A bioprocessing system for use in carrying out a biomanufacturing process is provided. The system includes a single-use bag configured to carry out a bioprocessing operation with at least one port welded to the single-use bag. The at least one port has a channel for providing fluidic access to an interior volume of the single-use bag. The system further includes at least one mating ring. The at least one port includes a first feature configured to engage with a corresponding second feature of the at least one mating ring, such that the at least one mating ring can be locked to the at least one port. The mating ring and bag port are configured to provide an array of structural functionalities to aid the assembly and use of the bioprocessing system.
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, or outer surfaces of which are manipulateable by the or each fluid pump, to provide fluid flow in one or more of the pats 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. A transfer mechanism for moving and weighing the fluid processing reservoir is disclosed also.
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.
A sensing chamber for a bioprocessing system includes a front plate, a back plate, at least one fluidic channel intermediate the front plate and the back plate, a first port in fluid communication with the fluidic channel and permitting a flow of fluid into the fluidic channel, and a second port in fluid communication with the fluidic channel and permitting a flow of fluid out of the fluidic channel. The at least one fluidic channel includes a plurality of segments permitting monitoring of a plurality of parameters of the fluid within the at least one fluidic channel via at least electrochemical and optical sensing techniques.
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.
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.
A bioreactor system includes a housing configured to house and support a vessel, a stereo camera having first and second imagers secured to the housing, the stereo camera configured to image a surface of a liquid and a foam exposed to a headspace of the vessel. The system further includes a controller operatively connected to the stereo camera and the stereo camera and controller are configured to create an image of the exposed surface and identify foam on the surface based on the image.
In an embodiment, a bioprocessing method includes securing a vessel containing a fluid to a platform capable of pivoting about a first axis, heating the fluid in the vessel while the platform is in a static, substantially upright position to facilitate a first bioprocessing procedure within the vessel. The method further includes pivoting the platform and vessel about the first axis to create a rocking motion to facilitate a second bioprocessing procedure within the vessel.
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.
The present invention provides a system for the insertion of a pre-sterilized sensor probe into a sterile vessel. The system of the invention provides a reliable and straightforward way to insert one or more sterile probes into a sterile vessel. The present invention also provides a sterile vessel that includes one or more of the systems of the invention. The sterile vessel can be a flexible or semi-rigid bag or tubing of the type typically used for carrying out biochemical and/or biological processes and/or manipulating liquids and other products of such processes. Furthermore, the present invention provides a method for aseptically inserting a probe into a sterile vessel where the method makes use of the system of the invention.
A method for assessing the integrity of a bioprocessing system includes the steps of determining a mass of a first container, transferring a volume of fluid from the first container to a second container, determining the mass of the second container, comparing the mass of the first container with the mass of the second container, and, if the difference between the mass of the first container and the mass of the second container exceeds a threshold, generating a notification indicating that a leak is present.
G01M 3/32 - Investigating fluid tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for containers, e.g. radiators
A sparger assembly for a bioprocessing system includes a base and a plurality of spargers connected to the base, each sparger including a plurality of pores, the plurality of spargers each have a generally cylindrical shape. Each of the plurality of spargers includes a sidewall and a top, which define the cylindrical shape, the sidewall and the top each include a plurality of pores. The pores of the sidewall can be arranged around a circumference of the sidewall at an array of heights. Ridges may also be located on the sidewall above a respective array of pores.
A biocompatible polymeric membrane includes pores defined between two material layers, where the first membrane material layer includes strips, and the second membrane material binds to each of the plurality of first membrane material layer strips includes a plurality of windows exposing each of the first membrane material strips. The biocompatible polymeric filtration membrane comprises pores defined by uniform passages defined by the first membrane material layer strips and the second membrane material layer within each window.
B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
14.
SYSTEM AND METHOD FOR HEAT AND MASS TRANSFER FOR A BIOPROCESSING SYSTEM
A method of bioprocessing includes the steps of providing a bioreactor vessel having a gas-permeable, liquid impermeable membrane, initiating a flow of gas, and passing the flow of gas across a bottom surface of the membrane to induce a turbulent interaction between the flow of gas and the membrane.
A foam identification system including a thermal imaging camera and a controller connected to the thermal imaging camera. The thermal imaging camera images a surface of a liquid in a vessel that is exposed to a headspace of the vessel. The headspace being either warmer or cooler than the liquid. The camera and the controller detect a change in temperature of the exposed surface of the liquid to identify foam on the exposed surface of the liquid.
A rocking mechanism for a bioreactor vessel includes a base, a motor mounted to the base and having an eccentric roller driven by the motor, and a rocking plate in contact with the eccentric roller, the rocking plate being configured to receive a bioreactor vessel thereon. The motor is controllable to drive the eccentric roller to transmit a force against an underside of the rocking plate to tilt the rocking plate and bioreactor vessel.
A bioprocessing apparatus includes a flexible bag having an interior volume configured to contain a fluid, and an integral fluid conduit within the flexible bioprocessing bag. The integral fluid conduit includes a panel of material joined to an interior sidewall of the flexible bag so as to define a fluid channel between the interior sidewall of the flexible bag and the panel of material. The integral fluid conduit may include a bottom outlet opening, a top outlet opening, or both. The apparatus may further include a port in a top of the flexible bag, a port in the bottom of the flexible bag, or both, wherein the integral fluid conduit is fluidly connected to the ports.
A bioprocessing apparatus includes a housing, a process drawer receivable within the housing and moveable between a closed position and an open position, the process drawer being configured to receive at least one culture vessel therein, and a cabinet positioned in stacked vertical relation to the housing, the cabinet including at least one vertical storage drawer slidably received within the cabinet.
A method for bioprocessing includes the steps of providing a bioprocessing system having a first bioreactor vessel and a second bioreactor vessel, activating a population of cells in the first bioreactor vessel, genetically modifying the population of cells to produce a population of genetically modified cells, and expanding the population of genetically modified cells within the first bioreactor vessel and the second bioreactor vessel.
Methods and apparatus for scaling in bioprocess systems are disclosed. An example apparatus for bioprocess scaling includes at least one memory to store instructions, and processor circuitry to execute the instructions to identify an operating parameter of a target bioreactor, determine an upper boundary or a lower boundary defining a design space for at least one bioreactor process parameter to match at least one of a first target parameter range or a second target parameter range based on the operating parameter, simulate changes in the first target parameter range or a second target parameter range based on an adjustment to the upper boundary or the lower boundary in the design space, and configure the target bioreactor using output obtained from the adjustment to the upper boundary or the lower boundary to identify a match between the first target parameter range or the second target parameter range.
An apparatus for magnetic cell isolation includes a base, a stopcock manifold interface located on the base and configured to receive a stopcock manifold of a cell processing kit, a magnetic field generator located within the base, and a slot formed in the base, the slot configured to removably receive a magnetic cell isolation holder. The magnetic field generator is movable into and out of engagement with the magnetic cell isolation holder.
A method for assessing the integrity of a bioprocessing system includes the steps of utilizing a pump of a bioprocessing system, pressurizing a plurality of flow lines, and measuring a decay of a pressure within the plurality of flow lines for a predetermined a duration.
C12M 1/34 - Measuring or testing with condition measuring or sensing means, e.g. colony counters
G01M 3/32 - Investigating fluid tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for containers, e.g. radiators
23.
DISPOSABLE KITS FOR CELL WASHING, MAGNETIC ISOLATION AND DOSING PREPARATION
A kit for magnetic cell isolation includes first stopcock manifold having at least four stopcocks, a separation chamber configured for use with a centrifugal processing chamber of the cell processing device, the separation chamber in fluid communication with the first stopcock manifold, a mixing bag configured for use with a heating/cooling mixing chamber of a cell processing device, the mixing bag in fluid communication with the first stopcock manifold, a second stopcock manifold having at least four stopcocks, the second stopcock manifold in fluid communication with the first stopcock manifold, a magnetic cell isolation holder in fluid communication with the second stopcock manifold, the magnetic cell isolation holder configured for use with a magnetic field generator of a magnetic cell isolation device, and a plurality of cell processing bags in fluid communication with the first and/or second stopcock manifolds.
A bioreactor vessel includes a base having a plurality of through openings, a lid connected to the base via a plurality of heat stakes, and a gas-permeable, liquid impermeable membrane sandwiched between the base and the lid and held in position by the plurality heat stakes.
Porous membranes are provided according to the invention having desirable coefficient of thermal expansion and large surface area, for example at least about 4,000 mm2. These porous membranes may be made according to an exemplary process employing lithographic patterning of a photoresist followed by development of the photoresist and etching. In one aspect, the etch barrier layer is chosen from a material that does not react with or incorporate metal or other contaminants into the membrane layer.
B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
26.
Micropore membranes and methods of fabrication thereof using pillar templates
Porous liquid-filtering membranes having a repeatable distribution of pores of a small dimension are provided, as well as pillar templates that are used to produce such liquid filtering membranes. Also disclosed are methods of making and using the pillar templates to make porous liquid filtering membranes.
B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
G03F 7/00 - Photomechanical, e.g. photolithographic, production of textured or patterned surfaces, e.g. printed surfaces; Materials therefor, e.g. comprising photoresists; Apparatus specially adapted therefor
A biocompatible polymeric membrane includes pores (106) defined between two material layers, where the first membrane material layer (101) includes strips, and the second membrane material (104) binds to each of the plurality of first membrane material layer strips (101) includes a plurality of windows (105) exposing each of the first membrane material strips (101). The biocompatible polymeric filtration membrane comprises pores (106) defined by uniform passages defined by the first membrane material layer strips (101) and the second membrane material layer (104) within each window (105).
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
Methods and apparatus for bioprocess monitoring are disclosed. An example apparatus includes a controller to monitor a first bioprocess instrument, a data logger to collect data for the first bioprocess instrument, the collected data including data collected while the first bioprocess instrument is transferred from a first location to a second location, a configurator to configure the first bioprocess instrument to operate in a first mode at the first location and in a second mode at the second location, the first or second mode determined based on a type of processing at the first or second location, and a user interface to display the collected data to a user, the collected data including real-time bioprocess monitoring data, the controller to adjust a setting of the first bioprocess instrument based on the monitoring data, the monitoring data used to maintain controlled environmental conditions within a vessel of the instrument.
C12M 1/36 - Apparatus for enzymology or microbiology including condition or time responsive control, e.g. automatically controlled fermentors
G16B 40/00 - ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
This invention relates to the storage on a solid matrix of genetic material, in particular DNA that has been purified prior to the application to the solid matrix. More specifically, the invention relates to a solid matrix for the storage of purified DNA, which matrix has been treated with a solution comprising plant polysaccharide inulin. One advantage of the invention is that an increased amount of DNA can be stored in the solid matrix of the present invention.”
A sterile foam breaking system, (14, 42, 52) includes a foam collector (20) having an opening (26), configured to be disposed in a source (12) which generates foam. The sterile foam breaking system (14, 42, 52) further includes a non-coated type suction unit (23) coupled to the foam collector (20). The non-contact type suction unit (23) is configured to transfer the foam via the opening (26) of the foam collector (20) and break a portion of the foam to generate a first quantity of liquid droplets. The sterile foam breaking system (14, 42, 52) additionally includes a foam breaking unit (28, 44, 54) coupled to the non-contact type suction unit (23). The foam breaking unit (28, 44, 54) is configured to receive remaining portion of the foam and the first quantity of liquid droplets and break the remaining portion of the foam to generate a second quantity of liquid droplets.
An apparatus for draining a bioreactor vessel includes a tubular body portion having an interior passageway, and at least one aperture in the tubular body portion providing for fluid communication with the interior passageway, the tubular body portion being configured for positioning at a bottom of a vessel, and a suction tube having a first end configured for fluid coupling with the tubular body portion, and a second end configured for fluid coupling with a port in a sidewall of the vessel.
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.
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.
A component management apparatus for a bioprocessing system includes a frame having a plurality of segments, including at least a first segment and a second segment pivotably connected to the first segment such that at least the second segment is movable between a closed position and an open position, and at least one mounting bracket connected to the frame for connection of a bioprocess component.
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 manipulatable 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. A transfer mechanism for moving and weighing the fluid processing reservoir is disclosed also.
An impeller, for example, a Rushton impeller for a bioreactor system is disclosed. The impeller includes a hub, optionaly including a slot, a plurality of blades, and one or more turbulators. The plurality of blades is disposed along a circumferential direction of the hub and spaced apart from each other. Each of the plurality of blades is coupled to at least a portion of a circumference and/or a top surface of the hub. Each blade of the plurality of blades includes a pressure face and a suction face. The one or more turbulators is disposed on at least a portion of the suction face, the pressure face, or both, of a blade of the plurality of blades.
C12M 1/06 - Apparatus for enzymology or microbiology with gas introduction means with agitator, e.g. impeller
B01F 27/1111 - Centrifugal stirrers, i.e. stirrers with radial outlets; Stirrers of the turbine type, e.g. with means to guide the flow with a flat disc or with a disc-like element equipped with blades, e.g. Rushton turbine
B01F 27/1125 - Stirrers characterised by the configuration of the stirrers with arms, paddles, vanes or blades with vanes or blades extending parallel or oblique to the stirrer axis
B01F 35/513 - Flexible receptacles, e.g. bags supported by rigid containers
B01F 27/053 - Stirrers characterised by their elements, materials or mechanical properties characterised by their materials
B01F 33/453 - Magnetic mixers; Mixers with magnetically driven stirrers using supported or suspended stirring elements
B01F 23/233 - Mixing gases with liquids by introducing gases into liquid media, e.g. for producing aerated liquids using driven stirrers with completely immersed stirring elements
B01F 27/191 - Stirrers with two or more mixing elements mounted in sequence on the same axis with similar elements
B01F 35/92 - Heating or cooling systems for heating the outside of the receptacle, e.g. heated jackets or burners
B01F 101/44 - Mixing of ingredients for microbiology, enzymology, in vitro culture or genetic manipulation
The bioprocessing perfusion system (10) includes a bioreactor (12) and a feed flow path (14). A first tangential flow filter (16) is coupled to the bioreactor (12) via the feed flow path (14) and a second tangential flow filter (18) is coupled to the bioreactor (12) via the feed flow path (14). The first tangential flow filter (16) is a microfiltration-type filter and the second tangential flow filter (18) is an ultrafiltration-type filter. The first tangential flow filter (16) and the second tangential flow filter (18) are further coupled to a receiving unit (58) via the permeate flow path (60). The first tangential flow filter (16) and the second tangential flow filter (18) are further coupled to the bioreactor (12) via the retentate flow path (46). A control unit (82) is communicatively coupled to the first feed control device (42), the second feed control device (44), the feed drive unit (40), the first permeate control device (64), the second permeate control device (66), the first retentate control device (48), and the second retentate control device (50).
A bioprocessing system (100, 200) including a storage unit (102, 202) for storing a feed fluid (103, 203), a filter (106, 206) coupled to the storage unit (102, 202) via a feed path (104, 204), and a feed pump (114, 212) coupled to the feed path (104, 204). The bioprocessing system (100, 200) further includes a collection unit (102, 216) coupled to the filter (106, 206) via a downstream path (118, 218) and a turbidity sensor (134, 224) coupled to the downstream path (118, 218). Furthermore, the bioprocessing system (100, 200) includes a processing unit (136, 226) configured to receive an output from the turbidity sensor (134, 224) and determine a concentration of a product in a filtration fluid (121, 222) based on the output. The processing unit (136, 226) is further configured to monitor an operating condition of the filter (106, 206) on-line based on concentration of the product.
The invention relates to the field of microcarrier perfusion culture of adherent cells. Specifically, the present invention relates to a high-density microcarrier retention device for perfusion culture of adherent cells, a microcarrier perfusion culture system for adherent cells containing the device, and methods of use thereof. The retention device of the present invention includes a sedimentation chamber, a pipeline connected to a bioreactor, a microcarrier retention filter membrane, a liquid backflushing device, an air backflushing device, a peristaltic pump and a pipeline connected to a receiver. The device has high efficiency in promoting the separation of microcarriers from cell culture medium and is helpful for perfusion culture of adherent cells and microcarriers. The retention device makes the culture volume in the bioreactor more flexible, can perform perfusion culture of 20%-100% of the maximum culture volume of the bioreactor, and the retention device can be linearly amplified according to the amplification of the bioreactor volume.
Disclosed herein is provided a virus purification and formulation process for purifying a flavivirus represented by one of a Yellow Fever Virus, Japanese Encephalitis virus, Dengue virus, and West Nile virus. The highly purified flavivirus virus product is characterized as having a low level of sucrose without significant virus loss such as that which is typically encountered by prior art virus purification processes. The disclosed process captures and purifies the virus, separating it from the host cell proteins and DNA, and leaving the host cell proteins and DNA behind. The process also can be used to inactivate and/or concentrate the virus sufficiently for use in formulations.
A mixing system (10) including a base module (12), a mixing unit (26), and an enclosure (14). The base module (12) includes a base support (16), a drive unit (18) disposed within the base support (16), a drive shaft (22) coupled to the drive unit (18), and a drive head (24) coupled to the drive unit (18) via the drive shaft (22) and disposed within the base support (16). The drive head (24) includes a first magnet (25). The mixing unit (26) includes a guide element (28) and an agitator (30) slidably coupled to the guide element (28). The agitator (30) includes a second magnet (32) and at least one vane (34). The enclosure (14) is coupled to the base support (16) encloses the guide element (28) and the agitator (30). The drive unit (18) and the drive head (24) are configured to generate a linear pulsating movement of the agitator (30) along the guide element (28) for mixing a fluid medium (47) within the enclosure (14).
B01F 33/453 - Magnetic mixers; Mixers with magnetically driven stirrers using supported or suspended stirring elements
B01F 31/44 - Mixers with shaking, oscillating, or vibrating mechanisms with stirrers performing an oscillatory, vibratory or shaking movement
B01F 31/441 - Mixers with shaking, oscillating, or vibrating mechanisms with stirrers performing an oscillatory, vibratory or shaking movement performing a rectilinear reciprocating movement
B01F 35/513 - Flexible receptacles, e.g. bags supported by rigid containers
42.
System and method for packaging a bioprocessing bag and associated components, and packaging for a bioprocessing bag
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.
B65B 61/14 - Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for incorporating, or forming and incorporating, handles or suspension means in packages
Filter holders and membranes are provided that can be included within a bioreactor bag system. The filter holders and membranes include features that allow incorporation of advanced membrane materials having differing material characteristics than traditional membranes that more closely matched the characteristics of the filter holder.
C12M 1/00 - Apparatus for enzymology or microbiology
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
Disclosed herein is an instrument suitable for processing cells for example culturing, concentrating or washing said cells, the instrument comprising: a housing for accommodating mechanical elements including at least one fluid pump; and a disposable processing kit complementary to the mechanical elements within the housing and comprising a fluid circuit including a fluid reservoir and plural fluid paths capable of carrying fluid flow caused by said pump(s), the instrument further including a mechanism for determining the quantity, or change in quantity of the fluid in the reservoir resulting from said fluid flow, the instrument yet further comprising a controller operable to control at least the pump and operable to perform a fault determination process, which includes the steps of determining the expected flow rate of said pump(s) calculated from the speed of the pump(s) and comparing that expected flow with the change in quantity of the fluid in the reservoir as determined by said mechanism.
Filter holders and membranes are provided that can be included within a bioreactor bag system. The filter holders and membranes include features that allow incorporation of advanced membrane materials having differing material characteristics than traditional membranes that more closely matched the characteristics of the filter holder.
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
46.
PERFUSION FILTER ASSEMBLY FOR INCREASED CROSS FLOW
Filter holders and membranes are provided that can be included within a bioreactor bag system. The filter holders and membranes include features that abut the bottom of the filter membrane and prevent or reduce sagging of the porous filter region during use.
A device (30) includes a base connector (32) having an opening (33) and an impeller connector (64) coupled to the base connector (32). The impeller connector (64) has a through-passage (66) aligned with the opening (33) of the base connector (32). Further, the device (30) includes a flexible tube (34) having a first end (36) and a second end (40), where the first end (36) of the flexible tube (34) is coupled to the impeller connector (64). Furthermore, the device (30) includes a seal component (38) and an impeller (42) coupled to the second end (40) of the flexible tube (34). Additionally, the device (34) includes an enclosure (46) disposed enclosing the impeller (42), the flexible tube (34), the impeller connector (64), and the base connector (32).
B01F 27/093 - Stirrers characterised by the mounting of the stirrers with respect to the receptacle eccentrically arranged
B01F 27/113 - Propeller-shaped stirrers for producing an axial flow, e.g. shaped like a ship or aircraft propeller
B01F 27/808 - Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with stirrers driven from the bottom of the receptacle
B01F 27/88 - Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with a separate receptacle-stirrer unit that is adapted to be coupled to a drive mechanism
B01F 27/91 - Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with propellers
B01F 35/513 - Flexible receptacles, e.g. bags supported by rigid containers
C12M 1/00 - Apparatus for enzymology or microbiology
C12M 1/06 - Apparatus for enzymology or microbiology with gas introduction means with agitator, e.g. impeller
C12M 1/12 - Apparatus for enzymology or microbiology with sterilisation, filtration, or dialysis means
48.
Method of forming a collapsible bag using a mold and mandrel
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.
2. These porous membranes may be made according to an exemplary process employing lithographic patterning of a photoresist followed by development of the photoresist and etching. In one aspect, the etch barrier layer is chosen from a material that does not react with or incorporate metal or other contaminants into the membrane layer.
G03F 7/00 - Photomechanical, e.g. photolithographic, production of textured or patterned surfaces, e.g. printed surfaces; Materials therefor, e.g. comprising photoresists; Apparatus specially adapted therefor
Apparatus, systems, and methods for tracking and management of bioprocess and/or other sterile product inventory are disclosed. An example apparatus includes: a communication interface to receive a message from a radiofrequency identification circuit associated with a product via an antenna at a location; a keycode verifier to verify a keycode from the message as authentic and associated with the product; a certificate generator to provide, when the keycode is verified, a certificate for the product, the certificate to be sent from a cloud-based server to a local computing device at the location to enable use of the product; an inventory predictor to predict, based on an identification of the product and usage information for the product and/or the location, an exhaustion of the product at the location; an output generator to trigger an order of the product when the exhaustion of the product at the location is predicted.
G06K 19/07 - Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards with integrated circuit chips
G06Q 10/06 - Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
H04L 67/1097 - Protocols in which an application is distributed across nodes in the network for distributed storage of data in networks, e.g. transport arrangements for network file system [NFS], storage area networks [SAN] or network attached storage [NAS]
51.
MULTIFUNCTIONAL BEADS AND METHODS OF USE FOR CAPTURING CELLS
Described are multi-functional beads and methods to capture rare cells directly from low-volume biological samples and perform both functional and genomic assays from those cells. This is accomplished using a multifunctional capture bead that allows co-localization of both the single cell capture element and the molecular assay components. When combined with a digital microfluidic platform this enables encoding and/or barcoding of specific single cells.
Porous liquid-filtering membranes having a repeatable distribution of pores of a small dimension are provided, as well as pillar templates that are used to produce such liquid filtering membranes. Also disclosed are methods of making and using the pillar templates to make porous liquid filtering membranes.
B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
G03F 7/00 - Photomechanical, e.g. photolithographic, production of textured or patterned surfaces, e.g. printed surfaces; Materials therefor, e.g. comprising photoresists; Apparatus specially adapted therefor
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
53.
Pillar template for making micropore membranes and methods of fabrication thereof
Porous liquid-filtering membranes having a repeatable distribution of pores of a small dimension are provided, as well as pillar templates that are used to produce such liquid filtering membranes. Also disclosed are methods of making and using the pillar templates to make porous liquid filtering membranes.
G03F 7/00 - Photomechanical, e.g. photolithographic, production of textured or patterned surfaces, e.g. printed surfaces; Materials therefor, e.g. comprising photoresists; Apparatus specially adapted therefor
G03F 7/11 - Photosensitive materials - characterised by structural details, e.g. supports, auxiliary layers having cover layers or intermediate layers, e.g. subbing layers
54.
REINFORCED COMPONENT FOR CELL CULTIVATION BIOREACTOR
The present invention relates to a bioprocess bag 118 comprising a bag wall defining an enclosed volume for holding biomaterials. The bag wall comprises at least one inlet port 142 and at least one outlet port 146. The bioprocess bag 118 also comprises a tube structure 400 comprising a first opened-end proximate the bag wall and a second distal end, the tube extending into the enclosed volume, and the tube structure 400 comprising a reinforced portion 402 proximate the first opened-end.
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.
A bioreactor support system configured to hold a bioreactor bag, said bioreactor support system (1) comprising: —a base module (3) comprising an impeller drive unit (5); and —at least two vessel units (11a, 11b, 11c) of different sizes, which are configured to support and substantially enclose a side wall of a bioreactor bag (111a, 111b, 111c) when a bioreactor bag is provided in the bioreactor support system (1), wherein said base module (3) and said at least two vessel units (11a, 11b, 11c) comprise mating connection devices (13a, 13b, 13c, 15a, 15b, 15c) such that the at least two vessel units (11a, 11b, 11c) can be connected to one and the same base module (3) and such that the impeller drive unit (5) of the base module (3) can be used to drive an impeller (113a, 113b, 113c) in a bioreactor bag (111a, 111b, 111c) when a bioreactor bag is provided in the bioreactor support system (1).
Provided are techniques for generating expression products using one or more nucleic acid concatemers that include tandem repeats of a nucleic acid sequence encoding the expression product or products. In one embodiment, different expression products may be co-expressed using a concatemer mixture of a first nucleic acid concatemer and a second nucleic acid concatemer having a predefined ratio to one another.
A sparger assembly for a bioprocessing system includes a first layer having a plurality of pores of a first size, and a second layer disposed above the first layer and having a plurality of holes of a second size, the second size being greater than the first size. The pores of the first layer and the holes of the second layer allow for the passage of a sparge gas through the first layer and the second layer.
B01F 23/231 - Mixing gases with liquids by introducing gases into liquid media, e.g. for producing aerated liquids by bubbling
C12M 1/00 - Apparatus for enzymology or microbiology
C12M 1/04 - Apparatus for enzymology or microbiology with gas introduction means
C12M 1/12 - Apparatus for enzymology or microbiology with sterilisation, filtration, or dialysis means
B01F 23/23 - Mixing gases with liquids by introducing gases into liquid media, e.g. for producing aerated liquids
B01F 23/233 - Mixing gases with liquids by introducing gases into liquid media, e.g. for producing aerated liquids using driven stirrers with completely immersed stirring elements
B01F 27/113 - Propeller-shaped stirrers for producing an axial flow, e.g. shaped like a ship or aircraft propeller
B01F 35/513 - Flexible receptacles, e.g. bags supported by rigid containers
59.
BIOPROCESSING SYSTEM AND TUBING AND COMPONENT MANAGEMENT APPARATUS FOR A BIOPROCESSING SYSTEM
A bioreactor vessel includes a bottom, a peripheral sidewall, the bottom and the peripheral sidewall defining an interior space for receiving a flexible bioprocessing bag, a recess in the bottom for receiving a base plate of the flexible bioprocessing bag, and a locking mechanism configured to retain the base plate in the recess.
A bioprocessing bag includes a plurality of panels joined to one another about respective edges of the plurality of sheets, by side welds, and a top panel joined to upper edges of the plurality of panels by a flat/convergence weld.
A bioreactor system, includes a base platform, a lid received atop the base platform and defining an interior space for receiving a bioprocessing bag, and a tubing management system supporting a tubing array a distance above the base platform and providing a means for quickly connecting and/or disconnecting a fluid supply line.
A method for clarifying a bioprocess fluid comprising particles suspending in a cell culture fluid is provided. The method includes providing a cell culture suspended in an unclarified bioprocess fluid in a bioreactor. A chromatography affinity resin is added directly to the unclarified bioprocess fluid. The chromatography affinity resin binds a biological target. The unclarified bioprocess fluid with the bound biological target is passed into an assisted gravity settler.
A sampling system includes a graduated sampling chamber configured for fluid connection to a sample source, a pump device configured for fluid connection with the sampling chamber, and a sterile air filter intermediate the pump device and the sampling chamber, wherein the pump device is selectively actuatable to draw a volume of fluid from the sample source into the sampling chamber.
An impeller assembly for a bioprocessing system includes a hub and at least one blade pivotally to the hub, the at least one blade including a first leg portion and a second leg portion extending at an angle from the first leg portion. The at least one blade is rotatable between a first position where the first leg portion extends generally outwardly from the hub and a second position where the second leg portion extends generally outwardly from the hub.
C12M 1/06 - Apparatus for enzymology or microbiology with gas introduction means with agitator, e.g. impeller
C12M 1/00 - Apparatus for enzymology or microbiology
B01F 27/054 - Deformable stirrers, e.g. deformed by a centrifugal force applied during operation
B01F 27/808 - Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with stirrers driven from the bottom of the receptacle
B01F 33/453 - Magnetic mixers; Mixers with magnetically driven stirrers using supported or suspended stirring elements
A biocompatible polymeric membrane includes pores defined between two material layers, where the first membrane material layer includes strips, and the second membrane material binds to each of the plurality of first membrane material layer strips includes a plurality of windows exposing each of the first membrane material strips. The biocompatible polymeric filtration membrane comprises pores defined by uniform passages defined by the first membrane material layer strips and the second membrane material layer within each window.
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
A flexible bag (1; 101; 201) comprising a component (3; 103; 203) inside the bag, wherein said flexible bag comprises a receiving device (5; 105; 205) provided in a wall (7; 107; 207) of the flexible bag, wherein said component (3; 103; 203) and said receiving device (5; 105; 205) are configured for being connectable to each other for keeping the component substantially stationary within the flexible bag when so connected.
Disclosed is an in-process cell monitoring device comprising: a flow channel having at least one inlet and at least one outlet exposeable to a cell culture; a microscope positionable to view the contents of a region of the channel; and a computer operable at least to count any cells in the region, providing a closed fluid circuit for cell monitoring. Disclosed also is a bioreactor including a cell culture volume, and an in-process cell monitoring device, said device comprising: a flow channel having at least one inlet and at least one outlet each in fluid communication with the volume, of sufficient cross-sectional area to allow fluids to drain from the inlet to the outlet; and a microscope positionable to view the contents of a region of the channel, and also A method for monitoring a cell culture including determining cell density.
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.
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.
B01F 27/2124 - Shafts with adjustable length, e.g. telescopic shafts
B01F 27/054 - Deformable stirrers, e.g. deformed by a centrifugal force applied during operation
B01F 27/192 - Stirrers with two or more mixing elements mounted in sequence on the same axis with dissimilar elements
B01F 27/88 - Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with a separate receptacle-stirrer unit that is adapted to be coupled to a drive mechanism
B01F 35/513 - Flexible receptacles, e.g. bags supported by rigid containers
C12M 1/06 - Apparatus for enzymology or microbiology with gas introduction means with agitator, e.g. impeller
B01F 101/44 - Mixing of ingredients for microbiology, enzymology, in vitro culture or genetic manipulation
70.
SEPARATION DEVICES, ASSOCIATED METHODS, AND SYSTEMS
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.
B01D 21/24 - Feed or discharge mechanisms for settling tanks
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
C12M 1/32 - Inoculator or sampler multiple field or continuous type
G01N 30/00 - Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography
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.
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.
A sparger assembly (700) for a bioprocessing system includes a base plate (710) and at least one aeration manifold (712, 714) removably connected to tire base plate. Each aeration manifold includes at least one inlet for receiving a gas and a plurality of gas outlet openings for delivering tire gas to a fluid within the bioprocessing system. An impeller assembly (740) fora bioprocessing system includes a hub and at least one blade (742) operatively connected to the hub. The at least one blade includes a first portion connected to the hub and extending generally vertically, and a second portion extending at an upward angle from tire first portion.
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.
F16K 3/26 - Gate valves or sliding valves, i.e. cut-off apparatus with closing members having a sliding movement along the seat for opening and closing with sealing faces shaped as surfaces of solids of revolution with cylindrical valve members with fluid passages in the valve member
B67D 7/02 - Apparatus or devices for transferring liquids from bulk storage containers or reservoirs into vehicles or into portable containers, e.g. for retail sale purposes for transferring liquids other than fuel or lubricants
B67D 7/36 - Arrangements of flow- or pressure-control valves
C12M 1/00 - Apparatus for enzymology or microbiology
C12M 3/06 - Tissue, human, animal or plant cell, or virus culture apparatus with filtration, ultrafiltration, inverse osmosis or dialysis means
A method for removing exhaust gas from a bioreactor (3) and a bioreactor system. The method comprises the steps of: —providing at least one exhaust filter (15; 115a, 115b) connected to an outlet (7) of the bioreactor (3) for transferring exhaust gas out from the bioreactor; —increasing a pressure at an inlet side (25) of the at least one exhaust filter (15; 115a, 115b) in a connection (16) between the bioreactor (3) and the at least one exhaust filter (15; 115a, 115b) or decreasing a pressure at an outlet side (23) of the at least one exhaust filter (15; 115a, 115b).
A cellbag bioreactor includes a stacked filter providing multiple porous membranes to define a filter cavity. Additionally, a filter within the cellbag bioreactor may be tethered so as to help maintain each membrane of a filter wetted during bioreactor operations.
The present disclosure relates to a system and method (10) for monitoring a set-up for manufacture and/or setting up for manufacture and/or tearing down after manufacture of a biopharmaceutical product. The method comprises: processing (S2, S3, S4) at least one image of a scene comprising the set-up for manufacture of the biopharmaceutical product. The processing of the at least one image comprises performing (S2) a first process on the at least one image for classifying first objects in the image, said first objects being devices such as clamps, pumps, valves and/or sensors and/or any other bio processing equipment. The first process comprising identifying, localizing and classifying the first objects in the image. A second process is performed (S3) on the at least one image for identifying and localizing connections in the images. The second process comprises classifying each pixel with an associated second object classifier, said second object classifier classifying a second object selected from a group comprising the first objects and connections, segmenting out pixels associated with a connection and identifying connection mappings with the first objects. The method further comprises forming (S4) compiled information comprising information relating to the identified connection mappings obtained from the second process and the first objects as identified by the first process.
G06T 3/4053 - based on super-resolution, i.e. the output image resolution being higher than the sensor resolution
G06V 10/764 - Arrangements for image or video recognition or understanding using pattern recognition or machine learning using classification, e.g. of video objects
G06V 10/82 - Arrangements for image or video recognition or understanding using pattern recognition or machine learning using neural networks
G06V 20/52 - Surveillance or monitoring of activities, e.g. for recognising suspicious objects
2. These porous membranes may be made according to an exemplary process employing lithographic patterning of a photoresist followed by development of the photoresist and etching. In one aspect, the etch barrier layer is chosen from a material that does not react with or incorporate metal or other contaminants into the membrane layer.
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
G03F 7/00 - Photomechanical, e.g. photolithographic, production of textured or patterned surfaces, e.g. printed surfaces; Materials therefor, e.g. comprising photoresists; Apparatus specially adapted therefor
2. These porous membranes may be made according to an exemplary process employing lithographic patterning of a photoresist followed by development of the photoresist and etching. In one aspect, the etch barrier layer is chosen from a material that does not react with or incorporate metal or other contaminants into the membrane layer.
B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
B01D 69/02 - Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
B01D 71/64 - Polyimides; Polyamide-imides; Polyester-imides; Polyamide acids or similar polyimide precursors
A storage vial (100, 200) may include a vial body (110, 210) having a first end (111, 211) and a second end (112, 212) and defining an internal volume (113, 213) configured to contain a biological material (B) therein, a first valve (120, 220) positioned at the first end of the vial body, a second valve (130, 230) positioned at the second end of the vial body, a first conduit connector (160, 260) positioned at the first end of the vial body, and a second conduit connector (170, 270) positioned at the second end of the vial body. The resulting construction may allow for closed system direct transfer of biological material from the storage vial to another vessel using aseptic techniques.
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 manipulatable 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. A transfer mechanism for moving and weighing the fluid processing reservoir is disclosed also.
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.
B65B 61/14 - Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for incorporating, or forming and incorporating, handles or suspension means in packages
Disclosed are bioreactor flasks (10) including a volume extending between a first volume end and a second volume end for the cultivation of cells or other microorganisms, said volume having a horizontal cross section area (CSA) which increases in a direction from the first volume end to the second volume end. The flask optionally includes a housing including a cylindrical lower portion (14) and an inverted truncated conical upper portion (16) which provides said increasing CSA. Disclosed also are arrays of flasks (10), supported in a tray for collective agitation.
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.
A connector for flexible tubing comprises a first hollow insert for allowing fluid flow, having a proximal end configured to fit inside the tubing, a first outer part, a joining member rigidly connecting the first insert to the outer part at a region spaced from the proximal end of the first insert and a generally annular gap between the first insert and the first outer part, which forms a tubing accepting opening at or adjacent the proximal end of the insert, the first outer part further comprising plural resilient protrusions extending into the gap, allowing the tubing to be inserted, but resisting removal of the tubing once inserted and wherein at least the insert, the joining member and the outer part are formed as a single integral molding.
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.
C12N 1/00 - Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
A61K 35/12 - Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
87.
Method of forming a collapsible bag using a mold and mandrel
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.
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.
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.
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.
This invention relates to the storage on a solid matrix of genetic material, in particular DNA that has been purified prior to the application to the solid matrix. More specifically, the invention relates to a solid matrix for the storage of purified DNA, which matrix has been treated with a solution comprising plant polysaccharide inulin. One advantage of the invention is that an increased amount of DNA can be stored in the solid matrix of the present invention.”
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.
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.
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.
H02K 5/128 - Casings or enclosures characterised by the shape, form or construction thereof specially adapted for operating in liquid or gas using air-gap sleeves or air-gap discs
H02K 21/24 - Synchronous motors having permanent magnets; Synchronous generators having permanent magnets with stationary armatures and rotating magnets with magnets axially facing the armatures, e.g. hub-type cycle dynamos
H02K 49/10 - Dynamo-electric clutches; Dynamo-electric brakes of the permanent-magnet type
95.
Method, apparatus, system and computer program product for selecting a filter for a filtration process
Methods for selecting a filter for a filtration process are described. Input data is received, and based on the input data, one or more filter characteristics for each of a plurality of filter candidates for a filtration process are identified. Process parameters of the filtration process are identified. A computer-implemented simulation process of the filtration process for each of the plurality of filter candidates is performed, based on the identified process parameters and identified filter characteristics. One or more output characteristics of the filtration process are determined based on the simulation. A filter candidate of the plurality of filter candidates is selected based on the one or more output characteristics.
An inflatable bioreactor (110, 210) may include one or more sheets joined to form a bag (111, 211) including a top sheet (118, 218) and a bottom sheet (119, 219) formed from the one or more sheets and being inflatable to provide an internal volume (117, 217) suitable for retaining a volume of culture liquid (10) during flow of the culture liquid resulting from a rocking motion (R) of the bag, and one or more perturbing protrusions (116, 116′, 116″, 216) extending upwardly from the bottom sheet toward, but not as far as, the top sheet and extending transversely to, or obliquely to, a direction of wave motion (W) of the culture liquid. The resulting construction may provide improved flow for low initial volumes of the culture liquid in the bag.
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 removing and introducing are performed subsequent to allowing the cells to settle on the gas permeable, liquid impermeable membrane, resuspending the cells in the cell culture medium in the cell culture vessel, wherein the resuspending is performed after the desired cell density is attained, and removing the resuspended cells and the cell culture medium through the drain port.
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.
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.
G05B 19/418 - Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control (DNC), flexible manufacturing systems (FMS), integrated manufacturing systems (IMS), computer integrated manufacturing (CIM)
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.
patents
