Controller for bioreactor, system and method

Abstract

The invention relates to a controller (100, 200, 302, 402, 406) for a bioreactor (102, 224, 304, 404, 408), comprising a housing (104, 202, 308), a drive element (106, 204, 310), a gas-conveying device (110, 208, 314) and a control device (112, 210, 316, 418, 424), wherein the housing (104, 202, 308) forms an interior (116, 120, 212) and the control device (112, 210, 316, 418, 424) is arranged in the interior (116, 120, 212). The controller is characterised in that the interior (116, 120, 212) of the housing (104, 202, 308) is sealed with respect to an atmosphere surrounding the housing (104, 202, 308), and in that the control device (112, 210, 316, 418, 424) is designed to control the drive element (106, 204, 310) according to a predetermined stirring rate and to control the gas conveying device (110, 208, 314) according to a predetermined gassing rate. The invention also relates to a system (300, 400) and to a method (500) for operating a bioreactor (102, 224, 304, 404, 408) having a gassing and stirring unit (142, 222, 332).

Description

[0001] December 17, 2025

[0002] Control system for a bioreactor, system and process

[0003] The present invention relates to a control system for a bioreactor, comprising a housing, a drive element, a gas conveying device, and a control unit, wherein the housing forms an interior space and the control unit is arranged within this interior space. The present invention further relates to a system comprising a bioreactor and a control unit, as well as a method for operating a bioreactor comprising a gassing and stirring unit.

[0004] In chemistry and biology, for example in microbiological investigations or cell cultures, mass transfer between fluids is frequently required. Examples of such mass transfer include the transfer of CO2 from the air into water or the transfer of a dissolved, nonpolar product of a preceding chemical reaction into an extraction fluid. Mass transfer is generally caused or at least facilitated by bringing the substances involved in the transfer into contact with each other, for example by mixing, blending, dispersing, or similar processes. Thus, it is often desirable to introduce both aeration and stirring of the fluids in question.

[0005] Systems with a bioreactor and a control unit, often called a "controller," are known from the prior art to induce or promote biological reactions through controlled fluid transfer. Typically, the bioreactor and the control unit are designed as separate units that are placed side-by-side in the laboratory.

[0006] The control unit or controller is typically equipped to manage the gas supply and exhaust, as well as any sensors, etc., associated with the bioreactor, for example, by retrieving sensor readings. Using gas or fluid flow control, the controller can, for instance, adjust the gas mixture that forms the atmosphere within the bioreactor for a specific cell culture. Thus, the controller serves as a unit for setting and, if necessary, determining experimental parameters.

[0007] In addition, it is common practice in a bioreactor to introduce a liquid or culture medium as the first fluid and a gas as the second fluid using an aeration and stirring unit immersed in the liquid. The aeration and stirring unit can be designed as a movable unit with at least one membrane element, which is intended for diffusive or convective transfer of the gas into the liquid. With such an aeration and stirring unit, the distribution of the gas in the liquid or medium can be optimized, and the formation and size of bubbles can also be controlled. Such an aeration and stirring unit is known, for example, from publication WO 2021 / 152128 Al.

[0008] The known systems offer, or rather require, adjustment of both gassing and stirring via the control system. However, such systems are rather cumbersome to configure. For example, while these systems may be suitable for cell cultures with a relatively large volume, they are less practical for experiments on a smaller scale or in smaller volumes, such as those involving expensive cell cultures.

[0009] Furthermore, so-called incubators are known, which allow for the creation of a controlled atmosphere within a closed interior. Parameters such as gas mixture or composition, temperature, humidity, acidity, pressure, etc., can be conveniently adjusted using the incubator. With such an incubator, long-term experiments, for example, those lasting several days, or even a month or more (e.g., a year), can be conducted, during which the atmosphere can be monitored throughout the entire experiment.

[0010] GO 241021WO

[0011] December 17, 2025 While a vessel containing a liquid to be treated can be placed in the incubator chamber and a simple magnetic stirrer can be used to agitate the liquid, such systems do not offer the possibility of adjusting the flow rate or aeration rate, in addition to simple contact aeration at the surface of the fluid in the vessel, to promote fluid transfer throughout the volume of the fluid.

[0012] Due to the conditions prevailing in the incubator, equipment with a metallic composition, such as iron, aluminum or copper, should generally be avoided, as it is susceptible to rust and reduction or oxidation due to the often high humidity, temperature (e.g. around 37 °C) and CO2 concentration in the incubator room.

[0013] Against this background, the present invention aims to provide improved means for the aeration and stirring of biological cultures.

[0014] The aforementioned problem is solved by a control system for a bioreactor, comprising a housing, a drive element, a gas conveying device and a control device, wherein the housing forms an interior space and the control device is arranged in the interior space, in that the interior space of the housing is sealed against an atmosphere surrounding the housing, and that the control device is configured to control the drive element according to a predetermined stirring rate and to control the gas conveying device according to a predetermined gassing rate.

[0015] The aforementioned problem is further solved by a system with a bioreactor and with a control system according to the present disclosure, in that the bioreactor has a housing forming a reactor chamber, a gassing and stirring unit arranged in the reactor chamber, a gas inlet connected to the gassing and stirring unit in a flow-permeable manner, and a connecting element.

[0016] GO 241021WO

[0017] December 17, 2025, that the connecting element of the bioreactor and the drive element of the control system are connectable, that the connecting element of the bioreactor is designed to transmit a force from the drive element of the control system to the gassing and stirring unit, that the control device of the control system is configured to control the drive element in such a way that the gassing and stirring unit is moved in the bioreactor at a predetermined stirring rate, that the gas supply device of the control system and the gas inlet of the bioreactor are flow-permeable and connectable, that the control device of the control system is configured to control the gas supply device in such a way that a predetermined gas flow is supplied to the gassing and stirring unit.

[0018] The aforementioned problem is further solved by a method for operating a bioreactor comprising a gassing and stirring unit, in particular for operating a system according to the present disclosure, in which an incubator with a housing forming an incubator chamber is provided, wherein an atmosphere prevails in the incubator chamber, in which the bioreactor is arranged in the incubator chamber, in which a gas or a gas mixture from the atmosphere of the incubator chamber is supplied to the gassing and stirring unit according to a predetermined gassing rate, and in which the gassing and stirring unit is moved in the bioreactor according to a predetermined stirring rate.

[0019] The design of the controller, with its sealed housing, protects the internal electronic components, including the control unit, cables, and metallic parts, from acidic or acidic moisture. This gives the controller resistance to the conditions typically found in an incubator, making it suitable for use within the incubator's interior. As a result, the controller can be safely placed inside the incubator along with the bioreactor.

[0020] GO 241021WO

[0021] December 17, 2025 The control system, comprising the gas delivery device, drive, and control unit, is also designed to set both a gassing rate and a stirring rate for a bioreactor, particularly when the control system and the bioreactor are housed within an incubator. Thus, the disclosed control system can be used to control a bioreactor within an incubator, utilizing the controlled atmosphere provided by the incubator for the purposes of the bioreactor.

[0022] In this way, an atmosphere in conjunction with, for example, gas mixture ratios, temperature, humidity can be provided with the incubator as already known, and this can then be used with little effort for a reaction or culture in the bioreactor by means of the control system.

[0023] This offers the particular advantage of being able to test reaction or culture experiments with minimal effort and material requirements, possibly before subsequent experiments are initiated on a larger scale.

[0024] Nevertheless, the system as revealed offers the advantage that the gas mixture supplied to the bioreactor has a similar, possibly identical, gas concentration to the gas concentration set in the incubator. Specifically, even without parallel measurements in the incubator and reactor chamber, it can be assumed that the oxygen concentration of the atmosphere supplied to the bioreactor corresponds to the oxygen concentration in the incubator atmosphere, according to the mass transfer described by Fick's law. This assumption is supported, firstly, by the fact that the atmosphere prevailing in the incubator chamber, which is controllable by the incubator, is used for gas transfer in the bioreactor, and secondly, by the use of a gassing and stirring unit in the bioreactor, which provides a large gas transfer surface area with the medium taken up in the bioreactor, ensuring continuous mixing of the reactor contents.The levels of CO2 and oxygen gas concentrations within the gas mixture are affected.

[0025] GO 241021WO

[0026] On December 17, 2025, the pH value and the DO value of the reactor fluid will be measured. The DO value, or "dissolved oxygen" value, is the concentration of dissolved oxygen in the reactor fluid.

[0027] Furthermore, the system can be used to process relatively small volumes, for example, with a bioreactor designed to hold a maximum liquid volume in the range of approximately 20 to 3000 ml, particularly in the range of approximately 50 to 2500 ml, preferably approximately 100 to 2000 ml, and more preferably in the range of approximately 150 to 1500 ml. Other examples include systems with a bioreactor designed to hold a maximum liquid volume in the range of approximately 20 to 2500 ml, particularly in the range of approximately 50 to 2000 ml, preferably in the range of approximately 100 to 1500 ml, and more preferably in the range of approximately 150 to 1000 ml. Such relatively small volumes help avoid losses and thus keep expenses and costs low, which is particularly advantageous when using expensive culture media.

[0028] The bioreactor can have a working volume in the range of 0 to 2000 L, particularly in one of the following ranges: 0.1 to 0.3 L, 0.3 to 2 L, or 2 to 5 L. Particularly preferred values ​​for the bioreactor working volume are: 0.2 L, 0.3 L, 1 L, 2 L, and 5 L. Working volumes up to approximately 2 L are especially suitable for therapeutic research and development. Working volumes in the range of approximately 2 to approximately 10 L are particularly suitable for biopharmaceuticals as preparation for production processes.

[0029] By designing the control system and the bioreactor with compatible connecting elements, and by ensuring the control unit is suitable for controlling the drive element and the gas supply system in conjunction with the bioreactor or its aeration and stirring unit, a system is provided that can be integrated into a single incubator room. This eliminates the need for additional control from outside the incubator room.

[0030] GO 241021WO

[0031] December 17, 2025. The disclosed solution allows, on the one hand, an atmosphere with controlled parameters such as humidity, oxygen concentration, and temperature to be provided by an incubator, and on the other hand, the drive element to be set to a stirring rate and the gas supply system to aeration rate via the control unit. This eliminates the need for sensors on the control unit or the bioreactor to detect atmospheric parameters, which are already controlled by the incubator. Consequently, the control unit does not require any additional equipment for controlling the sensors, resulting in a simpler overall control design. This allows the control unit to be manufactured cost-effectively, thus increasing its market appeal for rapid initial biological processes.In addition, with such a simplified design, the control system can be compact, allowing it to be used with a wider variety of incubators.

[0032] Overall, the control system and the procedure offer the combined advantages of a classic control system for a bioreactor and an incubator.

[0033] The control unit's housing forms an interior space that is sealed off from the surrounding atmosphere. For this purpose, the housing is preferably hermetically sealed, gas-tight, or flow-impermeable. The housing can be multi-part, for example, consisting of a first housing part and a second housing part, wherein the first and second housing parts can be hermetically or gas-tightly connected to each other. The connection between the at least two housing parts can be positive-locking, friction-locking, and / or material-locking, for example, by clamping, plug-in, or screw connections and supplementary bonding.

[0034] The housing, in particular the at least two housing parts, of the control unit can be made essentially, preferably entirely, of plastic. This makes the control unit housing resistant to acidic moisture, in particular

[0035] GO 241021WO

[0036] December 17, 2025, must be resistant to the atmosphere prevailing in the incubator room. Furthermore, the control unit housing can then be manufactured using processes such as 3D printing, sintering, or injection molding. Examples of usable plastics include: polyamide, PA, polycarbonate, PC, acrylonitrile butadiene styrene copolymer, ABS, polymethyl methacrylate, PMMA, polystyrene, PS, polypropylene, PP, polyamide, PA, polyetheretherketone, PEEK, Formlabs Biomed Clear, Formlabs Biomed White, Formlabs Biomed Black, Somos® BioClear™, Somos® EvoLVe™ 128, LOCTITE 3D MED412™, LOCTITE 3D MED 413™, and Autotex AM, although this list is not exhaustive. Preferably, the housing has a surface that can be cleaned or disinfected using known methods. For example, the surface could be smooth and made of polyamide.

[0037] Preferably, the control unit housing has a receiving area for receiving a fluid container of the bioreactor, in particular for receiving the bottom of a fluid container of the bioreactor. For this purpose, the receiving area preferably has a shape adapted to the shape of the bottom of the fluid container. Alternatively or additionally, the receiving area can have at least one receiving element, for example in the form of clamps or a guide rail or guide groove.

[0038] The control unit's drive element preferably comprises an agitator with an electric motor and a coupling for a drive shaft of the bioreactor's aeration and stirring unit. The drive element may be made of at least one of the following materials: polyamide, PA, polycarbonate, PC, acrylonitrile butadiene styrene copolymer, ABS, polymethyl methacrylate, PMMA, polystyrene, PS, polypropylene, PP, polyamide, PA, polyetheretherketone, PEEK, Formlabs Biomed Clear, Formlabs Biomed White, Formlabs Biomed Black, Somos® BioClear™, Somos® EvoLVe™ 128, LOCTITE 3D MED412™, LOCTITE 3D MED 413™, Autotex A, a metal, or stainless steel. The drive element can be designed to drive, in particular, the gassing and stirring unit of the bioreactor in such a way that it moves with a rotational movement at a stirring rate in the range of 0 to approximately 200 rpm (rotations per minute).

[0039] GO 241021WO

[0040] December 17, 2025. Preferably, the control unit of the controller comprises a data storage device, a microprocessor, and a communication module, wherein computer algorithms stored on the data storage device can be executed by the microprocessor. The execution of the algorithm results in commands that can then be transmitted by the communication module to other devices or components of the controller or the bioreactor, such as the drive element, the gas conveying device, or the communication interface.

[0041] The control unit can be configured to provide a power supply for at least one of the following elements: the drive element, the gas delivery device, the communication interface, a sensor, a lighting element, or a camera. For this purpose, the control unit can have a power connection, which may be connected, for example, to the control unit's battery or to a power connection for the control unit to the incubator.

[0042] The control unit is located within the interior formed by the control unit's housing and is configured to control the drive element and the gas delivery system. For this purpose, the control unit can be connected to both the drive element and the gas delivery system via a communication link, for example, a cable connection. In an embodiment of the control unit where the drive element is located outside the interior formed by the housing, or where the control unit and the drive element are located in separate interior spaces within the housing, the cable connection can pass through a wall of the housing. Alternatively, a power supply can be provided through the housing, with the power supply being configured to power at least one of the following elements: the control unit, the gas delivery system, the drive element, or the communication interface.

[0043] GO 241021WO

[0044] December 17, 2025. A stirring rate within the meaning of this disclosure can be expressed as the number of movement cycles per unit of time or units derivable therefrom. Examples include: number of rotations per minute, number of oscillations per minute, although this list is not exhaustive. The stirring rate can have a significant influence on a cell culture taken up by the bioreactor, both with regard to the input of kinetic energy (energy dissipation) and the homogenization of the reactor contents and gas transfer.

[0045] A gassing rate, as defined in this disclosure, can be understood as the volumetric flow rate of a volume of gas that is fed into the gassing and stirring unit of the bioreactor, or that exits the gas supply unit of the control system and is possibly fed into the bioreactor. The gassing rate can be expressed as gas volume per unit of time or as units derived therefrom. The influence of the gassing rate on the diffusive transfer of the gas into the medium of the bioreactor can be asymptotic or stabilize above a certain threshold.

[0046] In one embodiment, the stirring rate is predetermined by a predefined profile, where the profile specifies a development of the stirring rate over time or a development of the rotational speed of the aeration and stirring unit over time. Alternatively or additionally, the aeration rate can be predetermined by a predefined profile, where the profile specifies a development of the aeration rate over time or a development of the fluid flow rate into the aeration and stirring unit. In this way, the drive element and the gas delivery device or the aeration and stirring unit can be controlled according to a predefined sequence of stirring and / or aeration rates over time.

[0047] Thus, for example, the stirring rate can be dynamically adjusted over time, allowing for the programming of a fixed stirring rate or a sequence of different speeds or stirring rates. In a specific example, a profile can be defined using a mathematical formula, where the mathematical formula

[0048] GO 241021WO

[0049] On December 17, 2025, a profile cycle is specified as follows: first phase at a speed of approximately 20 rpm for approximately one minute; second phase at a speed of approximately 70 rpm for approximately 30 minutes; third phase at a speed of approximately 100 rpm for approximately 20 minutes. The profile can be cyclical and run for at least two cycles. In another concrete example, the mathematical formula can specify a continuous change in speed, for example, according to a linear, quadratic, polynomial, exponential, logarithmic, root-like, or trigonometric ratio. In this way, an increase, a decrease, or a constant stirring speed can be specified over time, so that the drive element and the gas delivery system or the aeration and stirring unit can be controlled accordingly. These embodiments and examples apply analogously to the aeration rate.

[0050] In addition, a gas input can be defined. The gas input corresponds to the introduction of a gas into a medium, such as a liquid, contained within the reactor chamber. If the medium contains a cell culture, the gas input has a significant impact on the cell culture. The gas input can be expressed as gas volume per volume of culture medium per unit of time, or as units derived from this. The gas input can result from fluid transfer via the at least one membrane element of the aeration and stirring unit, or alternatively or additionally from so-called "headspace aeration."

[0051] With the disclosed system, a gas can be fed into the aeration and stirring unit of the bioreactor via the gas supply unit of the control system. The gas input depends on several parameters, such as temperature, pressure, and humidity, as well as the aeration rate and the stirring rate. A gas pump is one example of a gas supply unit.

[0052] In this context, "headspace gassing" refers in particular to fluid transfer on the surface of a culture medium taken up in the bioreactor, whereby

[0053] GO 241021WO

[0054] December 17, 2025: A gas that at least partially penetrates, diffuses, mixes, or otherwise transfers into the culture medium in the space between the lid of the bioreactor and the surface of the culture medium contained in the bioreactor. Such headspace aeration can occur with or without the use of an aeration and stirring unit.

[0055] As a bioreactor within the meaning of this disclosure, fluid containers can be used in embodiments common in chemistry and bioprocess engineering, intended for multiple or single use. A non-exhaustive list of examples includes: stirred tank reactors, bubble column reactors, fixed-bed reactors, fluidized-bed reactors, membrane bioreactors, photobioreactors, and reactors for so-called "tissue engineering" such as roller bottles, flasks, and wave bags. The fluid container can be designed as disclosed in publication WO 2021 / 152128 Al.

[0056] The bioreactor preferably comprises a fluid vessel with a wall comprising a bottom region and a wall region, and a lid compatible with the fluid vessel. The fluid vessel and the lid can form a housing that includes a cavity for receiving at least one fluid. This cavity corresponds to a reactor chamber as defined in the present disclosure. The aeration and stirring unit can be connected to the lid of the bioreactor for fluid transfer, for example, gas transfer, and for power transmission to drive the aeration and stirring unit, such that, when the lid is connected to the fluid vessel, the aeration and stirring unit is located in the reactor chamber.

[0057] The fluid vessel, in particular its wall, can be at least partially transparent, translucent, or transparent. In addition, the control system can include at least one lighting element designed to illuminate the reactor chamber through the fluid vessel, particularly through the bottom and / or wall area. This allows for a

[0058] GO 241021WO

[0059] December 17, 2025. The medium, a flow, and / or particles absorbed in the fluid container can be illuminated and thus made more visible. This is particularly advantageous if no other light source is provided in the incubator.

[0060] Alternatively or additionally, the fluid vessel, particularly its wall, can be made of a thermally conductive material and / or have a relatively thin wall or base. This, combined with the use of aeration and stirring, allows for continuous fluid mixing throughout the reactor volume, thus improving the approximation of the fluid temperature in the reactor chamber with the ambient temperature around the fluid vessel, and potentially the temperature in the incubator. In other words, culture parameters such as temperature can be controlled easily and reliably. Examples of suitable materials include glass, polycarbonate, PC, Plexiglas, BioMed Clear (e.g., from Formlabs), or similar materials. Examples of wall or base thicknesses range from 1 to 4 mm, particularly 2 to 3 mm.

[0061] Preferably, the incubator is designed to establish and maintain a specific atmosphere within the incubation chamber. For example, the incubator may be configured to adjust at least one of the following parameters: gas composition, pH, temperature, humidity, pressure (this list is not exhaustive). Additionally, the incubator may have an adjustable light source, allowing for adjustment of the spectrum and / or intensity of the light provided. Alternatively or additionally, the incubator may include a camera, particularly for monitoring the bioreactor within the incubation chamber. Examples of incubators include: incubator, climate-controlled incubator, hypoxic incubator, multi-gas incubator, dry incubator, climate-controlled incubator, and cell incubator (this list is not exhaustive).

[0062] An atmosphere, especially one prevailing in the incubator room, can be characterized, for example, by a temperature, an oxygen concentration, a pH value,

[0063] GO 241021WO

[0064] December 17, 2025 and / or humidity. For example, the atmosphere in the incubator room may have a temperature in the range of 20 to 50°C, particularly in the range of 25 to 40°C, a humidity in the range of 70 to 100%, particularly in the range of 80 to 100%, and a CO2 concentration in the range of 0 to 50%, particularly in the range of 3 to 10%.

[0065] Preferably, the gas connection between the gas supply unit of the control system and the bioreactor, and the power connection between the drive element of the control system and the bioreactor, are detachable. This allows the control system and the bioreactor to be separated, so that the control system can be used with a different bioreactor if necessary, or the bioreactor can be cleaned separately from the control system.

[0066] The following describes various embodiments of the control system, the system, and the method, with each embodiment applying independently to the control system, the system, and the method, respectively. Furthermore, the individual embodiments can be combined with one another as desired.

[0067] In one embodiment of the control system, the gas conveying device is integrated into the housing, the housing has a gas inlet and a gas outlet, the gas inlet and the gas outlet are connected to the gas conveying device in such a way that the gas inlet, the gas conveying device and the gas outlet form a fluid path, and the interior of the housing is sealed against the fluid path.

[0068] In this way, the control system, including the gas supply unit, can be designed compactly while maintaining the suitability of the control system for use in an incubator room.

[0069] GO 241021WO

[0070] December 17, 2025. The gas inlet and gas outlet can each be designed as a penetrating opening in the control housing, wherein the respective penetrating openings accommodate a fluid-flowable hose, and wherein the edges of the penetrating openings are fluid-tightly connected to the hoses, for example by adhesive or a sealing element such as a sealing ring, a hose barb, or the like. The gas inlet and / or the gas outlet can have a filter to prevent foreign matter from entering the gas conveying device.

[0071] The gas conveying device can be designed for use with a conveying rate in the range of 0 to 500 ml / min, in particular in the range of 0 to 300 ml / min, preferably in the range of 0 to 100 ml / min, preferably in the range of 0 to 35 ml / min.

[0072] In one embodiment of the control system, the housing is designed in multiple parts with at least a first housing element and a second housing element, the interior is designed in multiple parts with at least a first interior and a second interior, wherein the first housing element forms the first interior and the second housing element forms the second interior, the control device is arranged in the first interior and the drive element or the motor of the drive element is arranged in the second interior, and the control device and the drive element are connected to each other via a communication link for the transmission of control commands, in particular concerning a stirring rate.

[0073] This allows the control unit to be designed in multiple parts, offering the advantage of improved adaptability to different bioreactors. Simultaneously, by arranging the drive element in a sealed interior within the control unit housing, metal components of the drive element, such as the motor, circuit board, cables, or similar parts, can be protected from potentially acidic humidity or atmospheres in the incubator chamber. In particular, metal components of the control unit and metal components of the drive element can be protected independently of each other or side by side.

[0074] GO 241021WO

[0075] December 17, 2025, that damage to the sealing of one of the interior spaces may not affect the protection provided by the rest of the interior space.

[0076] The communication connection can be a wired connection or wireless, for example as a Bluetooth or WLAN connection.

[0077] The first housing element can have a recess to accommodate the second housing element, for example, when the drive element is not in use. This allows the control unit to be stored in a compact and user-friendly manner.

[0078] In an alternative embodiment of the control system, the control unit and the drive element can be arranged together in the interior, particularly in the same interior space of the control unit's housing. This allows the control system to be designed compactly and offered as a single unit. Furthermore, such an embodiment offers the advantage of a simplified communication link between the control unit and the drive element.

[0079] Preferably, the control unit is configured to transmit information to or receive information from the communication interface and process this information. For example, the control unit can be configured to determine a diagnosis based on user or sensor information transmitted via the communication interface, or to store the information for maintenance purposes.

[0080] In one embodiment of the control system, a communication interface is provided, the communication interface is set up to detect at least one setpoint and to forward the at least one detected setpoint to the control device, and the at least one setpoint corresponds to a stirring rate or a gassing rate.

[0081] GO 241021WO

[0082] December 17, 2025 The communication interface enables operation of the controller, in particular the setting of parameters for controlling the gassing and / or stirring in a bioreactor connected to the controller.

[0083] The communication interface can be configured to capture user input and / or transmit information such as sensor data. Thus, the communication interface can be configured for bidirectional data transmission.

[0084] The communication interface can be designed as a user interface. Examples of a user interface include: display devices such as a screen, control buttons, touchscreens, although this list is not exhaustive.

[0085] Alternatively or additionally, the communication interface can be configured to transmit and / or receive data for further use by a computer system, particularly as a machine interface. Examples of machine interfaces include: USB port, WLAN module, NFC module, Bluetooth module, and internet connection, although this list is not exhaustive. Preferably, the communication interface is configured to communicate with a computer system located outside the incubator chamber. This allows the control system, and thus also any bioreactor connected to it, to be controlled from outside the incubator chamber without having to open the chamber. This enables improved continuity of an experiment or culture within the bioreactor in the incubator chamber.

[0086] An embodiment in which the control system is configured to illuminate the contents of the reactor chamber, the incubator has a camera, and the control system can be operated from outside the incubator chamber, allows monitoring of the cell culture and corresponding control of the system, taking into account possible interruptions of atmospheric conditions caused by opening the incubator chamber.

[0087] GO 241021WO

[0088] December 17, 2025 are minimized. Illumination of the bioreactor's contents can be achieved, for example, by a translucent wall of the fluid container in combination with a light source in the control unit, the bioreactor, or the incubator.

[0089] The communication interface may have a protective element to protect it from an atmosphere surrounding the housing, in particular from an atmosphere in the incubator room, for example a protective film for a communication interface designed as a screen or a protective cap for a communication interface designed as a USB port.

[0090] In a simplified control system, the communication interface can be configured to emit an acoustic signal, for example, when the control unit determines that a detected parameter value falls below, reaches, or exceeds a predefined threshold. This allows a user to be informed of the threshold being crossed, reached, or exceeded, even if the control system is located in an incubator.

[0091] In one embodiment of the control system, at least one sensor is provided, wherein the at least one sensor is designed to output at least one actual value, wherein the at least one actual value corresponds to an actual state of a culture recorded in a bioreactor connected to the control system or the at least one actual value corresponds to an actual state of an atmosphere around the bioreactor, and wherein the at least one sensor is configured to forward the at least one actual value to the control unit and, if applicable, to the communication interface.

[0092] By installing sensors on the control system, a reaction or culture in the bioreactor can be monitored and tracked. An actual value recorded by at least one sensor can be used to adjust or control the aeration rate and / or the stirring rate. In addition, a value recorded by at least one sensor can be used to...

[0093] GO 241021WO

[0094] On December 17, 2025, a sensor-detected actual value will be transmitted to other units, such as a computer system, via the communication interface for further use. Overall, user-friendliness is improved.

[0095] The at least one sensor can be integrated into the controller housing, or alternatively, designed for use in the reactor or incubator chamber and connected to the controller's control unit. This connection can be for data transmission, such as the transmission of measured or actual values, and / or for supplying power to the at least one sensor. The data transmission connection can be wired or wireless. Examples of the at least one sensor include: temperature sensor, probe, pH probe, dissolved oxygen probe, CO2 probe, humidity sensor, optical density sensor, pressure sensor, and oxygen sensor; this list is not exhaustive.

[0096] In one embodiment of the system, the gas inlet of the control unit is designed to allow a gas or gas mixture from the atmosphere surrounding the housing of the control unit into the gas conveying device, and the bioreactor has a gas outlet, wherein the gas outlet of the bioreactor is designed to release a gas or gas mixture from the reactor space into an atmosphere surrounding the housing of the bioreactor.

[0097] This allows for the use of an incubator-controlled atmosphere for gassing in the bioreactor. This makes it possible, in particular, to conduct long-term experiments, for example, with durations ranging from a few hours to 200 days, especially up to 10 days, in a controlled atmosphere.

[0098] In one embodiment of the system, an incubator with a housing is provided, wherein the housing of the incubator forms an incubator space with spatial dimensions, and wherein the spatial dimensions of the control

[0099] GO 241021WO

[0100] December 17, 2025, and the spatial dimensions of the bioreactor for an arrangement of the control system and the bioreactor together in the incubator room have been selected.

[0101] This allows the system to be used in combination with an incubator.

[0102] For example, the housing of a system's control unit can be deeper than it is wide. This allows several control units, possibly together with bioreactors, to be arranged side-by-side in the incubator. This enables multiple bioreactors to be positioned at essentially the same height within the incubator. Due to the specific CO2 concentration in the incubator, such an arrangement is advantageous for achieving comparable conditions in the adjacent bioreactors.

[0103] In one embodiment of the system, it is provided that at least two bioreactors are provided, that the control system for controlling the at least two bioreactors is provided, and that the control system and the at least two bioreactors are housed together in the incubator room.

[0104] One embodiment of the method is disclosed in which at least two bioreactors with a gassing and stirring unit are arranged in the incubator chamber, in which a gas or a gas mixture from the atmosphere of the incubator chamber is supplied to the respective gassing and stirring units according to a predetermined gassing rate, and in which the gassing and stirring unit for each of the at least two bioreactors is moved in the bioreactor according to a predetermined stirring rate.

[0105] This allows several experiments or cultures to be carried out in parallel under similar conditions and, if necessary, synchronized, at least with regard to stirring and aeration rates. In particular, similar aeration and stirring rates can be used for two bioreactors. Alternatively, different aeration and stirring rates can be used for two bioreactors.

[0106] GO 241021WO

[0107] December 17, 2025. Preferably, the at least two bioreactors are arranged at a similar, and in particular the same, height in the incubator room. This allows, for example, similar CCh concentrations or oxygen concentrations from the incubator room to be used in the respective bioreactors.

[0108] In one embodiment of the system, it is provided that at least two controllers according to one of the preceding claims and at least two bioreactors are provided, wherein the at least two controllers and the at least two bioreactors are together housed in the incubator room.

[0109] This allows experiments or cultures to be carried out in parallel. For example, for two cultures housed in adjacent bioreactors, the atmospheric conditions of the incubator chamber can be essentially the same, while different stirring rates and / or aeration rates can be set via separate controls.

[0110] Preferably, the control units located in the incubator chamber are oriented such that their respective communication interfaces face an incubator door. This allows for rapid operation when the bulkhead is opened, without having to access other systems or leave the incubator open for an extended period.

[0111] An embodiment of the method is disclosed in which a cultivation, in particular a cell culture, is included in the bioreactor, and in which the cultivation is stirred with the gassing and stirring unit and is essentially diffusively gassed with the gas or gas mixture from the atmosphere of the incubator room.

[0112] The aeration and stirring unit allows shear-sensitive biological processes to be carried out diffusively or essentially bubble-free under controlled atmospheric conditions.

[0113] GO 241021WO

[0114] They will be fumigated on December 17, 2025. A cultivation can contain individual organisms or organisms in groups. These organisms can be cells.

[0115] One embodiment of the method is disclosed in which organisms of a predetermined group of organisms are separated in cultivation using magnetic particles.

[0116] In a specific example, cells can be specifically labeled and separated using magnetic particles linked to antibodies.

[0117] Furthermore, this allows cells to be separated from the culture medium, and possibly from other cells included in the culture medium. Such separation can be carried out, for example, as part of a so-called "cell purification," "cell selection," or affinity purification.

[0118] Preferably, in this embodiment, the drive element that powers the gassing and stirring unit, or the drive element of the control system, is not a magnetic drive. This prevents the unwanted attraction of magnetic particles by the drive element.

[0119] Magnetic beads, with a diameter on the order of a few micrometers to less than one micrometer, can be used as magnetic particles. These beads must contain at least one magnetic component, such as a ferrite core, and must have an affinity carrier compatible with the cells to be separated. An example of such an affinity carrier is a polymer coating containing polyGMA, glycidyl methacrylate, and / or an antibody.

[0120] An embodiment of the method is disclosed in which a cell culture medium is included in the bioreactor, and in which the cell culture medium is at least partially replaced.

[0121] GO 241021WO

[0122] December 17, 2025. This allows for the replacement of used culture media. Furthermore, it enables the exchange of signaling molecules for cell differentiation and the harvesting of cells, organisms, or their synthesized products. Metabolic waste products of the organisms, which can lead to "self-poisoning," can also be removed, and potential products such as antibodies or viruses can be harvested.

[0123] The fluid can be exchanged by drawing it off with a syringe. Alternatively, a dedicated pump, along with appropriate fluid connections to the bioreactor or reactor chamber, can be provided. This pump can be integrated into the control system, with the control unit configured to operate the pump. Alternatively, the pump can be separate from the control system and may be part of the incubator's pumping system.

[0124] Alternatively or additionally, a so-called "at-line" perfusion system, set up in the incubator, can be used for medium changes. During the medium change, the cells are preferably either held in the bioreactor by a filter frit and the cell culture medium is pumped out of the reactor chamber, or the cells are pumped out of the reactor chamber along with the cell culture medium, and the separation of the cells takes place "at-line," i.e., outside the reactor chamber, by returning them to the reactor chamber together with new cell culture medium or with a low-pollutant medium.

[0125] Further features and advantages of the control system and the method will become apparent from the following description of exemplary embodiments, with reference to the attached drawing.

[0126] The drawing shows

[0127] Fig. 1 shows an embodiment of a control system;

[0128] GO 241021WO

[0129] December 17, 2025 Fig. 2 shows another embodiment of a control system;

[0130] Fig. 3 shows a first embodiment of a system; and

[0131] Fig. 4 shows another embodiment of a system; and

[0132] Fig. 5 shows an embodiment of a method for operating a bioreactor comprising a gassing and stirring unit in the form of a flow diagram.

[0133] Fig. 1 shows an embodiment of a control unit 100 for a bioreactor 102. The control unit 100 has a housing 104, a drive element 106 with a motor 108, a gas conveying device 110 and a control unit 112.

[0134] The housing 104 is designed in multiple parts and has a first housing element 114, which forms a first interior 116, and a second housing element 118, which forms a second interior 120.

[0135] The first housing element 114 comprises a first housing part 122 and a second housing part 124, wherein the first housing part 122 and the second housing part 124 are made of plastic. The first housing part 122 and the second housing part 124 are connected to each other via a screw connection 126 and a sealing element such that the first housing part 122 and the second housing part 124 are hermetically sealed, i.e., gas-tight. The screw connection 126 and the sealing element seal the first interior space 116 formed by the first housing part 122 and the second housing part 124 from the atmosphere surrounding the first housing element 114. The control device 112 is arranged in the first interior space 116. This seals the control device 112 from the surrounding atmosphere and prevents metal parts from entering.The electronic components of the control unit 112 are thus protected from oxidizing or harmful atmospheric conditions.

[0136] GO 241021WO

[0137] December 17, 2025. The first housing element 114 has a gas inlet 128 and a gas outlet 130. The gas inlet 128 and the gas outlet 130 are connected to the gas conveying device 110 in such a way that the gas inlet 128, the gas conveying device 110, and the gas outlet 130 form a fluid path 132. In the embodiment shown, the gas outlet 130 can be connected to a gas inlet 136 of a bioreactor 102 via a hose 134.

[0138] The gas conveying device 110 is integrated into the first housing element 114 or spatially arranged in the first interior space 116 and is fluidically sealed from the first interior space 116. Thus, the fluid path 132 runs through the first interior space 116 and is sealed from the interior volume of the first interior space 116.

[0139] The control unit 112 and the gas supply unit 110 are connected to each other via a first communication link 138, and the control unit 112 is configured to control 100 of the gas supply unit 110 according to a predetermined gassing rate. Furthermore, the gas supply unit 110 is configured to pump the atmosphere surrounding the first housing element 114 through the gas inlet 128 and to deliver it through the gas outlet 130 according to a gassing rate, optionally with a flow rate set as a function of a gassing rate specified by the control unit 112. The gas outlet 130 can be connected to the gas inlet 136 of a bioreactor 102, so that the atmosphere or gas flow delivered by the pump can be supplied to the bioreactor 102. In this way, a culture contained in the bioreactor 102 can be gassed with a gas input corresponding to the gassing rate.

[0140] The motor 108 of the drive element 106 is arranged in the second interior space 120 of the control unit 100. The motor 108 can be connected via a coupling element 140 to a gassing and stirring unit 142 of a bioreactor 102, the coupling element 140 being designed to transmit a driving force from the motor 108 to the gassing and stirring unit 142.

[0141] GO 241021WO

[0142] December 17, 2025 The control unit 112 and the drive element 106 are connected to each other via a second communication link 144 for the transmission of control commands and the control unit 112 is set up to control the drive element 106 or the motor 108 according to a predetermined stirring rate.

[0143] The control unit 112 is connected to a communication interface 148 via a third communication link 146. The communication interface 148 is designed for wireless data transmission, i.e., wireless sending and receiving of data. In this way, a setpoint, for example, a setpoint for a stirring rate or a gassing rate, can be received via the communication interface 148 and forwarded to the control unit 112 for a corresponding adjustment of the drive element 106 and / or the gas supply unit 110.

[0144] A battery 150 is provided to supply energy to the drive element 106, the control unit 112, and the communication interface 148. The battery 150 is located in the first interior space 116. In this way, the battery 150 and any cable connections to the battery 150 are protected from the atmosphere outside the first housing element 114.

[0145] Fig. 2 shows another embodiment of a control unit 200. The control unit 200 comprises a housing 202, a drive element 204 with a motor 206, a gas supply device 208, and a control unit 210. The housing 202 forms an interior space 212 in which the control unit 210, the drive element 204 (or the motor 206 of the drive element 204), and the gas supply device 208 are arranged.

[0146] The housing 202 comprises a first housing part 214 and a second housing part 216, wherein the first housing part 214 and the second housing part 216 are made of plastic. The first housing part 214 and the second housing part 216 are connected to each other by a clamping connection 218 with a sealing element.

[0147] GO 241021WO

[0148] On December 17, 2025, it was agreed that the first housing part 214 and the second housing part 216 are hermetically or gas-tightly connected to each other. In this way, the interior 212 of the housing 202 is sealed from the atmosphere surrounding the housing 202. Accordingly, the motor 206 and the control unit 210, as well as any existing cable connections, are protected from this atmosphere.

[0149] The motor 206 of the drive element 204 can be connected via a coupling element 220 to a gassing and stirring unit 222 of a bioreactor 224. Furthermore, the coupling element 220 has a gas inlet 226, which is connected via a hose 228 to a gas outlet 230 of the control unit 200. The gas outlet 230 of the control unit 200 is connected to the gas supply device 208. The gas inlet 226 of the coupling element 220, the gas outlet 230 of the control unit 200, and the gas supply device 208 together form part of a fluid path 232. The coupling element 220 is designed to transmit a driving force from the motor 206 to the gassing and stirring unit 222 and to transmit a gas flow or atmosphere supplied by the gas supply device 208 to the gassing and stirring unit 222.

[0150] The gas conveying device 208 is integrated into the housing 202 or is spatially arranged within the interior 212 and is fluidically sealed from the interior 212. The fluid path 232 thus runs through the interior 212 and is sealed from the interior volume of the interior 212.

[0151] The control unit 210 is connected to the drive element 204 via a first communication link 234, to the gas conveying unit 208 via a second communication link 236, and to a communication interface 240 via a third communication link 238. The communication interface 240 is designed as a touch-sensitive screen and is configured to capture user input regarding setpoints for a stirring rate and / or a gassing rate, which are then transmitted via the third communication link 238.

[0152] GO 241021WO

[0153] December 17, 2025 Communication link 238 can be forwarded to the control unit 210.

[0154] The control unit 210 is designed to control the drive element 204 and the gas conveying unit 208 on the basis of setpoints acquired through the communication interface 240.

[0155] In the embodiment shown, an electrical connection 242 is provided for supplying power to the control unit 210, the gas conveying unit 208, the drive element 204 or the motor 206 of the drive element 204 and the communication interface 240.

[0156] Fig. 3 shows a first embodiment of a system 300 comprising a controller 302, a bioreactor 304, and an incubator 306. The system 300 is shown in a state in which the bioreactor 304 is connected to the controller 302, and the bioreactor 304 and the controller 302 are arranged together in the incubator 306.

[0157] The control unit 302 is designed similarly to the control unit 100 from Fig. 1 and comprises a housing 308, a drive element 310 with a motor 312, a gas supply device 314, a control unit 316, a communication interface 318, and a battery 320. Here too, the gas supply device 314 is connected to a gas inlet 322 and a gas outlet 324 in such a way that the gas inlet 322, the gas supply device 314, and the gas outlet 324 form a fluid path 326.

[0158] The bioreactor 304 comprises a housing 330 forming a reactor chamber 328, a gassing and stirring unit 332 arranged in the reactor chamber 328, a gas inlet 334 permeably connected to the gassing and stirring unit 332, and a connecting element 336. The connecting element 336 of the bioreactor 304 is for transmitting a force from the drive element 310 of the control unit 302 to the

[0159] GO 241021WO

[0160] On December 17, 2025, a gassing and stirring unit 332 was formed. Here, the connecting element 336 of the bioreactor 304 is connected to the drive element 310 of the control unit 302 via a coupling element 338 of the drive element 310. Furthermore, the gas outlet 324 of the control unit 302 or the fluid path 326 of the control unit 302 and the gas inlet 334 of the bioreactor 304 are connected to each other in a flow-permeable manner.

[0161] The control unit of the control system 302 is designed, on the one hand, to control the drive element 310 in such a way that the gassing and stirring unit 332 of the bioreactor 304 is moved in the bioreactor 304 at a predetermined stirring rate, and on the other hand, to control the gas supply unit 314 in such a way that a predetermined gas flow is supplied to the gassing and stirring unit 332.

[0162] The incubator 306 has a housing 340, which forms an incubator chamber 342. The incubator 306 is designed to set and maintain the atmosphere in the incubator chamber 342 with regard to gas composition, temperature, and humidity.

[0163] The dimensions of the control unit 302 and the bioreactor 304 together are adapted to the dimensions or spatial dimensions of the incubator room 342, so that the control unit 302 and the bioreactor 304 together can be accommodated in the incubator room 342.

[0164] The communication interface 318 is designed to wirelessly receive data from outside the incubator room 342 when the incubator 306 is closed and to forward it to the control unit 316 for control 302 of the gas conveying unit 314 and the drive element 310.

[0165] Fig. 4 shows another embodiment of a system 400, wherein the system 400 comprises a first controller 402, a first bioreactor 404, a second controller 406, a second bioreactor 408 and an incubator 410.

[0166] GO 241021WO

[0167] December 17, 2025 The first controller 402 and the first bioreactor 404 on the one hand, and the second controller 406 and the second bioreactor 408 on the other, are each similar to the controller 402, 406 and the bioreactor of the one shown in Fig. 1, with the exception that, for the energy supply of the gas conveying device, the drive element, the control unit 418, 424 and the communication interface 420, 426, the controller 402, 406 has a plug 412, 414 instead of a battery.

[0168] Additionally, the first bioreactor 404 has a first sensor 416, which is connected to the control unit 418 of the first controller 402. The first sensor 416 is designed to detect an actual value for a parameter, for example, a temperature, and to transmit the detected actual value to the control unit 418. The control unit 418 of the first controller 402 is configured to evaluate the actual value and, if necessary, make it available to the first controller 402 via the communication interface 420.

[0169] Similarly, the second bioreactor 408 has a second sensor 422, which is connected to the control unit 424 of the second controller 406. The second sensor 422 is designed to detect an actual value for a parameter, for example, a temperature, and to transmit the detected actual value to the control unit 424. The control unit 424 of the second controller 406 is configured to evaluate the actual value and, if necessary, make it available to the second controller 406 via the communication interface 426.

[0170] The incubator 410 has a housing 428, which forms an incubator chamber 430. The incubator 410 is designed to set and maintain the atmosphere in the incubator chamber 430 with regard to gas composition, temperature, and humidity. Furthermore, the incubator 410 has at least two sockets 432, 434, to which the plugs 412, 414 of the first controller 402 and the second controller 406 can be connected.

[0171] GO 241021WO

[0172] December 17, 2025 With such a system 400, several bioreactors, in this case the first bioreactor 404 and the second bioreactor 408, can be operated under similar conditions for long-term experiments, at least with regard to the gas composition, temperature, and humidity of the atmospheres or gas flows supplied via the respective gas delivery devices. Furthermore, the actual values ​​recorded by the first sensor 416 and the second sensor 422 can be used for comparable data collection and monitoring of the medium or cultures taken up by the bioreactors.

[0173] Fig. 5 shows an embodiment of a method 500 for operating a bioreactor comprising a gassing and stirring unit in the form of a flow diagram.

[0174] In a first step, 502, a bioreactor with a gassing and stirring unit and a connecting element, and a control unit with a drive element and a gas supply device are provided. Preferably, a cell culture is accommodated by the bioreactor.

[0175] In a further step 504, the bioreactor and the control unit are connected by connecting the connecting element of the bioreactor and the drive element of the control unit for a power transmission from the drive element to the gassing and stirring unit of the bioreactor, and by connecting the gas conveying device of the control unit and the gas inlet of the bioreactor in a flow-permeable manner.

[0176] In a further step 506, an incubator with a housing forming an incubator room is provided, with an atmosphere prevailing in the incubator room.

[0177] In a further step 508, the bioreactor is arranged together with the control system in the incubator room.

[0178] GO 241021WO

[0179] December 17, 2025 In a further step 510, a gas or gas mixture from the atmosphere of the incubator chamber is supplied to the gassing and stirring unit according to a predetermined gassing rate. Simultaneously or in parallel, the gassing and stirring unit is moved within the bioreactor according to a predetermined stirring rate.

[0180] In a further step 512, the cell culture taken up by the bioreactor is stirred with the gassing and stirring unit for a predetermined period and is essentially diffusely gassed with the gas or gas mixture from the atmosphere of the incubator room.

[0181] GO 241021WO

[0182] December 17, 2025

Claims

- 33 - Patent claims 1. Control unit (100, 200, 302, 402, 406) for a bioreactor (102, 224, 304, 404, 408), comprising a housing (104, 202, 308), a drive element (106, 204, 310), a gas conveying device (110, 208, 314), and a control unit (112, 210, 316, 418, 424), wherein the housing (104, 202, 308) forms an interior space (116, 120, 212) and the control unit (112, 210, 316, 418, 424) is arranged in the interior space (116, 120, 212), characterized in that the interior space (116, 120, 212) of the housing (104, 202, 308) is sealed against an atmosphere surrounding the housing (104, 202, 308), and that the control device (112, 210, 316, 418, 424) is set up to control the drive element (106, 204, 310) according to a predetermined stirring rate and to control the gas conveying device (110, 208, 314) according to a predetermined gassing rate.

2. Control unit (100, 200, 302, 402, 406) according to claim 1, characterized in that the gas conveying device (110, 208, 314) is integrated in the housing (104, 202, 308), that the housing (104, 202, 308) has a gas inlet (128, 322) and a gas outlet (130, 230, 324), that the gas inlet (128, 322) and the gas outlet (130, 230, 324) are connected to the gas conveying device (110, 208, 314) in such a flow-permeable manner that the gas inlet (128, 322), the gas conveying device (110, 208, 314) and the gas outlet (130, 230, 324) 324) form a fluid path (132, 232, 326), and that the interior (116, 120, 212) of the housing (104, 202, 308) is sealed against the fluid path (132, 232, 326). GO 241021WO December 17, 2025 - 34 - 3. Control unit (100, 200, 302, 402, 406) according to one of the preceding claims, characterized in that the housing (104, 202, 308) is formed in multiple parts with at least a first housing element (114, 124) and a second housing element (114, 124), that the interior (116, 120, 212) is formed in multiple parts with at least a first interior (120, 212) and a second interior (120, 212), wherein the first housing element (114, 124) forms the first interior (120, 212) and the second housing element (114, 124) forms the second interior (120, 212), that the control device (112, 210, 316, 418, 424) is located in the first interior (120, 212) is arranged and the drive element (106, 204, 310) orthe motor of the drive element (106, 204, 310) is arranged in the second interior space (120, 212), and that the control device (112, 210, 316, 418, 424) and the drive element (106, 204, 310) are connected to each other via a communication link (144, 234) for the transmission of control commands, in particular concerning a stirring rate.

4. Control unit (100, 200, 302, 402, 406) according to one of the preceding claims, characterized in that a communication interface (148, 240, 318, 420, 426) is provided, that the communication interface (148, 240, 318, 420, 426) is configured to detect at least one setpoint and to forward the at least one detected setpoint to the control unit (112, 210, 316, 418, 424), and that the at least one setpoint corresponds to a stirring rate or a gassing rate. GO 241021WO December 17, 2025 5. Controller (100, 200, 302, 402, 406) according to one of the preceding claims, characterized in that at least one sensor (416, 422) is provided, wherein the at least one sensor (416, 422) is configured to output at least one actual value, wherein the at least one actual value corresponds to an actual state of a culture contained in a bioreactor (102, 224, 304, 404, 408) connected to the controller (100, 200, 302, 402, 406) or the at least one actual value corresponds to an actual state of an atmosphere around the bioreactor (102, 224, 304, 404, 408), and that the at least one sensor (416, 422) is configured to transmit the at least one actual value to the control unit (112, 210, 316, 418, 424) and, if necessary, forward to the communication interface (148, 240, 318, 420, 426).

6. Control (100, 200, 302, 402, 406) according to one of the preceding claims, characterized in that the stirring rate is predetermined by a predefined profile, wherein the profile specifies a development of the stirring rate over time or a development of a rotational speed of the aeration and stirring unit over time, and / or that the aeration rate is predetermined by a predefined profile, wherein the profile specifies a development of the aeration rate over time or a development of a fluid flow into the aeration and stirring unit.

7. System (300, 400) with a bioreactor (102, 224, 304, 404, 408) and with a controller (100, 200, 302, 402, 406) according to one of the preceding claims, characterized in that the bioreactor (102, 224, 304, 404, 408) comprises a housing (330) forming a reactor chamber (328), a control unit arranged in the reactor chamber (328) GO 241021WO December 17, 2025 a gassing and stirring unit (142, 222, 332), a gas inlet (226) connected to the gassing and stirring unit (142, 222, 332) in a flow-permeable manner, and a connecting element (336) such that the connecting element (336) of the bioreactor (102, 224, 304, 404, 408) and the drive element (106, 204, 310) of the control unit (100, 200, 302, 402, 406) are connectable to each other, and that the connecting element (336) of the bioreactor (102, 224, 304, 404, 408) is capable of transmitting a force from the drive element (106, 204, 310) of the control unit (100, 200, 302, 408). 402, 406) is configured for the gassing and stirring unit (142, 222, 332) such that the control device (112, 210, 316, 418, 424) of the control unit (100, 200, 302, 402, 406) is configured to control the drive element (106, 204, 310) such that the gassing and stirring unit (142, 222, 332) is moved at a predetermined stirring rate in the bioreactor (102, 224, 304, 404, 408), that the gas conveying device (110, 208,314) of the control unit (100, 200, 302, 402, 406) and the gas inlet (226) of the bioreactor (102, 224, 304, 404, 408) are permeable to each other, such that the control unit (112, 210, 316, 418, 424) of the control unit (100, 200, 302, 402, 406) is configured to control the gas supply unit (110, 208, 314) in such a way that a predetermined gas flow is supplied to the aeration and stirring unit (142, 222, 332).

8. System (300, 400) according to claim 7, characterized in that the gas inlet (128, 322) of the controller (100, 200, 302, 402, 406) is configured to admit a gas or a gas mixture from the atmosphere surrounding the housing (104, 202, 308) of the controller (100, 200, 302, 402, 406) into the gas conveying device (110, 208, 314), and that the bioreactor (102, 224, 304, 404, 408) has a gas outlet, wherein the gas outlet of the bioreactor (102, 224, 304, 404, 408) is configured to allow a GO 241021WO December 17, 2025 - 37 - to release gas or a gas mixture from the reactor chamber (328) into an atmosphere surrounding the casing (330) of the bioreactor (102, 224, 304, 404, 408).

9. System (300, 400) according to one of the preceding claims, characterized in that an incubator (306, 410) is provided with a housing (340), wherein the housing (340) of the incubator (306, 410) forms an incubator chamber (342, 430) with spatial dimensions, and that the spatial dimensions of the controller (100, 200, 302, 402, 406) and the spatial dimensions of the bioreactor (102, 224, 304, 404, 408) are selected for an arrangement of the controller (100, 200, 302, 402, 406) and the bioreactor (102, 224, 304, 404, 408) together in the incubator chamber (342, 430).

10. System (300, 400) according to claim 9, characterized in that at least two bioreactors (102, 224, 304, 404, 408) are provided, that the control unit (100, 200, 302, 402, 406) is provided for controlling the at least two bioreactors (102, 224, 304, 404, 408), and that the control unit (100, 200, 302, 402, 406) and the at least two bioreactors (102, 224, 304, 404, 408) are together housed in the incubator room (342, 430).

11. System (300, 400) according to one of claims 9 or 10, characterized in that at least two controllers (100, 200, 302, 402, 406) according to one of the preceding claims and at least two bioreactors (102, 224, 304, 404, 408) are provided, GO 241021WO December 17, 2025 - 38 - wherein the at least two controllers (100, 200, 302, 402, 406) and the at least two bioreactors (102, 224, 304, 404, 408) are together in the incubator room (342, 430).

12. System (300, 400) according to one of claims 7 to 11 characterized in that the stirring rate is predetermined by a predefined profile, wherein the profile specifies a development of the stirring rate over time or a development of the rotational speed of the aeration and stirring unit over time, and / or that the aeration rate is predetermined by a predefined profile, wherein the profile specifies a development of the aeration rate over time or a development of a fluid flow into the aeration and stirring unit.

13. Method (500) for operating a bioreactor (102, 224, 304, 404, 408) comprising a gassing and stirring unit (142, 222, 332), in particular for operating a system (300, 400) according to one of the preceding claims, wherein an incubator (306, 410) is provided with a housing (340) forming an incubator chamber (342, 430), wherein an atmosphere prevails in the incubator chamber (342, 430), wherein the bioreactor (102, 224, 304, 404, 408) is arranged in the incubator chamber (342, 430), wherein a gas or a gas mixture from the atmosphere of the incubator chamber is supplied to the gassing and stirring unit (142, 222, 332). (342, 430) is supplied according to a predetermined gassing rate, and the gassing and stirring unit (142, 222, 332) is moved in the bioreactor (102, 224, 304, 404, 408) according to a predetermined stirring rate. GO 241021WO December 17, 2025 - 39 - 14. Method (500) according to claim 13, wherein a cultivation, in particular a cell culture, is incorporated in the bioreactor (102, 224, 304, 404, 408), and wherein the cultivation is stirred with the gassing and stirring unit (142, 222, 332) and is gassed substantially diffusively with the gas or gas mixture from the atmosphere of the incubator chamber (342, 430).

15. Method (500) according to claim 14, wherein organisms of a predetermined group of organisms are separated in cultivation by means of magnetic particles.

16. Method (500) according to one of the preceding claims, wherein a cell culture medium is included in the bioreactor (102, 224, 304, 404, 408) and wherein the cell culture medium is at least partially exchanged.

17. Method (500) according to one of the preceding claims, wherein at least two bioreactors (102, 224, 304, 404, 408) with a gassing and stirring unit (142, 222, 332) are arranged in the incubator chamber (342, 430), wherein a gas or a gas mixture from the atmosphere of the incubator chamber (342, 430) is supplied to the respective gassing and stirring units (142, 222, 332) according to a predetermined gassing rate, and wherein for each bioreactor (102, 224, 304, 404, 408) of the at least two bioreactors (102, 224, 304, 404, 408) the gassing and stirring unit (142, 222, 332) is arranged accordingly a predetermined stirring rate in the bioreactor (102, 224, 304, 404, 408).

18. Method (500) according to any one of the preceding claims, GO 241021WO December 17, 2025 - 40 - in which the stirring rate is predetermined by a predefined profile, wherein the profile specifies a development of the stirring rate over time or a development of a rotational speed of the aeration and stirring unit over time, and / or - in which the aeration rate is predetermined by a predefined profile, wherein the profile specifies a development of the aeration rate over time or a development of a fluid flow into the aeration and stirring unit. GO 241021WO December 17, 2025

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