Abstract: The present invention relates to a computer implemented method for determining a weld integrity test result performed by a system configured to aseptically transferring cells to a container (BR), the method comprising welding (710) a vial to a connector to obtain a fluid-tight seal between the vial (V) and a connector (C), the connector being provided with a pair of conduits each having one end protruding through the connector and into the vial, sealing (720) an opposite end of one of the conduits, generating (730) a fluid pressure different to an ambient fluid pressure at an opposite end of the other conduit, measuring (740) a fluid pressure within at least one of the conduits, determining (750) a fluid pressure change based on the ambient pressure and the measured fluid pressure, determining (760) the weld integrity test result as pass or as fail based on the fluid pressure change.

Abstract: Methods for selecting a filter for a filtration process are described. Input data is received, and based on the input data, one or more filter characteristics for each of a plurality of filter candidates for a filtration process are identified. Process parameters of the filtration process are identified. A computer-implemented simulation process of the filtration process for each of the plurality of filter candidates is performed, based on the identified process parameters and identified filter characteristics. One or more output characteristics of the filtration process are determined based on the simulation. A filter candidate of the plurality of filter candidates is selected based on the one or more output characteristics.

Abstract: A microfluidic device (100) is disclosed for in-process monitoring of cell culture conditions including for example one or more of: cell density; cell viability; secreted proteins; protein analysis; epitope markers; concentrations of metabolites or nutrients and antigenic determinations; the device comprising: a cell inlet path (120); plural fluid reservoirs (130) in fluid communication with the cell input path, a cell analysis area (160) in fluid communication with the path and reservoirs, and a waste storage volume (166) also in fluid communication with the cell analysis area, the device being operable to cause a primary fluid flow along the inlet path to the analysis area, and to selectively cause secondary fluid flow(s) into the path from none, one or more of the selected reservoirs to combine, if one or more of the reservoirs are selected, with the primary fluid flow from the cell inlet path, in each case for analysis at the cell analysis area, the device being further operable to cause a fluid flow of t

Abstract: Disclosed is an in-process cell monitoring device comprising: a flow channel having at least one inlet and at least one outlet exposeable to a cell culture; a microscope positionable to view the contents of a region of the channel; and a computer operable at least to count any cells in the region, providing a closed fluid circuit for cell monitoring. Disclosed also is a bioreactor including a cell culture volume, and an in-process cell monitoring device, said device comprising: a flow channel having at least one inlet and at least one outlet each in fluid communication with the volume, of sufficient cross-sectional area to allow fluids to drain from the inlet to the outlet; and a microscope positionable to view the contents of a region of the channel, and also A method for monitoring a cell culture including determining cell density.

Abstract: The present invention relates to a computer implemented method for determining a weld integrity test result performed by a system configured to aseptically transferring cells to a container (BR), the method comprising welding (710) a vial to a connector to obtain a fluid-tight seal between the vial (V) and a connector (C), the connector being provided with a pair of conduits each having one end protruding through the connector and into the vial, sealing (720) an opposite end of one of the conduits, generating (730) a fluid pressure different to an ambient fluid pressure at an opposite end of the other conduit, measuring (740) a fluid pressure within at least one of the conduits, determining (750) a fluid pressure change based on the ambient pressure and the measured fluid pressure, determining (760) the weld integrity test result as pass or as fail based on the fluid pressure change.

Abstract: A monitoring system comprises a manufacture system with capability to manufacture a plurality of biopharmaceutical products, at least one image capture device arranged to capture a scene comprising the manufacture system, and a processing element connected to said at least one image capture device and arranged to process images captured by said at least one image capture device to track operator interactions and/or a result of operator interactions within the scene. The processing element is further is arranged to compare a predefined workflow process scheme relating to the selected biopharmaceutical product to at least a part of the tracked operator interactions with the manufacture system and/or to at least a part of the result of the tracked operator interactions with the manufacture system, and determine whether at least one pre-set criterion set by the workflow process scheme is fulfilled based on the comparison.

Abstract: Methods for selecting a filter for a filtration process are described. Input data is received, and based on the input data, one or more filter characteristics for each of a plurality of filter candidates for a filtration process are identified. Process parameters of the filtration process are identified. A computer-implemented simulation process of the filtration process for each of the plurality of filter candidates is performed, based on the identified process parameters and identified filter characteristics. One or more output characteristics of the filtration process are determined based on the simulation. A filter candidate of the plurality of filter candidates is selected based on the one or more output characteristics.

Abstract: The present invention relates to a novel bioreactor system for cell cultivation. More specifically, the invention relates to a compact bioreactor system which has several integrated functions and enables small scale static culture as well as scale-up rocking culture in the same bioreactor. The bioreactor system comprises tray for positioning of a cell culture bag having adjustable volume, a lid covering the cell culture bag and provided with heating function, an integrated perfusion unit, an integrated cell loading unit, and an integrated unit for automatic cell culture sampling, wherein the bioreactor system is controlled by a single control unit. The invention also relates to a method of cell culture using the bioreactor system for culture of therapeutic cells.

Abstract: A microfluidic device (100) is disclosed for in-process monitoring of cell culture conditions including for example one or more of: cell density; cell viability; secreted proteins; protein analysis; epitope markers; concentrations of metabolites or nutrients and antigenic determinations; the device comprising: a cell inlet path (120); plural fluid reservoirs (130) in fluid communication with the cell input path, a cell analysis area (160) in fluid communication with the path and reservoirs, and a waste storage volume (166) also in fluid communication with the cell analysis area, the device being operable to cause a primary fluid flow along the inlet path to the analysis area, and to selectively cause secondary fluid flow(s) into the path from none, one or more of the selected reservoirs to combine, if one or more of the reservoirs are selected, with the primary fluid flow from the cell inlet path, in each case for analysis at the cell analysis area, the device being further operable to cause a fluid flow of t

Abstract: The present invention relates to a novel bioreactor system for cell cultivation. More specifically, the invention relates to a compact bioreactor system which has several integrated functions and enables small scale static culture as well as scale-up rocking culture in the same bioreactor. The bioreactor system comprises tray for positioning of a cell culture bag having adjustable volume, a lid covering the cell culture bag and provided with heating function, an integrated perfusion unit, an integrated cell loading unit, and an integrated unit for automatic cell culture sampling, wherein the bioreactor system is controlled by a single control unit. The invention also relates to a method of cell culture using the bioreactor system for culture of therapeutic cells.