Abstract: A bioreactor control system comprises a batch server for controlling a bioreactor system in response to a recipe, a batch software system for generating a control sequence for the bioreactor system via the batch server for implementing the recipe, and a recipe conversion system that inputs the recipe into the batch software system. Preferably, the recipe conversion system reads a word processor file containing the recipe and interprets styles applied to text in the word processor file as indicating equipment and phases of the recipe to the recipe conversion system. Generally, the bioreactor system includes one or more bioreactors and additional hardware to perform the upstream and downstream processing. The document properties of the word processor file containing the recipe are applied as header information for the recipe input into the batch software system.

Abstract: The invention provides a method of increasing product yield per culture in a population of product-secreting cells bound to a scaffold, for example, a microcarrier, at least partially immersed in a culture medium in a bioreactor. The method comprising: semi-harvesting product by removing a volume of the culture medium with a first-secreted product concentration while leaving the scaffold with the bound cells in the bioreactor; re-feeding the cells by adding a fresh culture medium to increase the culture medium in the bioreactor to approximately the original volume; agitating the culture medium to allow the cells to grow and release a second-secreted product concentration; harvesting product by removing the culture medium with the second-secreted product concentration while leaving the scaffold with the bound cells behind. Also disclosed is a method of increasing virus yield per culture in a population of virus-infected cells bound to a microcarrier suspended in a culture medium.

Abstract: 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.

Abstract: 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.

Abstract: Disclosed is a sensor and housing assembly for a single-use bioreactor system, including a device for operatively associating a sensor with a flexible wall, the device comprising an internal housing portion that is removable and variably positionable on an internal surface of the flexible wall, the internal housing portion comprising a chemical detector sensor, which may be an optical chemical detector sensor.

Abstract: 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.

Abstract: A heat exchange module for use in a chemical, pharmaceutical or biological reactor system can include a body configured to be disposed in the reactor system having an inner replaceable reactant container is disclosed. The body can further include at least one thermally conductive surface adapted to contact the inner replaceable reactant container to facilitate heat transfer. Furthermore, the heat exchange module can include a heat exchanger disposed within the module body and can include a fluid circulation path through which a heat exchange fluid can be circulated.

Abstract: 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.

Abstract: Disclosed herein is a single use, controlled environment manufacturing module in the form of a sterile sealed bag formed of a substantially flexible material, such that the bag can be inflated and deflated for transport and/or disposal. The flexible bag has one or more access ports and connectors to accommodate a variety of biochemical or pharmaceutical manufacturing processes to be carried out within the flexible bag. The interiors of one or more disclosed modules can be connected, forming a module train.

Abstract: Embodiments of the present invention are directed to a customizable bio-manufacturing system which includes a manufacturing space having a first air handling system for providing supply air and a second air handling system for handling exhaust air, the supply air system being optionally provided with at least one of filtration, heating, cooling and or humidity control and a plurality of portable modules provided within the manufacturing space. At least one module having an interior capable of being interconnected with another module interior and each module's interior includes one or more components to perform at least one specific task of a biological, chemical, and/or pharmaceutical manufacturing process. At least one module includes an on-board environmental control system for controlling an environment within the module and a connection means for interconnecting the module interior with another module interior.

Abstract: 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.

Abstract: Disclosed herein is a single use continuous recovery, flow-through harvest vessel and corresponding method for harvesting culture medium and simultaneously either leaving the microcarrier beads behind in the vessel or flowing microcarrier beads and medium back into a bioreactor.

Abstract: Disclosed herein is a formulation capable of enhancing thermostability and shelf-life of a biological product, the formulation comprising: a tertiary amine N-oxide or a derivative thereof represented by the formulae: wherein R1, R2, and R3 may be identical or different and each is a straight or branched lower alkyl group having from 1 to 4 carbon atoms; an inorganic salt; glutamic acid or a salt thereof; a polyol; a physiologically acceptable buffer, and a pharmaceutically acceptable carrier. The tertiary amine N-oxide may be trimethylamine-N-oxide, (CH3)3NO. The formulation is useful for vaccine stabilisation.

Abstract: Disclosed is a method of increasing product yield per culture in a population of bound product-secreting cells in a bioreactor, the method comprising: semi-harvesting product by removing a volume of the culture medium with a first-secreted product concentration; re-feeding the bound population of product-secreting cells by adding an amount of a fresh culture medium sufficient to increase the volume of the culture medium to approximately the original volume of the culture medium; agitating the culture medium under sufficient conditions and for a sufficient time period to allow the bound population of product-secreting cells to grow and to release a second-secreted product concentration into the culture medium; and harvesting product.

Abstract: Disclosed herein is a chromatography system wherein a sensor, for example, a UV sensor, is tied to a continuously variable load pump in a feedback control loop, with an option to divert the feed stream back to the load vessel or reservoir or onto a second chromatography column, the disclosed chromatography system allowing a true feedback control across variable load rates, thereby adjusting chromatographic operating parameters, for example, variable load rates, to process conditions, while maximizing throughput.

Abstract: The invention provides a an inactive, non-replicating vaccine comprising whole virion, chemically inactivated Yellow Fever virus which is inactivated using a method that ensures preservation of critical, neutralizing epitopes. The Yellow Fever virus has been adapted to propagate in cells to higher yields than the unadapted virus. The invention also provides methods for preventing Yellow Fever viral infection.

Abstract: 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.

Abstract: 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.

Abstract: The invention provides methods for identifying and isolating cells that express high levels of protein. A method is described for identifying a cell or cell line expressing a desired protein comprising determining in a cell or cell line that has been transfected with a vector comprising a nucleotide sequence encoding the desired protein the intracellular expression levels of elements of the vector and also determining expression of the desired protein on the surface of the cell or cell line, in certain cases in a single assay.

Abstract: 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.