Abstract: A system for TFF filtration of a feedstock includes a feed vessel containing a solution comprising a target biomolecule, a filter membrane for filtering the solution, a feed pump for moving the solution from the feed vessel to the filter membrane, a buffer vessel coupled to the feed vessel by a buffer supply line, and a diafiltration pump disposed in the buffer supply line for delivering a buffer solution to the feed vessel. A variable path-length instrument is coupled to the feed line for determining, in real time, a concentration of the target biomolecule in the solution. A controller is coupled to the variable path-length instrument, the feed pump, and the diafiltration pump to control operation of the system based on the received information.

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 self-contained filtration assembly with a self-contained filtration cassette therein. The cassette may be formed from one or more layers membranes and spacers (spacers, screens, or combinations thereof) all having the same general shape. The cassette may have a feed inlet path and a retentate outlet path extending through the layers of the cassette within the perimeter of the cassette, and a permeate outlet path between the cassette exterior and the interior of the cassette housing. The housing may have a generally circular or elliptical cross-section. A clamping assembly may hold together the components of the housing, and may be elongated in a direction along the flow path of the feedstream through the cassette. Various port-defining zones defined in the layers of the cassette may be sealed in a manner facilitating assembly of the cassette as well as isolation of the flow paths therein.

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 improving volumetric productivity from a cell culture includes filtering a cell culture through an ultrafilter or a microfilter operating in tangential flow filtration mode or alternating flow filtration mode, and filtering the cell culture concurrently or intermittently through a tangential flow depth filtration system to remove cellular debris and/or to harvest cell product. A system for filtering biological materials includes a primary filtration system, and a secondary filtration system, where the secondary filtration system comprises a tangential flow depth filtration filter.

Abstract: Vessel configured to facilitate concentration of a product in a solution. The vessel may include outlet ports to deliver the solution to a processing system (such as a filtration system), and inlet ports. The inlet ports may be at progressively lower levels for return of fluid thereto reduced in volume as a result of filtration thereof. A smaller volume sump may be provided below a main tank of the vessel to facilitate concentration of the solution. The sump may include ridges facilitating collection of the product of interest from the solution, and/or reinforcing the sump walls, and optionally forming a vortex breaker. A spray ball may be provided to spray materials, such as buffer solution, into the vessel. The spray ball may direct materials to facilitate retrieval of product from the vessel. One or more components of the vessel may be advantageously formed of disposable material for single use thereof.

Abstract: A tubing system with a coupler join positioned between and joining tubing segments. The coupler join is formed to reduce dead legs and hold up volumes within, and/or to reduce materials used to form, and/or to simplify the manufacturing process of the tubing system. The coupler join may be sized, shaped, configured, and/or dimensioned to join tubing segments, such as pre-formed tubing segments, in a streamlined configuration, such as to substantially correspond with the outer and inner diameters of the tubing segments. The tubing system and coupler join may be formed with a mold configured to form a coupler join securely coupling spaced apart ends of tubing segments to be joined together in a configuration which reduces dead legs and hold up volumes within the resulting tubing system.

Abstract: This disclosure relates to the use of a hydrophobic hollow fiber filter for the filtration of cell cultures and other biological perfusions, due to its resistance to fouling, as well as the ability to filter solutions with a high solid content. A hydrophobic hollow fiber filter may be used within a filter housing in conjunction with a process vessel and a traditional separation system. When the system is used with alternating tangential flow or tangential flow filtration, the hydrophobic hollow fiber filter results in more effective filtration of the filtrate, leading to greater concentration of the retentate, even in solution containing high levels of solids.

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: The present disclosure pertains to filtration methods comprising: passing a first fluid that comprises cells, cell debris and targeted product produced by the cells through a first filter thereby separating the first fluid into a first retentate comprising cells and a first permeate comprising targeted product and cell debris; combining resin beads having affinity for targeted product with the first permeate to form a second fluid containing resin beads with bound target product and cell debris; passing the second fluid through a second filter thereby separating the second fluid into a second retentate comprising resin beads with bound target product and a second permeate comprising cell debris; combining an elution buffer with the second retentate to form a third fluid that comprises a mixture of resin beads and unbound targeted product; and passing the third fluid through a third filter thereby separating resin beads from targeted product.

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: 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: A filter screening tool, system, and method allowing high throughput screening of filters (such as hollow fiber filters), such as for use in bioprocessing workflows. Feed material may be fed through different filter modules to assess, measure, analyze, determine, evaluate, teste, compare, screen, etc., properties or characteristics, etc., of filters within the filter modules. Each filter module may house a different type (e.g., material or configuration) of filter so that different filters may be compared and screened, such as for a selected use.

Abstract: Disclosed herein are robust disposable alternating tangential flow (ATF) housing and diaphragm pump units and associated methods of manufacturing, testing, wetting, and using the same.

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: 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 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 system for managing flexible conduit or tubing used in pharmaceutical, bioprocess, or food/dairy applications includes a segment of flexible conduit or tubing and a plurality of conduit tracks, each conduit track including a conduit channel disposed on a first side thereof and extending along the length of each respective conduit track and dimensioned to receive the segment of flexible conduit or tubing therein, each conduit track further including a connector channel disposed on a second, opposing side and extending along the length of each respective conduit track and containing the one or more connectors that connect adjacent conduit tracks. The conduit tracks can be connected to each other or other process components.

Abstract: Embodiments of the present disclosure relate generally to systems and methods for perfusion cell culture involving alternating fluid flows between first and second flexible vessels. For example, a hollow fiber filter module may be attached to first and second culture vessels which each include inner and outer vessels. A pressure source may cause a pressure differential between the outer vessels, which may cause a responsive fluid flow between the inner vessels across a hollow fiber filtration unit.

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.