Abstract: A method of aerosol integrity testing of filters, capable of detecting single defects that are less than 20 ?m in diameter, and even as small as 2 ?m in diameter, in liquid sterilizing grade filters such as filter cartridges. The method challenges the filter in a dry state with a particle stream of aerosol particles of the appropriate size and in the appropriate concentration, such that at least one or more of the particles in the stream will penetrate a defective region or regions within the membrane but will not penetrate in the integral region of the membrane. Wetting of the filter is not required.

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 invention relates to chromatography ligands having improved caustic stability, e.g., ligands based on immunoglobulin-binding proteins such as, Staphylococcal protein A, as well as methods of making and using such ligands.

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 relates to a process for increasing the observed titer of a virus stock for the purpose of increasing the calculated log reduction (LRV) in virus clearance studies. A tissue culture or assay plate is seeded with an indicator cell line and titrated with a virus stock followed, by a centrifugation step for about 5 minutes to about 24 hours at a g-force ranging from about 50×g to about 2400×g, and at a temperature from about 4° C. to about 39° C. The resulting calculated virus titer after undergoing the centrifugation step is 10-fold higher than the virus titer would be if determined in the absence of the centrifuging step.

Abstract: The device and method relate to microfluidic particle analysis. The device is designed for trapping particles for solution analysis. Exemplary particles include beads and cells. The device has a microfluidics body, and a microfluidics channel formed in the body for receiving particles at an upstream region thereof. The channel has a deformable wall portion that defines a particle-capture region, and is responsive to a change in fluid pressure applied thereto, to selectively vary the particle-flow dimensions of the capture region. In this way, particles having a given size may be selectively retained in the capture region. In one embodiment, the deformable wall portion is expandable in response to a positive fluid pressure applied within the channel. In another embodiment, the deformable wall portion is expandable in response to a negative pressure applied to a cavity communicating with the wall portion, external to the channel.

Abstract: The present invention is an alignment device for a bag containing one or more ports. The alignment device is attached to either the one or more ports or to the bag adjacent the one or more ports. The plate has an indicator or a unique outer edge shape that is designed to fit into a corresponding unique opening in a holder to ensure proper alignment of the bag and its port(s) in the holder. The plate is has a series of holes equal to and in alignment with the one or more ports of the bag and the port(s) extend through the holes of the plate.

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: 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: 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: 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 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: 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: 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.