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.

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 compact light source for coupling to a movable optic probe may include a light emitting diode (LED), to generate a probe signal at a first bandwidth, an optic coupler, disposed adjacent to the LED, and arranged to couple the probe signal into the movable probe, and a narrow bandpass filter disposed to receive the probe signal at the first bandwidth, and to output the probe signal into the movable probe at a second bandwidth, less than the first bandwidth.

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 bleed recovery system for use in a bioreactor system is disclosed. The bleed recovery system being configured to recover product of interest from the bleed material of the bioreactor system. In one embodiment, the bioreactor system includes a bleed recovery system for removing cell cultures from the bioreactor. The bleed recovery system includes a bleed pump coupled to the bioreactor so that cell bleed material can be removed from the bioreactor, a bleed vessel for receiving the cell bleed material, a cell retention device coupled to the bleed vessel, a harvest pump coupled to the cell retention device to deposit the product of interest into a second harvest tank, and a bleed pump connected to the bleed vessel to deposit the spent bleed material into a waste tank. Thus arranged, some or all of the product of interest can be separated from the spent medium.

Abstract: An apparatus may include a light emitting diode (LED) assembly, comprising a plurality of LEDs that output radiation at a plurality of different wavelengths, respectively. The LED assembly may be arranged to output a composite probe signal at a plurality of instances, wherein the composite probe signal comprises a plurality of probe signals, generated from the plurality of LEDs, respectively. The apparatus may also include a measurement module that includes an optic probe to direct the composite probe signal through a fluid sample, while moving between a plurality of probe positions at the plurality of instances. The measurement module may include a detector, disposed to detect, at the plurality of instances, a transmitted intensity of the composite probe signal at the plurality of different wavelengths after the composite probe signal passes through the fluid sample.

Abstract: A system may include a light source, to generate a probe signal, comprising incident radiation; an optical probe, to direct the incident radiation through a fluid sample; a motor, to move the optical probe along a probe axis, to change a path length of the incident radiation through the fluid sample; and a detector, to receive the incident radiation as attenuated radiation after passing through the fluid sample. The system may include a control system, arranged to: initiate an absorbance measurement by directing movement of the optical probe along the probe axis; direct the light source to emit the incident radiation; and automatically adjust at least one measurement parameter of a set of measurement parameters for the sample measurement, based upon a slope parameter m, wherein m is derived from a rate of change in an intensity of the attenuated radiation with a change in the path length.

Abstract: A method includes determining whether a variation in probe radiation intensity meets a stability criterion; directing the probe radiation through a probe, when the probe is disposed at a first position, defining a first path length L1 of the probe radiation through the fluid sample; measuring a transmitted intensity I1 of the probe radiation after passing through the fluid sample when the probe is disposed at the first position; directing the probe radiation through the probe when the probe is disposed at a second position, defining a second path length L2 of the probe radiation through the fluid sample; measuring a transmitted intensity I2 of the probe radiation after passing through the fluid sample when the probe is disposed at the second position; and determining a concentration C of a material in the fluid sample based upon L1, I1, L2, and I2, when the stability criterion is met.

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: 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: 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: 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 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 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.