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. 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. In one aspect, a system includes an apparatus in the form of a bioreactor for harvesting cells. The apparatus may include a disposable, collapsible bag for containing a liquid, the collapsible bag in fluid communication with a liquid-solids separation device. 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. After separating the cells from the liquid in the separation device, the cells can flow back into the collapsible bag for re-harvesting.

Abstract: A probe assembly for inserting a probe into a flexible or semi-rigid object is provided. The probe assembly includes an aseptic connector for coupling to the object, a probe sheath that extends longitudinally from the aseptic connector, and an actuator for deploying the probe within the object. The probe sheath has a plurality of concentric sheath elements and an inner longitudinal volume that is configured to permit longitudinal movement of the probe within the probe sheath. The actuator moves the probe longitudinally within the probe sheath by telescoping a first sheath element of the plurality within another sheath element of the plurality such that the probe is moved to a position sufficient to measure at least one parameter within the object.

Abstract: A bioreactor configured to contain a volume of liquid is provided. The bioreactor includes a collapsible bag able to contain the volume of liquid, a first sparger connected to the collapsible bag, and a second sparger connected to the collapsible bag.

Abstract: A bioreactor configured to contain a volume of liquid is provided. The bioreactor includes a collapsible bag able to contain the volume of liquid, a support structure surrounding and containing the collapsible bag, a first sparger connected to the collapsible bag, the first sparger having a first aperture size, and a second sparger connected to the collapsible bag, the second sparger having a second aperture size that is different from the first aperture size.

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: 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: 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: A vessel configured to contain a liquid is provided. The vessel includes a collapsible bad, a reusable support structure, a sensor, and a controller. The collapsible bag is operative to contain the liquid. The reusable support structure is operative to support the collapsible bag. The sensor is operative to measure a parameter within the collapsible bag. The controller is in electronic communication with the sensor and operative to introduce an antifoaming agent into the collapsible bag based at least in part on a signal received from the sensor.

Abstract: A vessel configured to contain a liquid is provided. The vessel includes a collapsible bad, a reusable support structure, a sensor, and a controller. The collapsible bag is operative to contain the liquid. The reusable support structure is operative to support the collapsible bag. The sensor is operative to measure a parameter within the collapsible bag. The controller is in electronic communication with the sensor and operative to introduce an antifoaming agent into the collapsible bag based at least in part on a signal received from the sensor.

Abstract: A probe assembly for inserting a probe into a flexible or semi-rigid object is provided. The probe assembly includes an aseptic connector for coupling to the object, a probe sheath that extends longitudinally from the aseptic connector, and an actuator for deploying the probe within the object. The probe sheath has a plurality of concentric sheath elements and an inner longitudinal volume that is configured to permit longitudinal movement of the probe within the probe sheath. The actuator moves the probe longitudinally within the probe sheath by telescoping a first sheath element of the plurality within another sheath element of the plurality such that the probe is moved to a position sufficient to measure at least one parameter within the object.

Abstract: A probe assembly for inserting a probe into a flexible or semi-rigid object is provided. The probe assembly includes an aseptic connector for coupling to the object, a probe sheath that extends longitudinally from the aseptic connector, and an actuator for deploying the probe within the object. The probe sheath has a plurality of concentric sheath elements and an inner longitudinal volume that is configured to permit longitudinal movement of the probe within the probe sheath. The actuator moves the probe longitudinally within the probe sheath by telescoping a first sheath element of the plurality within another sheath element of the plurality such that the probe is moved to a position sufficient to measure at least one parameter within the object.

Abstract: A bioreactor configured to contain a volume of liquid is provided. The bioreactor includes a collapsible bag able to contain the volume of liquid, a support structure surrounding and containing the collapsible bag, a first sparger connected to the collapsible bag, the first sparger having a first aperture size, and a second sparger connected to the collapsible bag, the second sparger having a second aperture size that is different from the first aperture size.

Abstract: Disclosed is a jacketed, tiered baffle, bioreactor tank comprising an outer cylindrical-shaped jacket and a cylindrical tank having an inner tank surface defining a chamber configured for supporting a flexible bag disposed within the chamber, and an outer tank surface having tiered baffles configured for routing a heat exchange fluid around the entirety of the outer tank surface, the cylindrical tank disposed axially within the outer cylindrical-shaped jacket. The outer cylindrical-shaped jacket is sealed to the cylindrical tank in a manner sufficient to prevent or minimize loss of the heat exchange fluid.

Abstract: A heat exchange module for use in a chemical, pharmaceutical or biological reactor system includes a generally hollow body having an interior space for receiving a replaceable or single use reactant container, and at least one thermally conductive surface adapted to contact the replaceable reactant container to facilitate heat transfer, a fluid circulation path formed within the body between an outer wall of the body and an inner wall of the body through which a heat exchange fluid can be circulated, and at least one baffle protruding from the inner wall of the body into the interior space.

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: 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: Disclosed herein are embodiments of a valve assembly for preventing dead leg spaces in a container or tubing, the embodiments including a three-way valve system for controlling back-pressure in a fluid generating device, such as a single-use high pressure bioreactor. Also disclosed is a pressurized reactor system for bioprocessing, comprising a single-use container including a flexible wall or a semi-rigid wall.

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: 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 bio culture 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.

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.