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 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 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 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.

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.