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.

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 sparger device includes a sparge tube having opposed distal ends, an inlet opening, and a plurality of sparge holes along a longitudinal extent of the sparge tube between the opposed distal ends, and a central hub coupled with the sparge tube at a point intermediate the opposed distal ends of the sparge tube, the central hub having a fluid passageway in fluid communication with the sparge tube via the inlet opening.

Abstract: Disclosed is biomanufacturing apparatus 1 comprising a housing 20 including top 22 and bottom 24 faces which allow stacking of plural housings, an access door 25 at a front side of the housing, a substantially enclosed bioreactor chamber 30 inside the housing accessible via the door, and a further substantially enclosed region 36 inside the housing containing electrical parts and/or electronic control components, the chamber 30 including: a tray 40 for supporting a bioreactor, a tray support 45 including a mechanism 44,47 for rocking the tray in use; the tray support further including a load cell (41) to determine changes in the mass load on the tray.

Abstract: Disclosed is biomanufacturing apparatus 1 comprising a housing 20 including top 22 and bottom 24 faces which allow stacking of plural housings, an access door 25 at a front side of the housing, a substantially enclosed bioreactor chamber 30 inside the housing accessible via the door, and a further substantially enclosed region 36 inside the housing containing electrical parts and/or electronic control components, the chamber 30 including: a tray 40 for supporting a bioreactor, a tray support 45 including a mechanism 44,47 for rocking the tray in use; at least a fluid handling portion 48,49 of at least one fluid pump device 54/58; and at least one connection 43 for connecting to a conduit and/or path for carrying fluids, gas and/or electricity.

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 cell harvesting instrument suitable for concentrating cells from a source suspension of cells and/or washing said cells, the instrument comprising: a housing for accommodating mechanical elements including at least one fluid pump, at least one valve; and a processing kit removably insertable into the housing, said kit including a generally flat frame having or supporting plural sealed fluid paths arranged in a generally flat plane and such that fluids in the paths do not contact said mechanical elements, wherein at least portions of the fluid paths comprise flexible tubes, the outer surfaces of which are manipulateable by the or each fluid pump, to provide fluid flow in one or more of the paths and/or by the or each valve to restrict fluid flow in one or more of the paths. In an embodiment, the kit comprises also a fluid processing reservoir and a filter suitable for separating cells from fluid in said paths.

Abstract: An apparatus for bioprocessing includes a housing, a drawer receivable within the housing, the drawer including a plurality of sidewalls and a bottom defining a processing chamber, and a generally open top, the drawer being movable between a closed position in which the drawer is received within the housing, and an open position in which the drawer extends from the housing enabling access to the processing chamber through the open top, and at least one bed plate positioned within the processing chamber and configured to receive a bioreactor vessel.

Abstract: In an embodiment, a tubing module for a bioprocessing system includes a first tubing holder block configured to receive at least one pump tube and hold the at least one pump tube in position for selective engagement with a peristaltic pump, a second tubing holder block configured to receive a plurality of pinch valve tubes and hold each pinch valve tube of the plurality of pinch valve tubes in position for selective engagement with a respective actuator of a pinch valve array, and wherein the first tubing holder block and the second tubing holder block are interconnected.

Abstract: A bioreactor vessel includes a bottom plate, a vessel body coupled to the bottom plate, the vessel body and the bottom plate defining an interior compartment therebetween, and a plurality of recesses formed in the bottom plate, each recess of the plurality of recesses being configured to receive a corresponding alignment pin on a bed plate for aligning the bioreactor vessel on the bed plate.

Abstract: A bioprocessing method for cell therapy includes the steps of genetically modifying a population of cells in a bioreactor vessel to produce a population of genetically modified cells, and expanding the population of genetically modified cells within the bioreactor vessel to generate a number of genetically modified cells sufficient for one or more doses for use in a cell therapy treatment without removing the population of genetically modified cells from the bioreactor vessel. Cells are settled on a gas permeable, liquid impermeable membrane for expansion, and are resuspended when, or after, the desired cell density is reached.

Abstract: A system for bioprocessing includes a tray having plurality of sidewalls and a bottom surface defining an interior compartment, and a generally open top, and an opening formed in the bottom surface of the tray, the opening having a perimeter. The perimeter of the opening is shaped and/or dimensioned such that a bioreactor vessel can be positioned above the opening and supported by the bottom surface of the tray while a portion of the bioreactor vessel is accessible through the opening in the bottom surface. The tray is receivable within a processing chamber such that the bed plate extends through the opening in the bottom surface of the tray to support the bioreactor vessel.

Abstract: The aspects of the disclosed embodiments generally relate to an apparatus which allows for the controlled addition of antifoam to the foam present in the headspace of a disposable single-use bioreactor in a reliable manner. The aspects of the disclosed embodiments also generally relate to a method of using such apparatus which allows for the controlled addition of antifoam to the foam present in the headspace of a disposable single-use bioreactor in a reliable manner. The aspects of the disclosed embodiments generally relate to antifoam systems, methods and apparatus, and more particularly, to an antifoam device operably connected to a single use biobag.

Abstract: The methods of harvesting cells are provided, wherein the methods comprise introducing a processing material and a source material into a processing loop. The processing loop comprises a processing chamber and a filtering device. The processing material and the source material are circulating through the processing chamber and the filtering device, wherein the processing chamber has a mass; balancing an influx of the processing material into the processing chamber with a permeate flux of the filtering device to maintain the mass of the processing chamber at a constant value; and collecting the cells in a collection chamber. Cell harvesting devices are also provided for processing and harvesting cells using a control law to balance the mass of the processing chamber through the entire process.

Abstract: The present invention relates to a novel bioreactor system for cell cultivation. More specifically, the invention relates to a compact bioreactor system which has several integrated functions and enables small scale static culture as well as scale-up rocking culture in the same bioreactor. The bioreactor system comprises tray for positioning of a cell culture bag having adjustable volume, a lid covering the cell culture bag and provided with heating function, an integrated perfusion unit, an integrated cell loading unit, and an integrated unit for automatic cell culture sampling, wherein the bioreactor system is controlled by a single control unit. The invention also relates to a method of cell culture using the bioreactor system for culture of therapeutic cells.

Abstract: A bioreactor system and packaging is provided. The bioreactor system includes a vessel for housing biomaterials for processing and a support structure. The vessel includes a flexible material defining a chamber and a mixing system positioned within the chamber. The mixing system includes an agitator for imparting motion and mixing to the contents of the vessel and includes a base affixed to the flexible material at a base section of the chamber, a shaft moveably mounted in the base and extending from the base into the chamber and at least one mixing element mounted to the shaft, the shaft configured to be driven by a motor magnetically coupled to the shaft and external to the lower portion of the chamber. The support structure is connected to the mixing system such that the shaft is moveable therein and configured to cooperate with an external structure to provide support for the shaft.

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: The present disclosure relates to a manufacturing system, method and control circuitry for quality assured manufacturing of at least two biopharmaceutical products. The manufacturing system comprises a warehouse facility, a hydration facility, and at least two biopharmaceutical manufacturing facilities, wherein the warehouse facility and hydration facility are comprised in the macro structure. Each biopharmaceutical manufacturing facility is comprised in a respective micro node, and a control facility in the macro structure is configured to control interoperability of the macro structure and the micro nodes by means of a network spine interconnecting the macro structure with each micro node.

Abstract: The invention relates to a a single-use flexible bioreactor bag comprising a rigid multiport plate sealed to a side wall of said bioreactor bag, wherein said multiport plate comprises a plurality of ports. The invention further relates to a method of manufacturing the bag and to a method of installing the bag in a rigid support vessel.

Abstract: A method includes introducing a suspension including cells suspended in a cell culture medium through a feed port or a drain port into a cavity of a cell culture vessel, the suspension being in an amount sufficient to cover a gas permeable, liquid impermeable membrane positioned at a bottom of the cell culture vessel, the feed port being disposed through a surface of the cell culture vessel and configured to permit additional cell culture medium into the cavity, and the drain port being disposed through the surface of the cell culture vessel and configured to permit removal of the cells, cell culture medium, and used cell culture medium from the cavity, allowing the cells to settle on the gas permeable, liquid impermeable membrane by gravity, removing the used cell culture medium through the drain port and introducing the additional cell culture medium through the feed port such that a constant volume is maintained in the cell culture vessel until the cells expand to a desired cell density, wherein the removi