Abstract: A device assembly for calibrating a single-use sensor before, during or after a biopharmaceutical manufacturing process step including a single-use process equipment assembly for performing at least a part of the process step. The single-use process equipment assembly includes a flow line through which a medium flows in a defined direction during the process step and an integrated single-use sensor for measuring or detecting a property at a measurement location in the flow line. The device assembly includes a calibration line and a switch inserted into the flow line upstream of the measurement location. The switch includes a flow line inlet, a flow line outlet, and a calibration line inlet connected to the calibration line. The switch selectively switches between a first (main) flow path and a second (calibration) flow path. The device assembly includes a dedicated reference sensor, reference source, or reference standard solution in the calibration line.

Abstract: A bioreactor includes a rigid-walled vessel for containing a biological medium, the vessel having a lid. The bioreactor further includes a probe passing through an aperture in the lid and having a sensing end inside the vessel and a remote end outside the vessel. The sensing end has plural electrodes for immersion in the biological medium, and the remote end is configured for coupling to external devices and transmission thereto of electrical or electromagnetic measurements made by the electrodes. One of the lid and the probe has one or more resiliently deformable mechanisms and the other of the lid and the probe has one or more respective complementary surfaces.

Abstract: A device for mechanically stabilizing a sensor port on a flexible bag including a rigid, substantially plate-shaped support part, which has a receptacle for a rigid connecting part integrated in the bag, in particular a sensor, and a holding mechanism on the receptacle. The device further includes a fastening element adapted to be attached to the holding mechanism of the support part such that it fixes the support part to the connecting part. The device may include a rigid support part which can be assembled from at least two parts, preferably struts. The parts surround a free area or an opening in which a rigid connecting part integrated in the bag can be placed. In an assembled state of the parts, the free area or the opening has a smaller diameter than the connecting part, so that the parts form a load-receiving mechanism for the connecting part.

Abstract: A bioprocess device assembly includes at least a first bioreactor and a second bioreactor, and a transfer system for transferring a certain volume of a medium contained in the first bioreactor into the second bioreactor. A biomass sensor is associated to the first bioreactor. A control unit is configured for receiving measurement data from the biomass sensor and controlling the transfer system. An inoculation method makes use of such a device assembly wherein the biomass sensor measures at least one parameter of biomass contained in the first bioreactor; the biomass sensor sends measurement data to the control unit; and the control unit evaluates the measurement data and, based on an evaluation of the measurement data decides whether the viable cell density is sufficient for inoculation, determines a necessary inoculation volume, and controls the transfer system to transfer the determined inoculation volume from the first bioreactor into the second bioreactor.

Abstract: A modular system for providing a bioprocess device assembly including a rigid skid and grid-modules. The skid includes identical plug-in structures arranged in a regular two-dimensional grid. The grid arrangement defines two-dimensional plug-in fields. At least some of the grid-modules have a matching counterpart plug-in structure. At least some of the grid-modules, in an installed state, have a two-dimensional extension in the plane of the grid that is not greater than a standard size of the plug-in fields. At least some of the grid-modules include a connection port to receive a rigid universal flow connector of standard shape and size in a standard position and orientation. At least some of the grid-modules have an integrated fluid line through which a medium to be processed or analyzed can flow. The integrated fluid line is in flow communication with the connection port of the grid-module. The grid-modules includes a flow control grid-module.

Abstract: A device assembly for calibrating a single-use sensor before, during or after a biopharmaceutical manufacturing process step including a single-use process equipment assembly for performing at least a part of the process step. The single-use process equipment assembly includes a flow line through which a medium flows in a defined direction during the process step and an integrated single-use sensor for measuring or detecting a property at a measurement location in the flow line. The device assembly includes a calibration line and a switch inserted into the flow line upstream of the measurement location. The switch includes a flow line inlet, a flow line outlet, and a calibration line inlet connected to the calibration line. The switch selectively switches between a first (main) flow path and a second (calibration) flow path. The device assembly includes a dedicated reference sensor, reference source, or reference standard solution in the calibration line.

Abstract: System for detecting at least one presence of foam of a medium in a bioreactor plant, wherein the system comprises: —a bioreactor plant having at least one disposable container for receiving the medium that may comprise the foam; and—at least two capacitive sensor units which are attached at at least two different situating positions of the bioreactor plant, wherein the capacitive sensor units each comprise at least one electrode system for capacitive measurement and are able to detect the presence of foam at the at least two situating positions on the basis of the capacitive measurement; and wherein the capacitive sensor units are designed to transmit captured data relating to the presence of foam to at least one monitoring unit for monitoring, open-loop and/or closed-loop control of foam formation in the bioreactor plant on the basis of said data.

Abstract: A method for validating a filter unit. The method includes guiding a fluid flow of a fluid after the fluid flow passed through the filter unit to a measurement area that is connected to the filter unit. The measurement area the fluid is exposed to is at least one alternating electric field between at least two electrodes. The method includes obtaining at least one electric signal between the at least two electrodes. The at least one electric signal is at least affected by whether one or more cells of a plurality of cells in the fluid pass through the measurement area. The method includes determining, at least partially based on the obtained at least one electric signal, at least one validity information indicating a validity of the filter unit.

Abstract: A device assembly including a single-use device for sensing or influencing a parameter of a running bioprocess. The single-use device is configured to have at least two different defined functional states, a first functional state being an inactive delivery state in which the single-use device is sterile and inoperable according to its intended use, and a second functional state being an active use state in which the single-use device is operable according to its intended use. The device assembly further includes a signalling element for indicating a current functional state of the single-use device to a user. Each functional state is associated with a distinct signal. The device assembly is configured such that a transfer from the first functional state to any other functional state of the single-use device is irreversible and/or permanently prevents the signalling element from indicating the signal associated with the first functional state.

Abstract: The disclosure relates to monitoring or controlling bioprocesses by way of withdrawing discrete fluid samples from a reactor and performing on-line analysis of said sample using a fluidic manifold, for example, by way of a sensor based on label-free biomolecular interaction analysis. The disclosure relates to a system for measuring one or more analytes in discrete fluid samples from a vessel adapted to contain a fluid having one or more sensors for the measurement of the analytes in a contact volume of the fluid sample. An analysis module having at least one main sampling line in fluidic connection with the vessel and one or more pumps in fluidic connection with said main sampling line(s) and adapted to selectively pump fluid from in the main sampling line away from the vessel. At least one fluid distribution tubing in fluidic connection with the analysis module. A manifold has a body.

Abstract: A device for compensating short-term pressure or volume fluctuations of a medium in a continuously managed biopharmaceutical process including a receiving space in fluid communication with a process line through which a medium flows, an equalizing space, which is separated from the receiving space by a deflectable element, and a counter-pressure mechanism in the equalizing space for applying a counter-pressure to the deflectable element towards the receiving space. A method of compensating short-term pressure or volume fluctuations of a medium in a continuously managed biopharmaceutical process including providing a receiving space in fluid communication with a process line through which a medium flows, receiving an excess amount of the medium flowing into the receiving space, charging an energy storage device by the medium flowing into the receiving space, and expelling at least part of the excess amount if the pressure or flow rate falls below a set amount.

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: A bioreactor includes a rigid-walled vessel for containing a biological medium, the vessel having a lid. The bioreactor further includes a probe passing through an aperture in the lid and having a sensing end inside the vessel and a remote end outside the vessel. The sensing end has plural electrodes for immersion in the biological medium, and the remote end is configured for coupling to external devices and transmission thereto of electrical or electromagnetic measurements made by the electrodes. One of the lid and the probe has one or more resiliently deformable mechanisms and the other of the lid and the probe has one or more respective complementary surfaces.

Abstract: A centrifuge setup of a bioprocessing installation, wherein, for the centrifugation, the centrifuge setup comprises a centrifuge, wherein the centrifuge comprises at least one centrifuge chamber with a chamber inlet and a chamber outlet, wherein the centrifuge setup comprises a liquid pumping arrangement and a liquid network with a number of liquid lines communicating with the liquid pumping arrangement. The centrifuge setup comprises a sensor arrangement with at least one biomass sensor arrangement, which biomass sensor arrangement is assigned to a liquid line of the liquid network, that the process control calculates an occurrence level of biomass in the respective liquid line based on the sensor signals of the biomass sensor arrangement and that the process control controls the valve arrangement and/or the liquid pumping arrangement during the loading cycle and/or the washing cycle and/or the discharging cycle based on the sensor signals of the sensor arrangement.

Abstract: Summarizing the invention, a sensing element for monitoring the state of a single-use sterilizable element such as a single-use bioreactor, wherein the state of the single-use sterilizable element is determined by at least one environmental condition is provided. The sensing element comprises: a variable component having at least one physical property that is configured to change in response to the at least one environmental condition and/or a change thereof, wherein the variable component comprises a sensing material with changing absorption characteristics for electromagnetic radiation configured to change in response to the at least one environmental condition and/or a change thereof.

Abstract: A sparging device, especially for use in a bioprocess, including a medium chamber and at least one gas chamber. The gas chamber at least partially surrounds the medium chamber, or the medium chamber at least partially surrounds the gas chamber. The medium chamber and the gas chamber are separated from each other by a wall. The wall has a plurality of through-holes or is composed of a porous material, such as a membrane or a porous ceramic. The sparging device further includes at least one gas inlet port opening into the gas chamber for inflow of gas.

Abstract: The present application generally pertains to scaling of a production process to produce a chemical, pharmaceutical and/or biotechnological product and/or of a production state of a respective production equipment.

Abstract: A computer-implemented method of determining at least one recipe for a production process to produce a chemical, pharmaceutical and/or biotechnological product is provided, wherein the production process is defined by a plurality of steps specified by recipe parameter(s) controlling an execution of the production process and a recipe comprises the plurality of steps defining the production process.

Abstract: System for detecting at least one presence of foam of a medium in a bioreactor plant, wherein the system comprises: —a bioreactor plant having at least one disposable container for receiving the medium that may comprise the foam; and—at least two capacitive sensor units which are attached at at least two different situating positions of the bioreactor plant, wherein the capacitive sensor units each comprise at least one electrode system for capacitive measurement and are able to detect the presence of foam at the at least two situating positions on the basis of the capacitive measurement; and wherein the capacitive sensor units are designed to transmit captured data relating to the presence of foam to at least one monitoring unit for monitoring, open-loop and/or closed-loop control of foam formation in the bioreactor plant on the basis of said data.

Abstract: The present application generally pertains to scaling of a production process to produce a chemical, pharmaceutical and/or biotechnological product and/or of a production state of a respective production equipment.