Modular bioprocess system

Abstract

The present disclosure relates to a modular bioprocess system having a plurality of bioprocess modules, each independently receiving a bioprocess container and performing one or more unit operations on the bioprocess container and / or its contents; and a robot that moves the biological treatment container between each of the biological process modules.

Description

Technical Field

[0001] The present invention relates to modular bioprocessing systems and methods for processing materials such as biological materials. Background Art

[0002] The process of manufacturing biological products on a large scale is expensive due to the large amount of manpower required for each unit operation. In particular, in the manufacturing process of cell and / or gene therapy drugs, multiple unit operations are performed in various systems that lack synergy with each other, thereby increasing the complexity of the process, which leads to increased costs for therapeutic drug manufacturers. As a result, the vast majority of patients have limited access to treatment. Therefore, affordable cell-based research systems and / or therapeutic drug manufacturing systems are becoming increasingly important to patients.

[0003] Recently, there has been a push to develop towards automated cell-based research systems and / or therapeutic drug manufacturing systems. In some instances, an automated system is provided, whereby entire modules and equipment are moved between various locations of the system to carry out appropriate processing. However, such systems have many disadvantages. For example, such systems require a complex and mechanically sturdy robotic mechanism to enable such heavy equipment to be transported between various locations, which is typically expensive. Additionally, such systems are difficult to combine new or existing processing techniques, as end users need from time to time, because new modules must be created as a whole, rather than simply being directly incorporated into the system by readily available equipment.

[0004] It is therefore an object of the present invention to provide a scalable, automated and cost-effective bioprocessing system, in particular a system in which biotherapeutics such as cell and / or gene therapy products can be manufactured.

[0005] Furthermore, another object of the present invention is to provide a scalable and automated bioprocessing system that can be automated cost-effectively and / or is compatible with new or existing off-the-shelf technologies. Summary of the invention

[0006] According to one aspect of the present invention, a modular bioprocess system is provided, which includes a plurality of bioprocess modules, each bioprocess module being independently configured to receive at least one bioprocessing container and to perform one or more unit operations on the bioprocessing container and / or the contents therein; and a robot configured and arranged to move the bioprocessing container or each bioprocessing container between each of the plurality of bioprocess modules.

[0007] That is, there are multiple (i.e., more than one) bioprocessing modules, each of which is capable of receiving one or more bioprocessing containers. Each bioprocessing module may have a portion for receiving one or more bioprocessing containers, such as a bracket, a clamp, a mounting plate, a drawer, a shelf, etc. Alternatively or additionally, each bioprocessing module may have a portion that can perform one or more unit operations on the bioprocessing container itself, on the contents in the bioprocessing container, or on both the bioprocessing container itself and the contents in the bioprocessing container, such as a driver, a plunger, a clamp, a sensor, etc. In particular, each bioprocessing module may include a driver configured to drive a connector coupled to the bioprocessing container, such as a needle-based connector. Alternatively or additionally, the driver may be configured to drive the bioprocessing container to cause the distribution of the contents of the bioprocessing container. In particular, the driver may be configured to apply a force (such as a compressive force) to at least a portion of the bioprocessing container, wherein at least a portion of the bioprocessing container is flexible and / or compressible. The driver configured to drive the connector and / or the bioprocessing container may be composed of a single driver or a plurality of separate drivers.

[0008] That is, a robot is provided for moving one or more bioprocessing containers between each of the bioprocessing modules. The robot may include a robot arm, a gripper, etc., which enables the robot to receive or collect bioprocessing containers from a bioprocessing module. The robot may also be arranged on tracks, wheels, etc. to achieve movement between bioprocessing modules. The robot may also include a driver configured to drive a portion of the bioprocessing container. The driver may be configured to drive a connector coupled to the bioprocessing container, such as a needle-based connector. Alternatively or additionally, the driver may be configured to drive the bioprocessing container to cause the distribution of the contents of the bioprocessing container. In particular, the driver may be configured to apply a force (such as a compressive force) to at least a portion of the bioprocessing container, wherein at least a portion of the bioprocessing container is flexible and / or compressible. The driver configured to drive the connector and / or the bioprocessing container may be composed of a single driver or a plurality of separate drivers.

[0009] As used herein, the term "bioprocess system" is intended to refer to a system in which one or more operations in the manufacture of a biological product (such as a cell product) can be performed. The term "biological product manufacturing system" can be used synonymously. Such operations include, but are not limited to, any suitable materials for the manufacture of biological products (such as cell products) such as analysis, preparation, processing, storage, modification, manipulation, cultivation, mixing, dilution, harvesting, etc. The material may include culture medium for cells with or without cells, growth factors, viruses, bead-based reagents, final products such as final biological products, etc. The cell product may be a CAR-T product.

[0010] As used herein, the term "bioprocess module" is intended to refer to a module in which one or more specific operations in the manufacture of a bioproduct (such as a cell product) can be performed. In some instances, each bioprocess module is static or fixed. That is, they are not moved or cannot be moved by a robot or other alternative device. That is, each bioprocess module is static, and the robot is movable relative to each bioprocess module. Each bioprocess module can include one or more instruments for performing one or more specific operations. One or more instruments for performing one or more specific operations can remain static or fixed in its corresponding bioprocess module. That is, they are not moved or cannot be moved by a robot or other alternative device.

[0011] As used herein, the term "bioprocessing container" is intended to refer to a container suitable for processing biological materials or materials for manufacturing biological products. In some instances, the bioprocessing container can be a bioreactor, a single-use container (consumable), an auxiliary container, a sampling container, a vacuum container (vacutainer), etc. In some instances, the bioprocessing container may include an interface element (such as an interface plate) to provide fluid communication to the bioprocessing container. In a specific instance, the bioprocessing container includes at least a flexible and / or compressible portion, or the entirety of the bioprocessing container is compressible and / or flexible. In some instances, the bioprocessing container can be coupled to a connector, such as a needle-based connector. The needle-based connector can be as described in WO2021 / 123760A1.

[0012] Advantageously, the bioprocess systems described herein can produce bioproducts with minimal human intervention. Further advantageously, the bioprocess systems described herein can produce bioproducts in a semi-automatic or fully automatic manner. Still further advantageously, materials can be provided to the relevant bioprocess modules in a "just-in-time" manner, i.e., the relevant bioprocessing containers are transported to the relevant bioprocessing modules only when the user or system deems it necessary. In addition, by moving the bioprocessing containers rather than the bioprocessing modules themselves, the bioprocess systems described herein are more suitable for combining new and existing off-the-shelf technologies, such as required by the end user.

[0013] Optionally, the modular bioprocess system includes a bioprocessing vessel. In this case, a modular bioprocessing system is provided, which includes a bioprocessing vessel, a plurality of bioprocessing modules, each bioprocessing module being independently configured to receive a bioprocessing vessel and perform one or more unit operations on the bioprocessing vessel and / or contents therein; and a robot configured to move the bioprocessing vessel between each of the plurality of bioprocessing modules.

[0014] Optionally, at least one of the plurality of bioprocess modules is a bioreactor module configured to maintain suitable conditions for cell culture. That is, the bioreactor module is configured to receive a bioprocessing vessel, such as a bioreactor, and enable a cell culture process to be performed therein under suitable conditions to maintain such cell culture. Optionally, the bioreactor module includes a bioreactor contained therein.

[0015] Optionally, the bioreactor module comprises a first docking portion configured to receive a first bioprocessing container and a second docking portion configured to receive a second bioprocessing container. In particular, the first bioprocessing container can be a bioreactor and the second bioprocessing container can be an auxiliary container, with or without connectors coupled to them.

[0016] Optionally, the bioreactor module includes an incubator configured to substantially maintain an internal atmosphere and / or temperature. In some instances, the internal atmosphere may include a carbon dioxide content of about 5% to about 10%, preferably about 5%. In some instances, the temperature may be about 37 degrees Celsius.

[0017] Optionally, at least one of the plurality of bioprocess modules is a bioanalytical module. That is, the bioanalytical module is configured to receive a bioprocessing container and perform one or more analyses on the bioprocessing container itself and / or its contents. The bioprocessing container may be analyzed to confirm the sterility, integrity or other mechanical properties of the bioprocessing container. Alternatively or additionally, the contents of the bioprocessing container may be analyzed directly (in which case a sample of the contents is taken from the bioprocessing container) or indirectly (in which case the contents remain within the bioprocessing container).

[0018] Optionally, the bioanalysis module includes at least one of the following: a pH meter, a cell counter, a cell seeding density meter, a flow cytometer, a polymerase chain reaction device, a sterility analyzer, a culture medium analyzer, a metabolite analyzer, a cell imaging device, and a microscope.

[0019] Optionally, at least one of the multiple bioprocess modules is a preparation module. That is, the preparation module is configured to receive a bioprocessing container and prepare contents for distribution into the bioprocessing container. Optionally, the preparation module includes a dispensing device configured to distribute fluids into the bioprocessing container. The fluid may include liquids, gases, slurries, suspensions, gels and other fluid-like materials. Optionally, the preparation module includes multiple reservoirs (each reservoir containing fluids), a mixing device for optionally mixing fluids, and a dispensing device for dispensing fluids or mixed fluids into the bioprocessing container.

[0020] Optionally, the preparation module is configured to prepare and / or process at least one of: cell culture media, growth factors, viral vectors, non-viral vectors, and bead-based reagents.

[0021] Optionally, the preparation module is configured to dispense at least one of the following into the bioprocessing container: cell culture medium, growth factors, viral vectors, non-viral vectors, and bead-based reagents.

[0022] Optionally, at least one of the plurality of bioprocess modules is a cell selection module, in particular, the cell selection module may be a magnetically activated cell selection module. In particular, the cell selection module may include a selectively magnetizable device configured to select cells from a sample (i.e., positive sorting or negative sorting). Any such selectively magnetizable device is suitable for such a module.

[0023] Optionally, at least one of the plurality of bioprocess modules is a centrifugation module. That is, the centrifugation module may include a centrifuge configured to receive a bioprocessing container to centrifuge its contents.

[0024] Optionally, at least one of the plurality of bioprocess modules is a washing module. That is, the washing module may include an instrument configured to receive a bioprocessing container and wash its contents (e.g., a cell culture). In particular, the washing module may include a centrifuge, a countercurrent centrifugal elutriation (CCE) device, a filtration device, etc.

[0025] Optionally, at least one of the plurality of bioprocess modules is an electroporation module. That is, the electroporation module may include an electroporation device configured to apply an electric field to the contents of the bioprocessing device.

[0026] Optionally, at least one of the plurality of bioprocess modules is a cell harvesting module. That is, the cell harvesting module may include a device for harvesting cells, i.e., removing cells from the remaining contents in the bioprocessing container. The device may include a cell harvesting device and a container for receiving the harvested cells, such as a flexible bag.

[0027] Optionally, at least one of the multiple bioprocess modules is a formulation module. That is, the formulation module may include a device for preparing the cells harvested from the bioprocessing container into a final formulation for application to the patient. The device may include a container (such as a flexible bag) configured to receive (or include) harvested cells, and one or more other containers, each of which is configured to receive (or include) buffer, pharmaceutically acceptable excipients or media and similar reagents, so that the final formulation of the cell therapy product can be applied to the patient. The device may also include a device that can mix and / or distribute harvested cells and buffer, pharmaceutically acceptable excipients or media and other similar substances, so that the final formulation is provided in the final formulation container. The final formulation container can be a flexible bag, such as an intravenous (IV) bag.

[0028] Optionally, at least one of the multiple bioprocess modules is a storage module. That is, the storage module may include a storage device, such as an incubator, a storage cabinet, a refrigerator, or a freezer. The storage module may be configured to maintain a temperature of about 4 degrees Celsius. In such an example, the storage module may be a medium storage module, i.e., configured to maintain a bioprocessing container including a medium at a temperature of about 4 degrees Celsius. The storage module may be configured to maintain a temperature of about -20 degrees Celsius. In such an example, the storage module may be a growth factor or DNA storage module, i.e., configured to maintain a bioprocessing container including a growth factor and / or DNA at a temperature of about -20 degrees Celsius. The storage module may be configured to maintain a temperature of about -80 degrees Celsius. In such an example, the storage module may be a virus storage module, i.e., configured to maintain a bioprocessing container including a virus at a temperature of about -80 degrees Celsius. In some examples, the storage module may include various compartments, each of which is configured to maintain a different temperature, such as those mentioned herein. In some examples, the storage module may be configured to freeze or thaw the contents of the bioprocessing container.

[0029] Optionally, at least one of the plurality of bioprocess modules comprises a device for reading a specified feature on a bioprocessing container. That is, a device for detecting and reading features disposed on a bioprocessing container, such as a scanner, may be provided.

[0030] Optionally, the designated feature is one or more of an RFID tag, an NFC tag, a barcode or a QR code.

[0031] Optionally, the modular bioprocess system also includes a microprocessor configured to: receive a signal from at least one of the multiple bioprocess modules; and in response to the signal received from at least one of the multiple bioprocess modules, generate a signal and send a signal to the robot so that the robot moves the bioprocessing container from the first bioprocess module to the second bioprocess module.

[0032] Optionally, each bioprocess module is formed as a compartment. In some examples, the compartment consists of a substantially cubic volume.

[0033] Optionally, the bioprocess system comprises a first side and a second side, each compartment being formed on the first side, and a maintenance portion being formed on the second side, the maintenance portion comprising at least one of: a fluid connector, a fluid reservoir, an electrical connector, a gas connector, a gas source, a computer, a network adapter, and a control panel.

[0034] Optionally, the interior of each compartment is isolated from the interior of another compartment. Optionally, the internal environments of each compartment are isolated from each other.

[0035] Optionally, each compartment is integrally formed within the wall.

[0036] Optionally, the bioprocess modules are arranged in an array of rows, or columns, or a combination of rows and columns.

[0037] According to another aspect of the present invention, there is provided a mobile facility comprising a modular bioprocess system as described herein. Optionally, a trailer with wheels is provided as the mobile facility.

[0038] Optionally, the mobile facility comprises a clean room and a service room, wherein the clean room and the service room are separated by a modular bioprocess system. In some examples, the clean room and the service room are separated by a wall, and the modular bioprocess system is integrally formed in the wall.

[0039] According to another aspect of the present invention, a modular bioprocess system having a first side and a second side is provided, the system comprising: a plurality of bioprocess modules, each bioprocess module being formed as a compartment on the first side, and each bioprocess module being independently configured to receive at least one bioprocessing container and to perform one or more unit operations on the bioprocessing container and / or the contents therein; and a maintenance section formed on the second side, the maintenance section being configured to provide one or more services to each bioprocess module.

[0040] Optionally, the one or more services include at least one of: a fluid connection, an electrical connection, a gas connection and a network connection.

[0041] Optionally, the second side comprises a control panel configured to control one or more services provided to each bioprocess module.

[0042] It should be noted that any modular bioprocessing system embodiment described herein may be combined with any other modular bioprocessing system described herein.

[0043] It should be noted that the bioprocessing container can have any suitable form. For example, the bioprocessing container can include a top, a base arranged parallel to the top, and a flexible wall element extending between the top and the base. The flexible wall element can be compressible so that relative movement can be performed between the top and the base. The flexible wall element can have multiple folds, such as Z-shaped folds. The bioprocessing container can be a flexible bag, a flexible bag held in a rigid support, or a rigid container. The bioprocessing container can be substantially airtight, substantially airtight, or have a substantially airtight portion (such as an airtight flexible wall element and / or an airtight base). Each bioprocessing container is independent of another, so that one bioprocessing container can take the form of a compressible container, and another bioprocessing container can take the form of a rigid container, or any other combination contemplated herein.

[0044] According to another aspect of the present invention, a method for processing biological materials is provided, the method comprising: loading a bioprocessing container into a first bioprocess module among multiple bioprocess modules; performing a first unit operation on the bioprocessing container and / or its contents in the first bioprocess module; removing the bioprocessing container from the first bioprocess module via a robot; moving the bioprocessing container to a second bioprocess module among the multiple bioprocess modules via the robot; and performing a second unit operation on the bioprocessing container and / or its contents in the second bioprocess module.

[0045] Optionally, the first unit operation and / or the second unit operation comprises introducing a cell population into the bioprocessing vessel.

[0046] Optionally, the first unit operation and / or the second unit operation comprises introducing into the bioprocessing vessel at least one of: a cell culture medium, a growth factor, a viral vector, a non-viral vector, or a bead-based reagent.

[0047] Optionally, the first unit operation and / or the second unit operation comprises at least one of: culturing, genetically modifying, stimulating, expanding, washing, separating, selecting or harvesting the cells contained in the bioprocessing vessel.

[0048] Optionally, the first unit operation and / or the second unit operation comprises storing the bioprocessing container under predetermined conditions.

[0049] Optionally, the first unit operation and / or the second unit operation comprises analyzing, centrifuging or electroporating the contents of the bioprocessing vessel.

[0050] Optionally, the step of loading a bioprocessing container into a first bioprocess module of a plurality of bioprocessing modules comprises loading the bioprocessing container into the first bioprocess module via the robot.

[0051] Any feature or step described herein about one embodiment, aspect or example of a bioprocess system, bioprocess module, bioprocess container, robot, mobile facility or method for processing biological material as described herein can be equally applicable to any other embodiment, aspect or example as described herein.In particular, the bioprocess system as described herein can have any combination of bioprocess modules as described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The present disclosure is explained in more detail below with reference to the accompanying drawings:

[0053] Figure 1 An overview of the components included in an exemplary modular bioprocessing system is shown;

[0054] Figure 2A A mobile facility according to an exemplary modular bioprocessing system is shown;

[0055] Figure 2B shows a robotic and curved bioprocessing module library according to an exemplary modular bioprocessing system;

[0056] Figure 2C showing a robot on a track and a bioprocess module library according to an exemplary modular bioprocess system;

[0057] Figure 2D A robot on a track and a library of bioprocess modules embedded in a wall included in an exemplary modular bioprocessing system are shown;

[0058] Figure 3 shows a clean room having a robot and a library of bioprocess modules arranged around the robot;

[0059] Figure 4 A bioreactor module is shown;

[0060] Figure 5A A first example of a bioprocessing container is shown;

[0061] Figure 5B A second example of a bioprocessing vessel is shown;

[0062] Figure 5C Shows Figure 5B cross-section of a bioprocessing vessel;

[0063] Figure 5D A third example of a bioprocessing vessel is shown;

[0064] Figure 5E A fourth example of a bioprocessing vessel is shown;

[0065] Fig. 5F A fifth example of a bioprocessing vessel is shown;

[0066] Figure 6 A connector is shown; and

[0067] Figure 7 A partial cutaway view of a modular bioprocessing system is shown. DETAILED DESCRIPTION

[0068] refer to Figure 1 , a modular bioprocess system 100 is provided, which includes a plurality of bioprocess modules 102 and a robot 104. The bioprocess modules 102 are arranged in an array of rows and columns embedded in the wall. The bioprocess modules 102 can be selected from any suitable modules as discussed herein, but for illustrative purposes, a bioanalysis module 102a is provided, which includes a bioanalysis device 106, such as a pH meter, a microscope, a cell density meter, etc.; a bioreactor module 102b, which includes an incubator unit 108 for accommodating a bioreactor (not shown) and includes a docking portion 110; a server module 102c, which includes a server 112; a cell processing module 102d, which includes a rotary membrane filtration device 114; and a storage module 102e, which includes a plurality of docking portions (not shown). Typically, each module 102 can have a device for receiving a bioprocessing container 200, such as the docking portion 110 discussed above. The docking portion 110 may be provided as a holding or receiving mechanism and enables docking of the bioprocessing container 200 and one or more processing devices to enable unit operations to be performed on the container 200 and / or its contents.

[0069] The robot 104 is provided with a base 104a, an articulated arm 104b, and a gripping portion 104c. The gripping portion 104c can be driven to grip or otherwise receive a bioprocessing container 200 during use. The robot 104, i.e., the base 104a, can be provided on a track 104d to enable movement. Alternatively, the base 104a can be provided with wheels. Movement along the track 104d or with wheels can be remotely controlled by a computer system.

[0070] The modular bioprocess system 100 can be composed of a first side 150 and a second side 160. The first side 150 includes a hole or a frame with holes, in which each bioprocess module 102 is arranged. The first side 150 can be considered as a side from which the interior of each bioprocess module 102 can be approached. The second side 160 is arranged on the opposite side of the system 100 and can be regarded as a side from which maintenance of each bioprocess module 102 can be performed. In particular, the second side 160 can allow access to various services, such as gas connection 120, network connection 122 or electrical connection 124. An interface portion 155 arranged between the first side 150 and the second side 160 is also provided. The interface portion makes it possible to provide services (i.e., gas, network and electrical connections) from the second side 160 to each bioprocess module 102 on the first side 150. For example, the gas connection 120a, the network connection 120b and the electrical connection 120c can be provided by the interface portion 155. The first side 150 can be arranged in a clean room. The second side 160 may be disposed in a service room or a maintenance room or a passage.

[0071] like Figure 1 As shown, the bioprocessing container 200 may include a container portion and a connector portion 400. The bioprocessing container 200 is described in more detail below and in FIG. 5A to FIG. 5F , but typically includes a top and a bottom portion that are compressible relative to each other to cause dispensing. The connector portion 400 may be a needle-based connector, as described below and as Figure 6 The bioprocessing container 200 may be suitable for processing culture medium, cell material, virus, etc. The bioprocessing container 200 may be a bioreactor or an auxiliary container for inputting materials into the bioreactor.

[0072] Further references Figure 1During use, the robot 104 uses the gripping portion 104c to retrieve the bioprocessing container 200 from the bioprocessing module 102 and transport such container 200 to another, i.e., different, bioprocessing module 102. In this way, the bioprocessing container 102 can be transported between different modules 102 in an automated manner, each module processing a discrete unit operation in the bioproduct manufacturing process. For example, the robot 104 can retrieve a container 200 including a culture medium from a storage module 102e, transport the container 200 from the storage module 102e to a bioreactor module 102b, and place such a container 200 in a docking portion 110 within the bioreactor module 102b for distribution by a drive within the bioreactor module 102b. The contents of the container 200 (such as culture medium, cell material, virus, etc.) can be distributed to a bioreactor received in the bioreactor module 102b. Once the operation is completed, the robot 104 can retrieve the used container 200 for transportation back to the storage module 102e, or for disposal in a box or waste module (not shown).

[0073] As will be understood by those skilled in the art, the robot 104 can be automatically controlled by a control system via a network (such as a wireless network). Alternatively, the robot 104 can be controlled by a user interface or human-machine interface provided on a mobile application, tablet or screen.

[0074] The bioprocess module 102 can be any suitable module suitable for manufacturing a biological product (such as a cell and / or gene therapy product, more particularly a CAR-T product). Each bioprocess module 102 can be independently selected from any suitable module, such as a bioreactor module, which is composed of an incubator for accommodating a bioreactor therein; a bioanalysis module, which includes a pH meter, a cell counter, a cell seeding density meter, a flow cytometer, a polymerase chain reaction (PCR) device, a sterility analyzer, a culture medium analyzer, a metabolite analyzer, a cell imaging device or a microscope; a preparation module for preparing materials and / or distributing materials into a bioprocessing container; a cell selection module, which includes a magnetically activated cell selection device; a centrifugal module, which includes a centrifuge device; an electroporation module, which includes an electroporation device; a cell harvesting module, which includes a device capable of harvesting cell materials from a container (such as a bioprocessing container) into a final form and / or packaging; or a storage module as described above. The present disclosure is not intended to be limited in any way to the modules and / or devices used.

[0075] Reference now Figure 2A, provides an example of a bioprocess system 100 that is arranged in a mobile facility 300 having wheels 302 so that a user can move the mobile facility 300 from one location to another. The mobile facility 300 includes a plurality of bioprocess modules 102 therein. The mobile facility 300 may also include information about Figure 1 The features described above, such various services include gas, electricity and network connections. In this way, bioprocess module 102 can be provided with gas, electricity and network connectivity during transportation from a first location to a second location or on the spot without being transported. Mobile facility 300 may include a device for attaching to a vehicle, such as a tie point, so that mobile facility 300 can be transported on the road or in a larger facility such as a warehouse. Mobile facility 300 can be equipped with space (not shown) for a robot so that bioprocess module 102 and the robot can be transported simultaneously in a single trailer.

[0076] Reference now Figure 2B , provides an example of a bioprocess system 100. In this example, a robot 104 is disposed on a platform 170 and can rotate about a longitudinal axis on a base 172. The bioprocess modules 102 are arranged in an arcuate manner around the robot 104 so that the robot 104 can perform operations on each bioprocess module 102. This configuration increases the number of bioprocess modules 102 that a single robot 104 can operate while being movable about a single point (i.e., without tracks). Figure 2B In the embodiment, the bioprocess system 100 is provided with a bioprocess module 102 stacked on top of another bioprocess module, i.e., two bioprocess modules 102 are stacked one on top of another, but three or more bioprocess modules 102 can be stacked on top of another, wherein the robot 104 is able to translate and / or extend vertically or telescopically to reach a higher bioprocess module 102.

[0077] Reference now Figure 2C , provides an example of a bioprocessing system 100 in which bioprocessing modules 102 are arranged linearly in an array of rows and columns adjacent to robots 104 on tracks 104d, as described with respect to Figure 1 In this particular example, the track 104d can extend parallel to the array of bioprocess modules 102.

[0078] Reference now Figure 2D, provides an example of a bioprocess system 100 in which a bioprocess module 102 is embedded in a wall 180. The wall 180 can be a wall of a clean room, so that access to the interior of the bioprocess module 102 is limited to a limited number of users (i.e., only users who can access the clean room), thereby minimizing exposure to potentially harmful substances (such as viruses, fungi, or bacteria). In this configuration, the side of the wall 180 close to the bioprocess module 102 is the first side of the entire system 100 (see Figure 1 ), and the opposite side (not shown) is the second side of the entire system 100 (see Figure 1 ). The first side allows a robot or a designated human operator to approach the interior of the bioprocess module 102. The second side includes various features that are more difficult to optimize for robot control and / or can be approached by people who are not required, trained or qualified to enter the clean room side. For example, the second side is configured for maintenance operations and includes an air source, a network adapter and an electrical connection. These features may require human intervention for maintenance, repairs, etc., and preferably do not require human operators to enter the clean room environment for such activities. The first side and the second side are isolated, such as fluid isolation, that is, not fluidly connected, so that hazardous substances cannot pass between them. In particular, a fluid-tight or airtight seal 182 is provided around each bioprocess module to ensure isolation between the first side and the second side. In this way, the clean room is mainly occupied by the robot during normal operation, with minimal human intervention, and the second side can be approached by a human operator, thereby not requiring preparation for entering the clean room environment and / or potential exposure to hazardous substances.

[0079] Figure 3 An example of a clean room 300 is shown that includes an annular array of bioprocess modules 102 that are arranged around a robot 104. The bioprocess modules 102 are arranged in this manner to maximize the utility of floor space within a first area 302 of the clean room 300 because the robot 104 can access each of the bioprocess modules 102 without the need for a track. The first area 302 is generally defined by a surround wall 304 that separates the first area 302 from a second area 306. The surround 304 has an aperture through which each bioprocess module 102 is positioned and can be accessed by the robot 104 during use.

[0080] The first region 302 may be thermally controlled or maintained to ensure that the volume defined therein is maintained at a substantially constant temperature, such as 37 degrees Celsius. Additionally or alternatively, the first region 302 may have a controlled atmosphere such that the gas content therein is controlled or maintained. For example, the carbon dioxide content of the first region 302 may be maintained at about 5% to about 10%.

[0081] Each bioprocessing module 102 is located on a slidable access tray 308 so that they can each be slidably moved between a first position and a second position. Figure 3 As shown, each module 102 is arranged such that the open end of each module 102 (i.e., for access via the robot 104) is arranged in the first area 302. The open end can be sealed around its edges to ensure a heat-tight and / or fluid-tight and / or air-tight seal of the first area 302, in particular from and to the second area 306. In a second position (not shown), each module 102 is moved laterally away from the array of process modules 102 so that the entirety of each module 102 is arranged within the second area 306, thereby facilitating maintenance and / or servicing of each module 102.

[0082] The volume of the first region 302 and the volume of each process module 102 can be unitarily formed, i.e., there is no need for a door on each bioprocess module 102. In this way, a single thermal environment and / or atmospheric environment is provided without the need to control each module 102 individually. In other examples, each bioprocess module 102 is provided with a door. In addition, in some examples, each aperture through which the bioprocess module 102 is positioned includes a door so that the first region 302 is sealed before the bioprocess module 102 is moved to the second position. The user can access the first region 302 through a door 310 in the wall 304 separating the first region 302 and the second region 306.

[0083] As an example of one such module for use in any of the systems described herein, there is provided Figure 4 The bioreactor module 102b shown. The bioreactor module 102b has the form of an incubator having an enclosure 1020 that encloses an internal volume. Within the internal volume, a docking portion 110 configured to hold a bioprocessing container 200 is provided. The docking portion 110 may be static, i.e., fixed, or it may be movable. In some instances, the docking portion 110 may be rotatable about a central axis so that it may be indexed to a position at the front of the internal volume, close to an opening of the enclosure, thereby making it easy for the above-mentioned robot to approach. Additionally or alternatively, a plurality of docking portions may be arranged around the central axis, and several bioprocessing containers may be located within the internal volume. In this case, the docking portion may be moved like a turntable. For example, upon receiving a signal that a specific bioprocessing container is required for a unit operation, the relevant docking portion may be rotated or indexed to a position at the front of the internal volume. Similarly, when an empty docking portion is required, the empty docking portion is rotated or indexed to a position at the front of the internal volume. Thus, the movement of the robot may be simplified because only one position within the bioreactor module 102b needs to be approached.

[0084] Additionally or alternatively, the bioreactor module 102b includes a removable interface 1022. The removable interface 1022 can be moved along the longitudinal axis, i.e., moved up and down relative to the enclosure 1020, and / or the removable interface 1022 can be rotated about the central longitudinal axis. The removable interface 1022 can be attached to a bioreactor (not shown) and is used to allow the lumen of the bioreactor to dock with another component (such as a container). The removable interface 1022 includes an upper surface 1022a having a port 1022b. The port 1022b is configured to be connected via a connector (see Figure 6 ) docks with the bioprocessing container 200 and forms a sterile and fluid-tight or hermetic seal so that liquids (such as culture media and gases) can be provided therein. In particular, the ports 1022b can each be configured as a resealable septum seal. The ports 1022b can be provided with a further sterile barrier (such as a sterile paper seal) that is configured to mate with a corresponding sterile barrier (such as a corresponding sterile paper seal) that is resealed via a connector (see Figure 6 ) is removed before docking the bioprocessing container 200 with the corresponding port 1022b.

[0085] Figure 5A , 5B , 5C, 5D and 5E show various examples of bioprocessing containers 200, 200', 200", 200'", 200"', 200"" configured for use in the modular bioprocessing system 100. Each of the bioprocessing containers 200, 200', 200", 200'", 200"" includes a top 202, a bottom 204 and a flexible and compressible wall 206 arranged between the top 202 and the bottom 204. Each bioprocessing container 200, 200', 200", 200'", 200"', 200"" includes a connector 400 coupled to its distal end, particularly a needle-based connector, which will be described in more detail below. Generally, the connector 400 can be used as an inlet and outlet for fluids (including liquids, gases, suspensions, slurries, gels, etc.) between each bioprocessing container 200, 200', 200", 200'", 200"" and another container or component.

[0086] like Figure 5A As shown, the bottom 204 of the bioprocessing container 200 is coupled to and partially surrounds a bottle 208, which includes an internal volume for containing a fluid. The fluid in the internal volume can be dispensed via a connector 400. The compressible wall 206 above the bottle 208 is flexible and contains a plunger (not shown) that can reciprocate within the bottle 208, thereby applying a compressive force to the top 202 and / or the bottom 204 so that the volume of the bottle 204 can be changed. Figure 5AThe bioprocessing container 200 shown in FIG. 4 further includes a mounting collar 210. The mounting collar 210 includes features that allow it to be removably attached to the connector. One example feature is an external thread for connecting the mounting collar to a threaded portion of the connector 400. Additionally or alternatively, the mounting collar 210 can be push-fit onto the connector 400 and include an O-ring or other elastomeric member to increase retention. It should be understood that other connection mechanisms can be provided to the mounting collar 210 and the connector 400 to provide a connection mechanism.

[0087] Figure 5A The bioprocessing container 200 shown in FIG. 1 can be configured and arranged to store and / or dispense viruses, magnetically activated reagents, or magnetic beads.

[0088] like Figure 5B and Figure 5C As shown, the bottom 204 of the bioprocessing container 200' is coupled to and partially surrounds a bottle 208, which includes an internal volume for containing a fluid, similar to the above description of Figure 5A However, Figure 5B The bottle 208 is not provided with a plunger, but due to the air-driven mechanism (i.e., the generation of positive air pressure), the compression of the top 202 relative to the bottom 204 causes the contents in the bottle 208 to be dispensed. In particular, a one-way valve 212 is provided between the bottom 204 and the bottle 208 to allow the fluid (such as air) contained in the volume defined by the top 202, the bottom 204 and the compressible sidewall 206 to enter the bottle 208 in one direction and squeeze the fluid out of the bottle 208 through the hollow needle 11 of the connector 400. Figure 5B The illustrated bioprocessing container 200' further includes a feed tube 214 that can be used to add fluid to or remove fluid from the bottle 204 via a spigot 216. After use, the feed tube 214 can be removed or sealed, such as plugged or welded shut. Any portion of the feed tube 214 that remains attached to the bioprocessing container 200' can be clamped to the bottle 204. The bioprocessing container 200' further includes a funnel portion 216 extending from below the bottle 204, the funnel portion 216 gradually tapering inwardly so that in use, fluid is directed to the connector 400.

[0089] Figure 5B and 5C The bioprocessing container 200 ′ shown in FIG. 1 may be configured and arranged to store and / or dispense cell culture medium or cell starting material.

[0090] like Figure 5D As shown, Figure 5A and Figure 5BIn contrast to the examples of the bioprocessing container 200'", the bioprocessing container 200'" does not include a bottle. Instead, the volume defined by the top 202, the bottom 204 and the compressible sidewall 206 is arranged to hold a fluid for dispensing. In particular, the top 202, the bottom 204 and the compressible sidewall 206 define a truncated cone-shaped container. The bottom 204 includes a threaded portion 218 for coupling the bioprocessing container 200'" to the connector 400. During use, the top 202 is compressed relative to the bottom 204 to cause fluid to be dispensed from the volume defined therein.

[0091] Figure 5D The bioprocessing container 200" shown in Figure 2 can be configured and arranged to store and / or dispense cell culture medium or cell starting material.

[0092] like Figure 5E As shown, the bioprocessing container 200"" is substantially the same as Figure 5D The same as described above. In this example, the bioprocessing container 200"" has a first foldable side wall 206a and a second foldable side wall 206b. Each of the first side wall 206a and the second side wall 206b has a truncated cone shape. Each of the first side wall 206a and the second side wall 206b has a first end 220a, 220b and a second end 222a, 222b, and the first end 220a, 220b is larger than the second end 222a, 222b. The first foldable side wall 206a and the second foldable side wall 206b are connected end to end so that they define a single internal volume or lumen and fold in the same direction. In the example shown, the second ends 222a, 222b (i.e., the smaller ends) are connected to each other. The first end 220a of the first foldable side wall 206a is provided with a bottom 204 and is attached to the connector 400 via a threaded portion 224. The first end 220b of the second foldable side wall 206b is provided with a top 202. Thus, starting from the base 204, the first foldable sidewall 206a tapers inwardly to a narrower waist 226, and then the second foldable sidewall 206b tapers outwardly to the top 202. The base 204 also includes a threaded portion 218 to enable coupling to the connector 400.

[0093] Figure 5E The bioprocessing container 200''''' shown in FIG. 2 can be configured and arranged to store and / or dispense cell culture medium or cell starting material.

[0094] like Fig. 5FAs shown, in contrast to the previous examples, a bioprocessing container 250 can be provided without a connector. In this example, the bioprocessing container 250 includes a top 202, a bottom 204, and a flexible and compressible sidewall 206. As shown, and as described in other examples, the flexible and compressible sidewall has a plurality of annular rigid portions 252 arranged transversely parallel to the top 202 and the bottom 204. The annular rigid portions are interlaced with the deformable regions 254 to achieve compression. The bioprocessing container is also provided with a port 256 at the top 202, although in other examples this may be a threaded portion of the top 202.

[0095] Fig. 5F The bioprocessing vessel 250 shown in FIG. 2 may be a bioreactor.

[0096] The bioprocessing container 200, 200', 200", 200'", 200", 250 may include an on-board network adapter and may also include on-board control and analysis devices, such as batteries, sensors, heaters, pH meters, thermometers, etc., so that the contents can be continuously monitored. The network adapter can transmit signals indicating the status of the on-board control and analysis devices, including temperature, pH of the culture medium, charge level of the battery, etc.

[0097] It should be noted that, as an optional feature, Figure 5A , 5B Each of the bioprocessing containers 200, 200', 200", 200'", 200"', 200"" of 5C, 5D and 5E has an engagement feature 230, which is suitable for an actuator, which can be part of the robot 104 or part of the bioprocess module, to engage and cause the dispensing of the contents of the bioprocessing container 200, 200', 200", 200"', 200"" by compressing the top 202 relative to the bottom 204.

[0098] The bioprocessing containers 200, 200', 200", 200'", 200", 250 as described above may also include a designated feature, which may be an RFID tag, an NFC tag, a barcode or a QR code or any combination thereof. The robot 104, preferably the robot's gripper 104c has an attached reader, such as a scanner, which is used to detect which of the bioprocessing containers 200, 200', 200", 200'", 200", 250 the robot 104 is collecting. In this way, if a bioprocessing container 200, 200', 200", 200'", 200"', 200"", 250 has been moved from its known location, for example by an operator, and replaced in a different docking station to a location previously stored on the network, the reader can confirm which bioprocessing container 200, 200', 200", 200"', 200"", 250 in a group of bioprocessing containers 200, 200', 200", 200"', 200"", 250 has been collected. The microprocessor and associated memory can be used to specify each docking station 110 with an identity and a known location, and when a bioprocessing container 200, 200', 200", 200'", 200"", 250 is docked, the memory can be updated with information to confirm its presence or absence. The robot can scan the designated features each time it interacts with a bioprocessing container 200, 200', 200", 200'", 200"", 250 so that the correct bioprocessing container 200, 200', 200", 200'", 200"", 250 is collected each time. If the robot is performing an operation to collect a bioprocessing container 200, 200', 200", 200'", 200"", 250 and detects that it is missing or incorrectly specified, a signal indicating the error can be provided to the operator via the network adapter.

[0099] Figures 5A to 5E The bioprocessing container 200, 200', 200", 200"', 200"" includes a connector 400 configured to complement the docking portion 110 and / or the removable interface 1022 of the bioreactor module 102b (see Figure 4). The connector 400 may include one or more docking features, which additionally include a connection element for receiving gas from the gas source 120, a connection element for electrically connecting to the electrical connector 124, and a connection element to a network terminal for connecting to a network. In this way, when the bioprocessing container 200, 200', 200", 200"', 200"" (i.e., its connector 400) is docked, it can transmit signals indicating the status of culture medium, cells, temperature, battery charge, etc. If power, additional gas or fluid is required, the signal can be sent to the network adapter 122 via the on-board network adapter. The connector 400 is a needle-based connector having a hollow needle 11, which is arranged to pierce the septum seal of the connector (as described below with respect to Figure 6 The) and arranged at the far end of the bottle ( Figure 5A , 5B , 5C) or bottom 204( Figure 5D , 5E )'s diaphragm seal.

[0100] Figure 6 A cross-sectional view of a connector 400 is shown for connecting a bioprocessing container 200 to another component in use, such as an interface 1022 of a bioreactor module 102b (see Figure 4 ). The connector 400 includes a housing having an upper housing portion 12a and a lower housing portion 12b. The housing extends along a longitudinal axis between a distal end and a proximal end. The upper housing portion 12a can move or slide axially relative to the lower housing portion 12b, as will be further described below.

[0101] The housing comprises a threaded portion 17 at its distal end for connection to a corresponding threaded portion of the bottle. The threaded portion 17 is formed on the upper housing portion 12a. As will be clear to the skilled person, the housing may be provided without the threaded portion 17 but with another suitable connection mechanism for connection to a part of the bottle.

[0102] The connector 400 also includes a connector portion at its proximal end for connecting to the bioreactor module 102b of the removable interface 1022. The connector portion may be a groove 14 configured to receive one or more protrusions extending from the removable interface 1022. Alternatively, the connector 400 may include a threaded portion or other connector portion for connecting to the removable interface.

[0103] The connector 400 includes a first septum seal 18 disposed at a distal end of the housing and a second septum seal 10 disposed at a proximal end of the housing. The first septum seal 18 includes a substantially planar, i.e., flat, pierceable surface facing outward at the distal end. The second septum seal 10 includes a generally annular portion extending outward at the proximal end, which surrounds a substantially planar, i.e., flat, pierceable surface facing outward at the proximal end. The housing further includes a hollow needle 11 mounted offset within the housing. The hollow needle 11 is generally coaxially aligned with the longitudinal axis. The hollow needle 11 includes a first end 24 facing the first septum seal 18 and a second end 22 facing the second septum seal 10. The first end 24 is configured to be able to pierce the first septum seal 18 in use, and the second end 22 is configured to be able to pierce the second septum seal 10 in use. The first septum seal 18 , the second septum seal 10 , or both the first septum seal 18 and the second septum seal 10 may optionally be provided with a removable sterile paper seal 16 .

[0104] The hollow needle 11 is mounted in the housing by means of a collar 28, and the collar 28 is spring-biased by a first coil spring 20a and a second coil spring 20b. In other embodiments, the hollow needle 11 can be mounted in another suitable manner, for example, the hollow needle 11 can be statically mounted, that is, so that it does not move, and the housing can move around the hollow needle 11. The first spring 20a acts between the distal end of the housing and the collar 28. The second spring 20b acts between the proximal end of the housing and the collar 28. In this way, the first spring 20a provides a first biasing force to the hollow needle 11 via the collar 28 in a direction toward the proximal end of the housing, and the second spring 20b provides a second biasing force to the hollow needle 11 via the collar 28 in a direction toward the distal end of the housing.

[0105] The connector 400 further comprises a drive mechanism for causing the hollow needle 11 to pierce the septum seals 10, 18. By piercing the first septum seal 10 and the second septum seal 18, the hollow needle 11 forms a fluid path between the distal end and the proximal end of the connector 400, and thus forms a fluid connection between the bottle 204, 204' of the bioprocessing container and the bioreactor module 102b during use.

[0106] exist Figure 6 In the example shown, the drive mechanism includes an outer sleeve 13, which is arranged to fold the upper housing part 12a relative to the lower housing part 12b. The outer sleeve 13 can rotate relative to the housing around the central longitudinal axis of the housing. For example, one of the outer sleeve 13 and the housing may include a spiral groove, and the other of the outer sleeve 13 and the housing may include a protrusion that engages with the groove, so that when the upper housing part 12a is folded relative to the lower housing part 12b, the outer sleeve 13 rotates.

[0107] It should be noted that while a drive mechanism comprising an outer sleeve and a spring biasing the needle and / or housing is shown, other drive mechanisms are equally contemplated. The illustrated connector 400 is provided merely as an example of a means for providing a connection between components of a system.

[0108] Reference now Figure 7 , showing a portion of a modular bioprocess system 500 and five different bioprocess modules. Each bioprocess module is specialized for a different purpose and includes specific components. For example, the upper left module may be an analysis module 102a and contain an analysis device. One possible analysis device may be an automated cell counter that captures an image indicating the cell density within the bioprocessing vessel 200 so that the growth rate can be determined by performing conventional measurements. Alternatively or additionally, the analysis module may include a pH meter, a cell counter, a cell seeding density meter, a flow cytometer, a polymerase chain reaction device, a sterility analyzer, a culture medium analyzer, a metabolite analyzer, or a cell imaging device.

[0109] The top center bioprocess module can be Figure 4 Bioreactor module 102b as shown and described above.

[0110] The lower left module can be a server module 102c, and includes a server 112, which provides computing services including digital storage, control of robots, and network capabilities including Internet access. The server can process signals indicating the status and position of the docking unit 110 and the bioprocessing container 200 and the temperature in the modular bioprocess system 100, the remaining reserves of gas, empty bioprocessing containers, various supplies required for culture media and culture media, single-use containers, etc. These signals can be processed to generate warnings, such as low supply warnings of gas, low temperature warnings, or door opening warnings. The technician will understand that there are various other warnings that may need to be generated by the server. The server can also generate error messages, for example: if the bioprocessing container is mispositioned or dropped, or if maintenance is required for specific components such as heaters.

[0111] The bottom center module 102d is a preparation module, which includes a docking portion 110 and at least one preparation device 114. The preparation device can be a device for preparing culture medium to be added to the bioprocessing container 200, 200' by warming, mixing and gently pouring the culture medium. Alternatively or additionally, the preparation device can be a rotating membrane filtration device, a centrifuge, a water bath, a flow cytometer, or a purified water system. The skilled person will recognize that there are various other preparation devices that can be used in this module, and this is not an exhaustive list.

[0112] Each of the modules may be sized differently to be the right size for its function, but will preferably be a standard 1x1 size, and the larger modules will be sized to allow for mosaicking of modules, such that the larger modules are 1x2 or 2x2 or 3x1 or 4x4 relative to the standard size. As a non-limiting example, the rightmost module is a 1x2 sized storage module 102e. The storage module 102e may contain a plurality of docking portions 110 for bioprocessing vessels 200, 200', 200", 200', 200", 200", 250. The bioprocessing vessels 200, 200', 200", 200', 200", 250 may be held in the storage module 102e while biological material is grown therein. Routine operations may be performed on the bioprocessing vessels 200, 200', 200", 200', 200", 200", 250 to ensure that the biological material grows at the expected rate. Alternatively or additionally, the bioprocessing container 200, 200', 200", 200'", 200"", 250 can provide a signal to the server 112 indicating that an action needs to be performed, such as analysis by an analytical device or preparation of biological material for long-term storage or delivery. Alternatively, the storage module can be refrigerated to maintain a temperature of approximately 4 degrees Celsius or -20 degrees Celsius or -80 degrees Celsius for storing cell culture media and other components for future use.

[0113] Certain terms are used in the following description for convenience only and are not limiting. The words "right", "left", "lower", "upper", "front", "rear", "upward", "downward", "downward", "above", and "below" indicate directions referenced in the accompanying drawings and are relative to the directions of the described components when assembled and installed (e.g., in situ). The words "interior", "inwardly", and "exteriorly", "outwardly" refer to directions toward and away from a designated centerline or geometric center (e.g., central axis) of the described elements, respectively, and the specific meaning is apparent from the context of the description.

[0114] Furthermore, as used herein, "clean room," "cell culture laboratory," "sterile environment," and similar terms are intended to refer to a room in which external contaminants may lead to negative outcomes for cell culture, and in which the interface layer is preferably located, while the maintenance layer should be accessible from outside the clean room (or similar room).

[0115] In addition, as used herein, the terms "connected," "attached," "coupled," and "mounted" are intended to include a direct connection between two components without any other components interposed therebetween, as well as an indirect connection between components with one or more other components interposed therebetween. The terminology includes the words specifically mentioned above, their derivatives, and words of similar meanings.

[0116] Furthermore, unless otherwise stated, the use of ordinal adjectives such as "first," "second," "third," etc. merely indicates that different instances of similar objects are being referred to and is not intended to imply that the objects so described must be in a given order temporally, spatially, sequentially, or in any other manner.

[0117] Throughout the description and claims of this specification, the terms "comprises" and "comprising" and variations thereof are interpreted as meaning "including but not limited to", and they are not intended to (and do not) exclude other parts, additives, components, integral bodies or steps. Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification should be understood to contemplate the plural as well as the singular unless the context otherwise requires.

[0118] Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, unless the combination of at least some of such features and / or steps is mutually exclusive. The invention is not limited to the details of any foregoing embodiments. The invention extends to any novel feature or any novel combination of features disclosed in this specification (including any appended claims, abstract or drawings), or any novel step or any novel combination of steps of any method or process so disclosed.

Claims

1. A modular bioprocess system comprising: a plurality of bioprocess modules, each bioprocess module independently configured to receive at least one bioprocessing vessel and to perform one or more unit operations on the bioprocessing vessel and / or the contents therein; and A robot is configured to move the or each bioprocessing container between each of the plurality of bioprocessing modules.

2. A modular bioprocess system according to claim 1, wherein each bioprocess module is fixed.

3. A modular bioprocess system according to claim 1 or 2, wherein at least one of the multiple bioprocess modules is a bioreactor module configured to maintain suitable conditions for cell culture, and optionally wherein the bioreactor module includes an incubator configured to substantially maintain an internal atmosphere and / or temperature, and optionally wherein the bioreactor module includes a first docking portion configured to receive a first bioprocessing container and a second docking portion configured to receive a second bioprocessing container, and further optionally wherein the first bioprocessing container and the second bioprocessing container are received in the respective first docking portion and the second docking portion, and also optionally wherein the first bioprocessing container is a bioreactor and the second bioprocessing container is an auxiliary container.

4. A modular bioprocess system according to any of the preceding claims, wherein at least one of the plurality of bioprocess modules is a bioanalytical module, and optionally wherein the bioanalytical module comprises at least one of: a pH meter, a cell counter, a cell seeding density meter, a flow cytometer, a polymerase chain reaction device, a sterility analyzer, a culture medium analyzer, a metabolite analyzer, a cell imaging device and a microscope.

5. A modular bioprocessing system according to any of the preceding claims, wherein at least one of the plurality of bioprocessing modules is a preparation module, and optionally wherein the preparation module is configured to prepare and / or process at least one of: cell culture media, growth factors, viral vectors, non-viral vectors, and bead-based reagents.

6. The modular bioprocessing system of claim 5, wherein the preparation module is configured to dispense at least one of the following into the bioprocessing container: cell culture medium, growth factors, viral vectors, non-viral vectors, and bead-based reagents.

7. A modular bioprocess system according to any one of the preceding claims, wherein one or more of the plurality of bioprocess modules further comprises a bioprocessing vessel.

8. The modular bioprocessing system according to claim 7, wherein the bioprocessing container is any one of a bioreactor, a single-use container, an auxiliary container, a sampling container or a vacuum container.

9. A modular bioprocessing system according to any one of the preceding claims 7 or 8, wherein the bioprocessing container comprises a flexible wall element, and optionally, wherein the flexible wall element is compressible, or alternatively, the flexible wall element comprises a plurality of folds.

10. A modular bioprocessing system according to any of the preceding claims, wherein at least one of the plurality of bioprocessing modules is selected from: a cell selection module such as a magnetically activated cell selection module, a centrifugation module, a washing module, an electroporation module, a cell harvesting module, a formulation module and a storage module.

11. A modular bioprocessing system according to any of the preceding claims, wherein at least one of the multiple bioprocessing modules includes a device for reading a specified feature on the bioprocessing container, optionally wherein the specified feature is one or more of an RFID tag, an NFC tag, a barcode or a QR code.

12. The modular bioprocessing system according to any one of the preceding claims, further comprising a microprocessor configured to: receiving a signal from at least one of the plurality of bioprocess modules; and In response to the signal received from at least one of the plurality of bioprocess modules, a signal is generated and sent to the robot to cause the robot to move the bioprocessing container from a first bioprocess module to a second bioprocess module.

13. A modular bioprocess system according to any one of the preceding claims, wherein each bioprocess module is formed as a compartment.

14. A modular bioprocessing system according to claim 13, wherein the system includes a first side and a second side, each compartment is formed on the first side, and a maintenance part is formed on the second side, the maintenance part including at least one of the following: a fluid connector, a fluid reservoir, an electrical connector, a gas connector, a gas source, a computer, a network adapter and a control panel.

15. A modular bioprocessing system according to claim 13 or 14, wherein the interior of each compartment is isolated from the interior of another compartment.

16. A modular bioprocessing system according to any one of claims 13 to 15, wherein each compartment is integrally formed within a wall.

17. A modular bioprocess system according to any one of the preceding claims, wherein the bioprocess modules are arranged in an array of rows and / or columns.

18. A mobile facility comprising a modular bioprocess system according to any one of the preceding claims.

19. A method for processing biological material, comprising: loading a bioprocessing vessel into a first bioprocessing module of a plurality of bioprocessing modules; performing a first unit operation on the bioprocessing vessel and / or its contents within the first bioprocess module; removing the bioprocessing container from the first bioprocessing module via a robot; moving the bioprocessing container via the robot to a second bioprocess module among the plurality of bioprocess modules; and A second unit operation is performed on the bioprocessing vessel and / or its contents within the second bioprocessing module.

20. The method of claim 19, wherein the first unit operation and / or the second unit operation comprises introducing a cell population into the bioprocessing vessel.

21. The method of claim 19 or 20, wherein the first unit operation and / or the second unit operation comprises introducing into the bioprocessing vessel at least one of: a cell culture medium, a growth factor, a viral vector, a non-viral vector, or a bead-based reagent.

22. The method of any one of claims 19 to 21, wherein the first unit operation and / or the second unit operation comprises at least one of: culturing, genetically modifying, stimulating, expanding, washing, separating, selecting or harvesting the cells contained in the bioprocessing vessel.

23. The method of any one of claims 19 to 22, wherein the first unit operation and / or the second unit operation comprises storing the bioprocessing container under predetermined conditions.

24. The method of any one of claims 19 to 23, wherein the first unit operation and / or the second unit operation comprises analyzing, centrifuging or electroporating the contents of the bioprocessing container.

25. The method of any one of claims 19 to 24, wherein the step of loading a bioprocessing container into a first bioprocess module of a plurality of bioprocess modules comprises loading the bioprocessing container into the first bioprocess module via the robot.

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