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 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 smart single-use tube line assembly for use in a unit operation of a bioprocess including at least one tube line. The tube line includes a tube body surrounding a lumen through which a medium can flow. The tube line assembly also includes a functional element embedded in the tube body, the functional element being configured to perform an optical and/or electrical function. The tube line assembly further includes an interface for coupling both the lumen and the functional element of the tube line to another component. The tube line assembly still further includes a control unit for controlling the optical and/or electrical function.

Abstract: A valve block for single use in a bioprocess, having a plurality of valve units and a one-piece block body having a main conduit. Each valve unit includes a secondary conduit, a valve seat between the secondary conduit and the main conduit, a closure part having a gripping portion, and an actuator coupled to the gripping portion which can transfer the closure part from a first switching position, in which the closure part is pressed against the valve seat and blocks a fluid communication between the secondary conduit and the main conduit, to a second switching position, in which the closure part is lifted from the valve seat and unblocks the fluid communication between the secondary conduit and the main conduit. The gripping portion is sealed against both the main conduit and the secondary conduit in both switching positions of the valve unit.

Abstract: A container (1, 1b) of a bioreactor (1a, 1b) has a container interior (22) designed for being filled with a medium (8) including a photoreactive material, and designed for at least partially triggering a photochemical reaction of the photoreactive material. The container (1, 1b) has at least one illuminant receiving pouch (11) that is at least partially transparent for an electromagnetic radiation (14), and that is arranged on a illuminant opening (12) within the container interior (22) and is designed to receive at least one illuminant (15, 15a, 15b, 15c, 15d, 15e) from an outer side (A) through the illuminant opening (12, 12a, 12b). The illuminant at least partially irradiates the medium (8) such that the photochemical reaction of the photoreactive material can be triggered by electromagnetic radiation (14) emitted by the illuminant and the illuminant is isolated in relation to the medium (8) by the illuminant receiving pouch (11).

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: The invention relates to a device for examining a medium (100) inside a bioreactor (200; 201), comprising a sample-taking module (20) for taking a sample of the medium (100). The sample-taking module (20) comprises an uptake region (10; 10a; 10b) that can be arranged to make contact with the medium (100) inside the bioreactor (200; 201). At least two different membranes (15, 16) are positioned on the uptake region (10; 10a; 10b) of said sample-taking module (20), for the purpose of taking a sample of the medium (100).

Abstract: A valve block for single use in a bioprocess, having a plurality of valve units and a one-piece block body having a main conduit. Each valve unit includes a secondary conduit, a valve seat between the secondary conduit and the main conduit, a closure part having a gripping portion, and an actuator coupled to the gripping portion which can transfer the closure part from a first switching position, in which the closure part is pressed against the valve seat and blocks a fluid communication between the secondary conduit and the main conduit, to a second switching position, in which the closure part is lifted from the valve seat and unblocks the fluid communication between the secondary conduit and the main conduit. The gripping portion is sealed against both the main conduit and the secondary conduit in both switching positions of the valve unit.

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: 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 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: 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 medical product and a method of surface treatment and/or manufacture of a medical product. The medical product includes a metal or an alloy or consists of a metal or an alloy. The method includes the following steps: a) dulling a surface of the medical product, b) electropolishing the dulled surface of the medical product, c) electrochemically etching the dulled and electropolished surface of the medical product and d) electropolishing the dulled, electropolished and electrochemically etched surface of the medical product. The medical product has at least one of the following features: a pitting corrosion potential of 100 mV to 1200 mV, and/or a contact angle of 80° to 140°, and/or a passive layer having a thickness of 1 nm to 10 nm, which coats at least sections of the surface of the medical product.

Abstract: A filtration module for filtering a process medium in a bioprocess including a process flow path for a process medium, a filter membrane coupled to the process flow path, and a sampling membrane coupled both to the process flow path and to a sampling flow path for extracting a sample from the process medium. The sampling flow path guides the extracted sample to a sampling outlet of the filtration module or to an analyzer integrated into the filtration module. A filtration assembly including the filtration module and an analyzer coupled to the sampling outlet of the filtration module. A method of sampling during a bioprocess including providing such a filtration module, urging a process medium through the process flow path, filtering the process medium by using the filter membrane, extracting a sample from the process medium by using the sampling membrane, and guiding the extracted sample to a sampling outlet.

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.