Abstract: The present invention relates to Fc binding proteins comprising one or more domains with Cysteine in the C-terminal helical region. 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 disclosure is directed to pneumatic actuator assemblies for reduced dead leg. In one approach, an assembly may include a valve body, and a first actuator and a second actuator each coupled to the valve body by a bonnet assembly. The bonnet assembly may include a bonnet body having a first end opposite a second end, wherein the first end is connected with the valve body, and a nut threadedly connected to the second end of the bonnet body. The bonnet assembly may further include an actuator bonnet, wherein the nut partially surrounds the actuator bonnet, and wherein the actuator bonnet is rotatable about a lengthwise axis extending through a center of a stem of a piston.

Abstract: The present invention relates to Fc binding proteins comprising one or more domains with Cysteine in the C-terminal helical region. 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: 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: 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: The present invention relates to hollow fiber tangential flow depth filtration media adapted for perfusion bioprocessing, and related TFDF filtration units, bioprocessing systems, and methods, including methods for perfusion cell culture. The hollow fiber elements of the present invention combine a relatively thin porous wall with a relatively low porosity to provide filtration media resistant to fouling during perfusion culture.

Abstract: The invention provides tangential flow filtration systems and methods for capture and harvest of a biologic product, and related compositions.

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 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 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: The present disclosure relates to diaphragm pumps with one or more filters, e.g., tangential flow filters, membranes, and ultrafiltration membranes, for various applications, including, e.g., bioprocessing and pharmaceutical applications, systems employing such filters, and methods of filtration using the same. In an aspect, a pump for alternating tangential flow filtration may include a diaphragm. A housing may contain the diaphragm. The housing may have a first end open to a retentate channel of a first membrane. A magnetic member may be coupled to the diaphragm. An electromagnetic field generator may be disposed about the magnetic member.

Abstract: A valve assembly with a multidirectional flow path includes a valve body that includes respective hinged portions defining respective passageways extending through the valve body when in a closed state. A flexible conduit or tubing having a loop portion and a plurality of branches extending from the loop portion is at least partially positioned within the valve body. Portions of the loop that extend beyond the valve body are encapsulated by respective rigid jackets. Multiple valves are situated on the valve body and are used to selectively pinch the loop portion in different pinching configurations to direct fluid to or from the particular branches. The valve assembly may be integrated into a manufacturing or other production process with optional additional jackets used to encapsulate the flexible conduit branches.

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 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: 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: 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: The present invention relates to Fc binding proteins comprising one or more domains with Cysteine in the C-terminal helical region. 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 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 configured to measure and to relieve fluid within a fluid-containing structure, the pressure gauge relief valve including a housing having a first end, a second end, and an inner surface defining a passage between the first end and the second end, a movable element movable within the passage, wherein the housing first end is configured to be coupled with a fluid-containing structure, the housing second end is spaced from the housing first end; and the movable element is movable with respect to the housing to indicate pressure therein and to allow fluid to pass between the movable element and the inner surface of the passage at a selected pressure.

Abstract: A valve assembly with a multidirectional flow path includes a valve body that includes respective hinged portions defining respective passageways extending through the valve body when in a closed state. A flexible conduit or tubing having a loop portion and a plurality of branches extending from the loop portion is at least partially positioned within the valve body. Portions of the loop that extend beyond the valve body are encapsulated by respective rigid jackets. Multiple valves are situated on the valve body and are used to selectively pinch the loop portion in different pinching configurations to direct fluid to or from the particular branches. The valve assembly may be integrated into a manufacturing or other production process with optional additional jackets used to encapsulate the flexible conduit branches.