Abstract: A pressure gauge and/or relief valve which may be used in a single-use fluid system, such as a sterilizable fluid system. The pressure gauge and/or pressure relief valve may be formed of a disposable and/or sterilizable material, such as a non-metallic (e.g., polymeric) material. The material of the pressure gauge and/or pressure relief valve may be compatible with the material of a fluid-containing structure of the fluid system, such as to be bonded (e.g., welded) therewith. The fluid-containing structure may be retrofitted to integrate the pressure gauge and/or pressure relief valve therewith. The pressure gauge and/or pressure relief valve may have a simple configuration, such as a housing with a movable element therein. The movable element moves with respect to the housing to indicate pressure and/or to relieve pressure from within the housing and/or fluid-containing structure.

Abstract: Devices, systems, and methods described herein relate to determining a concentration of a species of interest in a sample by using a spectrometer. For example, a concentration of a species of interest may be determined by passing a first feed of a sample with a species of interest through a flow-through variable pathlength spectrophotometer and reading a first absorbance value. A change in the concentration of the species of interest may be effected in the sample, and a second feed of the sample may be passed through a flow through variable pathlength spectrophotometer. A second absorbance value may be read. The difference between the first absorbance value and the second absorbance value may be used to determine the concentration of the species of interest.

Abstract: Fluid management systems for handling pressurized fluid connect various subsystems or subunits without the need to use reinforced tubing. The system utilizes one or more segments of unreinforced conduit that are encapsulated at various points along a length of the segment with one or more rigid encapsulating members. The unreinforced conduit may be made a disposable element while the rigid encapsulating members may be re-used. In one aspect, the encapsulating member may include a two-part valve body that surrounds and encapsulates a portion of the unreinforced conduit. In another aspect, the encapsulating member may include a two-part jacket that surrounds and encapsulates a portion of the unreinforced conduit. The two-part valve bodies and two-part jackets may be joined at various points within the system as part of the overall flow system.

Abstract: A fluid plug for use with sterile processes such as the manufacture or production of pharmaceuticals and biologics is disclosed. The fluid plug is made of a material or materials that will tolerate sterilizing processes such as gamma irradiation. The fluid plug is used to selectively plug the ends of flexible polymer conduits that may be connected to fluids, reagents, or products used or generated as part of the manufacturing process. Also disclosed is the use of the plugs in combination with a series of valves in a block-and-bleed arrangement to enable the sterile transfer and connection of fluids, reagents, or products within a process flow.

Abstract: The present disclosure relates to tangential flow filters, membranes, and ultrafiltration membranes, for various applications, including bioprocessing and pharmaceutical applications, systems employing such filters, and methods of filtration using the same. In an aspect, an alternating tangential flow system for continuous processing may include a feed line containing a fluid. A retentate line may be in fluid communication with the feed line. A first diaphragm may be at an inlet of the retentate line configured to pump fluid toward an outlet of the retentate line. A second diaphragm may be at the outlet of the retentate line configured to pump fluid toward the inlet of the retentate line. A membrane may be in fluid communication with the retentate line between the first diaphragm and the second diaphragm. A retentate pump may be at the retentate outlet configured to pump the fluid out of the retentate line.

Abstract: The present disclosure is related to bioprocessing devices, systems, and methods, and particularly to sanitary connections for bioprocessing. The devices, systems, and methods described herein can relate to the sanitary connection of flow fittings, such as reducers, with considerations for ease of assembly and sealing. In some embodiments, the system may include a flow reducer, a ferrule and a gasket. The flow reducer may include a gasket channel, an overmold channel within the gasket channel, and one or more cavities within the overmold channel. The gasket may be overmolded within the gasket channel and extending within the one or more cavities.

Abstract: Tangential flow filtration systems utilizing flexible bags for permeate collection are provided.

Abstract: A fluid monitoring assembly includes a conduit having a wall defining a lumen for carrying fluid. A sensor mount is integrally formed with the wall of the conduit and extends generally transverse with respect to a longitudinal axis of the conduit, the sensor mount including an aperture defining an inner surface extending to the lumen. The assembly includes a sensor configured to be removably secured within the sensor mount, the sensor having an elongate body terminating at one end thereof in a sensing portion, the elongate body having a male projection on a portion thereof and configured to rest within the inner surface of the sensor mount. The assembly further includes a housing having first and second portions connected to one another, the housing defining an interior portion configured to encapsulate the conduit, at least a portion of the elongate body of the sensor, and the sensor mount.

Abstract: A fluid filtration assembly includes a filter housing having first and second ends and a connector for fluid communication with a fluid storage vessel. A filter element is disposable within the filter housing, and first and second pumps are coupled at the first and second ends of the filter housing. A controller may coordinate the operation of the first and second pumps to induce alternating tangential flow of fluid between the filter housing and the first and second pumps. At least one of the first and second pumps is a diaphragm pump or a plunger pump. The fluid storage vessel can be a bioreactor.

Abstract: Fluid management systems for handling pressurized fluid connect various subsystems or subunits without the need to use reinforced tubing. The system utilizes one or more segments of unreinforced conduit that are encapsulated at various points along a length of the segment with one or more rigid encapsulating members. The unreinforced conduit may be made a disposable element while the rigid encapsulating members may be re-used. In one aspect, the encapsulating member may include a two-part valve body that surrounds and encapsulates a portion of the unreinforced conduit. In another aspect, the encapsulating member may include a two-part jacket that surrounds and encapsulates a portion of the unreinforced conduit. The two-part valve bodies and two-part jackets may be joined at various points within the system as part of the overall flow system.

Abstract: An encapsulated valve system includes a first housing portion having a first facing surface, the first facing surface comprising a plurality of branch pathways formed as a recess within the first facing surface. The valve system further includes a second housing portion having a second facing surface, the second facing surface comprising a plurality of branch pathways formed as a recess within the second facing surface. A disposable conduit is configured to be interposed between the first and second housing portions and disposed within the recess of the first facing surface and the recess of the second facing surface. The disposable conduit is thus sandwiched between the first and second facing surfaces. A plurality of pinch valve actuators are mounted on one or both of the first housing portion and the second housing portion, the plurality of pinch valve actuators configured to pinch the disposable conduit at selective branch pathways.

Abstract: This disclosure relates generally to process filtration systems, and more particularly to systems utilizing tangential flow filtration.

Abstract: A fluid filtration system includes a fluid storage vessel such as a bioreactor, a filter housing including a filter element disposed therein, a pump coupled between the fluid storage vessel and the filter housing, and a flow diverter disposed between the pump and the filter housing. The pump is configured to move fluid from the fluid storage vessel through the filter element, and the flow diverter is configured for selectively directing fluid received from the pump to the first or second end of the filter housing. In a first mode of operation, the flow diverter directs flow through the filter housing in a first direction, while in a second mode of operation, the flow diverter directs flow through the filter housing in a second direction opposite the first direction.

Abstract: A fluid filtration system includes a fluid storage vessel such as a bioreactor, a filter housing including a filter element disposed therein, a pump coupled between the fluid storage vessel and the filter housing, and a flow diverter disposed between the pump and the filter housing. The pump is configured to move fluid from the fluid storage vessel through the filter element, and the flow diverter is configured for selectively directing fluid received from the pump to the first or second end of the filter housing. In a first mode of operation, the flow diverter directs flow through the filter housing in a first direction, while in a second mode of operation, the flow diverter directs flow through the filter housing in a second direction opposite the first direction.

Abstract: A control unit includes a first connector configured to connect a proportional pressure regulator to a positive pressure supply and a second connector configured to connect the proportional pressure regulator to a negative pressure supply. The control unit further includes at least one sensor configured to detect an amount of air flow (volume per unit of time), positive or negative, within an air flow line connected to an output of the proportional pressure regulator, and a third connector configured to connect the air flow line to an air side of a diaphragm. Additionally, the control unit includes a controller programmed to control at least an opening and closing function of the proportional pressure regulator to attain a desired amount of air flow (volume per unit of time), positive or negative, within the air flow line.

Abstract: Methods and systems of harvesting a cell product from a cell culture by culturing cells in a fluid medium until the cells have produced a cell product at a harvest concentration are disclosed. The cells are cultured in a cell culture system including a bioreactor connected to an ATF device. The methods include draining fluid medium from the bioreactor through the outlet and the ATF device until the bioreactor volume reaches a predetermined volume, and the ATF column yields at an ATF outlet a liquid containing cell product and passes fluid medium with a concentration of cell product that is lower than the harvest concentration back into the bioreactor, extracting the liquid containing cell product from the ATF outlet, refilling the bioreactor with sterile phosphate buffered saline or fluid medium without any cell product, and repeating steps until a desired amount of cell product has been removed.

Abstract: The present disclosure relates to hollow fiber tangential flow filter units, including hollow fiber tangential flow depth filter units, for various applications, including bioprocessing and pharmaceutical applications, systems employing such filters, and methods of filtration using the same.

Abstract: Methods and systems for removing gases and/or pressure formed during the sterilization, e.g., the gamma irradiation, of prepacked chromatography systems (column plus attached tube and valve set) are described. The methods include purging the gas and/or pressure through specially designed tube and valve sets without breaching the sterility of the prepacked sterile chromatography system. The systems include a sterile or aseptic pre-packed chromatography column including a column having an inlet and an outlet, a tubing and valve set attached to the inlet and the outlet, and a pump configured to pump sterile or aseptic liquid from the fluid source along the tubing and valve set, into the column tube inlet and out of the column tube outlet along a first flow path, thereby removing any entrapped gas and/or pressure from the chamber.

Abstract: A method for promoting biological activity uses a filter system to increase cell production of a fed batch bioreactor. The filter system cycles bioreactor fluid through a hollow fiber tangential flow filter which separates metabolic wastes (as well as proteins) from cells produced in bioreactor and returned to fed batch bioreactor, improving cell production in the fed batch bioreactor. The filter system includes a disposable pump and filter, and a reusable control system. The pump is a low shear gamma stable pump gently cycling bioreactor fluid through the filter with minimal damage to the cells produced in the bioreactor. The pumphead and hollow fiber tangential flow filter are disposable. The pump motor is part of the control system and is reusable. The pumphead and filter are provided as an assembled and pre-sterilized unit allowing simple and quick attachment to the fed batch bioreactor, and simple and quick disposal.

Abstract: A control unit includes a first connector configured to connect a proportional pressure regulator to a positive pressure supply and a second connector configured to connect the proportional pressure regulator to a negative pressure supply. The control unit further includes at least one sensor configured to detect an amount of air flow (volume per unit of time), positive or negative, within an air flow line connected to an output of the proportional pressure regulator, and a third connector configured to connect the air flow line to an air side of a diaphragm. Additionally, the control unit includes a controller programmed to control at least an opening and closing function of the proportional pressure regulator to attain a desired amount of air flow (volume per unit of time), positive or negative, within the air flow line.