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

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: 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: 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: 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 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 provides systems and methods that allow users to quickly determine titer and remove hold steps by determining a first concentration using slope spectroscopy, depleting the fluid of the expressed protein by selective adsorption, and determining a second concentration using slope spectroscopy. Further, the systems and methods of the present disclosure allows the user to forgo the use of a bioanalyzer or HPLC.

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.