Abstract: The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for providing a displacement of a rubber stopper for leakage testing of a connection between the rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.

Abstract: Provided are viral vector formulations comprising a globular protein such as an albumin Also provided are viral vector formulations comprising a polysaccharide such as an hyaluronic acid. The provided viral vector formulations have increased stability and reduced viral vector aggregation.

Abstract: A device for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat, a container carrier and a spacer. The plunger seat releasably holds the plunger in a predefined alignment. The container carrier is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer is arranged to position and align the plunger seat adjacent to and distant from the container carrier such that the opening of the container is open when the container is connected to the container carrier.

Abstract: The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for providing a displacement of a rubber stopper for leakage testing of a connection between the rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.

Abstract: A multi chamber syringe unit includes a longitudinal body with side wall, distal end side, proximal end side opposite to distal end side, an interior limited by side wall between distal end side and proximal end side and distal opening arranged in distal end side for providing a liquid out of the body. The syringe further includes a separating element arranged in the interior of the body such that distal chamber and proximal chamber are formed in the interior of the body, wherein the separating element seals the distal chamber from the proximal chamber. The syringe has a bypass arrangement provided in the side wall of distal chamber of the body. A first pharmaceutical liquid is arranged in distal chamber of the body and second pharmaceutical liquid in proximal chamber of the body. The multi chamber syringe unit allows for adequately administering plural pharmaceutical liquids by injection.

Abstract: The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for providing a displacement of a rubber stopper for leakage testing of a connection between the rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.

Abstract: The present disclosure provides a method of producing a population of lyophilized cells, comprising: (a) freezing a composition comprising a population of cells, an aqueous component, a polyol, a sugar, and a polysaccharide; and (b) removing at least 90% of the aqueous component from the frozen composition to produce the population of lyophilized cells. On some embodiments, the disclosure provides a method of producing a population of reconstituted viable cells, comprising: (a) freezing a composition comprising a population of cells, an aqueous component, a polyol, a sugar, and a polysaccharide; (b) removing at least 90% of the aqueous component from the frozen composition to produce the population of lyophilized cells, and (c) resuspending the population of lyophilized cells in a reconstitution agent to form a reconstituted composition, wherein at least 1% of the cells are viable.

Abstract: The present invention relates to a displacement device, DD, for providing a displacement of a syringe closure system for a syringe relative to the syringe, a testing device, TD, and a method for leakage testing of a connection of a syringe closure system for a syringe with the syringe.

Abstract: An inspection device (1) has a particle detector (3) adapted to detect particles (5) in a liquid, a seat (6) adapted to position a container (4) housing the liquid in an area of operation (311) of the particle detector (3) and a vibration arrangement (2) for vibrating the container (4). The vibration arrangement (2) comprises a frequency generator (21) adapted to provide an electrical signal and a transducer (22) adapted to transduce the electrical signal provided by the frequency generator (21) into an acoustic wave (221). The seat (6) is adapted to position the container (4) adjacent to the transducer (22). for inspecting a liquid inside a container (4) with respect to the existence of particles (5). The inspection device (1) allows for an accurate and gentle inspection of the liquid filled in the container and for detecting particles in the liquid.

Abstract: The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for leakage testing of a connection between a rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.

Abstract: The present disclosure is directed to in vitro methods for determining local tolerance. In some embodiments, the in vitro method is a miscibility test.

Abstract: The present invention relates to a testing device for testing the moving force of a plunger of a syringe, comprising a fixture, FX, (3) for holding a syringe (8) in the testing device, TD, (1) for moving force testing, wherein the fixture (3) comprises an annular holding element, AHE, (5) for holding part of the syringe (8), and a support frame, SF, (30) having a support plate, SP, (300) for supporting the annular holding element, AHE, (5), wherein the annular holding element, AHE, (5) is detachably connected to the support plate, SP, (300) via an indirect connection via at least one intermediate element, IE, (10) between the at least one annular holding element, AHE, (5) and the support plate, SP, (300), wherein one intermediate element, IE, (10) is a tempering cylinder, TC, (7) for tempering at least part of the syringe (8). The invention further relates to a method for testing the moving force of a plunger of a syringe.

Abstract: An inspection device has a particle detector adapted to detect particles in a liquid, the particle detector preferably including a camera. The inspection device including a seat adapted to position a container housing the liquid in an area of operation of the particle detector and a vibration arrangement for vibrating the container. The vibration arrangement includes a frequency generator adapted to provide an electrical signal and a transducer adapted to transduce the electrical signal provided by the frequency generator into an acoustic wave. The seat is adapted to position the container adjacent to the transducer for inspecting a liquid inside a container with respect to the existence of particles. The inspection device allows for an accurate and gentle inspection of the liquid filled in the container and for detecting particles in the liquid.

Abstract: The present invention relates to a displacement device, DD, for providing a displacement of a syringe closure system for a syringe relative to the syringe, a testing device, TD, and a method for leakage testing of a connection of a syringe closure system for a syringe with the syringe.

Abstract: The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for providing a displacement of a rubber stopper for leakage testing of a connection between the rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.

Abstract: The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for leakage testing of a connection between a rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.

Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Abstract: A dosing system for transferring an aseptic fluid in dosages into a container, comprising a peristaltic pump configured such that the filling accuracy for fill volumes of the aseptic fluid <100 ?L is ±3 ?L.

Abstract: A method of preparing a double chamber container is disclosed that includes filling a substance into the container, freeze-drying the substance therein, inserting a middle plunger in the container to form distal and proximal chambers, wherein the middle plunger seals the distal chamber from the proximal chamber and the freeze-dried substance is inside the distal chamber. The method includes filling a reconstitution medium in the proximal chamber, and sealing distal and proximal openings of the container. The method includes providing a holder having a seat and arranging the container in the seat in an upright position wherein a distal end side of the container extends downwardly and a proximal end side of the container extends upwardly. The container is arranged in the seat while the substance is filled, the substance is freeze-dried, the middle plunger is inserted, the reconstitution medium is filled, and the proximal opening is sealed.

Abstract: The present disclosure provides compositions, methods, and kits for detecting lipolytic activity. In some embodiments, the composition comprises an aqueous assay sample and an organic solvent, wherein the organic solvent comprises 4-methylumbelliferyl oleate (4MuO). Also provided herein are methods for determining the stability of a protein preparation.