Abstract: A device for storing, transporting and/or handling a liquid or liquids and methods for using the device are described. The device is suitable for use with sterile or aseptic liquids, particularly with large liquid volumes such as 10-1000 liters or more, and avoids the need for bags, bins and carriers commonly used for storing and transporting large volumes of liquids. The device comprises a coiled tubing. The coiled tubing can be loaded onto a spool to support the coiled tubing. The tubing can be filled, sealed, stored and transported in a more robust manner than previously achieved with bags, bins and carriers.

Abstract: The present invention relates to a selectively soluble polymer capable of binding to one or more constituents in a mixture containing various biological materials and the methods of using such a polymer to purify a biomolecule from such a mixture. The polymer is soluble in the mixture under a certain set of process conditions such as pH or temperature and is rendered insoluble and precipitates out of solution upon a change in the process conditions. While in its solubilized state, the polymer is capable of binding to a selected entity within the stream such as impurities (DNA, RNA, host cell protein, endotoxins, etc.) in a cell broth and remains capable of binding to that entity even after the polymer is precipitated out of solution. The precipitate can then be filtered out from the remainder of the stream and the desired biomolecule is recovered and further processed.

Abstract: A process for the primary clarification of feeds, including chemically treated flocculated feeds, containing the target biomolecules of interest such as mAbs, mammalian cell cultures, or bacterial cell cultures, using a primary clarification depth filtration device without the use of a primary clarification centrifugation step or a primary clarification tangential flow microfiltration step. The primary clarification depth filtration device contains a porous depth filter having graded porous layers of varying pore ratings. The primary clarification depth filtration device filters fluid feeds, including chemically treated flocculated feeds containing flocculated cellular debris and colloidal particulates having a particle size distribution of approximately about 0.5 ?m to 200 ?m, at a flow rate of about 10 litres/m2/hr to about 100 litres/m2/hr. Kits and methods of using and making the same are also provided.

Abstract: The invention concerns a device comprising a base (2) and a door (20), said device having a closed door position in which a circuit (8) of the device comprises a bag comprising two flexible films and connectors of the conveying network, and a press (9) comprising a first shell (16) disposed on a front face (5) of said base (2) and a second shell (17) disposed in said door (20); and a hinge system hinging said door (20) relative to said base (2), and disposed only on one side of said door (20) so as to form lateral clearances between said door (20) and said base (2) over the rest of a perimeter of said door (20).

Abstract: The present invention is an integral multilayered composite membrane having at least one ultrafiltration layer made by cocasting or sequentially casting a plurality of polymer solutions onto a support to form a multilayered liquid sheet and immersing the sheet into a liquid coagulation bath to effect phase separation and form a multilayered composite membrane having at least one ultrafiltration layer.

Abstract: The embodiments described herein relate to agarose ultrafiltration membrane composites and methods for making and using the same.

Abstract: In one embodiment, a removable pneumatic connector, comprises a body having a plurality of bores passing through, each bore surrounded by a sealing member on an inner surface of the body. A plurality of gas lines may be placed within a corresponding bore. A vacuum port is disposed on the inner surface of the body, and an outer seal on the inner surface of the body surrounds the sealing members and the vacuum port. A vacuum line may be placed within the vacuum port, and configured to deliver negative pressure to the vacuum port. A vacuum holding area is created in the volume between the outer seal and each of the sealing members when the inner surface of the body is placed against a substrate. When the vacuum line is activated, a vacuum is created within the vacuum holding area, creating a positive seal between the body and the substrate.

Abstract: A method for removing microorganisms from liquid samples and a nanofiber containing liquid filtration medium that simultaneously exhibits high liquid permeability and high microorganism retention. Microorganisms such as bacteria, particularly B. Diminuta, are removed from a liquid by passing the liquid through a porous nanofiber containing filtration medium having a B. Diminuta LRV greater than about 9, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. Another method for removing microorganisms such as bacteria and Mycloplasma, includes passing the liquid through a porous nanofiber containing filtration medium having a microorganism LRV greater than about 8, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. The filtration medium can be in the form of a fibrous electro spun polymeric nanofiber liquid filtration medium mat.

Abstract: A container, such as a disposable or single use bioreactor, optionally having one or more inlets and one or more outlets and a mixer associated with the container to cause mixing, dispersing, homogenizing and/or circulation of one or more ingredients contained or added to the container. The container includes a flexible baffle shaped and positioned within the container to improve mixing, particularly to improve low shear mixing. The baffle is positioned within the container so as to disrupt the vortex formed by the mixer, or prevent formation of a vortex. The baffle is shaped with both horizontal and vertical elements to enhance disruption of the vortex across the entire vessel height and provide homogeneous mixing throughout all operating volumes. In certain embodiments, the baffle is X-shaped.

Abstract: A method of integrity testing porous materials that is non-destructive to the material being tested. The method includes humidifying the inlet gas stream to minimize or prevent the porous material from drying out. The inlet gas stream includes at least two gases, wherein one of the gases has a different permeability in liquid than the other, such as oxygen and nitrogen. The permeate gas stream may be subjected to a driving force such as reduced pressure to increase the flow of gases and reduce test time. Multiple porous materials can be integrity tested at the same time, such as by manifolding a plurality of them together. The integrity test is capable of detecting the presence of oversized pores or defects that can compromise the retention capability of the porous material.

Abstract: A fluid transfer device includes a syringe barrel having a chamber, a first plunger slidably movable inside the chamber, and a second plunger slidably movable inside the chamber. The distal end portion of the first plunger is engageable with the proximal end portion of the second plunger such that when the distal end portion of the first plunger and the proximal end portion of the second plunger are engaged, the second plunger is movable by the first plunger. A check valve may be incorporated into the distal end portion of the second plunger to allow a fluid to pass therethrough in a direction towards the proximal end portion of the second plunger and prevent a fluid to pass therethrough in a reverse direction. A fluid transfer assembly and a sampling method are also described.

Abstract: A clamp device for a barb member having a barbed region for disposing within an end of a flexible tube having an outer surface. The clamp device includes a flexible member including a body having a plurality of finger members compressible between a first resting position and a second clamping position; at least one of the flexible finger members having a radially inwardly extending tooth; the body having a through bore and an outer surface comprising threads; the flexible member being slidable over the barbed region and the outer surface of the flexible tube; a compression member having a body having a through bore and an inner surface including threads; the compression member being slidable over the flexible member; wherein upon threadingly engaging the compression member with the flexible member, the compression member compresses the finger member against the barb member.

Abstract: Fluid transfer device and method that allows for sterile wet connections, allows the connection to be reversed, and allows the connection to be reconnected, while leaving the connectors sterile and reusable under pressure. In certain embodiments, the device includes a first member and a second member, the latter adapted to receive the former in locking engagement upon actuation of the device to create fluid communication between the two in a sterile manner. Each of the members include a door that when opened, allows the first member to be linearly displaced into the second member to allow fluid to be transferred. When fluid transfer is complete, the first member can be retracted from the second member, and the doors closed.

Abstract: Embodiments described herein relate to electrospun nanofiber ultrafiltration membrane compositions capable of operating in tangential filtration mode and methods of using the same.

Abstract: A biocontainer film enhanced with an abrasion resistant or “cut-proof” substrate. Such substrates can be combined with current biocontainer materials, via various techniques of embedding, coextrusion or laminating, to maintain the cleanliness and low extractables already validated for biotech manufacturing. The substrate of choice may be constructed from materials known to be more resistant to abrasion and sharp razor type cuts or from materials oriented in such a way to prevent puncture to occur. The new substrate must also be flexible to allow for typical folding as demonstrated by current packaging practices. The new substrate may be constructed from materials other than polymers such as metal, glass or carbon or in combination with polymers. A non-constrained pressure test is also disclosed.

Abstract: Fluid containment pressure vessel that eliminates the outer support housing present in certain conventional vessels, and provides an improved cap-to-body interface. In certain embodiments, the cap is threaded and configured to threadingly engage with the body of the pressure vessel, and has sufficient structural integrity to withstand the pressures in the device without the need for a support housing. In certain embodiments, an interlock mechanism is provided that prevents the cap from being opened (e.g., removed from the body) while the device is under pressure. In certain embodiments, a pressure relief valve is provided with a pre-loaded biasing mechanism to achieve the required pressure release rate. The vessel can be used for sample preparation, including purification or concentration of samples, particularly protein samples.

Abstract: The present disclosure relates to a filter capsule that supports direct integrity testing of an internal filter element. The filter capsule includes a filter housing having an inlet port, an outlet port, a passage running longitudinally between the inlet port and outlet port and holding a filter element, and an aseptic vent assembly. The filter housing also includes an integrity test assembly that can be used as a direct connection for integrity testing hardware, as opposed to upstream of the filter capsule. In one embodiment, the integrity test assembly comprises a body having a bore formed through its interior and a movable plunger within the bore. The plunger includes a handle to move the plunger between a closed position and an open position. Various seals between the plunger and the bore form a fluid tight seal between various portions of the plunger and the bore.

Abstract: Apparatus and method for Immunohistochemistry, including a slide holder assembly fixture, a slide holder, a slide holder frame, and a slide holder frame assembly adapted to be placed in communication with a driving force to draw fluid through the slide holder. The slide holder may include an injection port that allows consistent fluid delivery and recovery, while minimizing the introduction of air bubbles. The slide holder may include a reservoir that allows for filling, soaking, rinsing, flushing, uniform antibody coverage of the tissue and reduces handling time, space, and errors, and one or more sample chambers. The slide orientation in the slide holder allows for visualization of label information and tissue to confirm adequate antibody coverage. A multi-port frame allows multiple assays to be carried out concurrently, and is removable from a vacuum manifold and allows for easy transport from the vacuum manifold to an incubator/refrigerator and back.

Abstract: A disposable container, such as a deformable bag, for a fluid, having one or more inlets and one or more outlets and an impeller assembly within the container to cause mixing, dispersing, homogenizing and/or circulation of one or more ingredients contained or added to the container. The impeller assembly has a protective hood surrounding at least a portion of the moveable blades or vanes of the impeller assembly and being above at least a portion of the blades or vanes. The hood surrounds the blades or vanes and arcs over the height of the blades or vanes. The hood is shaped in a dome shape or semi-spherical shape that is around and above the impeller blades and acts as a protector for the container surface against the impeller assembly both during shipping and storage as well as when in use, particularly at lower liquid levels.

Abstract: The device for the microbiological analysis of a support adapted to contain microorganisms marked by a fluorophore agent, said agent being adapted to absorb light energy with an absorption spectrum (53) having a crest (53?) at a predetermined absorption wavelength (?2) and to release that energy by emitting light with an emission spectrum (54) having a crest (54?) at a predetermined emission wavelength (?3) distinct from said absorption wavelength (?2), comprises illuminating means; the spectrum (55) of the excitation light coming from the illuminating means having a crest (55?) at a predetermined excitation wavelength (?1) with a predetermined difference between the excitation (?1) and absorption (?2) wavelengths by virtue of which it is made easy to discriminate the light emitted by said fluorophore agent from that coming from the illuminating means.