Abstract: A mixing system includes a container for containing a fluid, and an agitator assembly disposable in the container for mixing the fluid. The agitator includes an extensible shaft and at least one impeller connected to the extensible shaft.

Abstract: A fluid handling apparatus for a bioprocessing system includes a first plate having a first surface and a second surface, at least one fluid flow channel formed in the first surface, at least one valve recess formed in the first surface along the at least one fluid flow channel, and at least one fluid passageway extending through the first plate from the at least one fluid flow channel to the second surface, and a sealing layer disposed over the first surface and enclosing the at least one fluid flow channel. The at least one valve recess is configured to cooperate with an actuator and the sealing layer to prevent a flow of fluid through the at least one fluid flow channel.

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. 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 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.

Abstract: An apparatus and an associated method is provided for waveguide spectroscopy of a sample inside a container. The apparatus may include a substrate with a window that is transparent at the wavelengths of interest and is coupled to the container holding a sample; a waveguide core of a material that is transparent at the wavelengths of interest located on an inner surface of the transparent window adjacent the sample, the waveguide core having a refractive index greater than that of the sample, an optical element configured to couple light into and out of the waveguide, and a light source and one or more detectors located outside of the container.

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: The invention discloses a flexible plastic bag for cultivation of cells, including a top wall film and a bottom wall film, each having an inside and an outside, sealed to each other inside-to-inside by durable weld seams, optionally via one or more side wall films, to form a bag with an inner volume delimited by the durable weld seams; one or more ports through the top and/or bottom wall film for introduction and withdrawal of fluids; one or more frangible weld seams joining the insides of said top and bottom wall films, dividing the bag inner volume into a plurality of cultivation compartments; and one or more gripping means affixed to the top and bottom wall films, adjacent each of the frangible weld seams and adapted to break a specific frangible weld seam by pulling apart the gripping means on the top and bottom wall films.

Abstract: An apparatus for minimizing dead leg spaces in a container or tubing includes a first member having a flange for attaching the first member to a wall of the container or tubing, the flange having at least one aperture, and a second member rotatably coupled to the first member, the second member having an upper end having at least one aperture, and an open distal end. The second member is rotatable relative to the first member between a closed position where the at least one aperture of the second member is misaligned with the at least one aperture in the flange to prevent the passage of fluid, and an open position where the at least one aperture of the second member is aligned with the at least one aperture in the flange to allow for the passage of fluid.

Abstract: Systems and methods for containing and manipulating liquids, including vessels and unit operations or components of cell culture, cell containment, bioreactor, and/or pharmaceutical manufacturing systems, are provided. In certain embodiments, such vessels and unit operations are directed to continuous perfusion reactor or bioreactor systems and may include one or more disposable components. For instance, in one aspect, a system includes an apparatus in the form of a bioreactor for harvesting cells which produce one or more products. The apparatus may include a disposable, collapsible bag adapted for containing a liquid, the collapsible bag in fluid communication with a liquid-solids (e.g., cell) separation device. For example, an outlet of the collapsible bag may be connected to an inlet of the separation device, and an outlet of the separation device may be connected to an inlet of the collapsible bag for recycle.

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 system and method for condensing moisture in a gas stream entering or leaving a bioreactor, the system comprising: a contact condenser container fluidically coupled to the bioreactor through an exhaust line; a condensate accumulator fluidically coupled to the contact condenser container through at least a first condensate line and a second condensate line; the condensate accumulator further fluidically coupled to the bioreactor through a condensate overflow line; a first condensate control device disposed on the first condensate line and configured to control a flow of condensate leaving the contact condenser container and entering the condensate accumulator; and a second condensate control device disposed on the second condensate line and configured to control a flow of condensate leaving the condensate accumulator to be mixed with the gas stream.

Abstract: Bioreactor bags formed from sheet materials are disclosed. The bioreactor bags include an opening which is openable and recloseable in a fluid tight manner for providing an opening for insertion of solid materials into the bag.

Abstract: Systems and methods for containing and manipulating liquids, including vessels and unit operations or components of cell culture, cell containment, bioreactor, and/or pharmaceutical manufacturing systems, are provided. The apparatus may include a disposable, collapsible bag adapted for containing a liquid, the collapsible bag in fluid communication with a liquid-solids (e.g., cell) separation device. For example, an outlet of the collapsible bag may be connected to an inlet of the separation device, and an outlet of the separation device may be connected to an inlet of the collapsible bag for recycle. Accordingly, after separating the cells from the liquid in the separation device, the cells can be flowed back into the collapsible bag where they can be re-harvested. Meanwhile, product contained in the liquid can be collected in a separate container. The efficiency of product formation in such a system may be enhanced by using mixing systems described herein.

Abstract: The system and method of the invention pertains to an axial flux stator is implemented to replace the drive-end magnets and the drive motor. The axial flux stator comprises a control circuit to control the voltage and current provided to the stator, to measure the torque and speed of rotation, and to measure the magnetic flux and magnetic flux density produced by the axial flux stator and impeller magnets, individually or in combination. The axial flux stator comprises a plurality of current carrying elements to produce magnetic flux in an axial direction and drive the impeller.

Abstract: The invention discloses a method for virus clearance of a cell culture medium, comprising the steps of: i) providing a bulk medium portion, comprising amino acids and glucose, and a first additive portion, comprising vitamins in aqueous solution; ii) subjecting the bulk medium portion to a high temperature short time treatment (HTST); iii) passing the first additive portion through a virus retentive filter or an ultrafilter; and iv) after steps ii) and iii), mixing the bulk medium portion with the first additive portion to obtain a cell culture medium.

Abstract: A packaging for a bioprocessing bag includes a housing having an open interior space, and a support base attached to an external side of the housing, the support base having a recess for receiving an impeller base plate of a bioprocessing bag.

Abstract: A container system is disclosed, where the container system includes a housing. A chromatography cartridge is disposed in the housing. A structural support in the housing is configured to retain the chromatography cartridge within the housing. The housing is configured to withstand a certain amount of pressure generated inside the chromatography cartridge. The chromatography cartridge is disposed in the housing either in horizontal or in vertical position.

Abstract: An apparatus for minimizing dead leg spaces in a container or tubing includes a first member having a flange for attaching the first member to a wall of the container or tubing, the flange having at least one aperture, and a second member rotatably coupled to the first member, the second member having an upper end having at least one aperture, and an open distal end. The second member is rotatable relative to the first member between a closed position where the at least one aperture of the second member is misaligned with the at least one aperture in the flange to prevent the passage of fluid, and an open position where the at least one aperture of the second member is aligned with the at least one aperture in the flange to allow for the passage of fluid.

Abstract: A system for isolating a target molecule from a bioprocess fluid includes a single-use disposable separation device having a plurality of perimeter-bonded layers defining one or more mesofluidic channels of the separation device, wherein each layer includes a biocompatible polymer material, wherein the separation device is configured to separate at least a portion of particles from the bioprocess fluid to generate a substantially clarified bioprocess fluid, and a chromatography system fluidically coupled at the outflow of the separation device in a configuration for further processing the clarified bioprocess fluid.

Abstract: A disposable cell enrichment kit includes a crossflow filtration device configured to be disposed along a main loop pathway and to receive a process volume containing a biological sample and utilize crossflow filtration, via a micro-porous membrane, to retain a specific cell population in a retentate from the process volume and to remove a permeate including certain biological components from the process volume. The crossflow filtration device includes a laminated filtration unit that includes the micro-porous membrane, a first mating portion, a second mating portion, and a membrane support. The membrane support includes a first plurality of structural features that define a first plurality of openings, wherein the first plurality of structural features are coupled to the micro-porous membrane and provide support to the micro-porous membrane, and the first plurality of openings allow the permeate to flow through them after crossing the micro-porous membrane.

Abstract: The present invention relates to a disposable container comprising a side wall, top and bottom, wherein the side wall and the bottom comprise a flexible material, wherein the side wall, top and bottom are joined together to define the container with an interior compartment for keeping a fluid inside the container. The bottom of the container comprises at least one portion of rigid or semi-rigid material comprising a folding means that enables folding of the bottom. Thus an easy way of folding the bottom of the container is provided.