Abstract: A non-transitory computer readable medium includes instructions configured to adapt a controller to maintain a first target environment in a bioreactor vessel containing a population of cells for a first incubation period to produce a population of genetically modified cells from the population of cells, initiate a flow of media to the bioreactor vessel, maintain a second target environment in the bioreactor vessel for a second incubation period to produce an expanded population of genetically modified cells.

Abstract: The present invention provides improved methods, facilities and systems for parallel processing of biological cellular samples in an efficient and scalable manner. The invention enables parallel processing of biological cellular samples, such as patient samples, in a space and time efficient fashion. The methods, facilities and systems of the invention find particular utility in processing patient samples for use in cell therapy.

Abstract: A bioprocessing system includes a first module configured for enriching and isolating a population of cells, a second module configured for activating, genetically modifying, and expanding the population of cells, and a third module configured for harvesting the expanded population of cells.

Abstract: A bioprocessing system includes a first fluid assembly having a first fluid assembly line connected to a first port of a first bioreactor vessel though a first bioreactor line of a first bioreactor vessel, a second fluid assembly having a second fluid assembly line connected to a second port of the first bioreactor vessel through a second bioreactor line of the first bioreactor vessel, and an interconnect line providing for fluid communication between the first fluid assembly and the second fluid assembly, and for fluid communication between the second bioreactor line of the first bioreactor vessel and the first bioreactor line of the first bioreactor vessel.

Abstract: The present invention provides a device and method for sampling from a cell culture bioreactor. The invention is useful where it is required to determine the cell count, provide a sample for off-line analyses or remove a sample while at the same time retain sterility of the sample for quality control (QC) assessment. The device of the invention allows for facile aseptic sampling at one or more instances in time during a cell expansion in a bioreactor.

Abstract: A bioprocess mixer (1), which comprises: —a support vessel (2) with at least one side wall (3, 4, 5, 6) and a bottom wall (7), where the walls define a support vessel inner volume (8), and at least a first (9) and a second (10) magnetic impeller drive unit; and —a flexible bag (11, 111) adapted to fit inside the support vessel inner volume, where the bag has at least one bag side wall (12, 112, 13, 113, 14, 15), a bag bottom wall (16, 116) and a bag top wall (17, 117) defining a bag inner volume (18), and at least a first (19) and a second (20) magnetic impeller rotatably attached to a bag wall in the bag inner volume.

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 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: The present invention provides improved methods for maintaining the physical separation and identity integrity of a biological cellular sample from a patient during processing. The invention enables parallel processing of biological cellular samples, such as patient samples, in a space and time efficient fashion. The methods of the invention find particular utility in processing patient samples for use in cell therapy.

Abstract: A flexible bioprocess bag comprising a number of flexible panels which are sealed to each other such that when the bag is filled they form at least a bottom of the bag and a side surface of the bag, wherein one of the flexible panels is called a bottom panel and when the bag is filled said bottom panel will constitute the bottom of the bag and parts of the side surface of the bag, said parts of the side surface being bent side parts of the bottom panel.

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: 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: This disclosure is directed to optical microscope calibration devices that can be used with optical microscopes to adjust the microscope imaging parameters so that images of samples can be obtained below the diffraction limit. The microscope calibration devices include at least one calibration target. Each calibration target includes a number of features with dimensions below the diffraction limit of a microscope objective. Separate color component diffraction limited images of one of the calibration targets are obtained for a particular magnification. The color component images can be combined and image processed to obtain a focused and non-distorted image of the calibration target. The parameters used to obtain the focused and non-distorted image of the calibration target can be used to obtain focused and non-distorted images of a sample for the same magnification by using the same parameters.

Abstract: The present disclosure relates to a computer-implemented system and its associated method for single channel whole cell segmentation of a sample image of a biological sample. The biological sample may be stained with one or more non-nuclear cell marker stains, and the system and the method are configured to transform the sample image of the biological sample stained with the one or more non-nuclear cell marker stains into a segmented image having one or more cells with delineated nuclei and cytoplasm regions.

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: Provided are techniques that may include a disposable magnetic cell isolation holder having one or more passages that accommodate a magnetic retention material to facilitate magnetic cell isolation without adjustment of magnetic field parameters between isolation procedures using different magnetic particle sizes. When the magnetic cell isolation holder is coupled to a magnetic field generator, a first passage corresponding to a smaller particle size is positioned in a magnetic field where the magnetic field characteristics are different relative to a second passage, of a second holder or in the same holder, for use with another bead size.

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: Provided are techniques that may include a disposable magnetic cell isolation holder having one or more passages that accommodate a magnetic retention material to facilitate magnetic cell isolation without adjustment of magnetic field parameters between isolation procedures using different magnetic particle sizes. When the magnetic cell isolation holder is coupled to a magnetic field generator, a first passage corresponding to a smaller particle size is positioned in a magnetic field where the magnetic field characteristics are different relative to a second passage, of a second holder or in the same holder, for use with another bead size.