Smart display tower

Abstract

The invention relates to a modular system for performing bioprocesses, comprising a bioprocess machine and at least one auxiliary device, each equipped with digital controllers. These controllers facilitate machine-to- machine communication and utilize a Discovery Negotiation Pairing (DNP) manager for establishing paired conditions, enabling integrated control. A capability manager organizes the functionalities of the system components. A dedicated auxiliary device, featuring a display and input / output (I / O) devices, provides a remote Human-Machine Interface (HMI) for remote control. This setup allows operators to manage bioprocesses efficiently from a distance, enhancing operational flexibility. The system supports user identification and authentication and automatic propagation of identification across devices, streamlining configuration and security. During production, the smart display tower continues to facilitate local control of auxiliary devices, maintaining process oversight and enabling real-time adjustments. This invention enhances the usability and efficiency of bioprocessing systems, offering improved control and monitoring capabilities for biotechnological fluid treatments, such as those used in the production of monoclonal antibodies, vaccines, and recombinant proteins. The system's innovative features provide significant advantages in terms of flexibility, security, and operational efficiency in biopharmaceutical manufacturing environments.

Description

[0001] P24-265 DAK

[0002] - 1 -

[0003] SMART DISPLAY TOWER

[0004] The hereby described invention discloses a system and a method for performing a bioprocess using a remote Human-Machine-Interface (HMI) to

[0005] 5 control the bioprocess system.

[0006] Technical Field

[0007] The invention relates to the field of process analytical technology (PAT) for monitoring and control of biopharmaceutical production processes, such as for monoclonal antibodies, vaccines, and recombinant proteins.

[0008] Background and description of the prior art

[0009] 15 In biopharmaceutical production facilities, process analytical technology (PAT) devices are used to monitor and control critical process parameters and quality attributes. To implement effective process control, scientists and engineers need to coordinate workflows across multiple interconnected PAT devices. PAT involves real-time measurements and analysis of critical quality

[0010] 20 attributes and process parameters to ensure consistent product quality.

[0011] Currently, this requires access to centralized systems like DCS, SCADA, or Process Orchestration Layers. However, these solutions are expensive, require significant expertise, and represent an additional centralized system to implement and maintain. At worst, operators are left to manually propagate setpoints between devices. Furthermore existing batch control systems can coordinate devices, but require significant expertise and cost. They are also centralized systems requiring separate configuration. The prior art technologies lack capabilities to enable modular bioprocess devices to

[0012] 30 directly interoperate and coordinate in a distributed fashion based on process analytics. P24-265 DAK

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[0014] Some biopharmaceutical production facilities utilize modular processing equipment for different unit operations connected via a batch control system. As described in the prior art WO 2023 / 046605 A1 modular automation systems with interconnected manufacturing units or devices having digital

[0015] 5 controllers are known in the field of analytical technology (PAT) for monitoring and control of biopharmaceutical production processes. The prior art describes an automated Manufacturing Execution System (MES) with orchestration capabilities to coordinate modular units and execute manufacturing workflows and recipes.

[0016] In recent years, the need for enhanced operational efficiency and usability in bioprocessing systems has become increasingly critical. Existing systems often rely on modular processing equipment comprising various bioprocess machines and auxiliary devices. However, these auxiliary devices frequently

[0017] 15 lack adequate local user interfaces, limiting operators' ability to monitor and control processes effectively. Many auxiliary devices are designed without physical displays, or they may feature only minimal interfaces, which can hinder the operator's ability to manage complex workflows, configure devices, monitor data, and respond to alarms in real time.

[0018] 20

[0019] The integration of digital controllers with machine-to-machine (MtoM) communication capabilities has emerged as a solution to improve connectivity and interaction among system components. Furthermore, the discovery negotiation pairing (DNP) protocol allows for the seamless establishment of paired conditions between devices, facilitating enhanced communication and control. This technology has been disclosed by previous patent applications, which highlight the potential for creating a more cohesive and interactive operational environment.

[0020] 30 Despite these advancements, there remains a significant gap in providing operators with a comprehensive remote human-machine interface (HMI) that can effectively consolidate the functionalities of various system components. P24-265 DAK

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[0022] The demand for a dedicated auxiliary device that can serve as an interactive display and control unit is evident, as it would enable operators to manage bioprocesses more efficiently, thereby improving overall productivity and safety in biotechnological applications.

[0023] 5

[0024] The task of this patent application is now to address these challenges and to ease the configuration of multiple PAT tools without requiring additional I / O devices and capabilities. Solving this task would allow biopharmaceutical manufacturers to more readily implement process analytical technology and effectively coordinate devices to improve process monitoring and control.

[0025] Summary of the invention

[0026] This task has been solved by a system for performing a bioprocess

[0027] 15 comprising of the following modular system components of a bioprocess machine with a digital controller for controlling the bioprocess machine; and at least one physical and / or software-based auxiliary device for being coupled to the bioprocess machine with a digital controller for controlling the auxiliary device; wherein the digital controllers each comprising a machine to

[0028] 20 machine communication tool (MtoM) configured for connecting to a network, a discovery negotiation pairing (DNP) manager configured for cooperating over the network for establishing a paired condition between either the bioprocess machine and the at least one physical or software-based auxiliary device and / or between the physical or software-based auxiliary devices, and a capability manager configured to organize capabilities of the paired bioprocess machine and / or the auxiliary devices; which is characterized in that at least one physical and / or software-based auxiliary device is a dedicated auxiliary device which is connected to a display and l / O-devices to interact with an user and which is configured to provide a remote Human-

[0029] 30 Machine-Interface (HMI) to control the bioprocess machine and / or any at least one physical auxiliary device remotely by using its respective DNP managers to perform the workflow of the bioprocess. The system is P24-265 DAK

[0030] - 4 - structured modular and comprises a bioprocess machine and at least one auxiliary device, either physical or software-based. These components are designed to work together to perform a bioprocess, enhancing flexibility and scalability in biotechnological applications. Each component is equipped with

[0031] 5 a digital controller, which facilitates precise control and monitoring of the bioprocess. The digital controller enhances automation and reduces manual intervention, improving process efficiency and consistency. The Machine-to- Machine Communication (MtoM) allows the controllers to connect to a network, enabling seamless communication between the bioprocess machine and auxiliary devices. MtoM communication supports real-time data exchange and coordination, which is crucial for maintaining optimal process conditions. The DNP manager facilitates the pairing of system components over the network, establishing connections that allow for integrated control and operation. This pairing capability simplifies the setup process and

[0032] 15 ensures that all components can work together harmoniously. The Capability Manager organizes and manages the capabilities of the paired devices, ensuring that the system operates efficiently and effectively. It further optimizes resource allocation and enhances system responsiveness. The core feature of the invented system is now that at least one auxiliary device

[0033] 20 is a dedicated device connected to a display and I / O devices, providing a remote Human-Machine Interface (HMI). This configuration allows users to control the bioprocess machine and auxiliary devices remotely. The dedicated auxiliary device acts as an interactive hub, enabling operators to manage the bioprocess from a distance, which is particularly advantageous in environments where physical access may be limited or inconvenient. The remote HMI capability enhances operational flexibility, allowing for remote monitoring and control, which can lead to improved process oversight and reduced response times to process deviations. By facilitating remote interaction, this feature minimizes the need for physical presence, thereby

[0034] 30 increasing efficiency and potentially reducing labor costs. Additionally, the integration of a display and I / O devices ensures that operators have access to comprehensive control functionalities, enhancing the overall user P24-265 DAK

[0035] - 5 - experience and process management capabilities. In summary: The core of the invention is a dedicated auxiliary device, called smart display tower. It has a bigger display and input devices to interact with an operator. It leverages DNP protocol to discover smart components that could provide

[0036] 5 remote HMI capability (e.g. a webbrowser-based HMI). The smart display tower thus does not provide any sensor, nor actuator, and does not treat any biotechnological fluid directly but it helps to locally control devices that do. It could also adapt the object displayed as per need based on components capabilities pairing.

[0037] Advantageous and therefore preferred further developments of this invention emerge from the associated subclaims and from the description and the associated drawings.

[0038] 15

[0039] One of those preferred further developments of the disclosed system comprise that for the display and l / O-devices a touch screen is used. The use of a touch screen for display and input / output (I / O) devices provides an intuitive and user-friendly interface. This feature enhances operator interaction with the system, allowing for easier navigation and control of the

[0040] 20 bioprocess, which can lead to reduced training time and improved operational accuracy.

[0041] Another one of those preferred further developments of the disclosed system comprise that the l / O-devices include a keyboard, a NFC card reader, or other identity recognition devices. The inclusion of devices such as a keyboard, NFC card reader, or other identity recognition tools provides additional means for user interaction, identification and authentication. These devices enhance security and allow for personalized user experiences, which are important in regulated environments like biopharmaceutical production.

[0042] 30 P24-265 DAK

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[0044] Another one of those preferred further developments of the disclosed system comprise that the l / O-devices include a mixed reality headset, in particular XR, VR or AR, with a base computing unit. Incorporating a mixed reality headset, such as XR, VR, or AR, with a base computing unit, offers an

[0045] 5 immersive experience for operators. This feature can improve training and operational efficiency by providing virtual simulations and real-time data overlays, which can help in visualizing complex processes and troubleshooting issues.

[0046] Another one of those preferred further developments of the disclosed system comprise that every bioprocess machine and / or any at least one physical and / or software-based auxiliary device provide a local, webbrowser-based HMI to which the remote HMI of the dedicated auxiliary device connects to. Each bioprocess machine and auxiliary device can provide a local,

[0047] 15 webbrowser-based HMI. Once discovered, the operator can pair them as per DNP, then the smart display tower displays to the operator the local HMI of the paired smart component and / or bioprocess machines as if it was natively integrated. Meaning, the remote HMI of the dedicated auxiliary device connects to these local interfaces, allowing operators to control and monitor

[0048] 20 the system remotely. This capability provides flexibility and convenience, enabling operators to manage processes from various locations.

[0049] Another one of those preferred further developments of the disclosed system comprise that the local HMI of the bioprocess machine and / or at least one auxiliary device provides a declarative description of its HMI for the remote HMI of the dedicated auxiliary device which interprets and converts the local HMI for the remote HMI to be displayed to the user. The local HMI can provide a declarative description, which the remote HMI interprets and converts for display. This feature allows for dynam ic and adaptable interfaces

[0050] 30 that can be customized based on user needs and device capabilities, enhancing usability and reducing the need for extensive reprogramming. P24-265 DAK

[0051] - 7 -

[0052] Another solution of the given task is a method for operating a bioprocess in a system as previously described via a digital controller, comprising the following steps of Setting up the bioprocess machine and the at least one physical auxiliary device by a user, wherein at least one physical and / or

[0053] 5 software-based auxiliary device is a dedicated auxiliary device; Identifying and authenticating the user via the remote HMI of one dedicated auxiliary device; Establishing a paired condition between all system components which are capable of remote HMI control; Relaying the local HMIs of each paired system component to the user via the remote HMI of the one dedicated auxiliary device; and Configuring of all paired system components by the user via the remote HMI of the one dedicated auxiliary device. The method includes setting up the bioprocess machine and auxiliary devices, with user identification and authentication via the remote HMI. This step ensures secure access and configuration of the system, which is critical for

[0054] 15 maintaining process integrity and compliance. The next step of establishing a paired condition between system components capable of remote HMI control ensures seamless integration and coordination, facilitating streamlined operations and reducing setup time. Relaying local HMIs to the user via the remote HMI then provides a centralized control point, enhancing

[0055] 20 operational oversight and simplifying process management. At least users can configure all paired components through the remote HMI, which allows for efficient and coordinated adjustments to the process, improving responsiveness and adaptability.

[0056] Another one of those preferred further developments of the disclosed method comprise that during the production time of the bioprocess, the one dedicated auxiliary device continues to be used to remote control the other auxiliary devices. During production, the dedicated auxiliary device continues to provide remote control, ensuring continuous oversight and the ability to make

[0057] 30 real-time adjustments. This feature enhances process stability and reduces downtime. P24-265 DAK

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[0059] Another one of those preferred further developments of the disclosed method comprise that the user identification and authentication is automatically relayed to the remote controlled auxiliary devices so that the operator no longer needs to identify and authenticate on each device. The system can

[0060] 5 automatically relay user identification and authentication to remote-controlled auxiliary devices, eliminating the need for repeated logins and enhancing user convenience and security. This capability streamlines operations and reduces the risk of unauthorized access.

[0061] Detailed description of the invention

[0062] The method and system according to the invention and functionally advantageous developments of those are described in more detail below with reference to the associated drawings using at least one preferred exemplary

[0063] 15 embodiment. In the drawings, elements that correspond to one another are provided with the same reference numerals.

[0064] The drawings show:

[0065] 20

[0066] Figure 1 : a schematic of an example of the invented system

[0067] Figure 2: a schematic of a preferred working example using the system

[0068] One exemplary preferred embodiment of the invented method will be described in the following. The steps itself are performed divergent in every exemplary embodiment dependent on the different conditions. In the chosen preferred embodiment Figure 1 shows an example of a preferred embodiment of the invented system. It is based on the system as disclosed by the mentioned prior art document WO 2023 / 046605 A1 and in this preferred embodiment discloses a bioprocess machine and two bioprocess

[0069] 30 auxiliary devices. All such system components comprise of a fluid treater, which is in a further preferred embodiment a bioreactor for the bioprocess P24-265 DAK

[0070] - 9 - machine and e.g. a pump for the auxuliar devices. They further comprise of a digital controller, wherein the digital controller comprises of a device shape file with a configuration and three tools: a machine to machine communication tool (MtoM) for connecting to a network, a discovery

[0071] 5 negotiation pairing (DNP) manager for cooperating over the network for establishing a paired condition between the bioprocess machine and / or the at least one physical or software-based auxiliary device and a capability manager configured to organize capabilities of the paired bioprocess machine and / or the auxiliary devices. Core of this invention is now the Configurable self-coordinated service-manager. A further novel system component is the Working Engineer Station which has a Configuration software stored which can be used to configure the bioprocess machine and / or the auxiliary devices.

[0072] 15 This system can now be used in a preferred way which is disclosed in Figure 2 as well as described further in the following chapters.

[0073] In the described working example of the invention, the process begins with the operator, who may be an automation engineer or other qualified

[0074] 20 personnel, preparing a new production line that utilizes modular processing equipment. This equipment is initially located in a warehouse and is transported to the plant floor where it is intended to be used for biotechnological fluid treatment. This step involves the physical movement and connection of the equipment, which can include a variety of bioprocess machines and auxiliary devices. These devices are essential for the treatment of biopharmaceutical fluids, aiding in the production of products such as monoclonal antibodies, vaccines, and recombinant proteins.

[0075] Once the equipment is in place, the operator connects the various

[0076] 30 components to a computer network. This network connection is crucial for enabling digital communication among the devices, allowing them to function in a coordinated manner. The network serves as the backbone for the digital P24-265 DAK

[0077] - 10 - controllers embedded within each piece of equipment, facilitating machine- to-machine (MtoM) communication. This communication capability allows for real-time data exchange and process monitoring, which can enhance the efficiency and reliability of the bioprocess.

[0078] 5

[0079] To streamline the configuration of the system, particularly concerning the Discovery Negotiation Pairing (DNP) protocol, the operator installs a smart display tower in proximity to the production line. The smart display tower is an auxiliary device equipped with a digital controller and a variety of input / output (I / O) devices. These I / O devices may include, in some embodiments, a touchscreen display, a keyboard, NFC card readers, or other identity recognition tools, such as fingerprint scanners or security keys. These features allow the operator to interact with the system effectively, supporting process security and cybersecurity controls.

[0080] 15

[0081] The operator identifies themselves on the smart display tower using these dedicated input devices. This identification process is crucial for ensuring that only authorized personnel can access and configure the system, thereby maintaining the integrity and security of the bioprocess. Following successful

[0082] 20 identification, the smart display tower automatically recognizes all DNP- capable auxiliary devices within the system. This recognition process is facilitated by the DNP manager, which establishes connections between devices and organizes their capabilities.

[0083] Once the devices are recognized, the operator can initiate the pairing process for those devices capable of remote Human-Machine Interface (HMI) control. This pairing allows the smart display tower to serve as a central hub for controlling and monitoring the bioprocess. The local HMI of each paired device is exposed on the smart display tower’s touchscreen, providing

[0084] 30 the operator with a comprehensive view of the system’s status and operations. P24-265 DAK

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[0086] In some embodiments, the identification of the operator is automatically propagated across all paired devices, eliminating the need for the operator to log in separately to each device. This feature enhances user convenience and streamlines the configuration process, allowing the operator to make

[0087] 5 adjustments as if they were physically present at each piece of equipment. The operator can configure the auxiliary devices through the remote HMI, ensuring that the system operates according to the desired specifications.

[0088] During the production phase, the smart display tower continues to function as a local control unit for the auxiliary devices. It allows the operator to manage the bioprocess efficiently, making real-time adjustments as needed to maintain optimal conditions. This capability can lead to improved process outcomes and reduced downtime, as the operator can quickly respond to any changes or issues that arise during production. The smart display tower’s

[0089] 15 integration into the bioprocessing system exemplifies how advanced digital tools can enhance operational efficiency and flexibility in biotechnological applications.

[0090] 20

[0091] 30

Claims

P24-265 DAK- 12 -Patent claims1. System for performing a bioprocess comprising of the following modular system components:5 a bioprocess machine with a digital controller for controlling the bioprocess machine; and at least one physical and / or software-based auxiliary device for being coupled to the bioprocess machine with a digital controller for controlling the auxiliary device; wherein the digital controllers each comprising a machine to machine communication tool (MtoM) configured for connecting to a network, a discovery negotiation pairing (DNP) manager configured for cooperating over the network for establishing a paired condition between either the bioprocess machine and the at least one physical or15 software-based auxiliary device and / or between the physical or software-based auxiliary devices, and a capability manager configured to organize capabilities of the paired bioprocess machine and / or the auxiliary devices; characterized in that20 at least one physical and / or software-based auxiliary device is a dedicated auxiliary device which is connected to a display and l / O- devices to interact with an user and which is configured to provide a remote Human-Machine-Interface (HMI) to control the bioprocess machine and / or any at least one physical auxiliary device remotely by using its respective DNP managers to perform the workflow of the bioprocess.

2. System according to claim 1 characterized in that30 for the display and l / O-devices a touch screen is used.P24-265 DAK- 13 -3. System according to any of the previous claims characterized in that the l / O-devices include a keyboard, a NFC card reader, or other identity5 recognition devices.

4. System according to any of the previous claims characterized in that the l / O-devices include a mixed reality headset, in particular XR, VR or AR, with a base computing unit.

5. System according to any of the previous claims characterized in that every bioprocess machine and / or any at least one physical and / or software¬15 based auxiliary device provide a local, web-browser based HMI to which the remote HMI of the dedicated auxiliary device connects to.

6. System according to any of the previous claims characterized in that20 the local HMI of the bioprocess machine and / or at least one auxiliary device provides a declarative description of its HMI for the remote HMI of the dedicated auxiliary device which interprets and converts the local HMI for the remote HMI to be displayed to the user.30P24-265 DAK- 14 -7. Method for operating a bioprocess in a system via a digital controller according to claims 1 to 6, the following steps comprising:5 • Setting up the bioprocess machine and the at least one physical auxiliary device by a user, wherein at least one physical and / or software-based auxiliary device is a dedicated auxiliary device;• Identifying and authenticating the user via the remote HMI of one dedicated auxiliary device;• Establishing a paired condition between all system components which are capable of remote HMI control;• Relaying the local HMIs of each paired system component to the user via the remote HMI of the one dedicated auxiliary device; and• Configuring of all paired system components by the user via the remote15 HMI of the one dedicated auxiliary device.

8. Method according to claim 7 characterized in that during the production time of the bioprocess, the one dedicated auxiliary20 device continues to be used to remote control the other auxiliary devices.

9. Method according to claim 7 or 8 characterized in that the user identification and authentication is automatically relayed to the remote controlled auxiliary devices so that the operator no longer needs to identify and authenticate on each device.

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