Sartorius Stedim Biotech Gmbh

The Automation Partnership (cambridge) Limited

Sartorius Stedim Data Analytics Ab

The Automation Partnership Ltd.

Christian Grimm

Thomas Regen

Marco Leupold

Marek Hoehse

Marek Höhse

Thorsten Adams

Mario Becker

Wei Gao

Henry Weichert

Gerhard Greller

Lars Boettcher

Stefan Schlack

Daniel Riechers

Sebastian Purmann

Adrian James Stacey

Jochen Scholz

Angus Woodhams

Swen Weitemeier

Bernward Husemann

Simon Topp-Manske

Lars Böttcher

Julia Lueders

Andreas Prediger

Chloe Lang

Nikoloudis Paschalis

Matthias Bode

Patrick Courtney

Alexander Graf

Jens Rupprecht

Johan Hultman

Marek HÖHSE

Charlie Daniels

A sensor positioning system for a bioprocess engineering unit, wherein a container is provided for receiving a biological medium which, when installed, extends in the axial direction from an upper container end to a lower container end, wherein a holder is provided for holding the container when installed, wherein a sensor is provided for fixing to the container. A positioning aid device for positioning the sensor to be fixed is provided on the container, the positioning aid device has a positioning aid that can be applied directly to or near the container on the holder, which can be brought into different vertical positions and/or circumferential positions relative to at least one reference point provided on the container and/or holder, and the positioning aid device has a technical storage medium or analog print medium with an allocation list.

Sensor positioning system for a bioprocess engineering installation

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 includes 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.

Optimized process control

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.

Multivariate process chart to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product

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; and apply open-loop and/or closed-loop control of the process for at least one parameter based on the projected value for the undetermined concentration.

Open-loop/closed-loop process control on the basis of a spectroscopic determination of undetermined substance concentrations

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.

Device and method for compensating short-term pressure or volume fluctuations of a medium in a continuous biopharmaceutical process

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.

Valve block for single use in a bio process

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

Illumination for a photobioreactor

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.

Computer-implemented method and system for spectroscopic analysis of biological material

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

Device and method for examining a medium

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.

Sensing element and wireless communication device for single-use elements

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.

Spectroscopy cell in or on an outer wall of a container and spectroscopy method

A sterile packaging unit includes a disposable bioprocessing component () and a packaging (). The disposable bioprocessing component () has a component wall that encloses a processing space and on which is secured a sensor system () with at least one sensor head (T, P, I, L, D) and with attached sensor electronics () that include a memory unit (). The packaging () hermetically encloses the disposable bioprocessing component () and has a flexible packaging wall. The disposable bioprocessing component () and the packaging (). are sterilized by being jointly irradiated with ionizing radiation. The sensor electronics () are connected electrically to a contact unit () extending through the packaging wall.

Sterile packaging unit and method for producing same

A single use probe, sterilizable by irradiation, for a single use component for use in a biopharmaceutical process, comprises at least one sensor relevant for the biopharmaceutical process, an RFID tag and a memory rewritable in principle, in which data with respect to an integrity check of the single use probe are stored. A method for quality assurance of such a single use probe comprises: providing the probe with an RFID tag and a memory rewritable in principle, in particular a FeRAM memory as part of the RFID tag; defining a measurement-principle-specific quality parameter of the single use probe; defining a tolerance value for the parameter; performing an integrity check of the probe by first determining and writing into the memory values of the defined quality parameter before sterilization of the probe by irradiation; determining the values of the defined quality parameter after irradiation; and comparing the values of the quality parameter determined before radiation to those determined after.

Single use probe sterilizable by irradiation and method for the quality assurance of a single use probe

The invention relates to a pinch valve comprising a valve element () with precisely one flow channel () that is surrounded by a circumferential wall () and has an inlet opening (), which is designed for connecting a connection member () or which adjoins a connection element (), at a first end and an outlet opening (), which is designed for connecting a connection member () or adjoins a connection element (), at a second end. The valve element () additionally has a pair of force transmitting elements (') or a force transmitting element () and a fixing element () which are connected to the circumferential wall () in a central closing region () that is arranged between the inlet opening and the outlet opening. The force transmitting elements (&#x2032;) or the force transmitting element () and the fixing element () are arranged at least substantially perpendicularly to the flow direction of the flow channel (). The circumferential wall () consists of an elastic material such that the force transmitting elements (&#x2032;), or the force transmitting element () and the fixing element (), can be moved towards each other under the effect of a pressure or tensile force perpendicularly to the flow direction of the flow channel (). In the absence of a pressure or tensile force acting on a force transmitting element (&#x2032;), the circumferential wall () has a cross-section which differs from a circle in the central closing region (). In the cross-section, the circumferential wall () surrounds a flow channel () surface area which is constant at least substantially over the entire valve element (). Thus, the average flow speed is at least substantially uniform at all positions along the valve element ().

Growing community of inventors

Heilbad Heiligenstadt, Germany

Christian Grimm