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.
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.
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.
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.
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.
GLOBAL LIFE SCIENCES SOLUTIONS OPERATIONS UK LIMITED (United Kingdom)
Inventor
Parvizi, Mojtaba
Mizzoni, Craig
Ryan, Mackenzie
Abstract
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.
An apparatus for bioprocessing includes a vessel having a flexible exterior surface defining an interior cavity configured to receive fluid for bioprocessing, the vessel configured for selective attachment to a bioreactor. The vessel includes at least one filter within the interior cavity for retaining cells in the vessel while waste is extracted from the interior cavity and a plurality of waste ports formed on the flexible exterior surface, each of the plurality of waste ports being fluidly connected to the at least one filters to allow waste to be extracted from vessel. The vessel is configured to reduce the likelihood of filter clogging at high cell densities during a bioprocessing procedure in the vessel.
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
GLOBAL LIFE SCIENCES SOLUTIONS OPERATIONS UK LIMITED (United Kingdom)
Inventor
Diana, Rafael
Abstract
A sparger assembly (100) for a bioprocessing system (10) includes a base (126) and a plurality of spargers (130) 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.
B01F 23/231 - Mixing gases with liquids by introducing gases into liquid media, e.g. for producing aerated liquids by bubbling
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 33/453 - Magnetic mixers; Mixers with magnetically driven stirrers using supported or suspended stirring elements
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
C12M 1/00 - Apparatus for enzymology or microbiology
B01F 101/44 - Mixing of ingredients for microbiology, enzymology, in vitro culture or genetic manipulation
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 flexible baffle (200) and methods of installation thereof into a bioreactor or mixer vessel are provided. The flexible baffle (200) includes a plurality of segments (210) connected to one another via hinges (220). Each segment includes at least one alignment element (230) that aids in aligning the segments as the baffle is placed within the bioreactor or mixer vessel, such that the baffle can change from a non-linear shape (e.g., curved) during installation to a linear shape upon completion of installation into the bioreactor or mixer vessel.
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
13.
APPARATUS, SYSTEM, AND METHOD FOR REDUCING A MINIMUM WORKING VOLUME OF A BIOREACTOR
GLOBAL LIFE SCIENCES SOLUTIONS OPERATIONS UK LIMITED (United Kingdom)
Inventor
Rao, Nagaraj
Smeltzer, Thomas
Mathapati, Milind
Tracy Beem, Heather
Murugesan, Kandakumar
Balakrishnan, Saravanan
Chattopadhyay, Subhanjan
Abstract
An apparatus (30) for reducing a minimum working volume of a stirred tank (12) includes a body (32) having upper (46) and lower (48) surfaces, and an exterior profile shaped to closely fit within an interior of the stirred tank. The body including an interior portion (34) extending through the body (32) from the upper surface to the lower surface, the interior portion configured to receive and partially surround an impeller (200) within the stirred tank, while allowing rotation of the impeller to agitate a fluid in the vessel when in use. The body further including an opening in a side surface of the body, the opening extending into the interior portion and configured to facilitate removal of fluid (60) from the vessel when the stirred tank is in use, and to be removed from the stirred tank via a drain.
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.
GLOBAL LIFE SCIENCES SOLUTIONS OPERATIONS UK LIMITED (United Kingdom)
Inventor
Murugesan, Kandakumar
Kandoth, Bineesh
Rao, Nagaraj
Abstract
A vessel (24) includes an interior volume (25) containing a liquid, a spiral shaft (28) located within the interior volume, and a rotatable impeller (30). The impeller has an aperture (38) that receives the spiral shaft and allows the impeller to travel bidirectionally along the spiral shaft. When the impeller travels along the spiral shaft, the impeller rotates axially about the spiral shaft to agitate a liquid in the interior volume.
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 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 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 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.
A closure 1; 1' for a bioreactor 200; 200'; 200", said closure being configured for being connectable to a container 100; 100'; 100" such that the closure 1; 1' and the container 100; 100'; 100" together constitutes the bioreactor 200; 200'; 200", wherein the closure 1; 1' comprises an impeller device 11 comprising an impeller shaft 13 and impeller blades 15 mounted to the impeller shaft 13, wherein said impeller device 11 is mounted to the closure 1; 1' such that the impeller shaft 13 and the impeller blades 15 protrude into the container 100; 100'; 100" when the closure 1; 1' is connected to the container 100; 100'; 100" and a gas delivery device 21 which is arranged in the closure 1; 1' such that it passes from a gas inlet 23 at an outside surface 3b of the closure 1; 1' to an inside surface 3a of the closure 1; 1' and protrudes from the inside surface 3a such that a gas outlet 25 of the gas delivery device is provided inside the container 100; 100'; 100" when the closure 1; 1' is connected to the container 100; 100'; 100".
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.
The present invention involves a sterilizable vacuum chamber (10) that provides for sealing a pharmaceutical fluid into a plurality of containers (60), the chamber comprising a vertically movable container nest holder (70) for holding a container nest (62) bearing a plurality of pharmaceutical containers filled with a pharmaceutical fluid, a container closure nest holder for holding a closure nest (82) bearing a plurality of corresponding container closures (80) and for locating a closure vertically above each corresponding container, a ram (25) for vertically moving the container nests to engage the containers with corresponding closures, and an elastically deformable closure nest restraining element (28, 28') disposed on an opposing side of the closure nest from the container nest. A method is provided for sealing the pharmaceutical fluid into the containers. The method comprises the closure nest restraining element acting on the closure nest to oppose any vertical upward motion of any of the plurality of containers after the engaging of the containers with the closures.
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65B 7/16 - Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
B65B 7/28 - Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
B65B 31/02 - Filling, closing, or filling and closing, containers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
Provided is a lipid formulation capable of forming a lipid-based nanoparticle comprising an ionizable lipid to phospholipid molar ratio of 0.1 – 1.30 of in association with a nucleic acid payload, and in some embodiments, a stabilizing agent. In embodiments, the nucleic acid payload is a vaccine genetic element.
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
28.
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.
A vessel including an interior volume configured to contain a liquid and a magnetically driven impeller (20) located within the interior volume. The impeller including a rotatable base portion (22) with a blade (28), a rotatable shaft (26), and a ferrous connector (24). The impeller may be coupled to an external motor and rotated to agitate liquid in the interior volume, via a magnetic bond between the ferrous connector and a selectively magnetizable drive head connector of the external motor. The ferrous connector is not a permanent magnet.
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
32.
DISPOSABLE KIT AND CULTURE VESSEL FOR A BIOPROCESSING SYSTEM
A disposable kit for a bioprocessing system includes a tray having a spine having a first window and a second window, at least one bioprocessing vessel received within the tray, a pinch valve manifold removably received by the spine within the first window, a first tubing segment removably received by the spine within the second window, and a second tubing segment removably received by the spine within the second window.
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 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
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
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.
Packaging for a bioprocessing bag includes a clam shell structure to receive a portion of the bag in a folded state, the bag having an impeller. The clam shell structure has a bottom shell and a top shell that mates with the bottom shell to define an interior portion with an opening extending therethrough to receive at least a portion of the folded bioprocessing bag and the impeller. The impeller, when placed in the packaging, is centrally disposed in the interior portion and a portion of the bioprocessing bag extends out from the opening of the clam shell structure. The bottom shell and the top shell each has a plurality of supporting features to secure and protect the bioprocessing bag and the impeller received in the clam shell structure from impact forces applied to the structure.
A sterile vent filter includes a filter housing containing a filter membrane and a female bonding port connected to the filter housing. The female bonding port (14) has a tapered passageway configured to receive a distal end of a length of tubing (20).
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
A61M 39/12 - Tube connectors or tube couplings for joining a flexible tube to a rigid attachment
49.
APPARATUS AND METHOD FOR FORMING A BIOPROCESSING BAG
A bioprocessing bag formed from a single sheet of flexible material including connected panels and a method of making is disclosed. In one embodiment, a bioprocessing bag is disclosed. The bioprocessing bag includes a single sheet of flexible material including a plurality of connected panels, wherein each of the panels are folded and sealed to form a sealed bioprocessing bag. In another embodiment, a method of assembling a bioprocessing bag is disclosed. The method includes obtaining a single sheet of flexible material including a plurality of connected panels, folding the panels, and sealing the folded panels to form a sealed bioprocessing bag.
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
52.
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 (401) and membranes (407) are provided that can be included within a bioreactor bag system (403). The filter holders (401) and membranes (407) include features (430) that abut the bottom of the filter membrane (407) and prevent or reduce sagging of the porous filter region during use.
Filter holders (301, 401) and membranes (307, 407, 720) are provided that can be included within a bioreactor bag system (303, 305, 403, 405). The filter holders and membranes (307, 407, 720) include features (332, 432) that allow incorporation of advanced membrane materials having differing material characteristics than traditional membranes that more closely matched the characteristics of the filter holder (301, 401).
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.
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
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
58.
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
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
17 - Rubber and plastic; packing and insulating materials
Goods & Services
Plastic bags and films used for cultivating micro-organisms,
cells or other biological and pharmaceutical material,
mixing and production of process fluids, and storage of
items such as process intermediates, including buffer
solutions and powders, both in frozen and liquid form, for
scientific and laboratory use. Flexible plastic bags for biological, medical and
pharmaceutical fluids. Plastic film, other than for wrapping.
09 - Scientific and electric apparatus and instruments
11 - Environmental control apparatus
Goods & Services
Computer hardware and recorded software; downloadable
software; scientific and laboratory apparatus and
instruments, namely, equipment in the nature of a bioreactor
used to grow cell cultures and fermentations and parts and
accessories therefor; scientific and laboratory apparatus
and instruments in the nature of a mechanical mixing machine
for agitating media laboratory equipment in the nature of a
filler machine used for packaging pharmaceutical products
and parts and accessories therefor (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations); scientific and laboratory apparatus and
instruments in the nature of a separation machine used for
isolating, purifying and concentrating materials and parts
and accessories therefor; scientific and laboratory
apparatus and instruments in the nature of microbial
fermenters and parts and accessories therefor; scientific
and laboratory equipment, namely, temperature probes,
sheaths for probes, probe holders, probe leads; consumables
for laboratory use, namely, bags. Industrial apparatus and instruments, namely, equipment in
the nature of a bioreactor used to grow cell cultures and
fermentations and parts and accessories therefor (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations); industrial apparatus and
instruments in the nature of a mechanical mixing machine for
agitating media laboratory equipment in the nature of a
filler machine used for packaging pharmaceutical products
and parts and accessories therefor (term considered too
vague by the International Bureau - Rule 13 (2) (b) of the
Regulations); industrial apparatus and instruments in the
nature of a separation machine used for isolating, purifying
and concentrating materials and parts and accessories
therefor (term considered too vague by the International
Bureau - Rule 13 (2) (b) of the Regulations); industrial
apparatus and instruments in the nature of microbial
fermenters and parts and accessories therefor (term
considered too vague by the International Bureau - Rule 13
(2) (b) of the Regulations).
62.
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.
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 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
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]
65.
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
67.
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
68.
MICROPORE MEMBRANES AND METHODS OF FABRICATION THEREOF USING PILLAR TEMPLATES
Porous liquid-filtering membranes (101, 201, 401, 501, 601) having a repeatable distribution of pores (105, 205, 405, 505, 605) of a small dimension are provided, as well as pillar templates (200, 400, 500, 600) that are used to produce such liquid filtering membranes (101, 201, 401, 501, 601). Also disclosed are methods of making and using the pillar templates (200, 400, 500, 600) to make porous liquid filtering membranes (101, 201, 401, 501, 601).
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
B81C 1/00 - Manufacture or treatment of devices or systems in or on a substrate
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
69.
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
74.
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.
09 - Scientific and electric apparatus and instruments
11 - Environmental control apparatus
Goods & Services
Computer hardware and recorded software; Downloadable software; Scientific and laboratory apparatus and instruments, namely, equipment in the nature of a bioreactor used to grow cell cultures and fermentations and parts and accessories therefor; Scientific and laboratory apparatus and instruments in the nature of a mechanical mixing machine for agitating media laboratory equipment in the nature of a filler machine used for packaging pharmaceutical products and parts and accessories therefor; Scientific and laboratory apparatus and instruments in the nature of a separation machine used for isolating, purifying and concentrating materials and parts and accessories therefor; Scientific and laboratory apparatus and instruments in the nature of microbial fermenters and parts and accessories therefor; Scientific and laboratory equipment, namely, temperature probes, sheaths for probes, probe holders, probe leads; Consumables for laboratory use, namely, bags. Industrial apparatus and instruments, namely, equipment in the nature of a bioreactor used to grow cell cultures and fermentations and parts and accessories therefor; Industrial apparatus and instruments in the nature of a mechanical mixing machine for agitating media laboratory equipment in the nature of a filler machine used for packaging pharmaceutical products and parts and accessories therefor; Industrial apparatus and instruments in the nature of a separation machine used for isolating, purifying and concentrating materials and parts and accessories therefor; Industrial apparatus and instruments in the nature of microbial fermenters and parts and accessories therefor.
77.
BIOPROCESSING SYSTEM AND CONSUMABLE BAG FOR A BIOPROCESSING SYSTEM
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.
09 - Scientific and electric apparatus and instruments
11 - Environmental control apparatus
Goods & Services
Industrial apparatus and instruments in the nature of a mechanical mixing machine for agitating media industrial equipment and structural and replacement parts therefor; Industrial apparatus and instruments in the nature of a separation machine used for growing or producing isolating, purifying and concentrating materials in the nature of pharmaceutical products and structural and replacement parts therefor Computer hardware and recorded software systems for use in biomanufacturing; Scientific and laboratory apparatus and instruments, namely, equipment in the nature of a bioreactor used to grow cell cultures and fermentations and structural and replacement parts therefor; Scientific and laboratory apparatus and instruments in the nature of a mechanical mixing machine for agitating media laboratory equipment and structural and replacement parts therefor; Scientific and laboratory apparatus and instruments in the nature of a separation machine used for growing or producing isolating, purifying and concentrating materials in the nature of pharmaceutical products and structural and replacement parts therefor; Scientific and laboratory apparatus and instruments in the nature of microbial fermenters and structural and replacement parts therefor; Scientific and laboratory equipment, namely, temperature probes, sheaths for probes, probe holders, probe leads; Consumables for laboratory use, namely, sterile sampling bags; Bioreactor for cell culturing, and structural and replacement parts therefor; Industrial apparatus and instruments, namely, equipment in the nature of a bioreactor used to grow cell cultures and fermentations and structural and replacement parts therefor Industrial apparatus and instruments in the nature of microbial fermenters for pharmaceutical product manufacturing and structural and replacement parts therefor; Industrial apparatus and instruments, namely, equipment in the nature of microbial fermenters and structural and replacement parts therefor
79.
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 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 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.
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.
C12M 1/12 - Apparatus for enzymology or microbiology with sterilisation, filtration, or dialysis means
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
83.
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 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.
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 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.
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 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.
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 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 duration.
C12M 1/12 - Apparatus for enzymology or microbiology with sterilisation, filtration, or dialysis means
C12M 1/34 - Measuring or testing with condition measuring or sensing means, e.g. colony counters
G01M 3/28 - 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 valves
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.
A rocking mechanism (640) for a bioreactor vessel includes a base (870), a motor (874) mounted to the base and having an eccentric roller (876) driven by the motor, and a rocking plate (878) 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 (704).
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.
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.
GLOBAL LIFE SCIENCES SOLUTIONS OPERATIONS UK LTD (United Kingdom)
Inventor
Castan, Andreas
Ohrvik, Helena
Konduru, Nagaraju
Handa, Ashish
Boddapati, Neelima
Chauhan, Alok, Singh
Abstract
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 at least one operating parameter of a target bioreactor, determine an upper boundary and/or a lower boundary defining a design space for at least one bioreactor process parameter to match at least one target parameter range based on the at least one operating parameter, simulate changes in the at least one target parameter range based on an adjustment to the upper boundary and/or the lower boundary in the design space, and configure the target bioreactor using output obtained from the adjustment to the upper boundary and/or the lower boundary to identify a match between the at least one target parameter range and a user-based input of a target bioprocess parameter value.
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.
B01D 15/02 - Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor with moving adsorbents
B01D 15/38 - Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups , e.g. affinity, ligand exchange or chiral chromatography
C12M 1/00 - Apparatus for enzymology or microbiology
C12N 1/02 - Separating microorganisms from their culture media
C12N 15/10 - Processes for the isolation, preparation or purification of DNA or RNA
B01D 21/00 - Separation of suspended solid particles from liquids by sedimentation
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.
GLOBAL LIFE SCIENCES SOLUTIONS OPERATIONS UK LTD (United Kingdom)
Inventor
Timmins, Mark, R
Sherman, Matthew
Ali, Yasser
Picardo, Marc
Benoit, Keith
Abstract
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.
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.
