Abstract: A method for operating a bioprocess installation with an electronic process control and at least one bioprocess unit, wherein the bioprocess unit comprises a cell broth source with a first receptacle for cell broth including cultivation media and cells, establishing a culture environment for cell cultivation and/or bio production, wherein the bioprocess unit comprises a clarification setup with a centrifuge for the clarification of the cell broth by centrifugation, with a liquid pumping arrangement assigned to the centrifuge and with a liquid network with a number of liquid lines communicating with the liquid pumping arrangement, wherein out of a first culture environment established by the first receptacle, the cell broth is transfered to the centrifuge via the liquid network, which centrifuge is operated in a forward operation for cell separation and/or cell washing and in a backward operation for cell discharging.

Abstract: A device assembly for controlling an integrated continuous pharmaceutical or biopharmaceutical manufacturing process including a first process equipment for performing a first process step; a second process equipment for performing a second process step subsequent to the first process step; a single measuring unit for measurement of a set of signals of a liquid process medium at a single location, the measured signals depending on first and second parameters; and an evaluation and control unit for evaluating the measured signals to determine values of the first and second parameters. The evaluation and control unit determines first and second corrective feedback based on the values of the first and second parameters, respectively. The evaluation and control unit controls the first process step by providing the first corrective feedback to the first process equipment and controls the second process step by providing the second corrective feedback to the second process equipment.

Abstract: A system for an automated production of high cell density seed culture, HCDC, preparations, for cryo-preservation comprising a cell expansion device for growing a HCDC in a medium inside a device volume of the cell expansion device, at least one sensor for collecting data by at least temporally monitoring at least one parameter being indicative of the physiological state of the HCDC; and a control unit for processing the collected data to determine whether at least one predetermined criterion is fulfilled by the monitored parameter to control, based on whether the at least one predetermined criterion is fulfilled by the monitored parameter, at least a partial exchange of the medium by a cryo-protective agent, CPA.

Abstract: The present invention relates to an operation process for a cell cultivation system, the cultivation system comprising two or more cultivation vessels for the production of at least one biologic agent and/or cell, which cultivation vessels comprise cells in a suitable cultivation medium, the process comprising the steps of taking two or more liquid samples from two or more or cultivation vessels, optionally, purifying the liquid samples, analyzing at least one sample to acquire data relating to at least one system parameter indicative for at least one of nutrient status and/or medium quality of the cultivation medium, or cell density, or cell viability and/or one product parameter indicative for biologic agent quality and/or cell quality, and, adjusting, preferably in real-time, at least one process parameter and/or at least one feeding input in at least one cultivation vessel of the cultivation system, or of a subsequent cultivation system.

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.