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: Systems for semi or fully automated non-parallel random access manufacturing of cells comprising (a) an incubator arranged to house multiple cell culture vessels, and (b) one or more connection interfaces, each of which comprises (i) a first connector, and (ii) a first sterilizable space, wherein the first connector is operable to connect a first container and a cell culture vessel in the first sterilizable space. Also provided herein are methods for manufacturing cells using the systems provided herein.

Abstract: An automated manufacturing system and method of manufacture of a cell therapy are disclosed herein. In some embodiments, the system includes one or more workstations for processing a cell culture, with the cell culture being moved between workstations in a cell culture vessel. In some embodiments, the cell culture vessel includes an inner container (350) and an outer shell (358). In some embodiments, the shell includes a top (374) and bottom (376) that cooperate with one another to form a chamber for holding the inner container.

Abstract: The disclosure includes a system and method for making a sterile connection for transferring a liquid between two containers, including: (a) positioning a first connection surface and a second connection surface; (b) coupling the first connector and the second connector, wherein the coupling defines a sterilization chamber comprising a gap between the first connection surface and the second connection surface; (c) activating a sterilization agent within the sterilization chamber to produce a sterile environment (d) fluidically coupling the first container with the second container through the first connection surface and the second connection surface, (e) transferring a liquid between the first container and the second container.

Abstract: Methods and devices for automated sterile connection and liquid transfer between containers. The methods and devices involve welding (e.g., nest welding) to form sterile fluidical connection between the containers. The method includes: (a) placing a first tube and a second tube into a welding mount, wherein the first tube is connected to a first container and the second tube is connected to a second container, and (b) welding the first tube and the second tube to form a first sterile fluidical connection between the first container and the second container. The method also includes (c) transferring a liquid between the first container and the second container via the first sterile fluidical connection. (d) scaling and cutting the first fluidical connection between the first container and the second container to disconnect the first sterile fluidical connection. The devices executing the method can be automated by a controller.

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 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: 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: 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: Systems for containing and manipulating fluids including systems and methods involving supported collapsible bags that may be used as reactors for performing chemical, biochemical and/or biological reactions contained therein are provided. Generally, a series of improvements and features for fluid containment systems such as gas delivery configurations, foam control systems and bag molding methods and articles for supported collapsible bag vessels and bioreactors are provided. For instance, in one aspect, fluids contained in a vessel can be sparged, e.g., such that a fluid is directed into a container of the vessel, and in some cases, the sparging can be controlled by rapidly activating or altering the degree of sparging as needed. Multiple spargers may be used in some cases. In another aspect, the vessel includes a seamless collapsible bag. In some cases, the collapsible bag may be injected, blown, or spin cast molded.

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 bioreactor, forming a dry gas stream for entering or leaving the bioreactor.

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: 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. 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 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.

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 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.

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.