Method and system for monitoring biopharmaceutical processes

Abstract

The present disclosure relates to methods and systems for monitoring a biopharmaceutical process that is controlled based on an instruction set for controlling the biopharmaceutical process. The method comprises the following steps performed by the biopharmaceutical process monitoring element: obtaining (S11) said set of instructions for controlling the biopharmaceutical process; and receiving (S13), for each executed instruction, an execution status update indicating which instruction is currently executed or just completed, while executing instructions in an instruction set for controlling the biopharmaceutical process; and forming (S14) an execution status indication relating the currently executed or just completed instruction to its location in the instruction set based on the received execution status update.

Description

This application is a divisional application of the invention patent application with national application number 202080024055.X, the application date of which is March 8, 2020, and the name of the invention is “Methods and systems for monitoring biopharmaceutical processes”. Technical Field

[0001] The present disclosure relates to a method for monitoring a biopharmaceutical process that is controlled based on an instruction set for controlling the biopharmaceutical process.

[0002] The present disclosure further relates to systems for monitoring a biopharmaceutical process. Background Art

[0003] The past decade has seen a major shift in the nature of products manufactured and sold by the innovative biopharmaceutical industry. Today's global biopharmaceutical portfolio reflects the greater prevalence of large molecule drugs, the expansion of the number of individualized or targeted products, and the rise of treatments for many orphan diseases. These developments provide extremely limited production runs, high specific manufacturing requirements, and genotype-specific products for biopharmaceutical products. The ongoing shift in product mix provides a need for continuous improvement in the efficiency and effectiveness of production biopharmaceutical manufacturing.

[0004] Biopharmaceuticals (also known as biologics) such as, for example, therapeutic proteins, monoclonal antibodies, vaccines, etc. are complex molecules made by or from living cells. They usually require parenteral administration by infusion or injection, thus requiring highly specialized manufacturing, special storage and manipulation, and close control, high-quality manufacturing and distribution networks to ensure safety and efficacy. The development of orphan drugs (i.e., drugs for diseases with a patient population of less than 200,000) has also been observed, and there has been a steady increase in the past decade. In addition, manufacturers are increasingly focusing on more complex diseases, for which there are few or no effective treatments. The new treatments for these diseases are characterized by small volume products.

[0005] Another important trend within biopharmaceuticals is the emergence of personalized medicine (i.e., products for specific patient populations). Over time, manufacturing and product supply complexity will likely increase with the introduction of patient-level personalized medicine. Typically, personalized medicine requires that the associated biomanufacturing processes be performed at a smaller scale and closer to the patient.

[0006] These drug combination trends have contributed to an increase in the number and complexity of products manufactured and commercially sold. Collectively, these drug combination trends indicate that there is a need for improved manufacturing flexibility with no compromise in quality, while creating operational efficiencies that can help reduce costs.

[0007] Today, processing systems for processing biopharmaceutical processes characteristically include: processing equipment, in which the biopharmaceutical process is performed; and a controller, which is arranged to store an instruction set for controlling the biopharmaceutical process and sequentially execute instructions in the instruction set to generate control signals for controlling the processing equipment. Summary of the invention

[0008] It is an object of the invention to facilitate the manufacturing and in particular the testing of a product.

[0009] This is achieved by a method for monitoring a biopharmaceutical process, which is controlled based on an instruction set for controlling the biopharmaceutical process. The method comprises the following steps performed by a biopharmaceutical process monitoring element: obtaining said set of instructions for controlling a biopharmaceutical process; and While executing instructions in an instruction set for controlling a biopharmaceutical process, for each executed instruction, an execution status update is received indicating which instruction is currently being executed or has just been completed, and an execution status indication is formed that relates the currently being executed or has just been completed instruction to its position in the instruction set based on the received execution status update.

[0010] Thereby, it will be possible to continuously obtain an overall understanding of the status of the manufacturing process.This makes it possible for the user to determine whether the pharmaceutical process is controlled as intended or whether some adaptation of the control of the pharmaceutical process is desired.

[0011] Furthermore, personnel who have left can gain a comprehensive understanding of the status of the biopharmaceutical process by viewing the resulting execution status indication.

[0012] Adopting the proposed biopharmaceutical process provides flexibility without compromising quality while creating operational efficiencies that can help reduce costs.

[0013] A method may be defined for easily visualizing the progress of a run of a biopharmaceutical process (eg, a chromatography run) by displaying the currently executing instructions in the process / recipe in the same view as the method / recipe.

[0014] A user may be able to graphically track the progress of a system operation in a display view that corresponds at least in part to a view used in programming instructions for controlling a biopharmaceutical process.

[0015] In various embodiments, the set of instructions for controlling a biopharmaceutical process includes or is associated with at least one process variable value, the at least one process variable value defining the biopharmaceutical process. The method may then include the steps of: receiving an update of at least one of the process variable values ​​defining the biopharmaceutical process at a biopharmaceutical process monitoring element during execution of the set of instructions; and receiving information related to an update of an update control for the biopharmaceutical process at a controller for controlling the biopharmaceutical process during execution of the set of instructions.

[0016] This means that it is possible to change the variable values ​​of a process / recipe during runtime, thus enabling variable value editing in system control.

[0017] Additional characteristic features of the method are found in the dependent claims.

[0018] The present disclosure further relates to a system for monitoring a biopharmaceutical process. The system comprises a processing system comprising: a processing device in which the biopharmaceutical process is executed; and a controller arranged to store an instruction set for controlling the biopharmaceutical process and execute instructions in the instruction set to generate control signals for controlling the processing device. The controller is further arranged to generate and transmit an execution status update for each executed instruction, the execution status update indicating which instruction is currently being executed or has just been completed. The system further comprises a biopharmaceutical process monitoring element arranged to receive the execution status indication and form an execution status indication that relates the currently being executed or just completed instruction to its position in the instruction set based on the received execution status update.

[0019] Additional characterizing features of the system are found in the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a block diagram schematically illustrating an example of a system for monitoring a biopharmaceutical process.

[0021] Figure 2 is a flow chart schematically illustrating an example of a method for monitoring a biopharmaceutical process according to the first aspect.

[0022] Figure 3 is a flow chart schematically illustrating an example of a method for monitoring a biopharmaceutical process according to the second aspect.

[0023] Figure 4 Schematic diagram illustrating an example of a software interface view for starting monitoring of a biopharmaceutical process.

[0024] Figure 5 Schematic diagram showing an example of a software interface view used when monitoring a biopharmaceutical process.

[0025] Figure 6 Schematic diagram illustrating an example of a software interface view for selecting a more detailed view used when monitoring a biopharmaceutical process. DETAILED DESCRIPTION

[0026] Figure 1 A system 100 for monitoring a biopharmaceutical process is disclosed. The system 100 includes a processing system 110. The processing system 110 includes a processing device 112 in the illustrated example, wherein the biopharmaceutical process is performed. The processing device 112 may include a workflow management system provided by an instrument or system (eg, a chromatography system).

[0027] The processing system 110 further comprises a controller 111 arranged to store an instruction set for controlling a biopharmaceutical process. The controller 111 is arranged to execute instructions in the instruction set for generating control signals for controlling the processing device 112.

[0028] Thus, the biopharmaceutical process is controlled based on an instruction set for controlling the biopharmaceutical process. In detail, this means that the controller executes instructions in the instruction set for generating control signals for controlling the processing device. The instruction set is arranged to be executed according to a preset execution scheme. For example, the instruction set may be arranged to be executed sequentially, non-sequentially, or a combination thereof. Thus, at least some of the instruction traces may be arranged to be executed in parallel.

[0029] The controller 111 is further arranged to generate and transmit, for each executed instruction, an execution status update indicating which instruction is currently executing or has just completed.

[0030] The processing system 110 may further include a plurality of sensors 113 arranged to monitor the status of the processing of the processing device.

[0031] The processing system 110 may further comprise a display (not shown) arranged to display the monitored status of the processing of the processing element.

[0032] The system 100 further comprises a biopharmaceutical process monitoring element 120. The biopharmaceutical process monitoring element 120 is arranged to communicate with the controller 111. The biopharmaceutical process monitoring system may further be arranged to communicate with (one or more) sensors 113 (if present). The biopharmaceutical process monitoring element 120 is arranged to receive the execution status update and form an execution status indication that relates the currently executed or just completed instruction to its position in the instruction set based on the received execution status update. The biopharmaceutical process monitoring element 120 may be arranged to store an instruction set for controlling the biopharmaceutical process. The formation of the execution status indication may include associating the received execution status update to a corresponding instruction in the stored instruction set.

[0033] An instruction set for controlling a biopharmaceutical process may include or be associated with at least one process variable value, the at least one process variable value defining the biopharmaceutical process. The corresponding variable value may be associated with a specific instruction in the instruction set or with multiple instructions. The corresponding variable may involve sensor data and / or time data. The corresponding variable associated with the sensor data may be formed based on sensor data from one or more sensors. The variable value associated with the sensor data that defines the biopharmaceutical process may define a maximum value and / or a minimum value and / or an allowable interval. The variable value associated with the time data may, for example, define a normal duration for executing a specific instruction or a group of instructions in the instruction set or a time interval for a normal duration.

[0034] The system may further comprise a user interface 140. The user interface may comprise a display 142. The user interface may comprise means for user data input 141, such as a keyboard, a computer mouse or a joystick. The user interface 140 may comprise an integrated display 142 means for data input 141, such as a touch screen.

[0035] The biopharmaceutical process monitoring element 120 is arranged to provide display data to a display 142. The display 142 is arranged to display an execution status indication. In detail, the display 142 is arranged to display the instruction set in a display view, and the display view at least partially corresponds to the view used in programming. The display of the instruction set may include the display of the instruction set constructed according to a preset execution scheme. The execution status indication may be displayed by marking the currently executed or just completed instruction in the display view. Moreover, the next instruction for execution may be indicated in the display view.

[0036] The user interface 140 having an input component 141 may be adapted for user input of instructions for updating at least one process variable value.

[0037] In response to obtaining an instruction to update at least one process variable value during execution of the instruction set, the biopharmaceutical process monitoring element can be arranged to modify the display view based on the obtained process variable value update, and transmit the updated at least one process variable value or information related thereto to the controller, wherein the controller is arranged to generate a control signal for controlling the processing equipment according to the update.

[0038] The biopharmaceutical process monitoring element 120 may be arranged to correlate corresponding obtained sensor data and / or time data with an execution status indication for at least a portion of a currently executing or just completed instruction.

[0039] The biopharmaceutical process monitoring element 120 may be arranged to monitor the resulting sensor data and / or time data associated with the biopharmaceutical process; detect when the resulting sensor data and / or time data deviates from a predetermined pattern or value or one or more boundaries, and determine that at least one potential process variable value should be updated. Thus, the process variable value may be updated to affect the execution of the process while the process is running. Thus, the process variable value may be updated to compensate for unanticipated deviations that occurred during operation. This may be used, for example, to save a batch currently being run by the biopharmaceutical process.

[0040] The process variable values ​​may be updated only temporarily. Thus, the process variable values ​​may be updated only for the currently running batch. Alternatively, the updates to the process variable values ​​are saved for use also in future executions of the process. Input component 141 may be used for user selection as to whether the update is permanent or intended only for the current run of the process.

[0041] As described above, the process monitoring element may be arranged to determine that at least one potential process value should be updated. The process monitoring element may also be arranged to determine the updated process value. Alternatively, the process monitoring element determines that the process value should be updated, and the user determines and inputs the updated process value.

[0042] Additionally, the user may determine that at least one potential process value should be updated based on detection of the time at which the resulting sensor and / or time data deviates and / or based on a degree of deviation from a predetermined pattern or value or one or more boundaries. The user may then input the updated process value.

[0043] Furthermore, the instruction set may include a jump function, wherein a jump to a predetermined instruction in the scheme is performed when at least one predetermined condition is met. For example, a jump to a predetermined instruction may be performed when a predetermined condition for sensor data is met. The predetermined condition forms a process value, for example: A maximum value which, when reached, activates a jump to a predetermined first instruction; and / or - A minimum value which, when reached, activates a jump to a predetermined second instruction, wherein the first and second instructions may be the same or different instructions.

[0044] In addition or as an alternative, a jump to a predetermined instruction may be performed when a predetermined condition for the time data is met. The predetermined condition forms a process value, such as a normal duration for executing a specific instruction or a group of instructions in the instruction set or a time interval for the normal duration. A jump to the predetermined instruction is activated when the execution of an instruction or a group of instructions takes longer than the normal duration or when the execution time exceeds the time interval for the normal duration.

[0045] Additionally or alternatively, the instruction set may be designed to allow user interaction to perform a jump to a desired instruction.

[0046] As is clear from the above, monitoring allows user interaction while the process is running. The user can learn from the detected deviations, and interact accordingly. Additionally or alternatively, the user can predict the potential occurrence of deviations, and interact accordingly. Additionally or alternatively, the user can predict the timing of upcoming events, and interact accordingly. As described above, user interaction can include updating (one or more) process values, and / or executing a jump in the instruction set.

[0047] The system 100 may further include a memory 130, which is arranged to store execution status indications and / or corresponding obtained sensor data (if the obtained sensor data exists). The memory may store corresponding obtained sensor data and / or execution status indications associated with at least a portion of the executed instructions. Therefore, the memory allows the storage of process tracking data. Thus, information related to the process is also accessible after the run. This allows troubleshooting in a step-by-step manner, wherein each instruction can be viewed and / or analyzed together with the corresponding sensor data. Therefore, there is transparency in the process, because if a fault has occurred, information indicating the location (i.e., in which instruction) of the fault during operation is accessible, and sensor and / or time data associated with the instruction before the fault occurred is further available. The transparency provided makes the system suitable, for example, for training personnel during operation.

[0048] exist Figure 2 In the embodiment, a method 10 for monitoring a biopharmaceutical process is illustrated. The biopharmaceutical process is controlled based on an instruction set for controlling the biopharmaceutical process. In detail, the control is performed by means of a controller, which controls the operation of a processing device based on the instruction set and possibly on sensor data related to the state of the biopharmaceutical process.

[0049] The method 10 for monitoring a biopharmaceutical process comprises obtaining the instruction set for controlling the biopharmaceutical process at the biopharmaceutical process monitoring element S11. Therefore, the biopharmaceutical process monitoring element obtains the same instructions for controlling the biopharmaceutical process as the instructions used by the controller to control the biopharmaceutical process.

[0050] Then, execution of a set of instructions for controlling the biopharmaceutical process may begin S12.

[0051] The method 10 for monitoring a biopharmaceutical process further includes executing the following steps for each executed instruction while executing the instructions in the instruction set for controlling the biopharmaceutical process according to a preset execution plan.

[0052] First, an execution status update S13 is provided to the biopharmaceutical process monitoring element. The execution status update indicates which instruction is currently being executed or has just been completed.

[0053] Therefore, characteristically, when the controller for controlling the biopharmaceutical process controls the execution of the instructions in the instruction set for controlling the biopharmaceutical process according to the preset execution scheme, for each executed instruction, the controller transmits an execution status update to the biopharmaceutical monitoring element. Therefore, the controller obtains the execution status update and transmits the execution status update to the biopharmaceutical process monitoring element.

[0054] When receiving the execution update, an execution status indication S14 is formed at the biopharmaceutical process monitoring element. The execution status indication relates the currently executed or just completed instruction to its position in the instruction set based on the received execution status update. In detail, the execution status indication relates the currently executed or just completed instruction to its position in the instruction set constructed according to the preset execution scheme.

[0055] The method may further include displaying the execution status indication formed in S15 for at least a portion of the currently executed or just completed instruction. Furthermore, the next instruction to be executed may be displayed in S15.

[0056] Characteristically, the instruction set is displayed in a display view. The display view corresponds at least in part to a view used in programming an instruction set for controlling a biopharmaceutical process. Thus, in the display view, all or part of the instruction set for controlling is continuously displayed.

[0057] The execution status indication is displayed by marking the currently executed or just completed instruction in the display view. For example, the currently executed or just completed instruction can be illuminated in the display view. For example, the currently executed or just completed instruction can be highlighted by marking the currently executed or just completed instruction with a color. Alternatively, the displayed instructions that are not currently executed or just completed are presented less brightly (e.g., by gray), and the currently executed or just completed instructions are presented more brightly (e.g., by black).

[0058] Therefore, when running a biopharmaceutical process, programmers and others obtain comprehensive and clear information about which step in the execution scheme the biopharmaceutical process is currently executing. This is advantageous, for example, in a test situation (wherein the biopharmaceutical process is tested). For example, if it is obvious from the display view and the monitoring of the biopharmaceutical process that after the execution of a certain execution step, the nature of the biopharmaceutical process deviates from the expected nature, it can be identified that the specific execution step can be modified. For example, it can be determined that a certain loop needs to be executed an additional number of times relative to the number defined by the instruction set. This can actually be noted during the execution of the process. Therefore, an update indicating the correction of the number of times the loop will be executed can be transmitted S16 to the controller, and the controller is adapted to execute. Therefore, the instruction itself (or the variable value associated with it) can be corrected by using updates during the execution of the instruction set. Examples of this aspect can be described in more detail later.

[0059] Thus, by using the display views, the biopharmaceutical process can be monitored step by step during the execution of the process. Thus, improved monitoring of the process is achieved. Furthermore, the step by step monitoring enables fine tuning of each execution step in the instruction set used to control the biopharmaceutical process. Furthermore, the testing of running the biopharmaceutical process can be accelerated, and an acceptable instruction set can be arrived at faster. This is very important when processing smaller batches, where the time used to set up the biopharmaceutical process has a significant impact on the overall time used to run the batch through the process.

[0060] Furthermore, the next instruction for execution may be indicated in the display view.

[0061] In the case of Figure 1 In the system described above, the following is achieved: Figure 2 Different examples of methods for monitoring biopharmaceutical processes are described in .

[0062] exist Figure 3 In the figure, the diagram is shown as relative to Figure 2 The controller for controlling a biopharmaceutical process controls execution according to an execution scheme of instructions in an instruction set for controlling a biopharmaceutical process while executing another example at a biopharmaceutical process monitoring element.

[0063] For each executed instruction, the biopharmaceutical process monitoring element receives (e.g., relative to Figure 1 As described above), status update S13 is performed.

[0064] An execution status indication is then formed S14. The execution status indication relates the currently executing or just completed instruction to its position in the instruction set based on the received execution status update.

[0065] In addition, sensor data S21 related to the biopharmaceutical process is obtained at the biopharmaceutical process monitoring element. The sensor data can be obtained from sensors that sense the biopharmaceutical process. Therefore, the sensor data can monitor the processing equipment used to perform the biopharmaceutical process and / or the biopharmaceutical materials processed by the processing equipment. The sensor data can be arranged to monitor quantities such as temperature, pressure, etc. for use in the control and / or monitoring of the biopharmaceutical process.

[0066] In the illustrated example, for at least a portion of a currently executing or just completed instruction, the corresponding obtained sensor data is correlated S22 with a corresponding execution status indication.

[0067] The method may further include displaying S25 an execution status indication and corresponding obtained sensor data for at least a portion of the currently executed or just completed instruction. Figure 2 In a characteristic, the instruction set is displayed in a display view. The display view corresponds at least in part to a view used in programming the instruction set for controlling a biopharmaceutical process.

[0068] The method may further comprise storing S25 an execution status indication for at least a portion of the currently executing or just completed instructions and possibly storing corresponding resulting sensor data and / or time data, if any.

[0069] According to this example, an instruction set for controlling a biopharmaceutical process includes or is associated with at least one process variable value, the at least one process variable value defining the biopharmaceutical process.

[0070] According to this example, the method comprises the step of receiving S31 at a biopharmaceutical process monitoring element an update of at least one of the values ​​of said process variables defining the biopharmaceutical process during execution of the set of instructions.

[0071] The display view may then be modified during execution of the set of instructions based on the received update of at least one of the process variable values.

[0072] Furthermore, updates or information related to updates are received S33 at a controller for controlling a biopharmaceutical process during execution of the set of instructions.

[0073] An update of at least one of the process variable values ​​may be received at the biopharmaceutical process monitoring element and / or the controller via a user interface. An update of at least one of the process variable values ​​may be received at the biopharmaceutical process monitoring element, possibly processed by the biopharmaceutical processing element, and the update as processed or information related thereto may be transmitted to the controller for updating control of the biopharmaceutical process.

[0074] The biopharmaceutical process monitoring element can monitor the resulting sensor data and / or time data related to the biopharmaceutical process, detect when the resulting sensor data and / or time data deviates from a predetermined pattern or value or one or more boundaries, and determine that at least one potential process variable value should be updated based on the detected deviation.

[0075] Control of the biopharmaceutical process may be automatically updated based on the at least one potential process variable value, or wherein the at least one potential process variable value is fed to a user interface for acceptance / rejection / modification by a user.

[0076] In the case of Figure 1 In the system described above, the following is achieved: Figure 3 Different examples of methods for monitoring biopharmaceutical processes are described in .

[0077] Figure 4 In the example of how to start tracing the execution of an instruction set for controlling a biopharmaceutical process, an example is shown. Starting to trace the execution is performed using a software interface in the illustrated example. For example, the software interface is provided at a biopharmaceutical process monitoring element as described herein. The software interface can be displayed on a display of the biopharmaceutical process monitoring element (e.g., as shown relative to Figure 1 A software interface is presented at the display).

[0078] In the illustrated example, the software for controlling the biopharmaceutical process is represented as "system control". In the illustrated example, the software interface includes a menu system, where software process control alternatives are selectable in the menu. When "method tracker" in the menu is selected, tracking of the execution of the software begins. In the illustrated example, "method tracker" is selectable in the view menu.

[0079] Once the operation of the biopharmaceutical process has been started, the biopharmaceutical process will be tracked.

[0080] Figure 5 A snapshot of a display view illustrating tracking the operation of a biopharmaceutical process is shown. The biopharmaceutical process is tracked once the operation of the process has been started. Thus, the execution of the execution plan according to the instructions for controlling the biopharmaceutical process is tracked. Figure 1-3 Give an example of how this tracing can be performed.

[0081] exist Figure 4 In the illustrated example, the tracking is performed by means of a method tracker control software. For example, the tracker control software is provided at a biopharmaceutical process monitoring element as described herein. The tracker control software may be arranged to be displayed on a display of the biopharmaceutical process monitoring element (e.g., as shown relative to Figure 1 The tracking is presented at the display).

[0082] The Method Tracker control software is specifically designed to display the operation of a biopharmaceutical process. Figure 5 In the illustrated example, the left view illustrates a display view of an instruction set that corresponds at least in part to the view used in programming. Therefore, the entire instruction set or a subset of the instruction set is illustrated in this left view, and the subset is large enough to provide the user with an overview of the position where the subset is located in the entire instruction set. In the illustrated example, the instruction set defines multiple phases, each of which includes a subset of the instruction set. In the illustrated example, a method setup phase, an equilibrium phase, a sample application phase, and a column cleaning phase are defined, each of which includes a corresponding subset of the instruction set. For each phase, the corresponding instruction set is executed step by step. This is illustrated in the illustrated display view that corresponds at least in part to the view used in programming.

[0083] Furthermore, in the left view 51, a mark 52 exists, indicating the currently running instruction or the instruction that has just been completed. Therefore, in the illustrated left view 51, an execution status indication is presented that relates the currently executing or just completed instruction to its position in the instruction set. It is clear from the illustrated display view that the system cleaning step of the equalization phase is currently being executed or has just been completed.

[0084] In the right view 53, the process variables (represented as method variables in the figure) defining the biopharmaceutical process are displayed. In the illustrated example, the process variables are presented in a stage-by-stage order. For each stage of the process, the process variables associated with it are defined. The corresponding process variables can be related to the entire stage or a part of the stage of a single step of the stage. Therefore, each variable can be associated with a single step of the stage and / or a part of the stage and / or that stage of the stage to which the variable is related. In the illustrated example, the stage column cleaning is associated with the variable "percent B" set to a value of 0. In addition, the method setting stage is associated with the "pressure control" variable set to a value of 1 in the illustrated example. The method setting stage is further associated with the "flow rate" variable set to a value of 0.9 in the illustrated example. In addition, the column cleaning stage in the illustrated example is associated with the "column cleaning capacity" variable set to 20 in the illustrated example. For each stage, the process variables are defined in the same way, and the values ​​are associated with them.

[0085] One or more of the process variable tags 54 are present, indicating the process variable(s) associated with the currently executing or just completed instruction.

[0086] Values ​​may be modified at any time during execution of the process. Moreover, variables and / or stages may be added and / or removed during execution of the process. This greatly contributes to reduced time in testing and fine-tuning of a process prior to, for example, manufacturing of a new product or batch of material. This in turn helps reduce costs.

[0087] In addition, other information may be displayed in the display view, such as sensor data obtained by sensors of the processing system. Some of the sensor data may be related to a specific process variable. The sensor data may then be displayed relative to the process variable. For example, the sensor data may be displayed in a column next to the variable column in a row corresponding to the variable to which the sensor data relates. The sensor data column may present the quantity measured by the sensor and the measured sensor value. Some of the sensor data may relate to the entire process or a portion thereof. This sensor data may be presented at a location for display of general data related to the process. Moreover, this sensor data column may present the quantity measured by the sensor and the measured sensor value.

[0088] Figure 6 An example of accessing a display view is shown, exposing, for example, Figure 5 The information presented in the display view is more detailed information. Figure 6In the example illustrated in , the marked process variable or another process variable can be clicked to obtain more detailed information related to the process variable. In detail, in the example illustrated, a menu is presented when the marked process variable or another process variable is clicked, and an option "Show detailed debugger information" can be selected for viewing detailed information.

Claims

1. A method (10, 20, 30) for monitoring a biopharmaceutical process, the biopharmaceutical process being controlled based on an instruction set for controlling the biopharmaceutical process, the method comprising the following steps performed by a biopharmaceutical process monitoring element (120): Obtaining (S11) the instruction set for controlling the biopharmaceutical process; and When the set of instructions for controlling the biopharmaceutical process is executed, for each instruction executed: a) receiving (S13) an execution status update, the execution status update indicating which instruction is currently being executed or has just been completed, and b) based on the received execution status update, forming (S14) an execution status indication, the execution status indication associating the instruction currently being executed or has just been completed with its position in the instruction set; The method further comprises: display (S25) at least the instruction set and the execution status indication; The instruction set defines multiple stages of the biopharmaceutical process, each stage contains a subset of the instruction set, and for each stage, the corresponding instruction set is executed step by step.

2. The method (10, 20, 30) of claim 1, further comprising: While the controller (111) for controlling the biopharmaceutical process controls the execution of the set of instructions for controlling the biopharmaceutical process, the controller (111) transmits the execution status update to the biopharmaceutical process monitoring element (120) for each executed instruction.

3. The method (10, 20, 30) of claim 1 or 2, further comprising: obtaining (S21) sensor data related to the biopharmaceutical process at the biopharmaceutical process monitoring element (120); as well as For at least a portion of the instructions currently being executed or just completed, the corresponding obtained sensor data is correlated with the execution status indication (S22).

4. The method (10, 20, 30) of claim 3, further comprising displaying (S25) the corresponding obtained sensor data for at least a portion of the instruction currently being executed or just completed.

5. The method (10, 20, 30) of claim 4, wherein: The next instruction for execution is displayed (S25).

6. The method (10, 20, 30) according to claim 4 or 5, wherein: The instruction set is displayed in a display view, which at least partially corresponds to a view used in programming, wherein the execution status indication is displayed by marking the currently executed or just completed instruction in the display view, and wherein the next instruction for execution can also be indicated in the display view.

7. The method (10, 20, 30) as claimed in claim 1 or 2 further includes storing (S24) the execution status indication for at least a portion of the instruction currently being executed or just completed and being able to store the corresponding obtained sensor data when the corresponding obtained sensor data exists.

8. The method (10, 20, 30) according to claim 1 or 2, wherein: The set of instructions for controlling the biopharmaceutical process includes or is associated with at least one process variable value, the at least one process variable value defining the biopharmaceutical process, the method comprising the steps of: receiving (S31) at the biopharmaceutical process monitoring element (120) an update of at least one of the process variable values ​​defining the biopharmaceutical process during execution of the set of instructions; as well as During the execution of the instruction set, information related to the update is received (S33) at a controller (111) for controlling the biopharmaceutical process for performing update control on the biopharmaceutical process.

9. The method (10, 20, 30) of claim 8, wherein: An update of at least one of the process variable values ​​is received via a user interface (140).

10. The method (10, 20, 30) of claim 8 or 9 when dependent on claim 3, further comprising, at the biopharmaceutical process monitoring element (120): monitoring the resulting sensor data associated with said biopharmaceutical process; detecting when the resulting sensor data deviates from a predetermined pattern or value or one or more boundaries; and A determination is made based on the detected deviation that at least one potential process variable value should be updated.

11. The method (10, 20, 30) of claim 10, wherein: Control of the biopharmaceutical process is automatically updated based on the at least one potential process variable value, or wherein the at least one potential process variable value is fed to a user interface (140) for acceptance or rejection or modification by a user.

12. The method (10, 20, 30) according to claim 1 or 2, wherein: The biopharmaceutical process is a chromatographic process and the instruction set for controlling the biopharmaceutical process comprises a chromatographic process or a method step or a formulation step.

13. The method (10, 20, 30) of claim 12, further comprising: The currently running chromatographic process, method step or recipe step is displayed on the display (142), and in the same display view, a predefined chromatographic process, method step or recipe corresponding to the currently running chromatographic process, method step or recipe step is displayed.

14. A system (100) for monitoring a biopharmaceutical process, the system comprising: A processing system (110) comprising: A processing plant (112) in which said biopharmaceutical process is performed; and characterized in that: a controller (111) arranged to store an instruction set for controlling the biopharmaceutical process and to execute the instruction set to generate control signals for controlling the processing device (112), wherein the controller (111) is further arranged to generate and transmit an execution status update for each executed instruction, the execution status update indicating which instruction is currently being executed or has just been completed, wherein the system (100) further comprises a biopharmaceutical process monitoring element (120), the biopharmaceutical process monitoring element (120) being arranged to: receive the execution status update, and form an execution status indication based on the received execution status update, the execution status indication associating the currently executed or just completed instruction with its position in the instruction set, and wherein the system (100) further comprises a display (142) arranged to display at least the set of instructions and the execution status indication; The instruction set defines multiple stages of the biopharmaceutical process, each stage contains a subset of the instruction set, and for each stage, the corresponding instruction set is executed step by step.

15. The system (100) of claim 14, wherein: The biopharmaceutical process monitoring element (120) is arranged to store the instruction set for controlling the biopharmaceutical process, and wherein forming the execution status indication comprises associating the received execution status update with a corresponding instruction in the stored instruction set.

16. A system (100) as described in claim 14 or 15, wherein the display (142) is arranged to display the instruction set in a display view, which at least partially corresponds to a view used in programming, wherein the execution status indication is displayed by marking the currently executing or just completed instruction in the display view, and wherein the next instruction for execution can also be indicated in the display view.

17. The system (100) according to any one of claims 14-15, wherein: The processing system (110) further comprises a plurality of sensors (113) arranged to monitor the status of a process of the processing device (112), and the display can be arranged to display the monitored status of the process of the process monitoring element (120).

18. The system (100) of claim 17, wherein: The biopharmaceutical process monitoring element (120) is arranged to correlate corresponding acquired sensor data with the execution status indication for at least a portion of the instruction currently being executed or just completed.

19. The system (100) of claim 17, further comprising a memory (130), wherein the memory (130) is arranged to store the execution status indication for at least a portion of the instruction currently being executed or just completed and is capable of storing the corresponding resulting sensor data when the corresponding resulting sensor data exists.

20. The system (100) of claim 14 or 15, wherein: The set of instructions for controlling the biopharmaceutical process includes or is associated with at least one process variable value, the at least one process variable value defining the biopharmaceutical process.

21. The system (100) of claim 20, wherein: In response to obtaining an instruction to update at least one process variable value during execution of the instruction set, the biopharmaceutical process monitoring element (120) is arranged to modify a display view based on the obtained process variable value update, and transmit the variable value update or information related thereto to the controller (111), wherein the controller (111) is arranged to generate a control signal for controlling the processing device (112) according to the variable value update.

22. The system (100) of claim 21, further comprising a user interface (140) for a user to input instructions for updating at least one process variable value.

23. The system (100) of claim 21 or 22, wherein: The biopharmaceutical process monitoring element (120) is arranged to monitor the obtained sensor data related to the biopharmaceutical process, detecting when the resulting sensor data deviates from a predetermined pattern or value or one or more boundaries, and It is determined that at least one potential process variable value should be updated.

24. The system (100) of any one of claims 14 to 23, wherein the biopharmaceutical process is a chromatographic process and the instructions for controlling the biopharmaceutical process comprise a chromatographic process or a method step or a recipe step.

25. The system (100) of claim 24, wherein the display is further arranged to display a currently running chromatographic process, method step or recipe step and, in the same display view, to display a predefined chromatographic process, method step or recipe step corresponding to the currently running chromatographic process, method step or recipe step.

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