Abstract: Filter elements for perfusion systems and methods are provided. A filter element sheet includes a microporous membrane having a mean pore size of at least about 0.65 ?m and a feed spacer comprising woven fibers and having an open area of at least about 35%. The filter element sheet can be arranged within a filter element, for example, in a spiral-wound format or in a cassette format. A perfusion system includes at least one filter element and a pump configured to control flow of a liquid feed through the at least one filter element.

Abstract: The invention concerns an installation for treating biological liquid by viral inactivation, comprising a main supply valve (4) for suppling biological liquid to treat, a first line (2) downstream of said valve and provided with a first main tank (7), a second line (3) downstream of said valve and provided with a second main tank (14), said second line being in parallel with said first line, and a third main tank (11) disposed at an outlet both from said first line and said second line and configured to be successively supplied by said first main tank and by said second main tank; said installation being configured such that in each of said first, second and third main treatment tanks, a determined volume of acid and a determined volume of base are introduced at least so as to adjust a pH of said biological liquid and to regulate a rate of drainage flow of said third main treatment tank so as to provide a continuous rate of flow of treated biological liquid at an outlet from said installation.

Abstract: A funnel-less filtration device that attaches directly to a storage container such as a cell culture media bottle. The device includes a filter collar containing one or more membranes, an inlet with a coupling device for attaching the filter device to a supply of liquid to be filtered, an outlet at a lower portion of the collar, a vacuum port in the collar below the membrane(s) and a filtered vent in the collar above the membrane(s). Optionally, the device may include a filtrate reservoir attached to the outlet, preferably by a threaded connection. Optionally, the upper opening to the filter collar is selectively and removably sealed with a lid until used. The lid is then removed the filter device inverted over a storage container such as cell culture media bottle and the two are attached via the upper opening of the filter collar. The assembly is then inverted so the supply container is above the filter device.

Abstract: A sample can be collected from an enclosed container by opening a sample collection valve and drawing the sample from the enclosed container. After delivery of the sample out of a fluid flow path, a sanitizing fluid can be directed along the fluid flow path to sanitize the fluid flow path.

Abstract: A depth filtration device for the clarification of biological fluids including a composite depth filter media having a nonwoven first layer integral with a second layer containing a polyacrylonitrile (PAN) fibers, a filter aid, and a wet-strength resin. The depth filter media exhibits increased binding capacity for soluble impurities such as DNA and host cell proteins from biological/cell culture feedstreams during secondary clarification and low-level impurity clearance of harvested cell culture fluids, such as those used for the manufacture of monoclonal antibodies. The depth filter media additionally exhibits significantly lower flushing requirements, resulting in lower levels of organic, inorganic and bioburden extractables released, high dirt holding capacities and good chemical and/or radiation resistance.

Abstract: A scaling tool for replicating filtration characteristics of a large-scale filtration device, the scaling tool comprising a housing having a fluid inlet and a fluid outlet, and a filter receiving region in fluid communication with the fluid inlet and the fluid outlet and configured to contain a membrane comprising one or more pleats, the filter receiving region being defined by a rigid wall framework configured to hold the one or more pleats of the membrane and compress the pleats in an amount effective to replicate the filtration performance of the large-scale filtration device. Also disclosed is a methodology for configuring a filter receiving region in a scaling tool.

Abstract: Methods of maintaining narrow residence time distributions in continuous flow systems, particularly applicable to virus inactivation such as during a protein purification process. Fluid sample is introduced into an axial flow channel and caused to flow therein in discrete packets or zones to minimize residence time distribution and axial dispersion. Embodiments described herein obviate or minimize the need for using large tanks or reservoirs for performing virus inactivation during a protein purification process; reduce the overall time required for virus inactivation, and/or reduce the overall physical space required to perform the virus inactivation operation during a protein purification process, which in turn reduces the overall footprint for the purification process.

Abstract: The invention relates to the filtering of liquid samples, preferably in a laboratory environment, for example for collecting micro organisms from the liquid sample for subsequent testing. The invention provides a method for filtering a liquid sample which comprises providing a blank of a deformable sheet material and a filtration medium, deforming the blank to form a funnel extending above and about the filtration medium, introducing the liquid sample to be filtered into the so formed funnel, and filtering the liquid sample from the funnel through the filtration medium, for example to a downstream receptacle. The method is accordingly based on the concept that the funnel is not or at least not completely preformed but provided in a form of a blank of a deformable material sheet which is deformed so as to form the funnel at the point and time of use during filtration.

Abstract: Treatment methods for reduction of (1?3)-?-D-glucan leachables from cellulose-containing filter materials are described.

Abstract: A valve having a body having a first section and a second section; an extended flange attached to the second section of the body or disposed as an integral part of the second section of the body; an elongate bore extending through the body and having a proximal end and a distal end; a longitudinally displaceable plunger disposed in and extending along the bore, the plunger having a proximal end and a distal end and having a first position displaced toward the distal end of the bore and a second position displaced toward the proximal end of the bore; a diaphragm seal attached to the proximal end of the plunger and sealing the bore at the proximal end thereof; a gland seal sealing the bore at a location intermediate the diaphragm seal and the distal end of the bore; the plunger extending through and being sealingly secured to the gland seal; a fluid transfer opening in the bore between the diaphragm seal and the gland seal; longitudinal displacement of the plunger moving the diaphragm seal to open the bore, the

Abstract: Processes and systems for filtering a liquid sample are provided. Batches of a liquid sample can be routed to two or more cycling tanks (e.g., first and second cycling tanks). Upon filling a first cycling tank, a first batch of the liquid sample can be routed to a filtration assembly by a continuous diafiltration process that includes routing produced retentate back to the first cycling tank or to a collection vessel. Upon filling a second cycling tank, a second batch of the liquid sample is routed to the filtration assembly by a continuous diafiltration process that includes routing produced retentate back to the second cycling tank or to the collection vessel. The filling and continuous diafiltration of batches of the liquid sample continues to alternate between the two or more cycling tanks until a total product volume is processed.

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 invention concerns an installation for treatment of biological liquid by chromatography, extending in a longitudinal direction and comprising a supply valve (20b), a supply pump (30) downstream of the valve, instrument members downstream of the pump including distribution valves (81a-c, 82a-c, 83a-c) and devices (78a-c, 85a-c, 86a-c) for measuring physico-chemical parameters of the liquid, chromatography columns (99a-c) downstream of the instrument members and pipes connecting the valve, the pump, the instrument members and the columns so as to form at least one supply line for biological liquid to treat of a treatment circuit of said installation, the chromatography columns being disposed relative to each other in a direction of extension generally transverse to said generally longitudinal direction of extension of the installation.

Abstract: A depth filtration device for the clarification of biological fluids including a composite depth filter media having a nonwoven first layer integral with a second layer containing a polyaeryionitrile (PAN) fibers, a filter aid, and a wet-strength resin. The depth filter media exhibits increased creased binding capacity for soluble impurities such as DNA and host eel! proteins from biological/cell culture feed-streams during secondary clarification and low-level impurity clearance of harvested cell culture fluids, such as those used for the manufacture of monoclonal antibodies. The depth filter media additionally exhibits significantly lower flushing requirements, resulting in lower levels of organic, inorganic and bioburden extractables released, high dirt holding capacities and good chemical and/or radiation resistance.

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 affecting the yield of the desired protein product.

Abstract: A needle protector, having a flexible material, a pocket defining an internal volume, a wrapping strap having a plurality of holes, and a main body disposed between the pocket and the wrapping strap; at least one rigid body or cylinder for placement within the internal volume; and; a pin for placement within one of the plurality of holes, wherein the pin is capable of releasably locking the pocket and the main body when the wrapping strap is wrapped around the pocket and the main body.

Abstract: Filtration apparatus for the assay of biological and biochemical reactants, for example, is provided and includes a substrate such as a plate having one or more wells open at each end, and a porous membrane positioned in each well forming a discrete filtering area. The filtration apparatus includes a seal that is in a compressible relationship with the face of the porous membrane, the surface of the compression element, and the well wall. Each well includes a compression element, such as an internal well insert or sleeve, which compresses the seal so that the seal contacts the membrane face, the surface of the compression element, and the well wall in a liquid-tight manner. The compression element may be configured so that it is fixed in the well such as by an interference fit with the well wall or by bonding to a surface of the substrate.