Abstract: A laminate is provided comprising at least one polysulfone and/or polyethersulfone porous membrane heat bonded to a polyvinylidene fluoride substrate.

Abstract: The present invention provides novel and improved protein purification processes which incorporate certain types of carbonaceous materials and result in effective and selective removal of certain undesirable impurities without adversely effecting the yield of the desired protein product.

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: 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 retroviruses from liquid samples and a nanofiber containing liquid filtration medium that simultaneously exhibits high liquid permeability and high microorganism retention is disclosed. Retroviruses are removed from a liquid by passing the liquid through a porous nanofiber containing filtration medium having a retrovirus LRV greater than about 6, and the nanofiber(s) has a diameter from about 10 nm to about 100 nm. The filtration medium can be in the form of a fibrous electrospun polymeric nanofiber liquid filtration medium mat.

Abstract: A disposable device for the sterile transfer of fluids, such as liquids or gases, includes a body, a bore formed through at least a portion of the interior of the body, and a linearly moveable plunger contained within the bore. The body is formed from a rotating section and a stationary section. Partial rotation of the rotating section around a portion of the stationary section and the plunger drives the plunger linearly within the bore, opening and closing the device. The plunger includes at least a first and a second opening, and a fluid channel in the interior of the plunger connecting the first and second openings forming a fluid pathway to downstream components when the device is open. A termination component at one end of the plunger connects to a downstream component. A flange at one end of the body attaches to an upstream component.

Abstract: The present invention relates to a selectively soluble polymer capable of binding to a desired molecules in an unclarified mixture containing various biological materials and the methods of using such a polymer to purify a molecule from such a mixture. The polymer is soluble in the mixture under a certain set of process conditions such as pH or temperature and/or salt concentration and is rendered insoluble and precipitates out of solution upon a change in the process conditions. The polymer is capable of binding to the desired molecule (protein, polypeptide, etc) and remains capable of binding to that molecule 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 such as by elution and further processed.

Abstract: The present invention provides, in various embodiments, hybrid single-pass tangential flow filtration assemblies, disposable single-pass tangential flow filtration assemblies, scalable single-pass tangential flow filtration assemblies and adaptable modular single-pass tangential flow filtration assemblies. In other embodiments, the invention relates to processes for recovering proteins from the surface of a filtration membrane in a single-pass tangential flow filtration assembly and for cleaning a tangential flow filtration assembly. In additional embodiments, the invention provides methods of increasing the processing capacity of a single-pass tangential flow filtration assembly.

Abstract: Redundant filtration system that includes at least one barrier filter as a process filter, the barrier filter having both hydrophilic and hydrophobic paths, allowing both fluid and gas permeability. The need for vents is eliminated, as is an intermediate drain filter. The device also can be dried in series. The filtration system includes a network of conduits and receptacles, the network receiving liquid raw and/or starting material at one end, conducting it through the process stream defined thereby, and producing the desired liquid product at another end. The network is provided with one or more inputs for introducing liquid raw material into the fluid process stream, and one or more output ports for discharging fluid out of the fluid process stream. The network is preferably an essentially closed network, and also, preferably sterile and/or aseptic.

Abstract: A method of filtering a liquid feed is described, comprising passing a liquid feed through a single pass tangential flow filtration (SPTFF) system and recovering the retentate and permeate from the system in separate containers. A method of filtering a liquid feed is also described comprising passing a liquid feed through a tangential flow filtration (TFF) system, recovering permeate and a portion of the retentate from the system in separate containers without recirculation through the TFF system, and recirculating the remainder of the retentate through the TFF system at least once. The methods of the invention can be performed using an SPTFF or a TFF system that comprises manifold segments to serialize the flow path of the feed and retentate without requiring diverter plates.

Abstract: The method comprises the step of forming pipes (12) by clamping a bag between shells (13, 14) and by injecting an inflating agent via an inflating connector. The circuit comprises a bag (126) and a press (10) comprising two shells (13, 14) clamping said bag in a state in which pipes (12) are formed between the films (25, 26) of the bag.

Abstract: A micro-incubator manifold for improved microfluidic configurations and systems and methods of manufacture and operation for a manifold and automated microfluidic systems are disclosed. Various embodiments relate to assays, systems, and/or devices for culturing cells or other biologic material in controlled environments and are applicable to related fields generally using microfluidic systems. Particular embodiments involve configurations that can be used with various standard automated handling systems, with active or passive loading and perfusion of medium and to provide high-throughput multi-assay automated systems for culturing, viewing, and analyzing cell growth, invasion, movement, chemotaxis or other properties. More specifically, specific embodiments relate to heat control systems for microfluidic culture plates and other automated systems for culture plates.

Abstract: A number of novel improved microfluidic configurations and systems and methods of manufacture and operation for a microfluidic invasion assay system.

Abstract: A valved microfluidics device, microfluidics cell-culture device and system incorporating the devices are disclosed. The valved microfluidics device includes a substrate, a microchannel through which liquid can be moved from one station to another within the device, and a pneumatic microvalve adapted to be switched between open and closed states to control the flow of fluid through a microchannel. The microvalve is formed of three flexible membranes, one of which is responsive to pneumatic pressure applied to the valve and the other two of which deform to produce a more sealable channel cross-section. The cell culture device provides valving to allow controlled loading of cells into the individual well of the device, and exchange of cell-culture components in the wells.

Abstract: A removable device that ensures that the port of a filter cartridge is liquid tightly sealed to the port of the head of a housing even when there is insufficient room beneath the bowl to allow one to physically secure the cartridge port to the head port before securing the head and bowl together. The invention uses one or more removably attached alignment devices to center the cartridge in the bowl and maintain it at a height sufficient to ensure that the two ports are aligned and liquid tightly sealed to each other when the bowl and head are mated together.

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: A graphical user interface on a computer provides for the analysis of location specific data and the presentation of analysis results for visual comparison by a user. Results of the analysis are visually presented as icons subdivided into regions and arranged in such a way that the user is able to associate each icon with a data location. A visual presentation of results in the icons and regions allows a user to visually compare the analysis results in two or more data sets according to location. The graphical user interface further provides for the definition and adjustment of an analysis through the interaction of a user with a graphical representation of the analysis. In some cases, the visual presentation of results tracks the analysis adjustments so the user can visually observe the effects that the adjustments have on the results. A method of interacting with the interface to define an analysis and represent results and a method of presenting two or more data sets using the interface are described.

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: A number of novel improved microfluidic configurations and systems and methods of manufacture and operation. In one embodiment, three wells are used for independent cell culture systems in a cell culture array. In a second aspect, artificial sinusoids with artificial epithelial barriers are provided with just one (optionally shared or multiplexed) fluidic inlet and one (optionally shared or multiplexed) fluidic output, where the medium output also functions as a cellular input. A pneumatic cell loader combined with other components provides a fully automated cell culture system. Magnetic alignment of plate molds provides advantages and ease of molded manufacture.

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.