Abstract: Novel compositions for removing impurities such as, protein aggregates, from a sample containing a protein of interest, e.g., an antibody. Such compositions can be used prior to the virus filtration step during protein purification, to remove aggregates and protect the virus filter from fouling, therefore improving virus filter capacity. A porous solid support including a co-polymer having at least two monomers, wherein at least one of the monomers comprises acrylamide and at least a second monomer comprises a hydrophobic binding group, where the solid support selectively binds protein aggregates, thereby to separate the monomeric protein of interest from the protein aggregates. The method can be performed under neutral to high pH and high conductivity conditions.

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: The invention concerns a treated water purification system (18) comprising a closed water flow loop (107) said loop comprising at least one treated water supply point (A), at least one point of use (U) of purified water, a pump means (101), a sterilization means (106) and a filtration means (103), characterized in that the zone (106) comprises the supply point (A) and a water extraction point (P), situated upstream of the supply point (A), and in that the extraction point (P) and the supply point (A) are both situated in a sector (106B) of the sterilization zone (106) that is isolated from the two connection points (RM, RV) of the loop (107) to the zone (106) by two other sectors (106A, 106C) of the zone (106). Method for use of such a system.

Abstract: The present invention relates to modified immunoglobulin-binding proteins, e.g., Staphylococcus protein A, having improved binding specificity for immunoglobulins and methods of making and using the same.

Abstract: A fluid transfer system (100) includes a transfer device (104) and an interface device (102). The transfer device (104) includes a fluid transfer member (164) and a transfer coupling member (125) to align the fluid transfer member (164) with the interface device (102). The interface device (102) includes a reservoir port (108), a fluid transfer member receptacle (144), an interface coupling member (124), and a reservoir valve (110). The interface coupling member (124) is configured to close the fluid transfer member receptacle (144) and to couple to the transfer coupling member (125) and open the fluid transfer member receptacle (144) to receive the fluid transfer member (164). The reservoir valve (110), e.g., a sliding seal, is configured to close the reservoir port (108) from the fluid transfer member receptacle (144) and to open the reservoir port (108) to the fluid transfer member (164) when the fluid transfer member (164) is positioned in the fluid transfer member receptacle (144).

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 present invention provides methods for determining whether activated carbon can be used for removing viruses or a certain virus from a sample containing a target protein.

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: Sample preparation device that allows for a complete bind, wash, elute, buffer-exchange and concentration process to be carried out without sample transfer between multiple devices. The device includes a reservoir, a column for holding chromatography media, a holder region for holding a filtration device, and an outlet. The filtration device plugs into the holder region of the centrifugal device, and the assembly can be placed in an optional holder. The assembly, with or without the optional holder, can be placed in a conventional centrifuge tube for centrifugation. The entire bind, wash, elute, buffer exchange and concentration steps can be carried out with the apparatus without any pipette transfers (and the associated sample losses. The sample preparation device also can be used for binding and washing steps, in which case the filtration device is not needed, and for buffer exchange and concentration steps, in which case the media is not needed.

Abstract: The present invention provides a process for incorporating a wireless device into a plastic container as part of the steps of manufacturing the container. The plastic container can be a flexible plastic bag and are formed of one or more sheets, generally two or more sheets of plastic film or a rigid plastic container such as a tub or tote. The bags are formed by sealing together adjacent edge portions of each film layer. One embodiment of the present invention is to incorporate a wireless device between the edge portions of the film(s) before or during sealing so that the wireless device becomes permanently sealed into the film material but is isolated from both the bag interior and the outside environment. Another embodiment is to incorporate the wireless device onto or into a plastic component that is sealed to the container, such as a nipple or port, so that the wireless device becomes permanently sealed to the container but is isolated from both the container interior and the outside environment.

Abstract: The embodiments disclosed herein are directed to an apparatus useful in conducting detection of compounds on blotting membranes. The device is comprised of several layers including a porous support layer below the blotting membrane(s), a flow distributor above the blotting membrane(s) and optionally a well on the flow distributor to contain the liquid to the desired area and to allow for lower starting volumes of such liquid. Preferably, the flow distributor is a non-binding or low binding hydrophilic porous membrane such as a 0.22 micron membrane and the support layer is a grid or sintered porous material. The distributor and support are held together to form an envelope around the membrane(s). The use of a hinge, clips and other such devices is preferred in doing so.

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: 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 container and a container engaging member. The container engaging member may include a sample holder or reservoir, a filtration element and collar. In the assembled condition, the sample holder or reservoir is upstream of the filtration element, the container is downstream of the filtration element, and the sample holder or reservoir is attached to the container. The container engagement member is engageable and disengageable from the bottle or container in a quick attach, quick release manner, such as with only a 90 degree, ¼ turn. A tactile and/or audible indication that the engagement is complete is provided.

Abstract: A feed bag construction is provided comprising a feed bag, a first conduit sealed to the feed bag, a second conduit sealed to the interior of the feed bag for supplying wash reagent to the feed bag and a one piece cap that is removably mounted on the first conduit. The first conduit is provided with a hand operated butterfly valve to open or close the conduit.

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 region within the container that can contain liquid is funnel shaped, which allows very low fluid level mixing, dispensing while mixing, and a reduction or elimination of vortex formation.

Abstract: The invention relates to a liquid sample preparation device such as a disposable, collapsible, flexible polymeric bag containing an adsorptive curtain of a functionalized shaped polymeric fiber bed for the direct capture of biomolecules from liquid samples. The functionalized shaped polymeric fiber bed includes fibrillated, ridged or winged-shaped fiber structures that significantly increases the surface area of the fiber resulting in enhanced separation, retention and/or purification of liquid samples containing biomolecules of interest as the liquid samples contact the adsorptive curtain of functionalized shaped fibers. Liquid samples include unclarified liquid feeds or other liquids containing one or more biomolecules of interest, including, but not limited to vaccines, recombinant proteins, cells, stem cells, monoclonal antibodies (mAbs), proteins, antibody, peptides, oligopeptides, nucleic acids, oligonucleotides, RNA, DNA, oligosaccharides and polysaccharides.

Abstract: Adsorptive media for chromatography, particularly ion-exchange chromatography, derived from a shaped fiber. In certain embodiments, the functionalized shaped fiber presents a fibrillated or ridged structure which greatly increases the surface area of the fibers when compared to ordinary fibers. Also disclosed herein is a method to add surface pendant functional groups that provides cation-exchange or anion-exchange functionality to the high surface area fibers. This pendant functionality is useful for the ion-exchange chromatographic purification of biomolecules, such as monoclonal antibodies (mAbs).