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 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: An improved device for enabling a non-sterile container of liquid, such as, for example, a bottle to be introduced into a sterile environment. In one embodiment, the device seals the non-sterile container within a drape so that the non-sterile container can be introduced into the sterile environment. The device may include a drape having an interior cavity for receiving the non-sterile container and a cap coupled to the enclosure for coupling to the non-sterile container so that the liquid product may flow through the sterile cap.

Abstract: The present invention relates to Fc binding proteins comprising one or more Fc binding domains wherein at least one domain comprises of an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-6 or 21. The invention further relates to affinity matrices comprising the Fc binding proteins of the invention. The invention also relates to a use of these Fc binding proteins or affinity matrices for affinity purification of immunoglobulins and to methods of affinity purification using the Fc binding proteins of the invention.

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: An improved device for enabling a non-sterile container of liquid, such as, for example, a bottle to be introduced into a sterile environment. In one embodiment, the device seals the non-sterile container within a drape so that the non-sterile container can be introduced into the sterile environment. The device may include a drape having an interior cavity for receiving the non-sterile container and a cap coupled to the enclosure for coupling to the non-sterile container so that the liquid product may flow through the sterile cap.

Abstract: Systems include a chromatography column tube having an inlet and outlet and port assembly arranged in a wall of the column tube between flow distributors that together form a chamber within the tube that is filled with packing medium are described. The port assembly facilitates the removal of resin from the pre-packed column and the port assembly does not affect fluid flow in the normal use of the column for chromatographic separation or ability to maintain sanitary conditions within the column. Also described are methods that include attaching tubing to a pump and to a column inlet and a column outlet, opening the port assembly, attaching tubing to the port assembly and to a second reservoir, and pumping aqueous solution from a reservoir into the chamber and out through the port assembly into the second reservoir, thereby removing packing medium from the column along with the flowing aqueous solution.

Abstract: A single-use fluid storage and filtration system includes a process vessel, a filter module including a hollow fiber filter element, and a drive module coupled to the filter module. The filter module is fixed to the process vessel and is in fluid communication with the process vessel for filtering a fluid received from the process vessel. The drive module includes a pump to induce flow of the fluid between the filter module and the process vessel. The process vessel, filter module and drive module comprise a single integrated and sterilized assembly.

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 a the assembly. The fluid filtration assembly can be provided as a disposable single-use arrangement.

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: 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 method of making and loading a chromatography column includes selecting a column tube having an appropriate elasticity, and inner diameter and length, selecting appropriately sized flow distributors, a second flow distributor having a diameter that is larger than the inner diameter of the tube, permanently securing a first flow distributor to a first end of the tube, loading packing medium into the tube, inserting the second flow distributor into a second end of the tube to drive the second flow distributor into the tube to form a sealed chamber within the tube, adjusting the longitudinal position of the second flow distributor within the tube by applying a force to the second flow distributor until it reaches a desired location within the tube, and/or forcing liquid into the chamber to move the second flow distributor and permanently securing the properly positioned second flow distributor within the tube.

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: 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: Improved screen filter modules, related compartmentalized filtration modules, and related filtration processes, suitable for filtering fluid to eliminate suspended particulate matter, such as living cells or microcarriers anchoring living cells, or to separate particulate matter based on size. The improvement is the presence of a barrier that channels redirected filtrate to the portion of the filter most susceptible to clogging by the particulate matter and induces flow patterns that act against clogging.

Abstract: If one sterilizes pre-packed, plastic chromatography columns with an appropriate level of gamma irradiation, the resulting sterile chromatography columns maintain sufficient packing media function and maintain column mechanical properties and pressure ratings.

Abstract: Chromatography media and devices containing chromatography media are disclosed. Methods of making chromatography devices and methods of using chromatography devices containing the chromatography media are also disclosed.

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: Improved screen filter modules, related compartmentalized filtration modules, and related filtration processes, suitable for filtering fluid to eliminate suspended particulate matter, such as living cells or microcarriers anchoring living cells, or to separate particulate matter based on size. The improvement is the presence of a barrier that channels redirected filtrate to the portion of the filter most susceptible to clogging by the particulate matter and induces flow patterns that act against clogging.