components, etc. Other embodiments of the invention involve articles that allow for the automated assembly of bioreactor systems.
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:
A nonporous vessel capable of holding a fluid comprises an outer wall surface and an inner wall surface, the inner wall surface defining an interior chamber for holding the fluid; a filter having a perimeter, a first surface and a second surface, and fixedly attached around its entire perimeter to a portion of the inner wall surface of the nonporous vessel, thereby forming an integrated interior bag within the nonporous vessel; and a fitment attached to the outer wall of the nonporous vessel at a portion of the outer wall that is adjacent to the first surface of the integrated interior bag, the fitment forming a port configured to allow fluid to flow from the interior chamber through the integrated interior bag, through the filter, and out of the port.
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.