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: 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: 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: In a method of referencing an analyte measurement in a purification system during a process step in a biopharmaceutical process, the following sub-steps are performed during the same process step: guiding a medium through a purification unit where the analyte is either removed from or added to the medium; measuring at least one parameter related to the presence and/or quantity of the analyte with a first measurement system at a first measurement location upstream of the purification unit; measuring the at least one parameter with a second measurement system at a second measurement location downstream of the purification unit; and referencing the upstream measurement to the downstream measurement, or referencing the downstream measurement to the upstream measurement.

Abstract: A bioreactor for cell cultivation including a reusable reactor vessel, preferably made of stainless steel, for receiving a fluid, and an optical spectroscopy interface including an adapter and a single-use optical spectroscopy insert. The reusable reactor vessel has a wall and a port formed in the wall. The adapter is configured to be fixed to the port in a predefined position at the port. The single-use optical spectroscopy insert is configured to be accommodated and fixed in the adapter, or the insert is an integral part of the adapter.

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: 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 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: 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 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: 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 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: 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: 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).