Abstract: A container for transporting and/or processing a biopharmaceutical fluid, the container comprising a wall, the wall comprising a shape memory material being adapted to change shape when induced by an external stimulus, so that the container can be alternately in a collapsed state and in an unfolded state, the wall of the container in the unfolded state delimiting an internal cavity adapted to contain the biopharmaceutical fluid.

Abstract: The present invention relates to a multiparameter lateral flow strip (1), comprising a microporous membrane layer (2) supported on a liquid-impermeable support layer (3), for lateral flow of a liquid through the microporous membrane layer (2), wherein the microporous membrane layer (2) has two or more flow lanes (4) in the direction of lateral flow, wherein said two or more flow lanes (4) are separated by hydrophobic separation channels (5), and wherein each of said two or more flow lanes (4) comprises a detection spot (6) including a binding agent, wherein said two or more flow lanes (4) are isomorphic lanes. Furthermore, the present invention relates to a multiparameter lateral flow immunoassay device comprising said multiparameter lateral flow membrane (1), the use of said multiparameter configured lateral flow membrane (1) in an immunological test, as well as to a method for the manufacture of said multiparameter configured lateral flow membrane (1).

Abstract: The present invention relates to a diatomaceous earth composition with a low endotoxin content, comprising an agglomerated mixture of calcined diatomaceous earth particles and water, wherein the mass ratio of calcined diatomaceous earth particles and water is in the range of 1:1.0 to 1:2.0, and wherein the endotoxin content of the diatomaceous earth composition is equal to or less than 0.5 EU/mL. In a further aspect, the present invention relates to a method for producing the diatomaceous earth composition with a low endotoxin content. In another aspect, the present invention relates to the use of the diatomaceous earth composition with a low endotoxin content as a precoat agent for the precoat filtration in biopharmaceutical applications.

Abstract: A method of molding an article includes positioning a dissolvable insert within a mold, filling the mold with material to form an article within the mold and about the dissolvable insert, and at least partially dissolving the dissolvable insert from within the article. The dissolvable insert forms internal features of the article and includes a porous core.

Abstract: Integrity of a flexible bag already filled with a biopharmaceutical fluid is verified by a receiving and controlling device. The first wall and a second wall, forming two opposite walls on both sides of a longitudinal axis of the bag, are in contact with the fluid and with two parallel restraining plates of the device, while test pressure is controlled. Additionally, an integrity/non-integrity indicator device that comprises a pair of covering walls is provided to be interposed between the bag walls and the restraining plates. A leak through the bag walls can be detected by a color change of at least one continuous colorimetric detection layer, integral with or included in the pair of covering walls. Such continuous colorimetric detection layer is included in a permeable or impregnable layer.

Abstract: A method for providing an integrity test of a double filter capsule can include providing the double filter capsule in such a way that in a filtration process the medium to be filtered flows in its flow direction from an upstream chamber in the housing through a first filter into an intermediate chamber between the first filter and a second filter and then through the second filter to an outlet. The housing can have an upstream-chamber access point for feeding a test fluid into the upstream chamber and an intermediate-chamber access point for feeding the test fluid into the intermediate chamber. Additional steps can include providing a connecting line between the upstream-chamber access point and the intermediate-chamber access point and determining the state of integrity of the double filter capsule on the basis of at least two test phases.

Abstract: A method for mounting at least one component on an installation includes attaching a carrier directly or indirectly to the installation, where the installation has at least one frame with at least two arms, at least one base plate, and at least one deformable element. The method further includes displacing the component toward the deformable element such that the deformable element is displaced from a receiving state (AUZ), in which the deformable element is ready to receive the component of the installation, toward a locked state (ARZ), as a result of which the deformable element surrounds and mounts the component of the installation at least in part.

Abstract: A valve setup for SMB chromatography includes a cassette block, a control block, a swiveling door, and a flexible pressurizing tube. The cassette block is configured to control each of a plurality of valves when an operation surface is in close contact with a control surface of the cassette block. The swiveling door is hinged to the valve control block such that an open state of the door arranges the cassette block such that the control surface is at the operation surface of the control block, and a closed position holds the cassette block with an inner surface of the swiveling door abutting a rear surface of the cassette block opposite the control surface. The flexible pressurizing tube is arranged at the inner surface of the swiveling door so the pressurizing tube presses against the rear surface of the cassette block when the pressure in the tube is increased.

Abstract: A device (1) and method for media filtration with a preparation container (2). A chamber (5) containing a dissolvable medium (29) is situated between the container inflow and outflow, and has a filter (22). A mixing arm (6, 7), connected to the inflow, protrudes into the medium in the chamber with at least one mixing nozzle (19, 20), disposed at the free end (17, 18) of the mixing arm for generating a directed jet of solvent. The preparation container has bottom (10) and top (8) parts bracketing the chamber. The filter is a sterile, has on the filtrate side facing the outflow, a circumferential outer edge (23) resting on a circumferential rest edge (37) of the bottom part of the preparation container and is connected fixedly thereto. A sterilised filtrate space (39) is formed between the filtrate side (38) of the filter and the outflow situated in the bottom part.

Abstract: A tilting mechanism including a base, a tilting deck, four hinges, and a lifting member. Each hinge is positioned adjacent a corner of the base and the tilting deck. Each hinge includes a globe and a receiver with the globe or the receiver secured to the base frame or the deck frame and the other secured to the other of the base or the tilting deck. Each hinge includes a locking member that selectively secures a globe within a respective receiver. The lifting member is secured at a center of the base frame and a center of the deck frame. The lifting member is configured to urge the tilting deck away from the base such that selective engagement allows for tilting of the tilting deck relative to the base in at least four directions.

Abstract: A chromatography system is provided. The chromatography system is configured to process a feed fluid containing a plurality of components, wherein at least one component of the plurality of components of the feed fluid is a target component. The chromatography system comprises: a flow path comprising a plurality of fluid control components configured to control a fluid flow; a stationary phase, wherein the stationary phase is at least one membrane adsorber connected to the flow path and the stationary phase is configured to isolate the target component. The flow path is configured such that harvesting of the target component is optimized.

Abstract: A computer-implemented method can configure and/or setup and/or control a downstream process for processing a biomass, including receiving at least one measurement value of at least one feature of an upstream process by which the biomass to be processed in the downstream process has been obtained and/or of at least one feature of a downstream process stage or operation, determining at least one downstream process parameter based on the received at least one measurement value, arid configuring and/or setup and/or controlling at least one downstream process stage or process operation based on the determined at least one downstream process parameter.

Abstract: The invention relates to a protective housing for a biopharmaceutical liquid bag having a lower shell with a bottom and side walls, and an upper shell. The upper shell includes a housing for receiving the bag, and can be inserted into the lower shell, in such a way that the opening of the housing is adjacent to and facing the bottom of the lower shell, and in such a way that the upper shell is laterally held in place between the side walls of the lower shell.

Abstract: Integrity of a flexible bag is verified by a testing system, using helium to detect existence of a possible hole. The flexible bag is preliminary placed in vacuum chamber of a fluid-tightly isolated enclosure. After connecting a port of the bag to a helium feeding pipe, vacuum suction is performed to obtain vacuum outside the bag in the enclosure. Then, a first amount of helium is diffused in the internal volume of the enclosure through a gas permeable wall, to increase helium partial pressure outside the flexible bag. After, in a test phase while said vacuum suction is still performed, the bag is filled with a second amount of helium. A detector detects information representative of helium partial pressure in the internal volume, to allow detection of helium escaping from the bag, by analysis of a helium partial pressure drop.

Abstract: The present invention relates to isolated nucleic acid molecules, comprising a functional mammalian EGR-1 (early growth response protein 1) promoter region that is operatively linked to a gene encoding a fluorescent protein and controls expression of said gene. The present invention further relates to nucleic acid vectors, comprising said nucleic, cells comprising said nucleic acids or vectors, being capable of sensing and indicating fluid shear stress acting on themselves, and methods of generating the same. Furthermore, the present invention relates to methods of evaluating fluid shear stress acting on cells in real-time during the operation of a biotechnological device or system, methods of evaluating a biotechnological device or system with respect to fluid shear stress acting on cells caused by operation of said device or system, and methods of designing a biotechnological device or system, said methods using said cells.

Abstract: Determining optimum operating binding capacity for a MCC process using one column, the process including N number of columns, comprises loading target product on a first column at a first residence time and/or flow rate; loading the product on the column at a second residence time and/or flow rate, the first residence time and/or flow rate being different than the second residence time and/or flow rate; generating a first breakthrough curve for the first residence time and/or flow rate and a second breakthrough curve for the second residence time and/or flow rate, wherein the first curve represents product breakthrough for the first column and the second curve represents product breakthrough for an Nth column; and using the curves to determine product loading capacity of the first column before product breakthrough at the Nth column; the product loading capacity of the first column equaling optimum operating binding capacity for the process.

Abstract: The present invention relates to an improved diatomaceous earth composition containing salt water. The diatomaceous earth composition according to the present invention comprises an agglomerated mixture of calcined diatomaceous earth particles, water and at least one inorganic salt, wherein the mass ratio of the calcined diatomaceous earth particles and water is in the range of 1:1.0 to 1:2.0, and wherein the content of the at least one inorganic salt is equal to or more than 0.25 parts by mass based on 100 parts by mass of water. In a further aspect, the present invention relates to a method for producing the diatomaceous earth composition according to the present invention. In another aspect, the present invention relates to the use of the diatomaceous earth composition according to the present invention as an agent for precoat filtration or dynamic body feed filtration in biopharmaceutical applications.

Abstract: A bioreactor (1; 2; 3) includes a receiving container (10) for receiving a disposable bag (44). A bottom surface (11) of the receiving container (10) is designed to support the disposable bag (44) in the receiving container (10). An outlet opening (5) is formed in the bottom surface (11) and tapers down with respect to the ground for receiving a drain port (45) of the disposable bag (44). The drain port is complementary to the outlet opening (5).

Abstract: An analysis container includes an outer tube and a plurality of inner tubes. The outer tube defines a buffer volume that is configured to receive a buffer material. The plurality of inner tubes is disposed within the buffer volume. Each inner tube has an inner diameter equal to or less than 6 mm and is configured to receive a biopharmaceutical composition therein. The outer tube is configured such that the buffer material and the biopharmaceutical composition are axially frozen.

Abstract: An assembly is provided that comprises: a valve cassette block (20) comprising a plurality of valves (25) which are controllable via a control surface (24) of the valve cassette block (20); a valve control block (10) having an operation surface (11), the valve control block (10) being configured to control each of the plurality of valves when the operation surface (11) is in close contact with the control surface (24) of the valve cassette block (20) in an operation position; at least one swiveling door (30) hinged to the valve control block (20) such that an open state of the swiveling door (30) allows arranging the valve cassette block (20) into the operation position with its control surface (24) arranged at the operation surface (11) of the valve control block, while a closed position of the swiveling door (30) is configured to hold the valve cassette block (20) in the operation position with an inner surface of the swiveling door (30) abutting a rear surface (26) of the valve cassette block (20) oppos