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 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: A container having at least one wall protrusion for mounting at least one sensor from the outside for sensing at least one variable of a medium contained in a container interior is provided. The wall protrusion can be arranged on a container wall and configured to at least partly extend around the container interior and the medium. The wall protrusion can include at least one sensor region that is configured so that the at least one variable can be sensed through the sensor region by means of the sensor.

Abstract: Devices and methods are provided for determining viability and/or a cell counts of biological cells in a cell suspension culture using collimated transmission. Devices can include an illumination source for generating an electromagnetic illumination beam; beam manipulation means for collimating the illumination beam; and a detection unit for detecting an electromagnetic transmission beam being a portion of the collimated illumination beam which has been transmitted through a sample of the cell suspension culture.

Abstract: A computer-implemented method for spectroscopic analysis of biological material is provided that includes analyzing samples of biological material from a plurality of sources, and delivering samples of biological material to at least one flow cell for spectroscopy, and determining whether the spectroscopic analysis for each sample of the plurality of samples is or is predicted to be ambiguous in that it is affected by at least two non-discriminable factors. If such a determination is made, a disambiguating step can be performed.

Abstract: A flow cell assembly for use in a bioprocess including a housing and a glass body. The housing includes an inlet tube connector and an outlet tube connector and a holding structure for immovably holding the glass body. The glass body is a universal single-piece glass body surrounding a measurement channel. The measurement channel has an inlet end and an outlet end defining a medium flow direction, and a defined dimension along an optical measurement axis perpendicular to the medium flow direction. The inlet end and outlet end of the measurement channel are in fluid communication with the inlet tube connector and the outlet tube connector of the housing, respectively. The housing or the glass body includes an aligning structure for aligning a probe head. The housing or the glass body includes a fixing structure for immovably fixing the aligned probe head relative to the glass body.

Abstract: Method for open-loop or closed-loop control of a process, in particular a downstream bioprocess, based on the projection of an unknown concentration of at least one substance in a sample using spectroscopy, in particular UV/vis spectroscopy, comprising the steps: Detect spectrums of a plurality of concentration samples, wherein at least two concentration samples have differing concentrations of the substance; generate several quantitative models based on the spectrums of the concentration samples, wherein the models each have a mapping of at least one spectral measurand of the spectrums to concentrations in concentration ranges, wherein the concentration ranges of two models are not identical; detect at least one sample spectrum of the sample; map the sample spectrum to at least one quantitative model of the generated quantitative models; apply the at least one quantitative model that was mapped to the sample spectrum against the sample spectrum to determine a projected value for the unknown concentration; an

Abstract: A computer-implemented method for spectroscopic analysis of biological material is provided that includes analyzing samples of biological material from a plurality of sources, and delivering samples of biological material to at least one flow cell for spectroscopy, and determining whether the spectroscopic analysis for each sample of the plurality of samples is or is predicted to be ambiguous in that it is affected by at least two non-discriminable factors. If such a determination is made, a disambiguating step can be performed.

Abstract: One aspect relates to a bioreactor and/or mixing container that includes an outer wall and a spectroscopy cell arranged in and/or on the outer wall. The spectroscopy cell includes a first optical area and a second optical area arranged opposite the first optical area. The first optical area and the second optical area can be set at at least two different distances from one another. A specimen-receiving area is located between the first optical area and the second optical area.

Abstract: A method of predicting a parameter of a medium to be observed in a bioprocess based on Raman spectroscopy including the steps of acquiring a first series of preparatory Raman spectra of an aqueous medium using a first measuring assembly; normalizing the first series of preparatory Raman spectra based on a characteristic band of water from at least one Raman spectrum acquired with the first measuring assembly; building a multivariate model for the parameter based on the normalized preparatory Raman spectra; acquiring predictive Raman spectra of the medium to be observed during the bioprocess with another measuring assembly; normalizing the predictive Raman spectra based on a characteristic band of water from at least one Raman spectrum acquired with the other measuring assembly; and applying the built model to the predictive Raman spectra for predicting the parameter.

Abstract: Aspects of the application relate to methods, a computer program and a process control device. According to one aspect, a computer-implemented method for determining a multivariate process chart is provided. The multivariate process chart is to be used to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product. The multivariate process chart includes a first trajectory, an upper limit for the first trajectory and a lower limit for the first trajectory.

Abstract: Aspects of the application relate to computer-implemented methods, process control devices, and a computer program. According to one aspect, a computer-implemented method for controlling a process in a plurality of first scale vessels via a first process control device is provided. Each of the first scale vessels contains fluid and the process is for producing a chemical, pharmaceutical, biopharmaceutical and/or biological product. The method comprises controlling, by the first process control device and at least partially in parallel, the process in each of the first scale vessels. The method can include periodically determining, prior to an assigning decision and at a first frequency, first sets of process parameter values for each of the process parameters from each of the first scale vessels.

Abstract: The invention relates to a bioprocess container (10) having an optical measuring device (100) for non-invasive spectroscopic measurement comprising: a container housing (12), a port housing (102), which is connected to the container housing (12) and is sealed off with respect to the interior (18) of the container housing (12); at least one radiation-emitting element (124), which is designed to transmit electromagnetic radiation through the at least one fluid contained in the container housing (12); at least one radiation-receiving element (126), which is designed to at least partly receive the radiation which was transmitted by the radiation-emitting element (124); and at least one measuring insert (122), which holds and supports the at least one radiation-emitting element (124) and/or the at least one radiation-receiving element (126).

Abstract: The invention relates to a bioprocess container (10) having an optical measuring device (100) for non-invasive spectroscopic measurement comprising: a container housing (12), a port housing (102), which is connected to the container housing (12) and is sealed off with respect to the interior (18) of the container housing (12); at least one radiation-emitting element (124), which is designed to transmit electromagnetic radiation through the at least one fluid contained in the container housing (12); at least one radiation-receiving element (126), which is designed to at least partly receive the radiation which was transmitted by the radiation-emitting element (124); and at least one measuring insert (122), which holds and supports the at least one radiation-emitting element (124) and/or the at least one radiation-receiving element (126).

Abstract: A disposable port device for connecting a functional unit to a flexible wall of a disposable container includes a flange to be connected to the flexible wall of the disposable container and an insert providing or receiving the functional unit. The flange and the insert are separate parts made from different materials with different material characteristics. A method of manufacturing such a disposable port device includes the steps of producing the flange from a first material, producing the insert from a different second material, the first and second materials having different material characteristics, and connecting the insert to the flange.

Abstract: A computer-implemented method for spectroscopic analysis of biological material is provided that includes analyzing samples of biological material from a plurality of sources, and delivering samples of biological material to at least one flow cell for spectroscopy, and determining whether the spectroscopic analysis for each sample of the plurality of samples is or is predicted to be ambiguous in that it is affected by at least two non-discriminable factors. If such a determination is made, a disambiguating step can be performed.

Abstract: A container having at least one wall protrusion for mounting at least one sensor from the outside for sensing at least one variable of a medium contained in a container interior is provided. The wall protrusion can be arranged on a container wall and configured to at least partly extend around the container interior and the medium. The wall protrusion can include at least one sensor region that is configured so that the at least one variable can be sensed through the sensor region by means of the sensor.

Abstract: One aspect relates to a bioreactor and/or mixing container that includes an outer wall and a spectroscopy cell arranged in and/or on the outer wall. The spectroscopy cell includes a first optical area and a second optical area arranged opposite the first optical area. The first optical area and the second optical area can be set at at least two different distances from one another. A specimen-receiving area is located between the first optical area and the second optical area.

Abstract: A container (1) has a measuring-cell housing (5) that protrudes into the container interior (2). The measuring-cell housing (5) has a measuring gap (6) bounded by two opposed spaced-apart lateral surfaces (8, 9), and a connecting surface (10) connects the lateral surfaces (8, 9). Each lateral surface (8, 9) has an optical window (11, 12). A first optical fiber (15, 15?) is arranged before the first window (11) and a second optical fiber (17, 17?) is arranged before the second window (12). Receiving channels (14, 16, 18) are arranged before the windows (11, 12, 13) and subsequently can be fit with the optical fibers (15, 15?, 17, 17?, 19) from the outside. The measuring-cell housing (5) having the windows (11, 12, 13) and the receiving channels (14, 16, 18) is connected fixedly to the wall (3) of the container interior (2).

Abstract: A container (1) has a measuring-cell housing (5) that protrudes into the container interior (2). The measuring-cell housing (5) has a measuring gap (6) bounded by two opposed spaced-apart lateral surfaces (8, 9), and a connecting surface (10) connects the lateral surfaces (8, 9). Each lateral surface (8, 9) has an optical window (11, 12). A first optical fiber (15, 15?) is arranged before the first window (11) and a second optical fiber (17, 17?) is arranged before the second window (12). Receiving channels (14, 16, 18) are arranged before the windows (11, 12, 13) and subsequently can be fit with the optical fibers (15, 15?, 17, 17?, 19) from the outside. The measuring-cell housing (5) having the windows (11, 12, 13) and the receiving channels (14, 16, 18) is connected fixedly to the wall (3) of the container interior (2).