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.

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: A fluid filtration assembly includes a filter housing having a first end for fluid connection with a fluid storage vessel. A filter cartridge is disposable within the filter housing, and a plunger pump is coupled at a second end of the filter housing. The plunger pump includes a housing having a rigid portion and a flexible portion. The flexible portion has a plunger-engaging portion for coupling to the plunger of an actuator. The flexible portion selectively movable with respect to the rigid portion via the actuator. The filter cartridge can be a hollow fiber filter. The plunger pump can be configured to induce alternating tangential flow in at least a portion of the assembly. The fluid filtration assembly can be provided as a disposable single-use arrangement.

Abstract: The present disclosure relates to spectroscopy with light emitting components including, e.g., UV and/or visible wavelength light, for various applications, including, e.g., chromatography, and more particularly, for a sampling device that facilitates spectroscopic measurements with a variable pathlength and methods for such a device. In an aspect, a device for measuring light absorbance of a sample may include a fluid conduit comprising a first portion, a midportion substantially perpendicular to the first portion, and a second portion substantially perpendicular to the midportion. A first probe may be within the midportion and substantially parallel with the midportion. The first probe may comprise a distal end. A light source may be operably coupled to the first probe. A detector may be aligned with the distal end of the first probe substantially perpendicular to the first probe at a pathlength from the distal end of the first probe.

Abstract: A micro alternating tangential flow (microATF) perfusion filter includes a hollow cylinder having a proximal end and a distal end. The proximal end is connected in series to a permeate chamber, followed by a retentate chamber. The proximal end either (i) terminates in or at the permeate chamber, or (ii) terminates in or at the retentate chamber. The portion of the proximal end within the permeate chamber, in a case of (ii), possesses at least one opening allowing fluid communication between an inside of the hollow cylinder and the permeate chamber. The microATF perfusion filter further includes an inlet, positioned over the retentate chamber, for communication with a source of positive or negative pressure, and an outlet, positioned in a wall of the permeate chamber, which can be connected to a check valve, which, in turn, can be connected to a hydrophobic fluid vent filter.

Abstract: The present disclosure relates to hollow fiber tangential flow filters, including hollow fiber tangential flow depth filters, 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: 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: The present disclosure relates generally to alternating tangential flow (ATF) perfusion pumping methods, including novel methods for generating positive and negative pressure at the point of use, and more particularly, to apparatuses, systems and methods for use of the same.

Abstract: Devices, systems, and methods for continually degassing/venting a feedstream within a filtration system. The filtration system may include a filter device utilizing hollow fiber filters to filter the feedstream. Additional venting hollow fiber filters vent gas from the filtration system to outside the filtration system. The venting hollow fiber filters may have ends which expose the interior lumens thereof to outside the filter unit to vent gases which pass through the walls of the hollow fiber filters. Degassed permeate thus flows through the filtering hollow fiber filters.

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: A method of using a fluid monitoring assembly for measuring the flow rate of a fluid through a flexible conduit comprising a wall that defines a lumen through which the fluid passes. The assembly includes a housing having first and second portions each defining respective recessed interior portions that define a cavity that is configured to encapsulate and retain the flow sensor and the flexible tubing contained therein. The flow sensor may be removably secured around the outside of the flexible conduit and include one or more transducer/receiver pairs.

Abstract: A micro alternating tangential flow (microATF) perfusion filter includes a hollow cylinder having a proximal end and a distal end. The proximal end is connected in series to a permeate chamber, followed by a retentate chamber. The proximal end either (i) terminates in or at the permeate chamber, or (ii) terminates in or at the retentate chamber. The portion of the proximal end within the permeate chamber, in a case of (ii), possesses at least one opening allowing fluid communication between an inside of the hollow cylinder and the permeate chamber. The microATF perfusion filter further includes an inlet, positioned over the retentate chamber, for communication with a source of positive or negative pressure, and an outlet, positioned in a wall of the permeate chamber, which can be connected to a check valve, which, in turn, can be connected to a hydrophobic fluid vent filter.

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: Track-etched membranes for filtration are provided. Filtration methods utilizing such membranes and cell culture methods are also provided.

Abstract: A product concentration device that utilizes a reservoir connected to a hollow-fiber filter element where the reservoir can serve as a container for filtrate emanating from another filtering device, such that product in the reservoir can be stored, concentrated and/or further processed as desired. Enclosed reactor systems, each of at least three chambers, fluid flow between the chambers controlled by selectively permeable barriers, flow controlled by an alternating flow diaphragm pump.

Abstract: The present disclosure provides apparatuses and methods that integrate sensors into bioprocessing systems and, advantageously, do not require significant re-engineering of these systems. The disclosure describes an assembly for alternating tangential flow filtration. The assembly also includes a sensor inserted into the first hemisphere of the pump housing via the port. In various embodiments, the port comprises a tri-clover connector, and the sensor is optionally inserted into the port through a plug sized to substantially occlude the port and to place the sensor in contact with a fluid in the pump housing.

Abstract: The disclosure provides tangential flow depth filtration (TFDF) systems which exhibit improved filter fluxes and process capacities and reduced fouling characteristics. The TFDF systems of the disclosure optionally utilize tubular depth filters (TDF). Methods are provided which include the passage of a non-laminar flow through at least a portion of a length of a TDF in a TFDF system.

Abstract: A method of using a fluid monitoring assembly for measuring the flow rate of a fluid through a flexible conduit comprising a wall that defines a lumen through which the fluid passes. The assembly includes a housing having first and second portions each defining respective recessed interior portions that define a cavity that is configured to encapsulate and retain the flow sensor and the flexible tubing contained therein. The flow sensor may be removably secured around the outside of the flexible conduit and include one or more transducer/receiver pairs.