Method for performing a bioprocess on immune or naive cell culture(s)

Abstract

The invention relates to a method for performing a bioprocess on immune or naive cell culture(s) to obtain processed cell culture(s) on a semi-automated bioprocessing system (1), comprising a primary workstation (2) and performing a workflow, the workflow comprising a plurality of unit operations performed by the primary workstation (2), wherein the primary workstation (2) comprises a unit operation interface (4), wherein the unit operations are performed by an interaction of the unit operation interface (4) with at least one cartridge (5), wherein a first unit operation (16) and a second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4) with different cartridge configurations (13), wherein between the first and the second unit operation (16, 17) the cartridge configuration (13) is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system (1).

Description

[0001] Method for performing a bioprocess on immune or naive cell culture(s)

[0002] The present invention relates to a method for performing a bioprocess on immune or naive cell culture(s) according to claim 1 , to a bioprocessing system for performing a bioprocess on immune or naive cell culture(s) according to claim 20 and to a method for performing a further iteration of the bioprocess performed according to the proposed method according to claim 33.

[0003] In recent years, the field of cell and gene therapy has garnered increasing attention. As promising therapies multiply, the focus intensifies on scaling up production systems. Some biotech firms are actively pursuing fully automated systems to simultaneously produce several batches of immune or naive cell culture(s) for cell and gene therapy. However, these systems encounter unique challenges. For example, cell and gene therapy may not have reached a stage where production capacities are the primary bottleneck, and there might not be enough experience for a fully automated system to enter the market at profitable rates. This renders the development of such a system both challenging and cost-intensive. As customers are also still inexperienced with automated systems and extremely focused on reliability over speed, gaining customer approval entails mastering a number of complex challenges simultaneously.

[0004] One of the main reason integrated systems are not widely used is that wholesale transfer of a process onto an integrated system requires first that the component parts of that process be verified on the integrated system. For many proposed systems there is no route by which individual component parts (unit operations) can be tested in isolation, without investment in the full system, and without obscuring the behavior of those individual components because they can only be run in conjunction with other components in the system (e.g., setting up a complex cartridge I tube-set), or because material moving into them and out of them cannot be objectively assessed offline (on separate equipment) as there is no way of getting an entirely representative sample out or ensuring the nature of the input material. A verification of the system is therefore very difficult. The invention is based on the problem of providing a method for performing a bioprocess and a corresponding bioprocessing system that improve the current manual methods and at the same time are less challenging to build and accept.

[0005] The above-noted object is solved by the features of claim 1 .

[0006] The main realization of the present invention is that a good balance between manual and automatic actions allows designing around many challenges in automation, e.g. complex transport processes. It is further possible to gradually move from a manual process towards a fully automated process by providing clear boundaries between automation and manual work which can be moved by adding unit operations one by one and at some point also automating the connection between the unit operations. With the proposed system, the manual processes relate specifically to movement of material before, between and / or after unit operations, and therefore total flexibility is retained in terms of running a short or long process (a single unit operation, just a few unit operations, or many unit operations), in routing material to external components and back (if the relevant unit operations are not covered by the system), and in system configuration.

[0007] Another crucial realization is that the proposed system provides a small number of physical units like a cartridge that can be handled by a system and by a human. The system therefore allows evaluating the automation of single unit operations and moving towards a fully automated system step by step.

[0008] Further, the system allows automating tasks that have a higher chance of failing if performed by a human. The right combination of automation and user support leads to a system which is less prone to errors than manual systems and automatic systems, as the user performs tasks that are hard to automate with very low error rates supported by the system and the system performs tasks that are error-prone when performed manually. Additionally, the system may perform tasks that are time-intensive in a semi-automated manner.

[0009] In summary, it is proposed to use one system interface for multiple unit operations and having the user reconfigure a cartridge configuration used in the unit operations between the unit operations supported by the system and / or having the user configure a cartridge configuration used in the unit operations before and / or after the unit operations. Such a system provides a high modularity by using cartridges instead of specialized system components for different unit operations and is easy to operate as the system interface doesn't change and does not need to automate highly complex reconfigurations and / or configurations of the cartridge configuration as the user does these. At the same time, the system guides and preferably controls the user actions. This approach results in a system that combines the benefits of both manual and automated processes, reducing overall errors and improving overall process efficiency.

[0010] In detail, a method for performing a bioprocess on immune or naive cell culture^) to obtain processed cell culture(s) on a semi-automated bioprocessing system, wherein the bioprocessing system comprises a primary workstation, wherein for performing the bioprocess the bioprocessing system performs a workflow, wherein the workflow comprises a plurality of unit operations performed by the primary workstation, wherein the primary workstation comprises a unit operation interface, wherein the unit operations are performed by an interaction of the unit operation interface with at least one cartridge, wherein the cartridge, optionally together with containers, placed at, in particular on, the unit operation interface define a cartridge configuration, wherein the unit operation interface comprises at least one active element interacting with the at least one cartridge to perform at least one unit operation of the plurality of unit operations, characterized in that a first unit operation and a second unit operation of the plurality of unit operations are performed by the unit operation interface with different cartridge configurations, wherein between the first and the second unit operation the cartridge configuration is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system and / or in that the first unit operation and the second unit operation of the plurality of unit operations are performed by the unit operation interface, preferably with the same cartridge configuration, wherein before and / or after the first and the second unit operation the cartridge configuration is manually configured in a configuration step, wherein the manual configuration in the configuration step is supported by the bioprocessing system, is performed inside the bioprocessing system and / or is performed outside the bioprocessing system is proposed.

[0011] The active element may transfer mechanical energy and / or may be used for two unit operations with different cartridges (claim 2 and / or 21 ). For example, the active element may be a rotating shaft driving a functional element inside the cartridge like a centrifuge. Having a standardized interface for a user to place cartridges on, for example, makes (re)configuring the cartridge configuration at least to some extent independent of the unit operation, thereby reducing the chance for errors. The ability to perform various unit operations with the same or different cartridges and containers allows the system to handle a wide range of cell and gene therapy applications.

[0012] According to the embodiment of claim 2 it is provided for the method that the same active element interacts with the differently configured cartridges to perform the first and the second unit operation, and / or, that the active element transfers mechanical energy to the cartridge to perform the first and / or the second unit operation.

[0013] According to the embodiment of claim 21 it is provided for the bioprocessing system that the same active element is configured to interact with the differently configured cartridges to perform the first and the second unit operation, and / or, that the active element is configured to transfer mechanical energy to the cartridge to perform the first and / or the second unit operation.

[0014] One target for automation are fluidic connections (claim 3 and / or 22). These may be present between the cartridge and other containers on the unit operation interface and the unit operation interface may actively transfer fluids between a container and the cartridge. Combining multiple unit operations using the same active element and fluidically connecting containers to cartridges results in faster processing times by minimizing the need for manual intervention and material transfer steps.

[0015] According to the embodiment of claim 3 it is provided for the method that a container is placed at, in particular on, the unit operation interface and fluidically connected to the cartridge during at least one of the plurality of unit operations, preferably, that the unit operation interface, in particular via the active element, pumps a liquid between the cartridge and the container, more preferably, that the cartridge and / or the container comprises a pump head, and, that the active element is a drive element for the pump head.

[0016] According to the embodiment of claim 22 it is provided for the bioprocessing system that the unit operation interface, in particular via the active element, is configured to pump a liquid between the cartridge and the container, more preferably, that the cartridge and / or the container comprises a pump head, and, that the active element is a drive element for the pump head.

[0017] Embodiments according to claim 4 and / or claim 23 relate to making fluidic connections with a tube welder. Connecting and disconnecting tubes is a risk for contamination if performed manually and takes a lot of time. Without automatic tube welding, each time a connection needs to be made, the system has to wait for a user. By automizing the (sterile) connections, the system may perform many consecutive operations without user intervention. The possibility of mistakes is reduced.

[0018] According to the embodiment of claim 4 it is provided for the method that the primary workstation comprises a welding interface with a weld robot, that the weld robot performs tube welding fluidically connecting and / or disconnecting the cartridge to and / or from at least one container, preferably, that the weld robot automatically grabs a tube of the cartridge and a tube of the container and automatically welds the tubes together.

[0019] According to the embodiment of claim 23 it is provided for the bioprocessing system that the primary workstation comprises a welding interface with a weld robot, that the weld robot is configured to perform tube welding fluidically connecting and / or disconnecting the cartridge to and / or from at least one container, preferably, that the weld robot is configured to automatically grab a tube of the cartridge and a tube of the container and to automatically weld the tubes together.

[0020] According to claim 5 and / or claim 24, welding may be done at the unit operation interface directly or by transporting the cartridge and / or container to a welding interface. If the interfaces are located close to each other, this short transport may be less complicated than automating all transports for the system, as, for example, conveyors can be used.

[0021] According to the embodiment of claim 5 it is provided for the method that the unit operation interface and the welding interface are the same interface, or, that the unit operation interface and the welding interface are different and preferably distant from each other, preferably, that the bioprocessing system automatically transports the cartridge and preferably the container or containers between the unit operation interface and the welding interface, or, that the bioprocessing system does not automatically transport the cartridge and the container or containers between the unit operation interface and the welding interface, and, that the cartridge and preferably the container or containers are manually transported between the unit operation interface and the welding interface.

[0022] According to the embodiment of claim 24 it is provided for the bioprocessing system that same interface or the unit operation interface and the welding interface are different and preferably distant from each other and, preferably, that the bioprocessing system is configured to automatically transport the cartridge and preferably the container or containers between the unit operation interface and the welding interface, or, that the bioprocessing system is not configured to automatically transport the cartridge and the container or containers between the unit operation interface and the welding interface, and the cartridge and preferably the container or containers are manually transported between the unit operation interface and the welding interface.

[0023] It is possible to use one cartridge for more than one unit operation after reconfiguration of the cartridge configuration, for example by exchanging containers connected to the cartridge (claim 6). This embodiment shows how a guided manual reconfiguration can be used to supplement automation. For example, the system may disconnect tube connections to a container, the user may replace the container and the system may connect the new container and start a new unit operation. The system may further check whether the user actions have been performed correctly. This example shows that the rather complex task of swapping out containers and placing them at the correct location does not need to be solved automatically with the present system while at the same time the correct replacement is checked by the user and the system. Performing multiple unit operations within the same cartridge minimizes downtime by reducing the need for manual reconfiguration between processes, allowing for continuous processing of materials.

[0024] According to the embodiment of claim 6 it is provided for the method that the first and the second unit operations are performed with, in particular partially or completely within, the same cartridge, preferably after a manual reconfiguration of the cartridge and / or after a connection of the cartridge to at least one container.

[0025] As specified in claim 7 and / or claim 25, the system may comprise mechanically defined positions, e.g. comprising small elevations, that allow precisely placing the cartridges and containers at the defined positions, for example by inserting the elevations into matching depressions of the respective cartridge or container. Mechanically defined positions make it easy for the user to place the cartridges and containers precisely and reproducibly such that the system can then localize the cartridges and containers. Proper alignment and handling of cartridges and containers minimize risks associated with incorrect connections or misalignment, which can lead to an automated action like welding failing.

[0026] According to the embodiment of claim 7 it is provided for the method that the unit operation interface and / or the welding interface comprise a, in particular mechanically, defined cartridge position and preferably at least one, preferably at least two, in particular mechanically, defined container positions, preferably, that the weld robot uses the defined cartridge position and container positions to detect the positions of the tubes.

[0027] According to the embodiment of claim 25 it is provided for the bioprocessing system that the unit operation interface and / or the welding interface comprise a, in particular mechanically, defined cartridge position and preferably at least one, preferably at least two, in particular mechanically, defined container position, preferably, that the weld robot uses the defined cartridge position and container position to detect the positions of the tubes. In an embodiment according to claim 8, claim 13, claim 26 and / or claim 27, the system may support the user by visually indicating how the cartridge configuration should be reconfigured and / or configured. Visual indications simplify the reconfiguration process and / or configuration process for users by providing clear instructions on what steps to take and where to place components, reducing confusion and potential errors during the process. Clear visual cues help ensure that cartridges and containers are placed correctly and securely during the reconfiguration process and / or configuration process, minimizing risks associated with incorrect placement or misalignment. Accurate reconfiguration instructions streamline the process, reducing downtime and improving overall system productivity.

[0028] According to the embodiment of claim 8 it is provided for the method that in the reconfiguration step the bioprocessing system visually indicates to a user how to perform the reconfiguration, in particular by indicating which cartridge to reconfigure and / or which container to reconfigure and / or which cartridge to remove and / or where to place a cartridge and / or which container to remove and / or where to place a container, and / or, that in the reconfiguration step the bioprocessing system detects a correct reconfiguration of the cartridge configuration, in particular by detecting the presence of the correct cartridge and / or container after reconfiguration at the correct position and / or the correct reconfiguration of the cartridge.

[0029] According to the embodiment of claim 13 it is provided for the method that in the configuration step the bioprocessing system visually indicates to a user how to perform the configuration, in particular by indicating which cartridge to configure and / or which container to configure and / or which cartridge to remove and / or where to place a cartridge and / or which container to remove and / or where to place a container, and / or, that in the configuration step the bioprocessing system detects a correct configuration of the cartridge configuration, in particular by detecting the presence of the correct cartridge and / or container after configuration at the correct position and / or the correct configuration of the cartridge.

[0030] According to the embodiment of claim 26 it is provided for the bioprocessing system that the bioprocessing system is configured to visually indicate in the reconfiguration step to a user how to perform the reconfiguration, in particular by indicating which cartridge to reconfigure and / or which container to reconfigure and / or which cartridge to remove and / or where to place a cartridge and / or which container to remove and / or where to place a container, and / or, that in the reconfiguration step the bioprocessing system is configured to detect a correct reconfiguration of the cartridge configuration, in particular by detecting the presence of the correct cartridge and / or container after reconfiguration at the correct position and / or the correct reconfiguration of the cartridge.

[0031] According to the embodiment of claim 27 it is provided for the bioprocessing system that the bioprocessing system is configured to visually indicate in the configuration step to a user how to perform the configuration, in particular by indicating which cartridge to configure and / or which container to configure and / or which cartridge to remove and / or where to place a cartridge and / or which container to remove and / or where to place a container, and / or, that in the configuration step the bioprocessing system is configured to detect a correct configuration of the cartridge configuration, in particular by detecting the presence of the correct cartridge and / or container after configuration at the correct position and / or the correct configuration of the cartridge.

[0032] The system may also comprise a storage location of containers, in particular an incubation location for incubation containers, and aid the user with storing and retrieving the correct containers (claim 9 and / or 28). Proper containment and storage of cell culture(s) minimize potential contamination risks and ensure that they remain in a controlled environment throughout the process. A dedicated storage location for containers allows for efficient management and retrieval of cell culture(s) during the process, ensuring that they are readily available when needed.

[0033] According to the embodiment of claim 9 it is provided for the method that the bioprocessing system comprises a storage location for containers, in particular incubation containers, containing the cell culture(s), that the bioprocessing system indicates to a user which container to remove from the storage location and place at the unit operation interface and / or which container to remove from the unit operation interface and place at the storage location and verifies the correct transfer of the container. According to the embodiment of claim 28 it is provided for the bioprocessing system that the bioprocessing system comprises a storage location for containers, in particular incubation containers, containing the cell culture(s), and that, preferably, the bioprocessing system indicates to a user which container to remove from the storage location and place at the unit operation interface and / or which container to remove from the unit operation interface and place at the storage location and verifies the correct transfer of the container, the bioprocessing system comprises a handling device for moving a container, preferably an incubation container, between the storage location and the primary workstation, in particular the unit operation interface and / or the welding interface, and / or the storage location and / or a container, preferably an incubation container, comprises a power interface for transferring power between the bioprocessing system and the respective connected container, a data interface for transferring data between the bioprocessing system and the respective connected container and / or a fluid interface for transferring at least one fluid between the bioprocessing system and the respective connected container.

[0034] Claim 10 explains how in one embodiment the system may confirm the correct placement of a container at the correct location and then proceed further automatically after having confirmed the correct user action.

[0035] According to the embodiment of claim 10 it is provided for the method that for performing the first unit operation the user places a container from the storage location at a defined container position of the primary workstation, that the bioprocessing system identifies the placement of the correct container at the correct defined container position, that the user places at least one cartridge at a defined cartridge position of the primary workstation, that afterwards the weld robot performs tube welding to fluidically connect the cartridge and the container, that afterwards the primary workstation performs the first unit operation with the cartridge, preferably, that afterwards the weld robot fluidically disconnects the cartridge and the container.

[0036] Claim 11 and / or claim 29 concerns a preferred boundary between system and user actions in the workflow and claim 12 specifies that preferably, a fluid transfer is done by the system between the cartridge and a container, thereby allowing replacement of the cartridge for the next user action.

[0037] According to the embodiment of claim 11 it is provided for the method that no user action is required while performing the unit operation and preferably while connecting and / or disconnecting the cartridge and the container, preferably, that the bioprocessing system detects a user action during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge and the container, more preferably, that the bioprocessing system performs an abort procedure if the user action is detected during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge and the container.

[0038] According to the embodiment of claim 12 it is provided for the method that the primary workstation pumps the cell culture from the cartridge used in the first unit operation into a container fluidically connected to the cartridge, that the weld robot disconnects the cartridge and the container, that the user replaces the cartridge guided by the bioprocessing system with a differently configured new cartridge, optionally that the bioprocessing system verifies that the correct new cartridge was placed at the correct position, that the weld robot connects the new cartridge to the container containing the cell culture, that the primary workstation pumps the cell culture from the container into the new cartridge and performs the second unit operation with the second cartridge.

[0039] According to the embodiment of claim 29 it is provided for the bioprocessing system that the bioprocessing system is configured so that no user action is required while performing the unit operation and preferably while connecting and / or disconnecting the cartridge and the container, and that the bioprocessing system is configured to detect a user action during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge and the container and, preferably, the bioprocessing system is configured to perform an abort procedure if the user action is detected during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge and the container. Claim 14 and / or claim 30 concerns the provision of one or more bioprocessing bases, wherein at least one defined cartridge position and / or at least one defined container position is arranged on at least one bioprocessing base of the one or more bioprocessing bases and, preferably, the bioprocessing bases respectively comprises an active element and / or the bioprocessing bases are movable relative to the primary workstation and / or the cartridge and / or the container are moveable relative to the bioprocessing base. In this way the cartridge, container and / or cartridge configuration can be more flexible configured and / or reconfigured and the unit operations can be more flexible performed.

[0040] According to the embodiment of claim 14 it is provided for the method that the bioprocessing system, preferably the primary workstation, in particular the unit operation interface and / or the welding interface, comprises one or more bioprocessing bases, that the defined cartridge position and / or the defined container position is, preferably at least during the first unit operation and / or the second unit operation, arranged at the one or more bioprocessing bases and in that, preferably, the one or more bioprocessing bases respectively comprise at least one of the active elements, the one or more bioprocessing bases interact with the cartridge and / or container to perform at least one unit operation of the plurality of unit operations, preferably the first unit operation and / or the second unit operation, the one or more bioprocessing bases are, preferably manually, movable, preferably moved, between a mounting position arranged in the primary workstation, preferably the unit operation interface and / or the welding interface, and an external position arranged outside the primary workstation, preferably the unit operation interface and / or the welding interface, preferably before and / or after the first unit operation and / or before and / or after the second unit operation, and / or the cartridge and / or the container are, preferably manually, movable, preferably moved, between a holding position arranged on at least one bioprocessing base of the one or more bioprocessing bases, the defined cartridge position and / or the defined container position and a release position spaced apart from the at least one bioprocessing base of the one or more bioprocessing bases, the defined cartridge position and / or the defined container position, preferably before and / or after the first unit operation and / or before and / or after the second unit operation. According to the embodiment of claim 30 it is provided for the bioprocessing system that the bioprocessing system, preferably the primary workstation, in particular the unit operation interface and / or the welding interface, comprises one or more bioprocessing bases, that the defined cartridge position and / or the defined container position is, preferably at least during the first unit operation and / or the second unit operation, arranged at the one or more bioprocessing bases and in that, preferably, the one or more bioprocessing bases respectively comprise at least one of the active elements, the one or more bioprocessing bases are configured to interact with the cartridge and / or container to perform at least one unit operation of the plurality of unit operations, preferably the first unit operation and / or the second unit operation, the one or more bioprocessing bases are, preferably manually, movable between a mounting position arranged in the primary workstation, preferably the unit operation interface and / or the welding interface, and an external position arranged outside the primary workstation, preferably the unit operation interface and / or the welding interface, and / or the cartridge and / or the container are, preferably manually, movable between a holding position arranged on at least one bioprocessing base of the one or more bioprocessing bases, the defined cartridge position and / or the defined container position and a release position spaced apart from the at least one bioprocessing base of the one or more bioprocessing bases, the defined cartridge position and / or the defined container position.

[0041] Claim 15 concerns the execution of the first and second unit operation in different locations and / or in different ways. This simplifies a more flexible execution of the first and second unit operation.

[0042] According to the embodiment of claim 15 it is provided for the method that the first unit operation and the second unit operation are performed by the same or different active elements, that the first unit operation and the second unit operation are different or the same unit operations, preferably different unit operations from the list comprising enrichment, selection, activation, loading, genetic modification, expansion, formulation and fill, wash and / or separation, that a further cartridge configuration is provided in the bioprocessing system, preferably the primary workstation, in particular the unit operation interface and / or the welding interface, and, preferably by the unit operation interface, the first unit operation is performed on the further cartridge configuration, preferably while the first unit operation is performed on the cartridge configuration, and / or the second unit operation is performed on the further cartridge configuration, preferably while the second unit operation is performed on the cartridge configuration, that in the first unit operation the cartridge of the cartridge configuration is provided in a different defined cartridge position and / or on a different bioprocessing base of the one or more bioprocessing bases than in the second unit operation, that in the first unit operation the container of the cartridge configuration is provided in a different defined container position and / or on a different bioprocessing base of the one or more bioprocessing bases than in the second unit operation and / or that multiple cartridge configurations are provided in the primary workstation, in particular the unit operation interface and / or the welding interface, simultaneously and that the first unit operation and / or the second unit operation are performed respectively, preferably at least in sections simultaneously, on the multiple cartridge configurations.

[0043] According to an advantageous embodiment of claim 16, tube welding comprises different phases to be performed, namely an arrangement phase, a trimming phase and / or a welding phase. Each phase by itself or a combination of these phases offers a simple sequence, which leads to a, in particular sterile, tube connection of the first tube and the second tube, when comprised by the tube welding. Moreover according to the embodiment (see also claim 31 ) the weld robot can also be movable relative to the cartridge and / or container, thus the cartridge and / or container can remain in the same location for welding as well as performing the unit operations.

[0044] According to the embodiment of claim 16 it is provided for the method that the weld robot is movable arranged in the bioprocessing system, preferably relative to the cartridge, the container, the defined cartridge position and / or the defined container position and, preferably, is moved relative to the cartridge, the container, the defined cartridge position and / or the defined container position before, during and / or after the first unit operation and / or the second unit operation, that tube welding comprises an arrangement phase, wherein the tube of the cartridge and the tube of the container are being arranged relatively to each other, preferably at least in an axial direction of the tube of the cartridge and / or the tube of the container, that tube welding comprises a trimming phase, wherein the tube of the cartridge and the tube of the container are being cut and / or that tube welding comprises a welding phase, wherein the tube of the cartridge and the tube of the container are being brought in contact and merged together such that a tube connection is formed.

[0045] According to the embodiment of claim 31 it is provided for the bioprocessing system that the weld robot is movable arranged in the bioprocessing system, preferably relative to the cartridge, the container, the defined cartridge position and / or the defined container position.

[0046] Claim 17 further specifies the trimming phase as well as the welding phase. During an advantageous heating step of the trimming phase, a blade is heated by a blade heater of a tube cutting unit to a certain temperature. Here, on the one hand, the blade itself is sterilized such that contamination can be avoided, when the tubes are being cut. On the other hand, the heated blade may also enable smoothed cutting of the tubes, since these are often made out of plastic material, which melds at certain temperatures, when being cut. During an advantageous alignment step of the trimming phase, the tube cutting unit is aligned such that the tube cutting unit is positioned relatively to the tube of the cartridge and / or the tube of the container, wherein the positioning may ensure proper cutting of the tubes. During an advantageous cutting step of the trimming phase, the tube of the cartridge and / or the tube of the container are being cut by the tube cutting unit. During an advantageous contacting step of the welding phase, the tubes might be axially aligned to enable a proper tube connection, when the tubes are welded. Alternatively or additionally during the contacting step, the tube cutting unit might be at least partly moved such that the tubes can be easily brought in contact, wherein movement of the tube cutting unit enables the tubes to be contacted. Alternatively or additionally during the contacting step, the tubes might be brought in contact by axial movement of at least one of the tubes, wherein the tubes are merged together, in particular if the material of the tubes is still heated because of the cutting process. In particular, if the tubes were already axially aligned, movement in merely axial direction of the tubes protects from improper tube connections.

[0047] According to the embodiment of claim 17 it is provided for the method that the welding interface, preferably the weld robot, comprises a tube disconnection arrangement, preferably that the tube disconnection arrangement comprises a sealing unit and / or a disconnecting unit, further preferably, that the method comprises a disconnection routine, wherein the tube of the cartridge and the tube of the container are disconnected, further preferably in that the disconnection routine comprises a sealing phase, wherein the tube of the cartridge and / or the tube of the container are sealed by the sealing unit such that a first sealing at the tube of the cartridge and / or a second sealing at the tube of the container are formed, and / or a disconnecting phase, wherein the tube of the cartridge and the tube of the container are cut by the tube disconnecting unit, in particular between the first sealing and the second sealing.

[0048] The advantageous embodiments according to claim 18 is directed to a disconnection routine, which makes it possible to disconnect the tubes, if required. The disconnection routine is performed by a tube disconnection arrangement. The disconnection routine may comprise a sealing phase, wherein at least one tube is being sealed such that the fluidical connection between the tubes is interrupted. The disconnection routine may comprise a disconnecting phase, wherein the tubes are being cut such that the physical connection between the tubes is interrupted.

[0049] According to the embodiment of claim 18 it is provided for the method that the welding interface, preferably the weld robot, comprises a tube disconnection arrangement, preferably that the tube disconnection arrangement comprises a sealing unit and / or a disconnecting unit, further preferably, that the method comprises a disconnection routine, wherein the tube of the cartridge and the tube of the container are disconnected, further preferably in that the disconnection routine comprises a sealing phase, wherein the tube of the cartridge and / or the tube of the container are sealed by the sealing unit such that a first sealing at the tube of the cartridge and / or a second sealing at the tube of the container are formed, and / or a disconnecting phase, wherein the tube of the cartridge and the tube of the container are cut by the tube disconnecting unit, in particular between the first sealing and the second sealing.

[0050] According to a preferred embodiment of claim 19, the method comprises performing of an integrity testing routine. Here, the integrity of the tube connection, which were formed by welding, can be tested such that if the integrity of the tube connection is not verified, an emergency routine for preserving the cell culture can be initiated. The emergency routine might comprise securing the sterility of the tubes and / or giving a notification to a user and / or initiating a disconnection routine and / or initiating another tube welding.

[0051] According to the embodiment of claim 19 it is provided for the method that the method comprises temporarily closing the tube of the cartridge and / or the tube of the container before tube welding or before the welding phase is performed, performing an integrity testing routine for verifying the integrity of the tube connection after tube welding or after the welding phase is performed and depending on the result of the integrity testing routine, if the integrity of the tube connection is verified, reversing the temporary closing of the tube of the cartridge and / or the tube of the container, and if the integrity of the tube connection is not verified, initiating a emergency routine for preserving the cell culture(s).

[0052] Another teaching according to claim 20, which is of equal importance, relates to a bioprocessing system for performing a bioprocess on immune or naive cell culture(s) to obtain processed cell culture(s) on a semi-automated bioprocessing system, wherein the bioprocessing system comprises a primary workstation, wherein for performing the bioprocess the bioprocessing system performs a workflow, wherein the workflow comprises a plurality of unit operations performed by the primary workstation, wherein the primary workstation comprises a unit operation interface, wherein the unit operations are performed by an interaction of the unit operation interface with at least one cartridge, wherein the cartridge, optionally together with containers, placed at, in particular on, the unit operation interface define a cartridge configuration, wherein the unit operation interface comprises at least one active element interacting with the at least one cartridge to perform at least one unit operation of the plurality of unit operations, characterized in that a first unit operation and a second unit operation of the plurality of unit operations are performed by the unit operation interface with different cartridge configurations, wherein between the first and the second unit operation the cartridge configuration is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system and / or in that the first unit operation and the second unit operation of the plurality of unit operations are performed by the unit operation interface, preferably with the same cartridge configuration, wherein before and / or after the first and the second unit operation the cartridge configuration is manually configured in a configuration step, wherein the manual configuration in the configuration step is supported by the bioprocessing system, is performed inside the bioprocessing system and / or is performed outside the bioprocessing system.

[0053] The embodiment of claim 32 relates to a sealing unit for sealing a tube of the cartridge and / or a tube of the container in a sealing phase such that a sealing is formed, wherein the sealing unit comprises at least one sealing surface, which is designed to crimp the tube of the cartridge and / or the tube of the container along the axial direction of the respective tube such that the tube of the cartridge and / or the tube of the container is or are self-sealed.

[0054] According to the embodiment of claim 32 it is provided for the bioprocessing system that the bioprocessing system, preferably the welding interface, in particular the weld robot, comprises a sealing unit for sealing a tube of the cartridge and / or a tube of the container in a sealing phase such that a sealing is formed, wherein the sealing unit comprises at least one sealing surface, which is designed to crimp the tube of the cartridge and / or the tube of the container along the axial direction of the respective tube such that the tube of the cartridge and / or the tube of the container is or are self-sealed.

[0055] All explanations given with regard to the proposed method are fully applicable. The bioprocessing system may be configured to perform any of the described method steps.

[0056] Another teaching according to claim 33, which is of equal importance, relates to a method for performing a further iteration of the bioprocess performed according to the proposed method as a previous iteration on an automated, in particular fully automated, further bioprocessing system, wherein the further bioprocessing system comprises a further primary workstation, wherein for performing the bioprocess the further bioprocessing system performs the workflow, wherein the plurality of unit operations are performed by the further primary workstation, wherein the further primary workstation comprises a further unit operation interface, wherein the unit operations are performed by an interaction of the further unit operation interface with at least one cartridge, wherein the cartridge, optionally together with containers, placed at, in particular on, the further unit operation interface define a cartridge configuration, wherein the further unit operation interface comprises at least one active element interacting with the at least one cartridge to perform at least one unit operation of the plurality of unit operations, characterized in that a first unit operation and a second unit operation of the plurality of unit operations are performed by the unit operation interface with different cartridge configurations, wherein between the first and the second unit operation the cartridge configuration is reconfigured in a reconfiguration step, wherein the reconfiguration in the reconfiguration step is performed at least partially, in particular fully, automatically and / or in that the first unit operation and the second unit operation of the plurality of unit operations are performed by the unit operation interface, preferably with the same cartridge configuration, wherein before and / or after the first and the second unit operation the cartridge configuration is at least partially, in particular fully, automatically configured in a configuration step, wherein the at least partially, in particular fully, automatic configuration in the configuration step is supported by the bioprocessing system, is performed inside the bioprocessing system and / or is performed outside the bioprocessing system.

[0057] As has been explained in the introduction, the proposed method and system may serve as a stepping stone on the way to a fully automated system. It is therefore proposed to increasingly automate the bioprocess with different systems up to a full automation. A main target of the increased automation is the reconfiguration and / or configuration which was done manually in the first proposed method. The further bioprocessing system may be substantially identical to the proposed bioprocessing system on a functional level. In a very preferred embodiment, the bioprocess is not changed with the change of the system and up to all system components directly influencing the bioprocess functionally stay the same.

[0058] Therefore, all explanations given with regard to the proposed method and the proposed bioprocessing system are fully applicable.

[0059] Claim 34 specifies preferred targets of the gradual automation. According to the embodiment of claim 34 it is provided for the method on an automated, in particular fully automated, further bioprocessing system that some or all user actions necessary for the previous iteration are automated in the further iteration, and / or, that the reconfiguration is at least partially done by robotic transfer of the cartridge and / or container.

[0060] In the following, embodiments of the invention are explained with respect to the drawing. The drawing shows in

[0061] Fig. 1 , a proposed bioprocessing system,

[0062] Fig. 2, detail views of a) a container and b) a cartridge,

[0063] Fig. 3, tube welding with tube holders,

[0064] Fig. 4, schematically the change of cartridge configurations for two unit operations,

[0065] Fig. 5, an integrated bioprocessing system for performing the workflow fully automated

[0066] Fig. 6, in a) to d) a schematic representation of different steps, in particular of the trimming phase,

[0067] Fig. 7, in a) to d) a schematic representation of a disconnection routine in top view,

[0068] Fig. 8, in a) and b) a schematic representation of a provided tube disconnection arrangement in a disconnection routine, in particular during a sealing phase,

[0069] Fig. 9, a further embodiment of a proposed bioprocessing system

[0070] Fig. 10a to 10b, a detail of the bioprocessing system of Fig. 9 and

[0071] Fig. 11 , a detail of a cartridge. Proposed is a method for performing a bioprocess on immune or naive cell culture(s) to obtain processed cell culture(s) on a semi-automated bioprocessing system 1 . Here and preferably, the processed cell culture(s) are destined for autologous or allogenic cell therapy. Fig. 1 shows an overview over an exemplary bioprocessing system 1 . The bioprocessing system 1 comprises a primary workstation 2. The shown bioprocessing system 1 may be scalable and may therefore also comprise several primary workstations 2. The bioprocessing system 1 is used for performing a bioprocess on an individual cell culture. For example, the bioprocess may comprise unit operations such as "enrichment" and / or "selection" and / or "activation" and / or "loading" and / or "genetic modification" and / or "expansion" and / or "formulation and fill" and / or "wash" and / or "separation". A unit operation is, as generally used in the art, a change of the cell culture performed by one or more actions, preferably of the bioprocessing system 1 .

[0072] For performing the bioprocess, the bioprocessing system 1 performs a workflow. Here and preferably the workflow is defined by a digital recipe which is executed by a control system of the bioprocessing system 1 . Different steps of the workflow may be displayed on a user interface 3 of the bioprocessing system 1 for information of a user. The workflow comprises a plurality of unit operations performed by the primary workstation 2. Here it should be noted that the primary workstation 2 may also perform the same unit operation with different configurations.

[0073] The primary workstation 2 comprises a unit operation interface 4. The unit operations are performed by an interaction of the unit operation interface 4 with at least one cartridge 5. A cartridge 5 preferably comprises at least one fluid vessel 6, in particular bag, and / or fluid conduits, in particular tubes 7 (Fig. 2b)). Additionally, a cartridge 5 preferably comprises at least one functional element 8 for interaction with the cell culture. The functional element 8 may be or form part of a pump, a centrifuge or a magnetic field generator for magnetic separation, for example. The cartridge 5, before being used, may comprise a preconfigured, in particular single-use, fluidic structure 9 and a, in particular multiuse, housing 10. The housing 10 preferably comprises a frame 11. The cartridge 5 may be preconfigured outside the bioprocessing system 1 by a user and then placed on the unit operation interface 4 such that a unit operation can be performed by a cooperation of the primary workstation 2 and the cartridge 5. For different unit operations, cartridges 5 with different fluidic structures 9 may be used. Fig. 2b) shows an exemplary cartridge 5.

[0074] The cartridge 5, optionally together with containers 12 (e.g. Fig. 2a)), placed at the unit operation interface 4 defines or define a cartridge configuration 13. When the term "container" is mentioned herein, it always refers to an additional container 12 and not the cartridge 5. Such a container 12 may comprise a fluid vessel 6 and / or fluid conduits. The cartridge 5 optionally with the containers 12 is here and preferably placed on the unit operation interface 4. As can be seen in Fig. 1 , generally, the primary workstation 2 may be a workbench type workstation and therefore the cartridge 5 and the containers 12 may be placed horizontally next to each other. The cartridge configuration 13 comprises the configuration of the cartridge 5 itself and fluidic connections of the cartridge 5 to the containers 12. Therefore, two cartridges 5 with different fluidic structures 9 which comprise different functional elements 8, different tubes 7 or the like, have different cartridge configurations 13. Two cartridges 5 of the same type have the same cartridge configuration 13, which may be changed by different connections to different containers 12 though.

[0075] The unit operation interface 4 comprises at least one active element 14 interacting with the at least one cartridge 5 to perform at least one unit operation of the plurality of unit operations. The at least one active element 14 may comprise a yet to be explained weld robot 15. Additionally or alternatively, the at least one active element 14 may comprise an active element 14 powering a functional element 8 of the cartridge 5 and / or an active element 14 directly interacting with the cell culture, for example by pumping the cell culture. The at least one active element 14 may comprise additionally or alternatively a functional element 8 directly performing at least a part of the unit operation, for example a magnetic field generator. Ambient control, e.g. a general heating of the surroundings of the cartridge 5 is not considered an active element 14.

[0076] The unit operation interface 4 may comprise several active elements 14 for different unit operations. It should be noted that unrelated workbenches for different unit operations without overlapping usage for different unit operations are not considered to be one and the same unit operation interface 4. The unit operation interface 4 may additionally to the functional element 8 comprise connectors for signals, e.g. a bus connection or a wireless connection like WiFi and / or an NFC reader and / or Bluetooth, and / or connectors for electrical energy. Here and preferably, cartridges 5 used for unit operations on the unit operation interface 4 are connected to at least one standard connector for electrical energy and / or signals in addition to above-mentioned active element 14 for at least one of the unit operations.

[0077] It is here the case that a first unit operation 16 and a second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4 with different cartridge configurations 13. Preferably, these different cartridge configurations 13 comprise different cartridges 5. Between the first and the second unit operation 16, 17 the cartridge configuration 13 is manually reconfigured in a reconfiguration step. The manual reconfiguration in the reconfiguration step is supported by the bioprocessing system 1 . Here and preferably, the first and the second unit operation 16, 17, in particular the plurality of unit operations, are performed automatically without user intervention. Alternatively or in addition the first unit operation 16 and the second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4, preferably with the same cartridge configuration 13. Before and / or after the first and the second unit operation 16, 17 the cartridge configuration 13 may be manually configured in a configuration step, wherein the manual configuration in the configuration step is supported by the bioprocessing system 1 , is performed inside the bioprocessing system 1 and / or is performed outside the bioprocessing system 1 . Here and preferably, the first and the second unit operation 16, 17, in particular the plurality of unit operations, can be performed automatically without user intervention. It is also conceivable that the reconfiguration step is performed inside the bioprocessing system 1 .

[0078] An exemplary use of the bioprocessing system 1 may start with placing a container 12 with the cell culture, possibly a container 12 with a medium, and a cartridge 5 for the first unit operation 16 on the unit operation interface 4, and then be followed by fluidically connecting the container 12 or containers 12 and the cartridge 5, transferring the cell culture and possibly medium into the cartridge 5, performing the first unit operation 16, transferring the cell culture back into the container 12, disconnecting the cartridge 5 and container 12 or containers 12, replacing, manually, the cartridge 5 with a second cartridge 5 for the second unit operation 17 and again transferring the cell culture and performing the second unit operation 17 in the second cartridge 5. Most of these steps can be performed automatically, however, the change of cartridges 5 would require a lot of supporting automation to move and place cartridges 5 which is not necessary for the workflow of the bioprocess itself. Leaving the change to the user simplifies the overall system and increases the flexibility of the system configuration. It becomes possible to automate some unit operations and scale the overall process by "adding" users for reconfiguration and transport steps under supervision of the bioprocessing system 1 .

[0079] Alternatively or in addition an exemplary use of the bioprocessing system 1 may start with configuring the cartridge configuration 13 manually, preferably outside the bioprocessing system 1 , by fluidically connecting the container 12 or containers 12 and the cartridge 5. The following steps may comprise placing the container 12 with the cell culture, the container 12 with a medium and the cartridge 5 as an already configured cartridge configuration 13 in the bioprocessing systems 1 , preferably the workstation 2. Then transferring the cell culture and possibly medium into the cartridge 5, performing the first unit operation 16 and the second unit operation 17 and transferring the cell culture back into the one or more containers 12. The following steps may comprise disconnecting the cartridge 5 and the one or more containers 12, configuring the cartridge configuration 13 by replacing, manually, the cartridge 5 with a second cartridge 5 and again transferring the cell culture to the second cartridge 5 and performing the additional unit operation in the second cartridge 5. Alternatively or in addition it can be provided, that the cartridge configuration 13 is removed from the bioprocessing system 1 after the second unit operation 17 and the configuration step is performed outside the bioprocessing system 1 .

[0080] Alternatively or in addition an exemplary use of the bioprocessing system 1 may comprise providing the cartridge 5 in a defined cartridge position 23 and at least one container 12 in a defined container position 24. Providing the cartridge 5 and the container 12 or containers 12 in the defined cartridge position 23 and the defined container position 24 can be performed by placing the cartridge 5 and the container 12 or containers 12 on one or more bioprocessing bases 44 and moving the on one or more bioprocessing bases 44 into the primary workstation 2. Subsequently the container 12 or containers 12 and the cartridge 5 can be fluidically connected, in particular while being provided in the defined cartridge position 23 and defined container position 24 inside the bioprocessing system 1 . The connection can be performed by the weld robot 15 performing tube welding. Thus, the cartridge configuration 13 is configured inside the bioprocessing system 1 . Then the cell culture and possibly medium can be transferred into the cartridge 5. During and / or after the transfer the first unit operation 16 and the second unit operation 17 can be performed, followed by transferring the cell culture back into the one or more containers 12. Between the first unit operation 16 and the second unit operation 17, the cartridge configuration 13 can stay the same, however, it is also conceivable that the cartridge configuration 13 is reconfigured. The following steps may comprise disconnecting the cartridge 5 and the one or more containers 12, configuring the cartridge configuration 13 by replacing, manually, the cartridge 5 with a second cartridge 5 and again transferring the cell culture to the second cartridge 5 and performing the additional unit operation in the second cartridge 5. Alternatively or in addition it can be provided, that the fluidic connection between the cartridge 5 and the container 12 is disconnected and, preferably, the cartridge 5 and / or the container 12 is removed from the defined cartridge position 23 and / or defined container position 24.

[0081] If the cartridges 5 have IDs readable by the bioprocessing system 1 , as is preferred, the bioprocessing system 1 may check that the correct cartridge 5 has been placed at the unit operation interface 4, thereby also increasing the overall security as the correct workflow is then, at least partially, checked by the user and the bioprocessing system 1 .

[0082] The bioprocessing system 1 may also comprise secondary workstations 18 dedicated to a single unit operation. Fig. 1 for example shows secondary workstations 18 for an incubation and / or expansion step. Other secondary workstations 18 like a controlled rate freezer are possible but not presently in focus. The bioprocessing system 1 may comprise more than one primary workstation 2 and / or more than one secondary workstation 18. To perform the bioprocess, some unit operations are performed at one primary workstation 2. Other unit operations may be performed at other primary workstations 2 and / or at a secondary workstation 18. Here and preferably, a transport between at least two primary workstations 2, in particular for consecutive unit operations, and / or between a primary workstation 2 and a secondary workstation 18, in particular for consecutive unit operations, the cell culture may be transported inside of a cartridge or container. In this way, the cell culture itself is not affected by transport operations. Therefore, here and preferably, at least two consecutive unit operations are performed on two different primary workstations 2 and / or a primary workstation 2 and a secondary workstation 18. The primary workstations 2 may be differently configured.

[0083] The bioprocessing system 1 shown in the drawings is preferably adapted to perform a bioprocess for the manufacturing of genetically modified T cells. Here, T cells are genetically modified to express a chimeric antigen receptor (CAR). Consequently, the term "CAR-T cells" describes T cells that have been genetically modified to express a CAR. The genetically modified CAR-T cells, which represent the product of the bioprocess, may be administered to a patient and used to start or resume cancer treatment in the patient. As the bioprocess is performed, the cell culture is gradually processed. All explanations given are mainly directed to such a bioprocess. It may be pointed out, however, that those explanations are fully applicable to other bioprocesses as well.

[0084] The term "immune cell culture" is to be understood in a broad sense and refers to an immune cell culture comprising at least one type of immune cells. The immune cell culture may comprise other cell types that are not immune cells. Hence, the term "immune cell culture" refers to an immune cell culture at any stage during the bioprocess. Consequently, the type and fraction of immune cells present in the immune cell culture will change during the bioprocess applied as certain immune cells are enriched or depleted from the immune cell culture and / or the immune cells are genetically modified.

[0085] The term "immune cells" generally refers to different types of white blood cells. Hence, the term "immune cells" includes a variety of cells, for example, but not limited to dendritic cells, T lymphocytes, also referred to as T cells, B lymphocytes, natural killer cells, macrophages or the like. Immune cells may also include subtypes of immune cells, for example tumor-infiltrating lymphocytes or different types of T cells. Subtypes of a certain type of immune cells may be classified based on the type of antigen present at the cell surface. Hence, the term immune cells may for example refer to T cells comprising the surface antigen CD4 ("CD4+ T cells"). Typically, a certain type of immune cells, e.g., T cells, preferably a certain subtype of immune cells, e.g., CD4+ T cells, will be selectively enriched by the bioprocess, while other immune cells, e.g. macrophages, and / or other cell types that are not immune cells, e.g., erythrocytes, and / or other subtypes of immune cells, e.g., CD8+ T cells, will be depleted from the immune cell culture. The immune cells to be enriched are referred to as target immune cells. Further, and as mentioned above, the target immune cells might be genetically modified.

[0086] The term "naive cells" refers to cells that can still differentiate into different target cell types. In particular, stem cells and their derivatives prior to full differentiation into a specific cell type are naive cells. The term also comprises naive immune cells.

[0087] It should be noted that the bioprocessing system 1 is used for small scale parallelized bioprocesses on individual cell culture(s).

[0088] It may be the case that the same active element 14 interacts with the differently configured cartridges 5 and / or identical configured cartridges 5 to perform the first and the second unit operation 16, 17, and / or, that the active element 14 transfers mechanical energy to the cartridge 5 to perform the first and / or the second unit operation 16, 17. For the latter case, the active element 14 may preferably be a rotating shaft to drive a pump head or any other functional element 8 of the cartridge 5 that needs rotational mechanical energy.

[0089] During at least one of the plurality of unit operations here and preferably a container 12 is placed at, in particular on, the unit operation interface 4 and flu idical ly connected to the cartridge 5. The term "is placed at" means the state of being placed and connected, not the action of placing and connecting. Therefore, the bioprocessing system 1 performs at least one unit operation with a cartridge configuration 13 comprising a container 12. Preferably, the unit operation interface 4, in particular via the active element 14, pumps a liquid between the cartridge 5 and the container 12. For that, the cartridge 5 and / or the container 12 may comprise a pump head, and, the active element 14 may be a drive element for the pump head. Including the pump head in the cartridge 5 or container 12 makes it easier to correctly contact the pump head and the tubes 7 as this connection may be done by a user outside the bioprocessing system 1 when preconfiguring a fluidic structure 9 of the cartridge 5 or container 12. Here and preferably, during at least one unit operation performed at the unit operation interface 4, the cartridge configuration 13 comprises at least two containers 12, which may be different types of containers 12. The term "preconfigured" means that the fluidic structure 9 is inserted into the cartridge 5 or container 12 outside of the bioprocessing system 1.

[0090] Fig. 2a) shows an exemplary container 12 which comprises essentially only a bag for a medium or the cell culture. Fig. 1 shows in addition to two of those containers 12 on the left side of the cartridge 5 a different type of container 12 on the right side of the cartridge 5. The container 12 on the right side is an incubation container 12 which may be placed in the secondary workstations 18 together with the cell culture for incubation and / or expansion. The incubation container 12 may comprise functional elements 8 for incubation like sensors, elements for perfusion, an extendable bag and the like.

[0091] In a preferred embodiment, the primary workstation 2 comprises a welding interface 19 with a weld robot 15. The weld robot 15 may perform tube connections and / or seal tubes 7 and may additionally perform integrity testing on tube connections. The weld robot 15 here and preferably performs tube welding fluidically connecting and / or disconnecting the cartridge 5 to and / or from at least one container 12. Tube welding is a way of making sterile connections between tubes 7 with a high success rate and good reliability. Including automatic tube welding into the bioprocessing system 1 enables automatically connecting different cartridges 5 and containers 12 and transferring liquids as needed. The bioprocessing system 1 is therefore highly flexible. A detailed description of a preferred weld robot 15 may be found in patent application EP23162143 and will also be described later on.

[0092] One challenge is correctly identifying and interacting with tubes 7 at cartridges 5 and containers 12 that have been manually placed at the welding interface 19. Preferably, the weld robot 15 automatically grabs a tube 7 of the cartridge 5 and a tube 7 of the container 12 and automatically welds the tubes 7 together. For that, it is preferably the case that the cartridge 5 and / or container 12 and / or containers 12, in particular including the incubation containers 12, comprise each at least one tube holder 20 holding a tube 7 and that the weld robot 15 interacts with the tube holder 20 to perform the tube welding. Fig. 2 shows tube holders 20 on the container 12 in a) and the cartridge 5 in b). The tube holder 20 may be removably attached to the cartridge 5 and / or container 12. It is simpler to automate an interaction with a rigid tube holder 20 than with a non-rigid tube 7. The tube holders 20 may be able to extrude and / or retract the tube 7 they hold, in particular driven by the weld robot 15.

[0093] Fig. 3 shows how the tube welding may be performed. Here and preferably, the tube holders 20 are attached to a frame 11 of the cartridge 5 and / or container 12. The weld robot 15 may be adapted to dock onto the tube holders 20, thereby bringing the tube holders 20 and the weld robot 15 into well-defined positions with regard to each other. The tube holders 20 may be movable by the weld robot 15 or of their own accord along a frame 11 of the cartridge 5 and / or container 12. At the beginning of the tube welding, the tube holders 20 may be positioned with an offset to each other such that the tubes 7 are positioned next to each other. The tubes 7 may be extruded (indicated by the horizontal arrows in Fig. 3a)) and the tubes 7 and / or tube holders 20 may be grabbed by the weld robot 15 or a weld head 21 of the weld robot 15. Fig. 3 shows in a) the positioning with offset of the tube holders 20 and in b) the extruded tubes 7 schematically grabbed by the weld head 21. For example, the weld head 21 may be positioned relative to the tube holders 20, for example by docking onto the tube holders 20, and the weld head 21 may comprise one or two funnels into which the tubes 7 are extruded. The weld head 21 may cut (Fig. 3c)) and weld (Fig. 3d)) the tubes 7. Fig. 3e)) shows the connected state. Fig. 3 also shows that the tube holders 20 may comprise a drive mechanism 22 engageable by the weld robot 15 to extrude and / or retract the tubes 7.

[0094] It is here and preferably the case, that the unit operation interface 4 and the welding interface 19 are the same interface. The weld robot 15 is therefore usable as the active element 14 to perform tube connections and / or tube sealing. The weld robot 15 may be a three-axis, in particular three-linear-axis, robot. The welding interface 19 is then defined by the reach of this robot. The weld robot 15 may be movable arranged in the bioprocessing system 1 , preferably relative to the cartridge 5, the container 12, the defined cartridge position 23 and / or the defined container position 24 and, preferably, is moved relative to the cartridge 5, the container 12, the defined cartridge position 23 and / or the defined container position 24 before, during and / or after the first unit operation 16 and / or the second unit operation 17 (The defined cartridge position 23 and the defined container position 24 will be described later). The movement of the weld robot 15 is preferably performed along the three-axis, in particular three-linear-axis, of the weld robot 15. In this way tube welding can be performed very flexible and rather independent of the exact locations of the individual parts of the cartridge configuration 13.

[0095] Alternatively, the unit operation interface 4 and the welding interface 19 are different and preferably distant from each other. It may then be the case, that the bioprocessing system 1 automatically transports the cartridge 5 and preferably the container 12 or containers 12 between the unit operation interface 4 and the welding interface 19, for example by means of a conveyor or another means of horizontal transfer. A simple conveyor between the interfaces is still easier to build and automate than a complex transport system for several cartridges 5 and containers 12.

[0096] In another embodiment, the bioprocessing system 1 does not automatically transport the cartridge 5 and the container 12 or containers 12 between the unit operation interface 4 and the welding interface 19, and, the cartridge 5 and preferably the container 12 or containers 12 are manually transported between the unit operation interface 4 and the welding interface 19.

[0097] A welding interface 19 distant from the unit operation interface 4 enables using one welding interface 19 for two or more unit operation interfaces 4, which consequently may be the case in one embodiment in which the bioprocessing system 1 comprises at least two unit operation interfaces 4. Alternatively or additionally, the welding interface 19 may be used for other welding operations not directly related to the performance of a unit operation by the unit operation interface 4. According to one embodiment it is proposed, that the first and the second unit operations 16, 17 are performed with, in particular partially or completely within, the same cartridge 5, preferably after a manual reconfiguration of the cartridge 5, preferably after and / or before manual configuration of the cartridge 5 and / or after a connection of the cartridge 5 to at least one container 12. As has been explained above, the cartridge 5 may be exchanged between the first and second unit operation 16, 17. Alternatively, one or more containers 12 may be exchanged, or the cartridge 5 may be reconfigured in another way manually. Alternatively the cartridge configuration 13 may be the same between the first and second unit operation 16, 17.

[0098] In another embodiment that simplifies the detection of and interaction with tubes 7, the unit operation interface 4 and / or the welding interface 19 comprise a, in particular mechanically, defined cartridge position 23 and preferably at least one, preferably at least two, in particular mechanically, defined container positions 24. The defined position or positions may comprise positioning elements, for example elevations, pins, or the like, that interact with corresponding counter positioning element, for example depressions, holes, or the like at the cartridge 5 and / or container 12. The positioning elements may be self-centering such that placing the cartridge 5 or container 12 on the elements is easy. Afterwards, the position of the cartridge 5 or container 12 is well-defined with regard to the bioprocessing system 1 . Preferably, the weld robot 15 uses the defined cartridge position 23 and container position 24 or container positions 24 to detect the positions of the tubes 7.

[0099] Turning towards the user interaction, in the reconfiguration step and / or configuration step the bioprocessing system 1 may visually indicate to a user how to perform the reconfiguration and / or configuration, in particular by indicating which cartridge 5 to reconfigure and / or to configure and / or which container 12 to reconfigure and / or to configure and / or which cartridge 5 to remove and / or where to place a cartridge 5 and / or which container 12 to remove and / or where to place a container 12. The visual indication may happen via the user interface 3 or locally at the unit operation interface 4, which may comprise light elements like LEDs. For example, the container 12 to be removed may have yellow LEDs lit around it or a position to place a container 12 at may be lit and turn green after correct placement of the container 12. Additionally or alternatively, for example, the position of an incubation container 12 at the secondary workstation 18 may be highlighted, for example lit if the incubation container 12 should be positioned at the unit operation interface 4.

[0100] In the reconfiguration step and / or configuration step, the bioprocessing system 1 may detect a correct reconfiguration and / or configuration of the cartridge configuration 13, in particular by detecting the presence of the correct cartridge 5 and / or container 12 after reconfiguration and / or configuration at the correct position and / or the correct reconfiguration and / or configuration of the cartridge 5. The cartridge 5 and / or container 12 may comprise a digitally readable ID, for example stored in an NFC chip, as a barcode, or the like. The bioprocessing system 1 may digitally read the ID and compare it to the recipe for the workflow. The bioprocessing system 1 may comprise ID readers at the defined locations.

[0101] As has already been mentioned with regard to the secondary workstation 18, the bioprocessing system 1 here and preferably comprises a storage location 25 for containers 12, in particular incubation containers 12, containing the cell culture(s). The storage locations 25 are here comprised by the secondary workstations 18. At the storage locations 25, the cell culture(s) in the incubation containers 12 can be incubated for a period of time, in particular during an expansion unit operation.

[0102] It is here and preferably the case, that the bioprocessing system 1 indicates to a user which container 12 to remove from the storage location 25 and place at the unit operation interface 4 and / or which container 12 to remove from the unit operation interface 4 and place at the storage location 25 and verifies the correct transfer of the container 12.

[0103] An exemplary use of the bioprocessing system 1 may comprise that for performing the first unit operation 16 the user places a container 12 from the storage location 25 at a defined container position 24 of the primary workstation 2, that the bioprocessing system 1 identifies the placement of the correct container 12 at the correct defined container position 24, that the user places at least one cartridge 5 at a defined cartridge position 23 of the primary workstation 2, that afterwards the weld robot 15 performs tube welding to fluidically connect the cartridge 5 and the container 12, that afterwards the primary workstation 2 performs the first unit operation 16 with the cartridge 5, and preferably, that afterwards the weld robot 15 fluidically disconnects the cartridge 5 and the container 12. Preferably, the weld robot 15 also performs an integrity test of the weld after connecting the tubes 7 and before transferring the liquid. Alternatively after the first unit operation 16 the second unit operation 17 is performed without a disconnection of the cartridge 5 and the container 12 and after the second unit operation 17 afterwards the weld robot 15 fluidically disconnects the cartridge 5 and the container 12.

[0104] According to one embodiment it is proposed, that no user action is required while performing the unit operation and preferably while connecting and / or disconnecting the cartridge 5 and the container 12. Preferably, the bioprocessing system 1 detects a user action during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge 5 and the container 12. If the user action is detected during the performance of the unit operation, for example by machine vision, and preferably while connecting and / or disconnecting the cartridge 5 and the container 12, the bioprocessing system 1 may perform an abort procedure. The bioprocessing system 1 may also comprise a closable protecting element for protecting the process, for example a glass door. A closeable protecting element will also protect the user from the robotics. The bioprocessing system 1 would typically involve some degree of protection of the user from the robotics e.g. glass door, light curtain, motion detection or other interlock.

[0105] Further steps that may be performed include that the primary workstation 2 pumps the cell culture from the cartridge 5 used in the first unit operation 16 into a container 12 fluidically connected to the cartridge 5, that the weld robot 15 disconnects the cartridge 5 and the container 12, that the user replaces the cartridge 5 guided by the bioprocessing system 1 with a differently configured new cartridge 5, optionally that the bioprocessing system 1 verifies that the correct new cartridge 5 was placed at the correct position, that the weld robot 15 connects the new cartridge 5 to the container 12 containing the cell culture, that the primary workstation 2 pumps the cell culture from the container 12 into the new cartridge 5 and performs the second unit operation 17 with the second cartridge 5. Fig. 4 shows schematically method steps for two exemplary unit operations. In a), the first unit operation 16 transitions with manual input to the second unit operation 17 with a different cartridge configuration 13. In b), this transition is shown more in detail with the weld robot 15 removing tube 7 connections in the first cartridge configuration 13 and connecting tubes 7 in the second cartridge configuration 13. In between, the user removes containers 12 from the first cartridge configuration 13 and places another container 12 at the unit operation interface 4 for the second cartridge configuration 13.

[0106] Turning towards the overall usage of the bioprocessing system 1 , the method may comprise one or more of the following steps, in particular in this order:

[0107] - a vessel, in particular bag, with patient material arrives and comprises an ID, in particular barcode, for identification

[0108] - the vessel is placed in a, preferably rigid, container 12 that also has an ID, e.g. a barcode, and preferably human readable material

[0109] - the IDs are sent to the bioprocessing system 1 , in particular by scanning both barcodes, to associate container 12 and vessel

[0110] - the bioprocessing system 1 plans what needs to be done and schedules tasks before or when the vessel arrives

[0111] - for the vessel or patient material a recipe has been defined that needs to be carried out, and the recipe also defines a rule set for that vessel, e.g. deviation handling

[0112] - certain media need to be prepared and a user is guided to prepare the correct amount and type of media for this recipe

[0113] - the bioprocessing system 1 forecasts what will be needed throughout the process and guides a user on preparation and storage of needed materials

[0114] - a user places materials in containers 12

[0115] - at some point a user is triggered by the bioprocessing system 1 to perform certain tasks, e.g., transfer of containers 12, docking and undocking from the unit operation interface 4.

[0116] It may be the case that in comparison to "usual" workflows, where a certain user is responsible for a certain vessel or patient material, here it may be the case that users respond to the bioprocessing system 1 and the bioprocessing system 1 schedules how the different processes on different vessels are performed and instructs the user to perform the steps as needed. In one embodiment, the user negotiates actions to be performed by the user with the bioprocessing system 1. For example, the bioprocessing system 1 needs to negotiate with a user e.g. a cell count needed at 12 pm. The user may respond that it can be provided at 11 am. The bioprocessing system 1 may adapt a schedule based on the negotiation with the user.

[0117] The described example also serves to explain why, here and preferably, the cartridge 5 and / or container 12 comprises a multi-use shell, e.g. a tray, and a single-use insert, e.g. the fluid vessel 6. Here and preferably, the bioprocessing system 1 tracks the combination of multi-use shells and single-use inserts to verify manual actions performed.

[0118] Another teaching which is of equal importance relates to a bioprocessing system 1 for performing a bioprocess on immune or naive cell culture(s) to obtain processed cell culture(s) on a semi-automated bioprocessing system 1 , wherein the bioprocessing system 1 comprises a primary workstation 2, wherein for performing the bioprocess the bioprocessing system 1 performs a workflow, wherein the workflow comprises a plurality of unit operations performed by the primary workstation 2, wherein the primary workstation 2 comprises a unit operation interface 4, wherein the unit operations are performed by an interaction of the unit operation interface 4 with at least one cartridge 5, wherein the cartridge 5, optionally together with containers 12, placed at, in particular on, the unit operation interface 4 define a cartridge configuration 13, wherein the unit operation interface 4 comprises at least one active element 14 interacting with the at least one cartridge 5 to perform at least one unit operation of the plurality of unit operations, wherein a first unit operation 16 and a second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4 with different cartridge configurations 13, wherein between the first and the second unit operation 16, 17 the cartridge configuration 13 is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system 1 and / or in that the first unit operation 16 and the second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4, preferably with the same cartridge configuration 13, wherein before and / or after the first and the second unit operation 16, 17 the cartridge configuration 13 is manually configured in a configuration step, wherein the manual configuration in the configuration step is supported by the bioprocessing system 1 , is performed inside the bioprocessing system 1 and / or is performed outside the bioprocessing system 1 .

[0119] Another teaching which is of equal importance relates to a method for performing a further iteration of the bioprocess performed according to the proposed method as a previous iteration on an automated, in particular fully automated, further bioprocessing system 26. Fig. 5 shows an exemplary integrated bioprocessing system as a further bioprocessing system. The further bioprocessing system 26 comprises a further primary workstation 27, wherein for performing the bioprocess the further bioprocessing system 26 performs the workflow, wherein the plurality of unit operations are performed by the further primary workstation 27, wherein the further primary workstation 27 comprises a further unit operation interface 28, wherein the unit operations are performed by an interaction of the further unit operation interface 28 with at least one cartridge 5, wherein the cartridge 5, optionally together with containers 12, placed at, in particular on, the further unit operation interface 28 define a cartridge configuration 13, wherein the further unit operation interface 28 comprises at least one active element 14 interacting with the at least one cartridge 5 to perform at least one unit operation of the plurality of unit operations, wherein a first unit operation 16 and a second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4 with different cartridge configurations 13, wherein between the first and the second unit operation 16, 17 the cartridge configuration 13 is reconfigured in a reconfiguration step, wherein the reconfiguration in the reconfiguration step is performed at least partially, in particular fully, automatically and / or in that the first unit operation 16 and the second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4, preferably with the same cartridge configuration 13, wherein before and / or after the first and the second unit operation 16, 17 the cartridge configuration 13 is at least partially, in particular fully, automatically configured in a configuration step, wherein the at least partially, in particular fully, automatic configuration in the configuration step is supported by the bioprocessing system 1 , is performed inside the bioprocessing system 1 and / or is performed outside the bioprocessing system 1 . It may be the case that gradually, further unit operations are performed by the bioprocessing system. At some point, the bioprocessing system may be swapped out with the further bioprocessing system, reducing the amount of user actions, preferably without losing any of the results of previous verifications of the automated steps.

[0120] According to one embodiment it is proposed, that some or all user actions necessary for the previous iteration are automated in the further iteration, and / or, that the reconfiguration is at least partially done by robotic transfer of the cartridge 5 and / or container 12.

[0121] Coming back to tube welding, tube welding may comprise different phases, namely an arrangement phase, a trimming phase and / or a welding phase. The different phases may be performed simultaneously, preferably at least partly simultaneously and / or sequentially. It is particularly preferred that the trimming phase is directly followed by the welding phase.

[0122] The arrangement phase has to a certain extend already been described with regard to Fig. 3. In the arrangement phase the tube 7 of the cartridge 5 and the tube 7 of the container 12 may be arranged relatively to each other, preferably at least in an axial direction of the tube 7 of the cartridge 5 and / or the tube 7 of the container 12.

[0123] During the arrangement phase, the tube 7 of the cartridge 5 and the tube 7 of the container 12 are being arranged relatively to each other at the welding location. Generally, relative arrangement of the tube 7 of the cartridge 5 and the tube 7 of the container 12 may happen by direct or indirect movement of at least one of the tubes 7. Direct movement might be performed by extrusion or retraction of the respective tube 7. Indirect movement might be performed by movement of a respective tube holder 20. Here and preferably, the tube 7 of the cartridge 5 and the tube 7 of the container 12 is or are moved, in particular only, in the axial direction of the tube 7 of the cartridge 5 and / or the tube 7 of the container 12.

[0124] It is preferred, that during the arrangement phase tube 7 of the cartridge 5 is, in particular automatically, moved, preferably extruded or retracted, in its axial direction and / or the tube 7 of the container 12 is, in particular automatically, moved, preferably extruded or retracted, in its axial direction, as exemplarily shown in Fig. 3a). The axial direction of the tube 7 of the cartridge 5 and the axial direction of the tube 7 of the container 12 are preferably inverse to each other, in particular if the tube 7 of the cartridge 5 is in a first cutting position and the tube 7 of the container 12 is in a second cutting position. In Fig. 3a), the tubes 7 are moved in the x-dimension, wherein the tube 7 of the cartridge 5 is moved in an inverse direction regarding to the moving direction of the tube 7 of the container 12. Preferably and as shown in Fig. 3a), the tube 7 of the cartridge 5 is held by a tube holder 20 and the tube 7 of the container 12 is held by a tube holder 20 in the arrangement phase. In Fig. 3a to 3e the tube 7 of the cartridge 5 may be shown on the right hand side and the tube 7 of the container 12 may be shown on the left hand side.

[0125] Furthermore, it is possible, that the tube 7 of the cartridge 5 is moved in a transverse direction, in particular orthogonal direction, of its axis and / or that the tube 7 of the container 12 is moved in a transverse, in particular orthogonal, direction of its axis. In Fig. 3a), the orthogonal direction of the axis of the tube 7 of the cartridge 5 and of the tube 7 of the container 12 is within the y-dimen- sion.

[0126] During the arrangement phase, the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 may be moved into respectively the first cutting position and / or the second cutting position. In Fig. 3b), the tube 7 of the cartridge 5 and the tube 7 of the container 12 are in their respective cutting positions. It is preferred, that the tube 7 of the cartridge 5 and the tube 7 of the container 12 are arranged next to each other, in particular in parallel, if the tube 7 of the cartridge 5 is in the first cutting position and the tube 7 of the container 12 is in the second cutting position. Preferably, the tube 7 of the cartridge 5 and the tube 7 of the container 12 are at least partly overlapping each other if the tubes 7 are in the respective cutting position. The tube 7 of the cartridge 5 and the tube 7 of the container 12 may be arranged alongside each other in the respective cutting position.

[0127] Furthermore, it is preferred that the method comprises temporarily closing the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 before tube welding is performed. The tube 7 of the cartridge 5 and / or the tube 7 of the container 12 might be temporarily closed by one or more closing elements, such as a clamp or the like. It is possible that the tube closing element for closing the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is or are provided by the respective tube holder 20.

[0128] It is preferred that after tube welding is performed, an integrity testing routine for verifying the integrity of the tube connection is performed. This verification check makes it possible to determine if the tube connection, which was formed by welding, is intact or unsafe. Intact means that the interior of the tubes remains separated from the outer atmosphere, whereby the sterility of the liquid within the tubes is maintained. Unsafe means that the tubes are not connected properly, particularly that the interior of the tubes is not completely sealed towards the outer atmosphere. If the seal is not complete, potential contaminants might enter the tubes from the outer atmosphere, which would compromise the sterility of the liquids to be transferred to the tubes. It is preferred that the temporary closing is reversed after the tube welding, preferably after an integrity testing routine was performed and the integrity of the tube connection was detected. The temporary closing maintains sterility in the closed section of the tube 7 if the welding fails. In this case, it is possible to perform a disconnection routine, as described in more detail in the following. Here and preferably, a sealing phase of the disconnection routine is performed before removing the closing elements.

[0129] It is preferred that depending on the result of the integrity testing routine, if the integrity of the tube connection is verified, reversing the temporary closing of the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is performed. Here, the medium can then be transferred from the tube 7 of the cartridge 5 to the tube 7 of the container 12 or vice versa via the tube connection. However, if the integrity of the tube connection is not verified, initiating an emergency routine for preserving the cell culture(s) is performed. In the emergency routine, the temporary closing is not reversed such that a contamination of the cell culture(s) via the unsafe tube connection can be prevented. Thus, the sterility of the tubes and accordingly the sterility of the liquids within the tubes and the sterility of the liquids the tubes connect to can be secured. The emergency routine might comprise reporting a notification to a user and / or initiating a disconnection routine and / or initiating a disconnection routine that is followed by another tube welding. It is in particular possible, that the part of the tube 7 of the cartridge 5 and / or the tube 7 of the container 12, which is or are respectively potentially exposed to the outside environment, remains closed by the closing element or the closing elements, for example by clamping. Furthermore, it is possible, that the part of the tube 7 of the cartridge 5 and / or the tube 7 of the container 12, which is or are respectively potentially exposed to the outside environment, is or are sealed and particularly cut off, for example by performing a disconnection routine. After sealing the tubes 7 in the disconnection routine, which will be described in detail below, the closing element or the closing elements can be removed. After the disconnection routine was performed, another tube welding may be performed.

[0130] Alternatively or additionally, tube welding comprises the trimming phase. During the trimming phase the tube 7 of the cartridge 5 and the tube 7 of the container 12 are being cut, preferably at the welding location. It is preferred that the trimming phase follows the arrangement phase such that the tubes 7 are being cut in their cutting positions. Preferably, the tubes 7 are being cut by using a high temperature cutting procedure. The trimming phase may be at least partly performed by a tube cutting unit 29, which in particular comprises a blade 29a, a blade mount 29b and / or a blade heater 29c.

[0131] It is preferred that the welding interface 19, preferably the weld robot 15, comprises the tube cutting unit 29, wherein the tube cutting unit 29 comprises a blade 29a and preferably a blade heater 29c.

[0132] In context with the trimming phase, it is preferred that the trimming phase comprises a heating step, wherein during the heating step the blade heater 29c heats the blade 29a to a cutting temperature. This high temperature cutting procedure, wherein high temperatures are meant to be above 150°C, preferably above 250°C, further preferably above 350°C, provides decontamination during tube welding. Furthermore, cutting of the tubes 7 might be simplified, because the tubes 7 which are preferably plastic tubes, are melted during cutting by the heated blade 29a. Here and preferably the trimming phase comprises an alignment step, wherein the tube cutting unit 29 is aligned relatively to the tube 7 of the cartridge 5 and / or the tube 7 of the container 12. The alignment of the tube cutting unit 29 relatively to the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 can be made such that the tube cutting unit 29 is moved and / or such that the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is or are moved. Preferably, the tube 7 of the cartridge 5 is in the first cutting position and / or the tube 7 of the container 12 is in the second cutting position, when the alignment step takes place. Here, the tube cutting unit 29 may be moved for alignment. It is preferred that the alignment step follows the heating step or that the heating step follows the alignment step or that the alignment step is performed at least partially simultaneously to the heating step and vice versa.

[0133] In Fig. 3b) the heating step as well as the alignment step of the trimming phase are exemplarily shown in a preferred embodiment. The tube 7 of the cartridge 5 and the tube 7 of the container 12are in the respective first cutting position or second cutting position. The tubes 7 are being held by the tube holders 20. The tube cutting unit 29 is aligned relatively to the tubes 7, wherein the tube cutting unit 29 itself is moved during the alignment step, see Fig. 3b) compared to Fig. 3a). The tube cutting unit 29 is aligned such that the blade 29a is transversely, in particular orthogonally, orientated to the tube 7 of the cartridge 5 and / or the tube 7 of the container 12. The blade 29a is heated by the blade heater 29c of the tube cutting unit 29 during the heating step. Another example of the alignment step is shown in Fig. 6a), wherein the tube cutting unit 29 is moved relative to the tubes 7, as exemplarily indicated by the arrow in Fig. 6a). Fig. 6b) shows exemplarily the heating step, wherein the blade 29a is heated by the blade heater 29c.

[0134] Further preferably in context with the trimming phase, the trimming phase comprises a cutting step, wherein the tube 7 of the cartridge 5, in particular being in the first cutting position, and / or the tube 7 of the container 12, in particular being in the second cutting position, is or are being cut by the tube cutting unit 29, in particular by the blade 29a. During the cutting step the tubes 7 are being cut. Preferably, the tube 7 of the cartridge 5 and the tube 7 of the container 12 are being cut at least partly, preferably completely, simultaneously. It is preferred that the cutting step follows the heating step and / or alignment step. Further preferably, the blade 29a is heated to a certain temperature by the blade heater 29c during the cutting step. The tubes 7 may be at least partially melted during the cutting step. It is possible that during the trimming phase the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is or are squeezed in a squeeze direction and the cutting is performed in transverse direction, in particular orthogonally, to the squeeze direction. In this way, the cutting might be optimized and simplified. Due to squeezing of the tubes 7, the cross section of the respective tube 7 comprises temporarily a short and a long side, whereat cutting may be simplified by cutting along the long side.

[0135] In Fig. 3c) the cutting step of the trimming phase is exemplarily shown in the preferred embodiment. The heated blade 29a cuts the tube 7 of the cartridge 5 and the tube 7 of the container 12 at least partly simultaneously. During the cutting step, the tube 7 of the cartridge 5 and the tube 7 of the container 12 are generally opened one-sided, but the blade 29a blocks the openings of the tubes 7 towards the surrounding atmosphere. As a result, contamination can be prevented, in particular because of the temperature of the blade 29a. Another example of the cutting step is exemplarily shown in Fig. 6c), wherein the blade 29a cuts through the tubes 7. As it can be seen and preferably, the tube cutting unit 29 comprises a cutting table 29d, which faces the blade 29a. The cutting table 29d may support the cutting process by the blade 29a.

[0136] Additionally or alternatively to the trimming phase, tube welding comprises the welding phase. During the welding phase the tube 7 of the cartridge 5 and the tube 7 of the container 12 are being brought in contact and merged together, preferably at the welding location, such that the tube connection is formed. The welding phase preferably follows the arrangement phase and / or the trimming phase. The welding phase, in particular, directly follows the trimming phase such that after cutting the tube 7 of the cartridge 5 and the tube 7 of the container 12 within the trimming phase, the tube 7 of the cartridge 5 and the tube 7 of the container 12 are contacted and merged together within the welding phase. Contacting and merging of the tubes 7 is preferably performed by at least one, preferably at least two, tube holder 20, which, for example, extrudes the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 such that these are contacted. The welding phase is exemplarily shown in Fig. 3d), 6c) und 6d). The formed tube connection 30 is shown in Fig. 6d).

[0137] It is possible that the tube connection is opened after welding is performed. The tube connection may be opened by an external force, which is applied at the tube connection on the outer surface of the tube 7 of the cartridge 5 and the tube 7 of the container 12.

[0138] It is furthermore preferred that the method comprises temporarily closing the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 before tube welding or before the welding phase is performed. The tube 7 of the cartridge 5 and / or the tube 7 of the container 12 might be closed by a clamp. It is preferred that after tube welding or after the welding phase is performed, an integrity testing routine for verifying the integrity of the tube connection is performed. This verification check makes it possible to determine if the tube connection, which was formed by welding, is intact or unsafe. Depending on the result of the integrity testing routine, if the integrity of the tube connection is verified, reversing the temporary closing of the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is performed. Then, the medium can be transferred through the tube connection. However, if the integrity of the tube connection 3 is not verified, initiating an emergency routine for preserving the cell culture(s) is performed. Here, the temporary closing is not reversed such that a contamination of the cell culture(s) via the unsafe tube connection can be prevented. The emergency routine might comprise reporting a notification to a user and / or initiating a disconnection routine and / or initiating another tube welding.

[0139] It is furthermore preferred that the bioprocessing system 1 , preferably the welding interface 19, in particular the weld robot 15, comprises a tube disconnection arrangement 31 . The bioprocessing system 1 , preferably the welding interface 19, in particular the weld robot 15, further in particular the tube disconnection arrangement 31 , preferably comprises a sealing unit 32 and / or a disconnecting unit 33.

[0140] In a further preferred embodiment, the method comprises a disconnection routine, wherein the tube 7 of the cartridge 5 and the tube 7 of the container 12 are disconnected. By the disconnection routine the tubes 7 may be fluidically and / or physically disconnected. “Fluidically disconnected” means that fluid cannot be transferred through the tubes 7, because, for example the tubes 7 are being sealed. “Physically disconnected” means that the tubes 7 are fully disconnected and might be handled, for example moved, independently from each other. The disconnection routine might be performed by the tube disconnection arrangement 31 .

[0141] It is preferred that the disconnection routine comprises a sealing phase, wherein the tube 7 of the cartridge 5 and / or the tube 7 of the container 12, which are in particular currently connected, is or are sealed such that a first sealing 35 and / or a second sealing 36 are formed. This is exemplarily depicted in Fig. 7. It is preferred that during the sealing phase, the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 are sealed by compression and heat. Here, the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is compressed, in particular transversely to the respective tube axis, and heated such that the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is partly melted and sealed, in particular self-sealed. The sealing phase might be performed by the tube disconnection arrangement 31 , in particular by a sealing unit 32 of the tube disconnection arrangement 31. The sealing unit 32 may comprise a sealing surface 45 for compressing and heating.

[0142] Advantageously, the disconnection routine comprises a disconnecting phase, wherein the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 are cut, in particular between the first sealing 35 and the second sealing 36. It is also possible, to cut the tube 7 of the cartridge 5 or the tube 7 of the container 12 in the range of the respective sealing 35, 36 itself. Thus, the tubes 7 are being physically disconnected. The disconnecting phase may be performed by the tube disconnection arrangement 31 , in particular by a disconnecting unit 33 of the tube disconnection arrangement 31 .

[0143] Fig. 7a), 7b), 7c) and 7d) show exemplarily the disconnection routine. Here and preferably, the tube 7 of the cartridge 5 and the tube 7 of the container 12 are physically and fluidically connected first, as depicted exemplarily in Fig. 7a). Preferably and, for example, shown in Fig. 7b), during the disconnection routine the tube 7 of the cartridge 5 and the tube 7 of the container 12 are sealed at least partly simultaneously by the sealing unit 32 of the tube disconnection arrangement. However, the sealings might be performed sequentially, namely one after another, too. The sealing unit 32 comprises two sealing surfaces 45, which compress the tubes 7 and are heated such that the tubes 7 are self-sealed, as exemplarily shown in Fig. 7c). As a result, the first sealing 35 and the second sealing 36 occur. After sealing of the tubes 7 in the sealing phase, the tubes 7 are being cut in the disconnecting phase by the disconnecting unit 33, in particular by a disconnecting blade 34, as also exemplarily shown in Fig. 7c). Preferably, the disconnecting blade 34 is heated to simplify the cutting. Here and preferably, the sealing phase is performed before the disconnecting phase. Alternatively, it is also possible that the sealing phase is performed after the disconnecting phase, for example if the disconnecting blade 34 cuts the tubes 7 and temporarily seals the resulting openings. Here and preferably, the disconnecting blade 34 cuts the tube 7 of the cartridge 5 and the tube 7 of the container 12 in a cutting plane, which is perpendicular to the axis of the tubes 7. The cutting plane may be transversely orientated to the sealing surfaces 45 and / or the first sealing 35 and / or the second sealing 36.

[0144] The sealing unit 32, in particular of a tube disconnection arrangement 31 , is provided for sealing the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 in a sealing phase such that a sealing 35, 36 is formed. The sealing unit 32 comprises at least one sealing surface 37, which is designed to crimp the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 along the axial direction of the respective tube 7 such that the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is or are self-sealed.

[0145] However, it is particularly preferred that the sealing unit 32 comprises a sealing surface 37, which is designed to crimp the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 along the axial direction of the respective tube 4, 5 such that the tube 7 of the cartridge 5 and / or the tube 7 of the container 12 is or are self-sealed, in particular if the sealing surface 37 is heated when the respective tube 4, 5 is crimped. An example for such an embodiment is shown in Fig. 8a), 8b).

[0146] Here and preferably, the sealing surface 37 comprise a crimp element 38, which is designed as a pin 39, in particular as an elongated pin 39. The elongated pin 39 is, as exemplarily shown in Fig. 8a), elongated in axial direction of the tube 7, which is going to be sealed. It is preferred that the sealing surface 37 forms a sealing which in cross section, in particular along the main axis of the sealed tube 7, is U-shaped, as it is depicted exemplarily in Fig. 8b). The cross sections may extend in axial direction of the tube 7 for at least the length of the original diameter of the sealed tube 7, preferably for at least two times the length of the original diameter of the sealed tube 7. It is furthermore possible that the cross section of the sealing comprises at least a subsection over an angular range of at least 180°, preferably at least 235°, wherein within the subsection the original diameter of the sealed tube 7 is maintained. As it can be seen in Fig. 8b) and preferably, the sealing, which is formed by the sealing surface 37, comprises a circumference with at least one inflection point, preferably at least two inflection points.

[0147] It is particularly preferred that the sealing surface 37 is a first sealing surface 40 and the sealing unit 32 comprises a second sealing surface 41 , which is designed to receive the tube 7 to be sealed. The second sealing surface 41 is designed correspondingly to the tube 4, 5 to be sealed. The second sealing surface 41 particularly comprises a cylindrical groove 42 to receive the respective tube 7. Here and preferably, the sealing unit 32 comprise four sealing surfaces, wherein a pair of sealing surfaces 40, 41 correspond to each other. Each pair of sealing surfaces 41 , 40 is arranged at either side of the cutting location 43, where cutting takes place. It is preferred that the crimp element 38 of one of the first sealing surfaces 40 aligns with the center of the groove 42 of the corresponding second sealing surface 41 such that the crimp element 38 compresses the tube 7 in the center and the tube 7 is compressed and sealed without changing the diameter of the tube 7.

[0148] Fig. 9 shows a further possible embodiment of a proposed bioprocessing system 1 . The bioprocessing system 1 of Fig. 9 in general corresponds to the bioprocessing systems 1 and / or methods for performing a bioprocess as described before. Therefore, all explanations given with regard to the bioprocessing systems 1 and / or methods for performing a bioprocess described before are fully applicable to the now described bioprocessing system 1 and / or now described method for performing a bioprocess, in particular using the following described bioprocessing system 1 , and vice versa. The bioprocessing system 1 shown in Fig. 9 preferably comprises a primary workstation 2, wherein for performing the bioprocess the bioprocessing system 1 performs a workflow, wherein the workflow comprises a plurality of unit operations performed by the primary workstation 2, wherein the primary workstation 2 comprises a unit operation interface 4, wherein the unit operations are performed by an interaction of the unit operation interface 4 with at least one cartridge 5, wherein the cartridge 5, optionally together with containers 12, placed at, in particular on, the unit operation interface 4 define a cartridge configuration 13, wherein the unit operation interface 4 comprises at least one active element 14 interacting with the at least one cartridge 5 to perform at least one unit operation of the plurality of unit operations.

[0149] The unit operation interface 4 and / or the welding interface 19 may comprise a, in particular mechanically, defined cartridge position 23 and preferably at least one, preferably at least two, in particular mechanically, defined container positions 24.

[0150] The primary workstation 1 , in particular the unit operation interface 4 and / or the welding interface 19, comprises one or more bioprocessing bases 44 and the defined cartridge position 23 and / or the defined container position 24 is, preferably at least during the first unit operation and / or the second unit operation, arranged at the one or more bioprocessing bases 44. Preferably it can be provided that the defined cartridge position 23 and / or the defined container position 24 are part of the one or more bioprocessing bases 44.

[0151] It can be provided that the one or more bioprocessing bases 44 respectively comprise at least one of the active elements 14. The one or more bioprocessing bases 44 can thus interact via the respective active element 14 with the cartridge 5 and / or container 12 to perform at least one unit operation of the plurality of unit operations, preferably the first unit operation 16 and / or the second unit operation 17. In this way the bioprocessing bases 44 can perform the first unit operation 16 and / or the second unit operation 17 itself. Alternatively or in addition another active element 14, preferably comprising the weld robot 15, can be used to interact with another cartridge and / or container and / or to interact with the cartridge 5 and / or container 12 provided on the one or more bioprocessing bases 44 to perform another unit operation than the active element of the respective one or more bioprocessing bases 44 and / or to perform tube welding. This can help to increase the speed of the bioprocess and / or to perform unit operations on different cartridge configurations 13 simultaneously. The respective active element 14 of the one or more bioprocessing bases 44 may comprise an active element 14 powering a functional element 8 of the cartridge 5 and / or the container 12 and / or may comprise an active element 14 directly interacting with the medium, preferably cell culture, contained in the cartridge 5 and / or container 12, for example by pumping the medium, preferably cell culture.

[0152] Preferably it can additionally or alternatively be provided that the one or more bioprocessing bases 44 are, preferably manually, movable, preferably moved, between a mounting position arranged in the primary workstation 2, preferably the unit operation interface 4 and / or the welding interface 19, and an external position arranged outside the primary workstation 2, preferably the unit operation inter-face 4 and / or the welding interface 19, preferably before and / or after the first unit operation 16 and / or before and / or after the second unit operation 17. In this way it is simplified that the cartridge configuration 13 is manually configured in a configuration step before and / or after the first unit operation 16 and / or the second unit operation 17 as the cartridge configuration 13 can for example be moved already configured into the primary workstation 2 on the one or more bioprocessing bases 44. Subsequently the first unit operation 16 and the second unit operation 17 can be performed, preferably on and / or using the one or more bioprocessing bases 44. Moreover, this simplifies performing the first unit operation 16 and / or the second unit operation 17 without a reconfiguration step as the cartridge configuration 13 can be moved by means of the movable one or more bioprocessing bases 44, preferably after the first unit operation 16, to another area of the unit operation interface 4 and / or another active element 14 to perform another unit operation, preferably the second unit operation 17. Movable bioprocessing bases 44 also simplify cleaning of the bio processing system 1 .

[0153] In case that the first unit operation 16 and the second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4, preferably with the same cartridge configuration 13, wherein before and / or after the first and the second unit operation 16, 17 the cartridge configuration 13 is manually configured in a configuration step, wherein the manual configuration in the configuration step is supported by the bioprocessing system 1 , is performed inside the bioprocessing system 1 and / or is performed outside the bioprocessing system 1 , it can preferably be provided that no reconfiguration step is performed between the first unit operation 16 and second unit operation 17. This is in particular expedient when the first unit operation 16 and the second unit operation 17 can be performed with the same cartridge configuration 13. In this case, however, the cartridge configuration 13 can be moved by means of the movable one or more bioprocessing bases 44, preferably after the first unit operation 16, to another area of the unit operation interface 4 and / or another active element 14 to perform the second unit operation 17.

[0154] Preferably it can additionally or alternatively be provided that the cartridge 5 and / or the container 12 are, preferably manually, movable, preferably moved, between a holding position arranged on at least one bioprocessing base 44 of the one or more bioprocessing bases 44, the defined cartridge position 23 and / or the defined container position 24 and a release position spaced apart from the at least one bioprocessing base 44 of the one or more bioprocessing bases 44, the defined cartridge position 23 and / or the defined container position 24, preferably before and / or after the first unit operation 16 and / or before and / or after the second unit operation 17. In this way the cartridge 5 and / or container 12 can be easily connected to and / or disconnected from the one or more bioprocessing bases 44. This also can be used for providing the cartridge 5 and the container on different bioprocessing bases 44 and / or for more easily cleaning the one or more bioprocessing bases 44.

[0155] In the bioprocessing system 1 shown in Fig. 9 at least one active element 14, which may comprise the weld robot 15, can be arranged spaced apart from, preferably above, the one or more bioprocessing bases 44. This, in particular spaced apart, active element 14 may be movable arranged in the bioprocessing system 1 , preferably relative to the cartridge 5, the container 12, the defined cartridge position 23 and / or the defined container position 24. This simplifies a more flexible use of the respective active element 14. Preferably, this, in particular spaced apart, active element 14 is moved relative to the cartridge 5, the container 12, the defined cartridge position 23 and / or the defined container positions 24 before, during and / or after the first unit operation 16 and / or the second unit operation 17.

[0156] Preferably it can be provided that the first unit operation 16 and the second unit operation 17 are performed by the same or different active elements 14. By using the same active element, a simpler and / or more compact bioprocessing system 1 can be used. Using different active elements 14 can increase the speed of the bioprocess.

[0157] Preferably it can additionally or alternatively be provided that the first unit operation 16 and the second unit operation 17 are different or the same unit operations 16, 17, preferably different unit operations 16, 17 from the list comprising enrichment, selection, activation, loading, genetic modification, expansion, formulation and fill, wash and / or separation.

[0158] Preferably it can additionally or alternatively be provided that a further cartridge configuration is provided in the bioprocessing system 1 , preferably the primary workstation 2, in particular the unit operation interface 4 and / or the welding interface 19, and that, preferably by the unit operation interface 4, the first unit operation 16 is performed on the further cartridge configuration, preferably while the first unit operation 16 is performed on the cartridge configuration 13, and / or the second unit operation 17 is performed on the further cartridge configuration, preferably while the second unit operation 17 is performed on the cartridge configuration 13. The first unit operation 16 and / or the second unit operation 17 on the cartridge configuration 13 and on the further cartridge configuration 13 can be performed by at least one active element 14 of the one or more bioprocessing bases 44. Preferably the cartridge configuration 13 and the further cartridge configuration are provided at least in sections on different bioprocessing bases 44 and the respective first unit operation 16 and / or second unit operation 17 are performed by the respective active elements 14 of the, in particular different, bioprocessing bases 44 on which the cartridge configuration 13 and the further cartridge configuration are respectively arranged. In this way on multiple cartridge configurations a unit operation 16, 17 can be performed at the same time. At least of the bioprocessing bases 44 shown in Fig. 9 can for example comprise the further cartridge configuration. As with the cartridge configuration 13 it can be provide that the a first unit operation 16 and the second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4 with different further cartridge configurations, wherein between the first and the second unit operation 16, 17 the further cartridge configuration 13 is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system 1 and / or that the first unit operation 16 and the second unit operation 17 of the plurality of unit operations are performed by the unit operation interface 4, preferably with the same further cartridge configuration 13, wherein before and / or after the first and the second unit operation 16, 17 the further cartridge configuration 13 is manually configured in a configuration step, wherein the manual configuration in the configuration step is supported by the bioprocessing system 1 , is performed inside the bioprocessing system 1 and / or is performed outside the bioprocessing system 1 .

[0159] Preferably it can additionally or alternatively be provided that in the first unit operation 16 the cartridge 5 of the cartridge configuration 13 is provided in a different defined cartridge position 23 and / or on a different bioprocessing base 44 of the one or more bioprocessing bases 44 than in the second unit operation 17. This can for example be used to perform the first unit operation 16 and the second unit operation 17 without the need for reconfiguration.

[0160] Preferably it can additionally or alternatively be provided that in the first unit operation 16 the container 12 of the cartridge configuration 13 is provided in a different defined container position 24 and / or on a different bioprocessing base 44 of the one or more bioprocessing bases 44 than in the second unit operation 17. This can for example be used to perform the first unit operation 16 and the second unit operation 17 without the need for reconfiguration.

[0161] Preferably it can additionally or alternatively be provided that multiple cartridge configurations 13 are provided in the primary workstation 2, in particular the unit operation interface 4 and / or the welding interface 19, simultaneously and that the first unit operation 16 and / or the second unit operation 17 are performed respectively, preferably at least in sections simultaneously, on the multiple cartridge configurations 13. This simplifies conducting several bioprocess simultaneously. In the bioprocessing station 1 shown in Fig. 9 the storage locations 25 and the primary workstation 2 may be arranged within the same bioprocessing station housing. In this way a more compact design is achieved, which design simplifies movement of the containers 12, in particular incubation containers 12, from the storage locations 25 to the primary workstation 2.

[0162] As shown in Fig. 9 the bioprocessing system 1 may comprise a handling device 46 for moving a container 12, preferably an incubation container 12, between a storage location 25 and the primary workstation 2, in particular the unit operation interface 4 and / or the welding interface 19. In this way the container 12, preferably an incubation container 12, can be moved at least partially, preferably fully, automatic from the respective storage location 25 to the primary workstation 2, thus simplifying and / or speeding up the process for a user.

[0163] As shown in Fig. 10a to 10b the storage location 25 and / or a container 12, preferably an incubation container 12, may comprise a power interface 47, 47’ for transferring power between the bioprocessing system 1 and the respective connected container 12, a data interface 48, 48’ for transferring data between the bioprocessing system 1 and the respective connected container 12 and / or a fluid interface 49, 49’ for transferring at least one fluid between the bioprocessing system 1 and the respective connected container 12. This simplifies providing data, power and / or a fluid, in particular between a storage location 25 and a container 12, preferably an incubation container 12, arranged in the respective storage location 25. The respective connected container 12 is preferably the container, preferably an incubation container 12, arranged in the respective storage location 25.

[0164] In the shown embodiment in Fig. 10a the back side of an incubation container 12 is shown, however, the one or more interfaces 47, 48, 49 can also be arranged on another side of the incubation container 12. In Fig. 10b the inside of a storage location 25 is shown, which storage location comprises on the back side the interfaces 47’, 48’, 49’ of the storage location 25 for interfacing with the interfaces of the incubation container 12.

[0165] Fig. 11 shows a detail of a cartridge 5. The cartridge 5 is intended to be arranged on a bioprocessing base 44, thus the cartridge 5 is shown in the release position. The shown bioprocessing base 44 can comprise several active elements 14. One of the active elements 14 comprises a pumping element 50 for pumping fluid through a tube 7 of the cartridge 5, here the pumping element 50 is in the form of a peristaltic pump head. In addition, the bioprocessing base can comprise active elements 14 in the form of one or more interface elements 51 , here two interface elements 51 . The one or more interface elements 51 can comprise a device for agitating a cartridge 5 and / or container 12 provided on the respective interface element 51 , a device for weighing a cartridge 5 and / or container 12 provided on the respective interface element 51 and / or a device for heating and / or cooling a cartridge 5 and / or container 12 provided on the respective interface element 51 . In this way a unit operation and / or another operation can be performed by one or more active elements 14 of the bioprocessing system, preferably the workstation, in particular the bioprocessing base 44, and, preferably, also at the same time by the active element 14 movable arranged in the bioprocessing system 1 , preferably relative to the cartridge 5, the container 12, the defined cartridge position 23 and / or the defined container position 24. The defined cartridge position 23 and / or the defined container position 24 can be respectively provided on at least one interface element 51 of the one or more interface elements 51 .

[0166] Further embodiments of the present disclosure

[0167] The following embodiments provide further advantages of the present disclosure:

[0168] 1 . Method for performing a bioprocess on immune or naive cell cultures to obtain processed cell cultures on a semi-automated bioprocessing system (1 ), wherein the bioprocessing system (1 ) comprises a primary workstation (2), wherein for performing the bioprocess the bioprocessing system (1 ) performs a workflow, wherein the workflow comprises a plurality of unit operations performed by the primary workstation (2), wherein the primary workstation (2) comprises a unit operation interface (4), wherein the unit operations are performed by an interaction of the unit operation interface (4) with at least one cartridge (5), wherein the cartridge (5), optionally together with containers (12), placed at, in particular on, the unit operation interface (4) define a cartridge configuration (13), wherein the unit operation interface (4) comprises at least one active element (14) interacting with the at least one cartridge (5) to perform at least one unit operation of the plurality of unit operations, wherein a first unit operation (16) and a second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4) with different cartridge configurations (13), wherein between the first and the second unit operation (16, 17) the cartridge configuration (13) is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system (1 ).

[0169] 2. Method according to embodiment 1 , characterized in that the same active element (14) interacts with the differently configured cartridges (5) to perform the first and the second unit operation (16, 17), and / or, that the active element (14) transfers mechanical energy to the cartridge (5) to perform the first and / or the second unit operation (16, 17).

[0170] 3. Method according to embodiment 1 or 2, characterized in that a container (12) is placed at, in particular on, the unit operation interface (4) and fluidically connected to the cartridge (5) during at least one of the plurality of unit operations, preferably, that the unit operation interface (4), in particular via the active element (14), pumps a liquid between the cartridge (5) and the container (12), more preferably, that the cartridge (5) and / or the container (12) comprises a pump head, and, that the active element (14) is a drive element for the pump head.

[0171] 4. Method according to embodiment 3, characterized in that the primary workstation (2) comprises a welding interface (19) with a weld robot (15), that the weld robot (15) performs tube welding fluidically connecting and / or disconnecting the cartridge (5) to and / or from at least one container (12), preferably, that the weld robot (15) automatically grabs a tube (7) of the cartridge (5) and a tube (7) of the container (12) and automatically welds the tubes (7) together.

[0172] 5. Method according to embodiment 4, characterized in that the unit operation interface (4) and the welding interface (19) are the same interface, or, that the unit operation interface (4) and the welding interface (19) are different and preferably distant from each other, preferably, that the bioprocessing system (1 ) automatically transports the cartridge (5) and preferably the container (12) or containers (12) between the unit operation interface (4) and the welding interface (19), or, that the bioprocessing system (1 ) does not automatically transport the cartridge (5) and the container (12) or containers (12) between the unit operation interface (4) and the welding interface (19), and, that the cartridge (5) and preferably the container (12) or containers (12) are manually transported between the unit operation interface (4) and the welding interface (19).

[0173] 6. Method according to one of the preceding embodiments, characterized in that the first and the second unit operations (16, 17) are performed with, in particular partially or completely within, the same cartridge (5), preferably after a manual reconfiguration of the cartridge (5) and / or after a connection of the cartridge (5) to at least one container (12).

[0174] 7. Method according to one of the preceding embodiments, characterized in that the unit operation interface (4) and / or the welding interface (19) comprise a, in particular mechanically, defined cartridge position (23) and preferably at least one, preferably at least two, in particular mechanically, defined container positions (24), preferably, that the weld robot (15) uses the defined cartridge position (23) and container positions (24) to detect the positions of the tubes (7).

[0175] 8. Method according to one of the preceding embodiments, characterized in that in the reconfiguration step the bioprocessing system (1 ) visually indicates to a user how to perform the reconfiguration, in particular by indicating which cartridge (5) to reconfigure and / or which container (12) to reconfigure and / or which cartridge (5) to remove and / or where to place a cartridge (5) and / or which container (12) to remove and / or where to place a container (12), and / or, that in the reconfiguration step the bioprocessing system (1 ) detects a correct reconfiguration of the cartridge configuration (13), in particular by detecting the presence of the correct cartridge (5) and / or container (12) after reconfiguration at the correct position and / or the correct reconfiguration of the cartridge (5).

[0176] 9. Method according to one of the preceding embodiments, characterized in that the bioprocessing system (1 ) comprises a storage location (25) for containers (12), in particular incubation containers (12), containing the cell cultures, that the bioprocessing system (1 ) indicates to a user which container (12) to remove from the storage location (25) and place at the unit operation interface (4) and / or which container (12) to remove from the unit operation interface (4) and place at the storage location (25) and verifies the correct transfer of the container (12).

[0177] 10. Method according to embodiment 9, characterized in that for performing the first unit operation (16) the user places a container (12) from the storage location (25) at a defined container position (24) of the primary workstation (2), that the bioprocessing system (1 ) identifies the placement of the correct container (12) at the correct defined container position (24), that the user places at least one cartridge (5) at a defined cartridge position (23) of the primary workstation (2), that afterwards the weld robot (15) performs tube welding to fluidically connect the cartridge (5) and the container (12), that afterwards the primary workstation (2) performs the first unit operation (16) with the cartridge (5), preferably, that afterwards the weld robot (15) fluidically disconnects the cartridge (5) and the container (12).

[0178] 11 . Method according to embodiment 10, characterized in that no user action is required while performing the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12), preferably, that the bioprocessing system (1 ) detects a user action during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12), more preferably, that the bioprocessing system (1 ) performs an abort procedure if the user action is detected during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12).

[0179] 12. Method according to one of embodiments 4 to 11 , characterized in that the primary workstation (2) pumps the cell culture from the cartridge (5) used in the first unit operation (16) into a container (12) fluidically connected to the cartridge (5), that the weld robot (15) disconnects the cartridge (5) and the container (12), that the user replaces the cartridge (5) guided by the bioprocessing system (1 ) with a differently configured new cartridge (5), optionally that the bioprocessing system (1 ) verifies that the correct new cartridge (5) was placed at the correct position, that the weld robot (15) connects the new cartridge (5) to the container (12) containing the cell culture, that the primary workstation (2) pumps the cell culture from the container (12) into the new cartridge (5) and performs the second unit operation (17) with the second cartridge (5).

[0180] 13. Bioprocessing system for performing a bioprocess on immune or naive cell cultures to obtain processed cell cultures on a semi-automated bioprocessing system (1 ), wherein the bioprocessing system (1 ) comprises a primary workstation (2), wherein for performing the bioprocess the bioprocessing system (1 ) performs a workflow, wherein the workflow comprises a plurality of unit operations performed by the primary workstation (2), wherein the primary workstation (2) comprises a unit operation interface (4), wherein the unit operations are performed by an interaction of the unit operation interface (4) with at least one cartridge (5), wherein the cartridge (5), optionally together with containers (12), placed at, in particular on, the unit operation interface (4) define a cartridge configuration (13), wherein the unit operation interface (4) comprises at least one active element (14) interacting with the at least one cartridge (5) to perform at least one unit operation of the plurality of unit operations, wherein a first unit operation (16) and a second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4) with different cartridge configurations (13), wherein between the first and the second unit operation (16, 17) the cartridge configuration (13) is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system (1 ).

[0181] 14. Method for performing a further iteration of the bioprocess performed according to the method of one of embodiments 1 to 12 as a previous iteration on an automated, in particular fully automated, further bioprocessing system (26), wherein the further bioprocessing system (26) comprises a further primary workstation (27), wherein for performing the bioprocess the further bioprocessing system (26) performs the workflow, wherein the plurality of unit operations are performed by the further primary workstation (27), wherein the further primary workstation (27) comprises a further unit operation interface (28), wherein the unit operations are performed by an interaction of the further unit operation interface (28) with at least one cartridge (5), wherein the cartridge (5), optionally together with containers (12), placed at, in particular on, the further unit operation interface (28) define a cartridge configuration (13), wherein the further unit operation interface (28) comprises at least one active element (14) interacting with the at least one cartridge (5) to perform at least one unit operation of the plurality of unit operations, wherein a first unit operation (16) and a second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4) with different cartridge configurations (13), wherein between the first and the second unit operation (16, 17) the cartridge configuration (13) is reconfigured in a reconfiguration step, wherein the reconfiguration in the reconfiguration step is performed at least partially, in particular fully, automatically. 15. Method according to embodiment 14, characterized in that some or all user actions necessary for the previous iteration are automated in the further iteration, and / or, that the reconfiguration is at least partially done by robotic transfer of the cartridge (5) and / or container (12).

Claims

Claims1. Method for performing a bioprocess on immune or naive cell culture(s) to obtain processed cell culture(s) on a semi-automated bioprocessing system (1 ), wherein the bioprocessing system (1 ) comprises a primary workstation (2), wherein for performing the bioprocess the bioprocessing system (1 ) performs a workflow, wherein the workflow comprises a plurality of unit operations performed by the primary workstation (2), wherein the primary workstation (2) comprises a unit operation interface (4), wherein the unit operations are performed by an interaction of the unit operation interface (4) with at least one cartridge (5), wherein the cartridge (5), optionally together with containers (12), placed at, in particular on, the unit operation interface (4) define a cartridge configuration (13), wherein the unit operation interface (4) comprises at least one active element (14) interacting with the at least one cartridge (5) to perform at least one unit operation of the plurality of unit operations, characterized in that a first unit operation (16) and a second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4) with different cartridge configurations (13), wherein between the first and the second unit operation (16, 17) the cartridge configuration (13) is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system (1 ) and / or in that the first unit operation (16) and the second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4), preferably with the same cartridge configuration (13), wherein before and / or after the first and the second unit operation (16, 17) the cartridge configuration(13) is manually configured in a configuration step, wherein the manual configuration in the configuration step is supported by the bioprocessing system (1 ), is performed inside the bioprocessing system (1 ) and / or is performed outside the bioprocessing system (1 ).

2. Method according to claim 1 , characterized in that the same active element(14) interacts with the differently configured cartridges (5) to perform the first and the second unit operation (16, 17), and / or, that the active element (14)transfers mechanical energy to the cartridge (5) to perform the first and / or the second unit operation (16, 17).

3. Method according to claim 1 or 2, characterized in that a container (12) is placed at, in particular on, the unit operation interface (4) and fluidically connected to the cartridge (5) during at least one of the plurality of unit operations, preferably, that the unit operation interface (4), in particular via the active element (14), pumps a liquid between the cartridge (5) and the container (12), more preferably, that the cartridge (5) and / or the container (12) comprises a pump head, and, that the active element (14) is a drive element for the pump head.

4. Method according to claim 3, characterized in that the primary workstation (2) comprises a welding interface (19) with a weld robot (15), that the weld robot (15) performs tube welding fluidically connecting and / or disconnecting the cartridge (5) to and / or from at least one container (12), preferably, that the weld robot (15) automatically grabs a tube (7) of the cartridge (5) and a tube (7) of the container (12) and automatically welds the tubes (7) together.

5. Method according to claim 4, characterized in that the unit operation interface (4) and the welding interface (19) are the same interface, or, that the unit operation interface (4) and the welding interface (19) are different and preferably distant from each other, preferably, that the bioprocessing system (1 ) automatically transports the cartridge (5) and preferably the container (12) or containers (12) between the unit operation interface (4) and the welding interface (19), or, that the bioprocessing system (1 ) does not automatically transport the cartridge (5) and the container (12) or containers (12) between the unit operation interface (4) and the welding interface (19), and, that the cartridge (5) and preferably the container (12) or containers (12) are manually transported between the unit operation interface (4) and the welding interface (19).

6. Method according to one of the preceding claims, characterized in that the first and the second unit operations (16, 17) are performed with, in particular partially or completely within, the same cartridge (5), preferably after a manualreconfiguration of the cartridge (5) and / or after a connection of the cartridge (5) to at least one container (12).

7. Method according to one of the preceding claims, characterized in that the unit operation interface (4) and / or the welding interface (19) comprise a, in particular mechanically, defined cartridge position (23) and preferably at least one, preferably at least two, in particular mechanically, defined container positions (24), preferably, that the weld robot (15) uses the defined cartridge position (23) and container positions (24) to detect the positions of the tubes (7).

8. Method according to one of the preceding claims, characterized in that in the reconfiguration step the bioprocessing system (1 ) visually indicates to a user how to perform the reconfiguration, in particular by indicating which cartridge (5) to reconfigure and / or which container (12) to reconfigure and / or which cartridge (5) to remove and / or where to place a cartridge (5) and / or which container (12) to remove and / or where to place a container (12), and / or, that in the reconfiguration step the bioprocessing system (1 ) detects a correct reconfiguration of the cartridge configuration (13), in particular by detecting the presence of the correct cartridge (5) and / or container (12) after reconfiguration at the correct position and / or the correct reconfiguration of the cartridge (5).

9. Method according to one of the preceding claims, characterized in that the bioprocessing system (1 ) comprises a storage location (25) for containers (12), in particular incubation containers (12), containing the cell culture(s), that the bioprocessing system (1 ) indicates to a user which container (12) to remove from the storage location (25) and place at the unit operation interface (4) and / or which container (12) to remove from the unit operation interface (4) and place at the storage location (25) and verifies the correct transfer of the container (12).

10. Method according to claim 9, characterized in that for performing the first unit operation (16) the user places a container (12) from the storage location (25) at a defined container position (24) of the primary workstation (2), that the bioprocessing system (1 ) identifies the placement of the correct container (12) at the correct defined container position (24), that the user places at least one cartridge (5) at a defined cartridge position (23) of the primary workstation (2),that afterwards the weld robot (15) performs tube welding to fluidically connect the cartridge (5) and the container (12), that afterwards the primary workstation (2) performs the first unit operation (16) with the cartridge (5), preferably, that afterwards the weld robot (15) fluidically disconnects the cartridge (5) and the container (12).

11. Method according to claim 10, characterized in that no user action is required while performing the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12), preferably, that the bioprocessing system (1 ) detects a user action during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12), more preferably, that the bioprocessing system (1 ) performs an abort procedure if the user action is detected during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12).

12. Method according to one of claims 4 to 11 , characterized in that the primary workstation (2) pumps the cell culture from the cartridge (5) used in the first unit operation (16) into a container (12) fluidically connected to the cartridge (5), that the weld robot (15) disconnects the cartridge (5) and the container (12), that the user replaces the cartridge (5) guided by the bioprocessing system (1 ) with a differently configured new cartridge (5), optionally that the bioprocessing system (1 ) verifies that the correct new cartridge (5) was placed at the correct position, that the weld robot (15) connects the new cartridge (5) to the container (12) containing the cell culture, that the primary workstation (2) pumps the cell culture from the container (12) into the new cartridge (5) and performs the second unit operation (17) with the second cartridge (5).

13. Method according to one of the preceding claims, characterized in that in the configuration step the bioprocessing system (1 ) visually indicates to a user how to perform the configuration, in particular by indicating which cartridge (5) to configure and / or which container (12) to configure and / or which cartridge (5) to remove and / or where to place a cartridge (5) and / or which container (12) to remove and / or where to place a container (12), and / or, that in the configuration step the bioprocessing system (1 ) detects a correct configuration of the cartridge configuration (13), in particular by detecting the presence of the correctcartridge (5) and / or container (12) after configuration at the correct position and / or the correct configuration of the cartridge (5).

14. Method according to one of the preceding claims, characterized in that the bioprocessing system (1 ), preferably the primary workstation (2), in particular the unit operation interface (4) and / or the welding interface (19), comprises one or more bioprocessing bases (44), that the defined cartridge position (23) and / or the defined container position (24) is, preferably at least during the first unit operation and / or the second unit operation, arranged at the one or more bioprocessing bases (44) and in that, preferably,- the one or more bioprocessing bases respectively comprise at least one of the active elements (14),- the one or more bioprocessing bases (44) interact with the cartridge (5) and / or container (12) to perform at least one unit operation of the plurality of unit operations, preferably the first unit operation (16) and / or the second unit operation (17),- the one or more bioprocessing bases (44) are, preferably manually, movable, preferably moved, between a mounting position arranged in the primary workstation (2), preferably the unit operation interface (4) and / or the welding interface (19), and an external position arranged outside the primary workstation (2), preferably the unit operation interface (4) and / or the welding interface (19), preferably before and / or after the first unit operation (16) and / or before and / or after the second unit operation (17), and / or- the cartridge (5) and / or the container (12) are, preferably manually, movable, preferably moved, between a holding position arranged on at least one bioprocessing base (44) of the one or more bioprocessing bases (44), the defined cartridge position (23) and / or the defined container position (24) and a release position spaced apart from the at least one bioprocessing base (44) of the one or more bioprocessing bases (44), the defined cartridge position (23) and / or the defined container position (24), preferably before and / or after the first unit operation (16) and / or before and / or after the second unit operation (17).

15. Method according to one of the preceding claims, characterized in that- the first unit operation (16) and the second unit operation (17) are performed by the same or different active elements (14),- that the first unit operation (16) and the second unit operation (17) are different or the same unit operations (16, 17), preferably different unit operations (16, 17) from the list comprising enrichment, selection, activation, loading, genetic modification, expansion, formulation and fill, wash and / or separation,- that a further cartridge configuration is provided in the bioprocessing system (1 ), preferably the primary workstation (2), in particular the unit operation interface (4) and / or the welding interface (19), and, preferably by the unit operation interface (4), the first unit operation (16) is performed on the further cartridge configuration, preferably while the first unit operation (16) is performed on the cartridge configuration (13), and / or the second unit operation (17) is performed on the further cartridge configuration, preferably while the second unit operation (17) is performed on the cartridge configuration (13),- that in the first unit operation (16) the cartridge (5) of the cartridge configuration (13) is provided in a different defined cartridge position (23) and / or on a different bioprocessing base (44) of the one or more bioprocessing bases (44) than in the second unit operation (17),- that in the first unit operation (16) the container (12) of the cartridge configuration (13) is provided in a different defined container position (24) and / or on a different bioprocessing base (44) of the one or more bioprocessing bases (44) than in the second unit operation (17) and / or- that multiple cartridge configurations (13) are provided in the primary workstation (2), in particular the unit operation interface (4) and / or the welding interface (19), simultaneously and that the first unit operation (16) and / or the second unit operation (17) are performed respectively, preferably at least in sections simultaneously, on the multiple cartridge configurations (13).

16. Method according to one of claims 4 to 15, characterized in that- the weld robot (15) is movable arranged in the bioprocessing system (1 ), preferably relative to the cartridge (5), the container (12), the defined cartridge position (23) and / or the defined container position (24) and, preferably, is moved relative to the cartridge (5), the container(12), the defined cartridge position (23) and / or the defined container position (24) before, during and / or after the first unit operation (16) and / or the second unit operation (17),- that tube welding comprises an arrangement phase, wherein the tube (7) of the cartridge (5) and the tube (7) of the container (12) are being arranged relatively to each other, preferably at least in an axial direction of the tube (7) of the cartridge (5) and / or the tube (7) of the container (12),- that tube welding comprises a trimming phase, wherein the tube (7) of the cartridge (5) and the tube (7) of the container (12) are being cut and / or- that tube welding comprises a welding phase, wherein the tube (7) of the cartridge (5) and the tube (7) of the container (12) are being brought in contact and merged together such that a tube connection is formed.

17. Method according to one of claims 4 to 16, characterized in that the welding interface (19), preferably the weld robot (15), comprises a tube cutting unit (29), that the tube cutting unit (29) comprises a blade (29a) and preferably a blade heater (29c) and in that, preferably,- the trimming phase comprises a heating step, wherein during the heating step the blade heater (29c) heats the blade (29a) to a cutting temperature,- the trimming phase comprises an alignment step, wherein the tube cutting unit (29) is aligned relatively to the tube (7) of the cartridge (5), in particular being in a first cutting position, and / or the tube (7) of the container (12), in particular being in a second cutting position, and / or- the trimming phase comprises a cutting step, wherein the tube (7) of the cartridge (5), in particular being in the first cutting position, and / or the tube (7) of the container (12), in particular being in the second cutting position, is or are being cut by the tube cutting unit (29), in particular by the blade (29a).

18. Method according to one of claims 4 to 17, characterized in that the welding interface (19), preferably the weld robot (15), comprises a tube disconnection arrangement (31 ), preferably that the tube disconnectionarrangement (14) comprises a sealing unit (32) and / or a disconnecting unit (33), further preferably, that the method comprises a disconnection routine, wherein the tube (7) of the cartridge (5) and the tube (7) of the container (12) are disconnected, further preferably in that the disconnection routine comprises a sealing phase, wherein the tube (7) of the cartridge (5) and / or the tube (7) of the container (12) are sealed by the sealing unit (32) such that a first sealing (35) at the tube (7) of the cartridge (5) and / or a second sealing (36) at the tube (7) of the container (12) are formed, and / or a disconnecting phase, wherein the tube (7) of the cartridge (5) and the tube (7) of the container (12) are cut by the tube disconnecting unit (33), in particular between the first sealing (35) and the second sealing (36).

19. Method according to one of claims 4 to 18, characterized in that the method comprises temporarily closing the tube (7) of the cartridge (5) and / or the tube (7) of the container (12) before tube welding or before the welding phase is performed, performing an integrity testing routine for verifying the integrity of the tube connection after tube welding or after the welding phase is performed and depending on the result of the integrity testing routine, if the integrity of the tube connection is verified, reversing the temporary closing of the tube (7) of the cartridge (5) and / or the tube (7) of the container (12), and if the integrity of the tube connection is not verified, initiating a emergency routine for preserving the cell culture(s).

20. Bioprocessing system for performing a bioprocess on immune or naive cell culture(s) to obtain processed cell culture(s) on a semi-automated bioprocessing system (1 ), wherein the bioprocessing system (1 ) comprises a primary workstation (2), wherein for performing the bioprocess the bioprocessing system (1 ) performs a workflow, wherein the workflow comprises a plurality of unit operations performed by the primary workstation (2), wherein the primary workstation (2) comprises a unit operation interface (4), wherein the unit operations are performed by an interaction of the unit operation interface (4) with at least one cartridge (5), wherein the cartridge (5), optionally together with containers (12), placed at, in particular on, the unit operation interface (4) define a cartridge configuration (13), wherein the unit operation interface (4) comprises at least one active element (14) interacting withthe at least one cartridge (5) to perform at least one unit operation of the plurality of unit operations, characterized in that a first unit operation (16) and a second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4) with different cartridge configurations (13), wherein between the first and the second unit operation (16, 17) the cartridge configuration (13) is manually reconfigured in a reconfiguration step, wherein the manual reconfiguration in the reconfiguration step is supported by the bioprocessing system (1 ) and / or in that the first unit operation (16) and the second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4), preferably with the same cartridge configuration (13), wherein before and / or after the first and the second unit operation (16, 17) the cartridge configuration (13) is manually configured in a configuration step, wherein the manual configuration in the configuration step is supported by the bioprocessing system (1 ), is performed inside the bioprocessing system (1 ) and / or is performed outside the bioprocessing system (1 ).

21. Bioprocessing system according to claim 20, characterized in that the same active element (14) is configured to interact with the differently configured cartridges (5) to perform the first and the second unit operation (16, 17), and / or, that the active element (14) is configured to transfer mechanical energy to the cartridge (5) to perform the first and / or the second unit operation (16, 17).

22. Bioprocessing system according to claim 20 or 21 , characterized in that the unit operation interface (4), in particular via the active element (14), is configured to pump a liquid between the cartridge (5) and the container (12), more preferably, that the cartridge (5) and / or the container (12) comprises a pump head, and, that the active element (14) is a drive element for the pump head.

23. Bioprocessing system according to one of claims 20 to 22, characterized in that the primary workstation (2) comprises a welding interface (19) with a weld robot (15), that the weld robot (15) is configured to perform tube welding fluidically connecting and / or disconnecting the cartridge (5) to and / or from at least one container (12), preferably, that the weld robot (15) is configured toautomatically grab a tube (7) of the cartridge (5) and a tube (7) of the container (12) and to automatically weld the tubes (7) together.

24. Bioprocessing system according to one of claim 23, characterized in that- the unit operation interface (4) and the welding interface (19) are the same interface or the unit operation interface (4) and the welding interface (19) are different and preferably distant from each other and,- preferably, that the bioprocessing system (1 ) is configured to automatically transport the cartridge (5) and preferably the container (12) or containers (12) between the unit operation interface (4) and the welding interface (19), or, that the bioprocessing system (1 ) is not configured to automatically transport the cartridge (5) and the container (12) or containers (12) between the unit operation interface (4) and the welding interface (19), and the cartridge (5) and preferably the container (12) or containers (12) are manually transported between the unit operation interface (4) and the welding interface (19).

25. Bioprocessing system according to one of claims 20 to 24, characterized in that the unit operation interface (4) and / or the welding interface (19) comprise a, in particular mechanically, defined cartridge position (23) and preferably at least one, preferably at least two, in particular mechanically, defined container position (24), preferably, that the weld robot (15) uses the defined cartridge position (23) and container position (24) to detect the positions of the tubes (7).

26. Bioprocessing system according to one of claims 20 to 25, characterized in that the bioprocessing system (1 ) is configured to visually indicate in the reconfiguration step to a user how to perform the reconfiguration, in particular by indicating which cartridge (5) to reconfigure and / or which container (12) to reconfigure and / or which cartridge (5) to remove and / or where to place a cartridge (5) and / or which container (12) to remove and / or where to place a container (12), and / or, that in the reconfiguration step the bioprocessing system (1 ) is configured to detect a correct reconfiguration of the cartridge configuration (13), in particular by detecting the presence of the correct cartridge (5) and / or container (12) after reconfiguration at the correct position and / or the correct reconfiguration of the cartridge (5).

27. Bioprocessing system according to one of claims 20 to 26, characterized in that the bioprocessing system (1 ) is configured to visually indicate in the configuration step to a user how to perform the configuration, in particular by indicating which cartridge (5) to configure and / or which container (12) to configure and / or which cartridge (5) to remove and / or where to place a cartridge (5) and / or which container (12) to remove and / or where to place a container (12), and / or, that in the configuration step the bioprocessing system (1 ) is configured to detect a correct configuration of the cartridge configuration (13), in particular by detecting the presence of the correct cartridge (5) and / or container (12) after configuration at the correct position and / or the correct configuration of the cartridge (5).

28. Bioprocessing system according to one of claims 20 to 27, characterized in that the bioprocessing system (1 ) comprises a storage location (25) for containers (12), in particular incubation containers (12), containing the cell culture^), and that, preferably,- the bioprocessing system (1 ) indicates to a user which container (12) to remove from the storage location (25) and place at the unit operation interface (4) and / or which container (12) to remove from the unit operation interface (4) and place at the storage location (25) and verifies the correct transfer of the container (12),- the bioprocessing system (1 ) comprises a handling device (46) for moving a container, preferably an incubation container, between the storage location (25) and the primary workstation (2), in particular the unit operation interface (4) and / or the welding interface (19), and / or- the storage location (25) and / or a container (12), preferably an incubation container (12), comprises a power interface (47, 47’) for transferring power between the bioprocessing system (1 ) and the respective connected container (12), a data interface (48, 48’) for transferring data between the bioprocessing system (1 ) and the respective connected container (12) and / or a fluid interface (49, 49’) for transferring at least one fluid between the bioprocessing system (1 ) and the respective connected container (12).

29. Bioprocessing system according to one of claims 20 to 28, characterized in that- the bioprocessing system (1 ) is configured so that no user action is required while performing the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12), and- that the bioprocessing system (1 ) is configured to detect a user action during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12) and, preferably, the bioprocessing system (1 ) is configured to perform an abort procedure if the user action is detected during the performance of the unit operation and preferably while connecting and / or disconnecting the cartridge (5) and the container (12).

30. Bioprocessing system according to one of claims 20 to 29, characterized in that the bioprocessing system (1 ), preferably the primary workstation (2), in particular the unit operation interface (4) and / or the welding interface (19), comprises one or more bioprocessing bases (44), that the defined cartridge position (23) and / or the defined container position (24) is, preferably at least during the first unit operation and / or the second unit operation, arranged at the one or more bioprocessing bases (44) and in that, preferably,- the one or more bioprocessing bases respectively comprise at least one of the active elements (14),- the one or more bioprocessing bases (44) are configured to interact with the cartridge (5) and / or container (12) to perform at least one unit operation of the plurality of unit operations, preferably the first unit operation (16) and / or the second unit operation (17),- the one or more bioprocessing bases (44) are, preferably manually, movable between a mounting position arranged in the primary workstation (2), preferably the unit operation interface (4) and / or the welding interface (19), and an external position arranged outside the primary workstation (2), preferably the unit operation interface (4) and / or the welding interface (19), and / or- the cartridge (5) and / or the container (12) are, preferably manually, movable between a holding position arranged on at least one bioprocessing base (44) of the one or more bioprocessing bases (44), the defined cartridge position (23) and / or the defined container position (24)and a release position spaced apart from the at least one bioprocessing base (44) of the one or more bioprocessing bases (44), the defined cartridge position (23) and / or the defined container position (24).31 . Bioprocessing system according to one of claims 23 to 30, characterized in that the weld robot (15) is movable arranged in the bioprocessing system (1 ), preferably relative to the cartridge (5), the container (12), the defined cartridge position (23) and / or the defined container position (24).

32. Bioprocessing system according to one of claims 20 to 31 , characterized in that the bioprocessing system (1 ), preferably the welding interface (19), in particular the weld robot (15), comprises a sealing unit (32) for sealing a tube (7) of the cartridge (5) and / or a tube (7) of the container (12) in a sealing phase such that a sealing (35, 36) is formed, wherein the sealing unit (32) comprises at least one sealing surface (37), which is designed to crimp the tube (7) of the cartridge (5) and / or the tube (7) of the container (12) along the axial direction of the respective tube (7) such that the tube (7) of the cartridge (5) and / or the tube (7) of the container (12) is or are self-sealed.

33. Method for performing a further iteration of the bioprocess performed according to the method of one of claims 1 to 19 as a previous iteration on an automated, in particular fully automated, further bioprocessing system (26), wherein the further bioprocessing system (26) comprises a further primary workstation (27), wherein for performing the bioprocess the further bioprocessing system (26) performs the workflow, wherein the plurality of unit operations are performed by the further primary workstation (27), wherein the further primary workstation (27) comprises a further unit operation interface (28), wherein the unit operations are performed by an interaction of the further unit operation interface (28) with at least one cartridge (5), wherein the cartridge (5), optionally together with containers (12), placed at, in particular on, the further unit operation interface (28) define a cartridge configuration (13), wherein the further unit operation interface (28) comprises at least one active element (14) interacting with the at least one cartridge (5) to perform at least one unit operation of the plurality of unit operations, characterized in that a first unit operation (16) and a second unit operation (17) of the plurality of unit operations are performed by the unit operation interface(4) with different cartridge configurations (13), wherein between the first and the second unit operation (16, 17) the cartridge configuration (13) is reconfigured in a reconfiguration step, wherein the reconfiguration in the reconfiguration step is performed at least partially, in particular fully, automatically and / or in that the first unit operation (16) and the second unit operation (17) of the plurality of unit operations are performed by the unit operation interface (4), preferably with the same cartridge configuration (13), wherein before and / or after the first and the second unit operation (16, 17) the cartridge configuration (13) is at least partially, in particular fully, automatically configured in a config- uration step, wherein the at least partially, in particular fully, automatic configuration in the configuration step is supported by the bioprocessing system (1 ), is performed inside the bioprocessing system (1 ) and / or is performed outside the bioprocessing system (1 ).

34. Method according to claim 33, characterized in that some or all user actions necessary for the previous iteration are automated in the further iteration, and / or, that the reconfiguration is at least partially done by robotic transfer of the cartridge (5) and / or container (12).

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