Support structure for an automated cell manipulation system.
By designing an automatic selection and support system, efficient storage, maintenance and location switching of multiple biological processing units are achieved, solving the problem of large space occupation and single automated production of existing systems, improving cell production efficiency and space utilization efficiency, and supporting personalized treatments for multiple patients.
Patent Information
- Application Number
- JP2024537581
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-01-24
- Filing Date
- 2023-01-23
- Publication Date
- 2025-01-30
AI Technical Summary
The existing automatic cell culture system occupies a large amount of laboratory space, requires a lot of capital investment, and is difficult to achieve large-scale automated operations. At the same time, it cannot meet the personalized cell therapy needs of multiple patients, resulting in inefficient space utilization and single automated production.
An automatic selection and support system is designed, including multiple biological processing units. Through the transfer between a movable support structure and fixed location, the storage, maintenance and user presentation of biological processing units are realized. The system includes infrastructure such as power, gas supply and temperature control, supporting independent operation and position switching of multiple biological processing units.
It improves cell production efficiency, reduces the occupation of laboratory space, supports the simultaneous operation of multiple biological processing units, meets the personalized treatment needs of multiple patients, and optimizes space utilization and automated production capacity.
Smart Images

Figure 2025502937000001_ABST
Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 302,366, filed January 24, 2022, the disclosure of which is incorporated herein by reference in its entirety.
[0002] The present technology generally relates to a storage structure for cell manipulation systems. The storage structure allows multiple automated cell manipulation systems to be held via a single structure, presented to a user when desired or required for direct access to the cell manipulation systems, and then returned to a storage or working location. Many storage structures can be located together in a clinical or hospital environment, or other cell therapy manipulation manufacturing environment. [Background technology]
[0003] Existing robotic manipulation systems for automated cell culture processes are complex, require significant laboratory space to operate, and require large capital investments.
[0004] Facility design is often recognized as a critical component in successful GMP (Good Manufacturing Practice) biologics manufacturing, but is not always implemented with a full understanding of the implications of the process. In the case of mammalian cell culture, there are recognized issues and risks that arise when moving to large-scale automated operations. The increasing demand for cell culture production capacity in the biopharmaceutical industry has led to an increase in the scale of automated operations.
[0005] There is also an increasing demand for patient-specific therapies, such as autologous cell therapies. Autologous cell therapies require complex multiple simultaneous processing events, which places considerable demands on automation. Automated production units can only serve one patient in any given production cycle. Scaling massively parallel processing for multiple patients creates the need for space-efficient tissue expression and access to multiple production units within the production facility.
[0006] It is therefore desirable to develop methods for achieving maximized cell production within the confines of existing production equipment. It is further desirable to develop methods for achieving maximized cell production within the confines of existing production facilities that do not adversely affect the integrity of the cell culture system. It is also desirable to improve the ergonomics for users of automated cell and tissue manipulation systems. The present invention meets these needs. Summary of the Invention
[0007] In one embodiment, an automated selection and support system is provided. The automated selection and support system may include a plurality of biological processing units, each of which may be translatable between a first position for storing and maintaining the plurality of biological processing units and a second position for presenting at least one or more of the plurality of biological processing units. A movable support structure may be provided to transition each of the plurality of automated biological processing units between the first position and the second position. The electrical system may include a power source and an interface device, both of which are operably connected to each of the plurality of automated biological processing units and the movable support structure. The gas supply system may include a gas line fluidly coupled to each of the plurality of automated biological processing units.
[0008] In another embodiment, an automated selection and support system is provided. The automated selection and support system can include a plurality of automated biological processing units, each of which can have a first position for storing and maintaining the plurality of automated biological processing units and a second position for presenting the automated biological processing unit to a user. A plurality of swing arms can be provided, each of which can include a first end operably coupled to an automated biological processing unit of the plurality of automated biological processing units and a second end operably coupled to a drive motor. The drive motor can be configured to rotate the swing arm to transition the automated biological processing unit between the first position and the second position. The swing arm can maintain the automated biological processing unit rotationally level. The electrical system can include a power source and an interface device, both of which are operably coupled to each of the automated biological processing units and the drive motor. The gas supply system can include a gas line fluidly coupled to each of the plurality of automated biological processing units.
[0009] In another embodiment, an automated selection and support system is provided. The automated selection and support system can include a plurality of automated biological processing units, each of which can have a first position for storing and maintaining the plurality of automated biological processing units and a second position for presenting the automated biological processing units to a user. The automated selection and support system can include a plurality of vertical rails. It can also include a gantry configured to move on the vertical rails and select one of the automated biological processing units and transition the automated biological processing unit between the first position and the second position. The electrical system can include a power source and an interface device, both operably coupled to each of the automated biological processing units. The gas supply system can include a gas line fluidly connected to each of the plurality of automated biological processing units. The vertical rails, the electrical system, the gas supply system, and / or the thermal management system can all be housed within a housing.
[0010] In another embodiment, an automated selection and support system is provided. The automated selection and support system may include a plurality of automated biological processing units, each of which may have a first position for storing and maintaining the plurality of automated biological processing units and a second position for presenting the automated biological processing units to a user. The plurality of modular holding cells may be configured to hold one of the automated biological processing units, respectively. A shuttle may be configured to move between each of the modular holding cells to select one of the automated biological processing units and transition the automated biological processing units between the first and second positions. The electrical system may include a power source and an interface device, both of which are operably coupled to each of the automated biological processing units. The gas supply system may include a gas line fluidly coupled to each of the plurality of automated biological processing units. The electrical system, the gas supply system, and / or the thermal management system may be housed within a housing.
[0011] In another embodiment, an automated selection and support system is provided. The automated selection and support system can include a plurality of automated biological processing units, each of the plurality of automated biological processing units can have a first position for storing and maintaining the plurality of automated biological processing units and a second position for presenting the automated biological processing units to a user. A plurality of transport blocks can be provided, each transport block can be configured to couple to one of the plurality of automated biological processing units. The coupler can be configured to mate with one of the plurality of blocks. The first track can be configured to move the coupler in a first direction. The second track can be configured to move the first track in a second direction, the second track being substantially perpendicular to the first track. The electrical system can include a power source and an interface device, both of which are operably connected to each of the plurality of automated biological processing units and the transport block. The gas supply system can include a gas line fluidly coupled to each of the plurality of automated biological processing units. The first track and the second track can be configured to move one of the plurality of automated biological processing units from a first location to a second location.
[0012] In another embodiment, a method for presenting an automated biological processing unit to a user is provided, which may include the steps of selecting an automated biological processing unit from an automated selection and storage system, the automated selection and storage system including a plurality of automated biological processing units, each of the plurality of automated biological processing units having a first position for storing and maintaining the automated biological processing unit and a second position for presenting the automated biological processing unit to a user, a movable support structure for transitioning each of the plurality of automated biological processing units between the first position and the second position, an electrical system including a power source and an interface device, both of which are operably connected to each of the plurality of automated biological processing units and the movable support structure, and a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological processing units, transitioning the selected automated biological processing unit from the first position to the second position using the movable support structure, and returning the selected automated biological processing unit from the second position to the first position.
[0013] The above and other features and advantages of the present invention will become apparent from the following description of the embodiments herein as illustrated in the accompanying drawings, which are incorporated in and form a part of this specification and further serve to explain the principles of the invention and to enable those skilled in the art to make and use the invention. The drawings are not to scale. [Brief description of the drawings]
[0014] [Figure 1A] FIG. 2 is a schematic diagram of the automatic selection and support system in a first position. [Figure 1B] 1B is a schematic diagram of the automated selection and support system of FIG. 1A in a second position. [Diagram 2] FIG. 2 is a perspective view of a second embodiment of the automated selection and support system. [Diagram 3]FIG. 3 is an internal view of the swing arm of the second embodiment of the automatic selection and support system of FIG. 2. [Figure 4] 3 is an internal view of a second embodiment of the automated selection and support system of FIG. 2. [Diagram 5] 3 is an alternative internal view of the second embodiment of the automated selection and support system of FIG. 2. [Figure 6] FIG. 13 illustrates a third embodiment of the automatic selection and support system. [Figure 7] FIG. 7 is an internal view of a third embodiment of the automated selection and support system of FIG. 6. [Figure 8] 7 is an alternative internal view of the third embodiment of the automated selection and support system of FIG. 6. [Figure 9] 7 illustrates a third embodiment of the automated selection and support system of FIG. 6 for moving an automated biological processing unit between a first position and a second position. [Figure 10] FIG. 13 is a perspective view of a fourth embodiment of the automated selection and support system. [Figure 11] 11 is an internal view of the fourth embodiment of the automated selection and support system of FIG. 10. [Figure 12] 11 is an alternative internal view of the fourth embodiment of the automated selection and support system of FIG. 10. [Figure 13] 11 illustrates a fourth embodiment of the automated selection and support system of FIG. 10 for moving an automated biological processing unit between a first position and a second position. [Figure 14] FIG. 13 is a perspective view of a fifth embodiment of the automated selection and support system. [Figure 15] 15 is an interior perspective view of a fifth embodiment of the automated selection and support system of FIG. 14. [Figure 16] 15 is an interior side view of the fifth embodiment of the automated selection and support system of FIG. 14 while in a first position. [Figure 17] 15 is an interior side view of the fifth embodiment of the automated selection and support system of FIG. 14 while in the second position. [Figure 18]FIG. 15 is a perspective view of end-user interaction with the fifth embodiment of the automated selection and support system of FIG. 14, with the automated biological processing unit in a second position. [Figure 19] 15 is another perspective view of the fifth embodiment of the automated selection and support system of FIG. 14 having an open automated biological processing unit. [Figure 20] FIG. 15 is a side view of the fifth embodiment of the automated selection and support system of FIG. 14. [Figure 21] FIG. 15 is a front view of the fifth embodiment of the automated selection and support system of FIG. 14. [Figure 22] 15 is another perspective view of the fifth embodiment of the automated selection and support system of FIG. 14. [Figure 23A] FIG. 2 illustrates a first half of an example system and architecture for implementing or facilitating an automated selection and support system according to embodiments herein, divided by line AA. [Figure 23B] A diagram showing the second half of an example system and architecture for implementing or facilitating an automated selection and support system according to embodiments herein, divided by line AA. [Figure 24] FIG. 1 illustrates an exemplary system for an integrated and centralized analysis platform for use with embodiments of the automated selection and support system described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0015] It should be understood that the various aspects disclosed herein may be combined in different combinations than those specifically presented in the description and accompanying drawings, and that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, added, merged, or omitted entirely (e.g., not all described acts or events may be required to practice the present technology).
[0016] Unless otherwise defined herein, scientific and technical terms used in this disclosure shall have the meanings commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include the plural and plural terms shall include the singular.
[0017] Published patents, patent applications, websites, company names, and scientific literature mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each was specifically and individually indicated to be incorporated by reference. Any conflict between any reference cited herein and the specific teachings of this specification shall be resolved in favor of the latter. Similarly, any conflict between the art definition of a word or phrase specifically taught in this specification and the definition of the word or phrase shall be resolved in favor of the latter.
[0018] As used herein, the singular forms "a", "an", and "the" specifically include the plurals of the terms they refer to, unless the content clearly indicates otherwise. The term "about" is used herein to mean approximately, within the region of, approximately, or around. When the term "about" is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the stated numerical values. In general, the term "about" is used herein to modify a numerical value above and below the stated value with a variance of 20%.
[0019] Although use of the term "or" in the claims is used to mean "and / or" unless expressly indicated to refer to alternatives only or the alternatives are not mutually exclusive, the present disclosure supports a definition that refers to alternatives only and "and / or."
[0020] As used herein, the terms "comprising" (and any variation or form of including, such as "comprise" and "comprises"), "having" (and any variation or form of having, such as "have" and "has"), "including" (and any variation or form of including, such as "includes" and "include") or "containing" (and any variation or form of containing, such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.
[0021] Use of the term "for example" and its corresponding abbreviation "eg," unless expressly stated otherwise, means that the particular term recited is representative of examples and embodiments of the present disclosure that are not intended to be limited to the particular example referenced or cited.
[0022] As used herein, "between" is a range that includes the ends of the range. For example, a number between x and y explicitly includes the numbers x and y, as well as any number that falls within the range between x and y.
[0023] As described throughout the specification and drawings, the automated biological processing unit 102 is a fully enclosed (i.e., sterility is maintained within the unit through interconnected tubing and elements or containers within the unit) automated system for performing activation, transduction, expansion, enrichment, and / or harvesting steps of cell cultures. The automated biological processing unit (also referred to throughout as an automated cell manipulation system) provides for the automated production of cell cultures. As used herein, "cell culture" refers to any suitable cell type, including individual cells as well as cells that can form multiple cells or tissue structures. Exemplary cell cultures include blood cells, skin cells, muscle cells, bone cells, cells from various tissues and organs, and the like. In embodiments, genetically modified immune cells, including CAR T cells, as described herein, can be produced. An exemplary automated cell manipulation system is also referred to throughout as COCOON™ or the COCOON™ system (see, e.g., U.S. Patent Application Publication No. 2019 / 0169572, now U.S. Pat. No. 11,447,745, the disclosure of which is incorporated by reference in its entirety herein).
[0024] The automated selection and support system 100 is configured to store, maintain, and support a plurality of automated biological processing units 102. When placed within the automated selection and support system 100, each automated biological processing unit 102 has a first position 120a configured to store, operate, and maintain the automated biological processing unit 102, and a second position 120b (i.e., a user-presented position) for presenting one or more of the automated biological processing units 102 to a user. A user can interact with the automated selection and support system 100 to individually select a biological processing unit 102, allowing the user to monitor information about the biological processing unit 102 and transition the selected biological processing unit 102 from the first position 120a to the second position 120b. It should be understood that the terms "first position" and "second position" are used herein only to indicate two distinct positions that can be acquired by the support system 100, and that multiple additional positions can be acquired between the first position and the second position, and before and after acquiring the first position and the second position.
[0025] In an embodiment, the biological processing unit 102 can be translated to multiple positions, i.e., nth positions, between a first position 120a configured to store and maintain the automated biological processing units and a second position 120b for presenting one or more of the automated biological processing units 102 to a user, where the value of nth position n is any number of positions between the first position 120a and the last position. For example, the biological processing unit 102 can be translated from the first position 120a to a first intermediate position between the first position 120a and the second position 120b. The biological processing unit 102 can then be translated from the first intermediate position to a third intermediate position between the first intermediate position and the second position 120b. The biological processing unit 102 can then repeat such translational movement n times until it finally translates to the second position 120b for presenting one or more of the biological processing units 102 to an end user, or it can be further translated to additional positions before returning to the first position 120a. The biological processing unit 102 may also be translated to each of n positions between the first position 120a and the second position 120b. In an embodiment, the first position 120a, the n position, and / or the second position 120bs may further include a tilt angle of each of the biological processing units 102 such that the tilt angle of at least one of the biological processing units 102 at the first position 120a is different from the tilt angle of the same biological processing unit 102 at the n position and / or the second position 120b. In an embodiment, the tilt angle of at least one of the biological processing units 102 at the first position 120a and the second position 120b is the same, while the tilt angle of the same biological processing unit 102 at the n position is the same as the tilt angle of the first position 120a and the second position 120b, thereby maintaining the cell culture in the automated biological processing unit 102 in a stable manner without significant disturbance. The translational and / or tilting movement of at least one of the biological processing units 102 between the first position 120a and the second position 120b preferably does not affect the activation, transduction, proliferation, enrichment, and / or harvesting steps of the cell culture in the other remaining (i.e., non-translating) biological processing units 102.
[0026] An exemplary automated selection and support system is shown in Figures 1A and 1B. The automated selection and support system 100 generally includes a movable support structure 104 and a housing 106 capable of providing resources to each of the biological processing units 102. The movable support structure 104 is capable of both supporting and transferring the biological processing units 102 between the first position 120a and the second position 120b described above. The first position 120a shown in Figure 1A is characterized by being the primary position of the biological processing units 102 during storage and maintenance, allowing the biological processing within each biological processing unit 102 to be completed. As used herein, "storage and maintenance" or "for storage and maintenance" includes cases where the biological processing units 102 are not active or activated (i.e., do not contain cells or other biological components) as well as cases where the biological processing units are active in that one or more biological processes (e.g., cell culture, growth, transfection, etc.) are occurring. While in the first position 120a, the automated selection and support system 100 is configured to hold the biological processing units 102 substantially stable to allow each of the biological processing units 102 to continue a desired biological process or to be inactive. The second position 120b is shown in FIG. 2A and may be characterized as allowing a user to access components of the automated biological processing units 102, allowing the user to check progress, perform maintenance, introduce or remove various buffers, cells, cell cultures, viruses or vector systems, and the like.
[0027] The movable support structure 104 may be coupled to either the housing 106 and one or more automated biological treatment units 102. In some embodiments, the movable support structure 104 is configured to move each biological treatment unit 102 between the first position 120a and the second position 120b while keeping each of the biological treatment units 102 stable. Each biological treatment unit 102 requires a level of stability to maintain laminar flow conditions required for reliable function. The movable support structure 104 may achieve the required level of stability by moving the automated biological treatment units 102 to limit any forces on the units 102, such as by eliminating abrupt starts and stops, utilizing a constant or substantially constant speed of movement, etc. Furthermore, in some embodiments, it is envisioned that the movable support structure 104 may rotate or translate to keep each biological treatment unit 102 rotationally level during transitions to further limit any possible forces, such as gravity, that may adversely affect each unit 102. In an embodiment, the movable support structure 104 may allow each biological treatment unit 102 to rotate through a 360° rotation relative to the movable support structure. In an embodiment, the movable support structure 104 may allow each biological treatment unit 102 to rotate through at least a 180° rotation relative to the movable support structure. Depending on the configuration of the automated selection and support system 100, each automated biological treatment unit 102 may be connected to a dedicated movable support structure 104. In an embodiment, a single movable support structure 104 may service each of the automated biological treatment units 102.
[0028] Exemplary movable support structures 104 include various types of arms, swing arms, rotating units, track structures, pulley structures, or any other type of translatable support structure capable of translating each of the multiple biological treatment units 102 as described herein.
[0029] The housing 106 can contain all of the components necessary for the movable support structures 104 to move the automated biological processing unit 102, as well as any resources necessary for the automated biological processing unit 102 to function properly. For example, the housing 106 can contain the mechanical and electrical components necessary to operate the multiple movable support structures 104, such as motors, pulleys, processors, electrical wires, etc. Additionally, an interface device 114 can be positioned at or on the housing 106 to allow a user to interact with the systems of the automated selection and support system 100. In an embodiment, the interface device may include a graphical user interface (GUI), a radio frequency identification (RFID) sensor, such as low frequency RFID, high frequency RFID, very high frequency RFID, passive RFID (e.g., radio signal response), active RFID (e.g., battery powered RFID tags), semi-passive RFID (e.g., battery assisted RFID tags), a wireless identification and sensing platform (WISP), and any other form of identification sensor technology, a barcode scanner, a camera, a fingerprint sensor, an optical sensor, a multi-spectral sensor, and / or any other applicable form of biometric security technology.
[0030] As mentioned, each of the automated biological processing units 102 may require access to resources such as electrical, gas, and temperature control systems in order to function properly. These processes may be internally coupled to the automated biological processing units 102 via the movable support structure 104 and / or housing 106, or in some embodiments may be positioned external to the automated selection and support system 100. For example, it is contemplated that multiple automated selection and support systems 100 may be positioned within a temperature controlled room that provides sufficient ventilation to support each of the automated biological processing units 102. Further details regarding the electrical, gas, and temperature control systems are described below.
[0031] An electrical system 108 may be positioned within the automated selection and support system 100, particularly within the housing 106, to provide support for each of the automated biological processing units 102. Additionally, in some embodiments, it is envisioned that a single electrical system 108 may be positioned external to the automated selection and support system 100, and that the electrical system 108 may be connected to multiple automated selection and support systems 100. The electrical system 108 may be controlled by a central computer system of the automated selection and support system 100, or by a separate computer system specifically configured to control the electrical system 108. The electrical system 108 may independently generate electrical power (e.g., photovoltaic power, or mechanical power generated through movement of the movable support structure 104, power generated from these examples may be stored on a battery for later use, etc.), or may receive electricity from an external source, for example, through a means such as a wall plug. In some embodiments, the electrical system 108 is configured to control the current and voltage of electricity provided to the automated biological treatment units 102 and to monitor the electrical usage of each of the biological treatment units 102 so as to provide an independent, regulated flow of electricity to each unit 102.
[0032] Each of the automated biological processing units 102 may be independently connected to the electrical system 108 through a series of electrical conduits that may be positioned within the automated selection and support system 100, particularly the movable support structure and / or housing 106. The automated biological processing units 102 may each be connected to a continuous single circuit, or each may be independently connected to the electrical system 108, to provide a safety feature compared to providing a single circuit.
[0033] A gas supply system 110 may be connected to each individual automated biological processing unit 102 and may be positioned within the housing 106 of the automated selection and support system 100. The gas source may be positioned internal to the automated selection and support system 100 in the form of a tank, or gas may be provided to the gas supply system 110 externally, such as from a gas supply line from a building or laboratory. In some embodiments, the gas supply system 110 is configured to supply a consistent flow of carbon dioxide to each of the automated biological processing units 102, although it is envisioned that other gases (e.g., nitrogen, hydrogen, oxygen, etc.) may be used. The gas supply system 110 may be controlled by a central computer system or by a separate computer system specifically configured to control the gas supply system 110.
[0034] Each of the automated biological treatment units 102 may also be connected to a gas supply system 110 through a system of conduits, which may be positioned within the housing 106 and / or the movable support structure 104. In some embodiments, a main gas line may be positioned through the housing 106, and a series of auxiliary gas lines may branch off from the main gas line and connect each automated biological treatment unit 102. In some embodiments, the gas supply system 110 may be configured to maintain consistent gas pressure in the main and auxiliary gas lines, regardless of possible fluctuations in gas usage by each of the biological treatment units 102. The gas supply system 110 may further control and monitor the usage of each of the biological treatment units 102 to provide an independent, regulated gas flow to each unit 102.
[0035] In some embodiments, the automated biological treatment units 102 require a consistent temperature (e.g., ±5° C.) to operate properly. It is envisioned that each automated biological treatment unit 102 may generate heat, and in some embodiments, a thermal management system 112 may be used to remove heat from each of the automated biological treatment units 102 to cool the units. The thermal management system 112 may be positioned within the housing 106 of the automated selection and support system 100, or may be positioned external to the automated selection and support system 100. For example, multiple automated selection and support systems 100 may be positioned in a temperature-controlled room, and the thermal management system 112 may be configured to regulate the temperature of the room or provide live data regarding the temperature of the units 102 to an external ventilation system. If positioned internally, the thermal management system 112 may use multiple fans to either push or pull ambient air across the surface of each of the automated biological treatment units 102. The ambient air may then be counter-flowed to the surrounding ambient air, or may be cooled by an internal or external temperature interface device, such as an air conditioner.
[0036] In an embodiment, the thermal management system 112 can include a fluid cooling system in which tubing or similar structures can extend over or near the surface of the automated biological treatment unit 102 or can extend within the automated biological treatment unit 102 to cool the unit. For example, a tubular structure, hose, or other liquid impermeable structure (not shown) designed to allow fluid flow therethrough can be wrapped around, adjacent to, or disposed on or within each of the biological treatment units 102. When the temperature of the biological treatment unit 102 is determined to exceed a desired threshold, either manually or automatically via a central computer system, a flow of fluid can be introduced through the fluid impermeable structure. The flow rate of said fluid through the fluid impermeable structure can be based on the difference between a predetermined threshold temperature and the actual temperature of the biological treatment unit 102. For example, if more heat removal (i.e., greater cooling) is desired, the flow rate of fluid through the fluid impermeable structure can be higher. If less heat removal is desired, the flow rate of fluid through the fluid impermeable structure can be lower.
[0037] In an embodiment, the thermal management system 112 may include mechanisms for controlling condensation resulting from the heat removal procedures described herein. For example, if the liquid is flowed through a fluid-impermeable structure, the thermal management system 112 may further include means for ensuring that the liquid is maintained above the local dew point (i.e., the temperature to which the ambient air must be cooled in order for the liquid to become a vapor) relative to the immediate environment and ambient temperature (i.e., the air temperature of the biological treatment unit 102 and associated components, and / or the environment in which the biological treatment unit 102 is stored). This may be accomplished by a humidity monitor / sensor disposed on or within the biological treatment unit 102 and / or integrated with the thermal management system 112.
[0038] The thermal management system 112, if located internally or externally, can be controlled by a central computer system or by an independent computer system configured specifically for the thermal management system 112. It is further envisioned that the temperature of each of the biological treatment units 102 will be monitored to provide a user and the computer system with information as to whether the biological treatment units 102 are outside of an acceptable temperature range and to make any necessary corrections.
[0039] The interface device 114 may be positioned on the housing 106 and configured to provide a user with information regarding each of the biological treatment units 102, the movable support structure 104, the electrical system 108, the gas supply system 110, and the thermal management system 112. Additionally, the interface device 114 may allow a user to independently select each of the automated biological treatment units 102, both for monitoring the status of the units 102 and for transitioning the units 102 between a first position and a final position. The interface device 114 may take the form of an integrated touch screen, an internal computer, or may be positioned externally from the housing 116 in the form of a desktop, tablet, or other computing means. The interface device 114 also allows a user to adjust each of the biological treatment units 102 to change a selected process of the biological treatment units 102, the electrical current to the units 102, the gas flow to the units 102, and the temperature of the units 102.
[0040] In an embodiment, information or data relating to each of the biological processing units 102 can be extracted in real time from each individual biological processing unit 102. For example, information regarding the location, temperature, electrical supply, gas supply, and / or status of cells or cell cultures within each individual biological processing unit 102 can be separately relayed to the interface device 114 in a contemporaneous manner as the information is generated, or can be extracted via the interface device 114 for automated analysis and display. User adjustment of each biological processing unit 102 via the interface device 114 may also be accomplished in real time and for each biological processing unit 102 separately.
[0041] In an embodiment, the interface device 114 may be a processing unit separate from the housing 116 to allow remote access / connection thereto. For example, the interface device 114 may be capable of wirelessly connecting to the housing 116 and / or each individual biological processing unit 102 (i.e., via a wireless LAN, wireless MAN, wireless PAN such as Bluetooth or Zigbee, wireless WAN, etc.). In an embodiment, the interface device 114 may be a processing unit that is separate from the housing 116 but still connected to the housing 116 and / or each biological processing unit 102 via a hardwire connection such as Ethernet, optical fiber, etc. The hardwire connection may allow semi-flexible placement of the end user relative to the housing 116 without requiring a wireless connection. In an embodiment, multiple automated selection and support systems 100 may be connected to a hardwire connection (e.g., a wired LAN network) to provide remote access, data collection, and monitoring.
[0042] As described herein, preferably, automated selection and support structures are provided such that the biological processing units are stacked, supported, or otherwise arranged vertically or substantially vertically relative to one another. This reduces the footprint of the combined biological processing units, allowing for maximum use of laboratory, clean room, warehouse, or hospital floor space, etc. This vertical orientation is unique to the various support structures described herein, as opposed to conventional biological processing units that are traditionally supported in a horizontal manner (i.e., adjacent to one another on the same or substantially the same plane).
[0043] FIG. 2 shows a perspective view of an automated picking and support structure 200 that uses multiple swing arms 204. In one exemplary embodiment of the movable support structure 200, multiple swing arms 204 having a first end 216 and a second end 218 are used to store and move the biological treatment units 102. The first end 216 of each swing arm 204 is coupled to the housing 206, and the second end 218 is coupled to a single biological treatment unit 102. The swing arms 204 are configured to move each single biological treatment unit 102 between the first position 120a and the second position 120b described above. More specifically, each swing arm 204 may be configured to rotate about the first end 216 to cause the second end 218 to move rotationally relative to the first end 216. That is, the second end 218 moves in an arcuate or rotational path relative to the fixed first end 216. In such an embodiment, the first position 120a may be associated with a particular position of the second end 218 relative to the first end 216. For example, as shown in FIG. 2, the first position 120a may be determined as when the second end 218 is substantially perpendicular to the first end 216. Furthermore, the second position 120b may be associated with a rotational position in which the second end 218 is positioned to be accessible by a user. In some embodiments, the second embodiment is associated with the biological processing unit 102 positioned at a height relative to the floor that is accessible to a user. Furthermore, as shown in FIG. 5, it is envisioned that the first positions 120a of each of the biological processing units 102 are different to allow each biological processing unit 102 to be stored simultaneously in the first position 120a (i.e., in a perpendicular position relative to the first end 216). However, as shown in FIG. 2, in some embodiments, each biological processing unit 102 may be positioned in the same second position 120b to allow only a single biological processing unit 102 to be presented to a user at a time. However, configurations are envisioned that allow multiple biological processing units 102 to be presented to a user simultaneously.
[0044] The swing arm 204 may be of various dimensions to meet the requirements of supporting each biological treatment unit 102. For example, as shown in FIG. 2, there are four biological treatment units 102 stacked vertically, and therefore the top and bottom biological treatment units 102 have longer swing arms 204 compared to the two inner biological treatment units 102. Furthermore, the two inner biological treatment units 102 have shorter swing arms 204 with overlapping first ends in some embodiments. This is merely an exemplary configuration, and it is envisioned that the number of biological treatment units 102 supported by each automatic selection and support structure 200 may vary. By having a single swing arm 204 that independently controls each biological treatment unit 102, it is envisioned that the movement of a single biological treatment unit 102 does not affect the other biological treatment units 102.
[0045] In some embodiments, the swing arms 204 may be limited in rotation to protect the biological processing unit 102 from damage due to unintended movement. More specifically, each swing arm 204 may be limited to only be able to rotate between a first position 120a and a second position 120b. For example, a series of hard stops or guards may be positioned to limit the rotational movement of the swing arms 204. In one embodiment, it is contemplated that the arms may be required to rotate between -100 and +100 degrees (relative to the plane of the base 210 or the surface on which the housing 206 sits) to transition between the first position 120a and the second position 120b. Preferably, the first position 120a is approximately +80 to +100 degrees relative to the plane of the base 210 or the surface on which the housing 206 sits, and in an embodiment, the first position 120a is approximately +90 degrees (i.e., perpendicular) relative to the plane of the base 210 or the surface. In an embodiment, the second position is between about -10 degrees and about +45 degrees relative to the plane of the surface on which the base 210 or housing 206 sits. That is, the second position 120b is preferably horizontal, including substantially parallel (i.e., 0 degrees relative to the plane of the surface on which the base 210 or housing 206 sits) relative to the plane of the base 210 or surface. In such an embodiment, the swing arm 204 itself need not be substantially parallel to the plane of the base 210 or surface.
[0046] The position guard 429 can be located within the swing arm 204, particularly at the first end 216, or within the housing 206. The position guard 429 allows the swing arm 204 and biological processing unit 102 to be stored in the first position 120a without requiring the motor 424 to maintain the swing arm 204 in the first position 120a. The position guard 429 may be positioned at the first end 216 to stop the ability of the swing arm 204 to rotate. In some embodiments, the position guard 429 may be controlled by the interface device 114 and may selectively control when the swing arm 204 may rotate. Additionally, the guard at the second position 120b may be positioned to stop the swing arm 204 and second end 218 when they reach the second position 120b, such that the motor 424 is not required to hold the swing arm 204 in the second position 120b. It is further envisioned that in some embodiments, the position guard 429 may be automatically selected and communicated with the interface device 114 of the support system 200 so as to be automatically and / or selectively engaged and disengaged. Additional position guards 429 may be utilized in the support system 200 to maintain the biological processing unit 102 in any number of desired positions between the first position 120a and the second position 120b, for example, to perform certain maintenance requirements, etc.
[0047] In some embodiments of the automatic selection and support structure 200, four individual swing arms 204 (or 2, or 3, or 4, or 5, or 6, or 6, or 7, or 8, etc.) are connected to the housing 206 such that four biological processing units 102 can be supported by the automatic selection and support structure 200, as shown in FIG. 2. As shown in FIG. 2, a first end 216 of each swing arm 204 is connected to the housing 206 to allow each biological processing unit 102 to move between a first position 120a and a second position 120b without interfering with the other biological processing units 102. Each biological processing unit 102 is configured to move independently of the movement of the other biological processing units 102, and further, each swing arm 204 is configured to reduce forces that may be applied to other non-moving parts.
[0048] 3, which shows an internal view of the swing arm 204, the swing arm includes a first gear 320 attached to the housing 206 at a first end 216 and a second gear 322 attached to the biological treatment unit 102 at a second end 218. The first and second gears 320, 322 are coupled by a chain 324 or other connecting device (e.g., a band or belt) such that as the swing arm 204 rotates about the first end 216, the chain 324 moves to rotate the second gear 322 to level the single biological treatment unit 102. The movement of the chain 314 maintains the biological treatment unit 102 in a horizontal position between the first position 120a and the second position 120b, i.e., keeps it rotationally horizontal during the first position 120a, the second position 120b, and the transition between the two positions. Preferably, the biological treatment unit 102 is configured to rotate proportionally to the rotation of the swing arm 204 relative to the first end 216, allowing the biological treatment unit 102 to remain level as the swing arm 204 rotationally displaces the biological treatment unit 102. In some embodiments, by maintaining the biological treatment unit 102 at a consistent level, rotational and translational forces on the biological treatment unit 102 are reduced or minimized, lowering the overall risk of damage to the biological treatment unit 102 or processes therein. This form of leveling system is merely exemplary, and other leveling systems known in the art may be used.
[0049] 4 shows the interior of the housing 206 of one embodiment of the automatic selection and support structure 200. The rotation of each of the swing arms 204 is controlled by a motor 424 operably coupled to the first end 216 of the swing arm 204 by a drive belt 428 (or, in embodiments, a chain, rod, cam, band, or any other possible active control device). In some embodiments, it is envisioned that each swing arm 204 has an independent motor 424 for controlling the rotation and movement of each swing arm 204. Alternatively, each of the swing arms 204 may be controlled by a single central motor 424, which may selectively engage with each individual swing arm 204. As shown in FIG. 4, the drive belt 428 may be positioned at the rotation point, i.e., the first end 216, of the swing arm 204, which in some embodiments results in the drive belts 428 being positioned to overlap each other.
[0050] 5 shows a schematic diagram of the housing 206 of the automatic selection and support structure 200, with a possible layout of electrical and gas inputs shown. The electrical system 108 and gas supply system 110 may be operatively coupled (i.e., connected to enable power, control, data transfer, and gas supply and return) to each of the processing units 102 via a series of conduits 530 positioned within the housing 106, which in some embodiments extend from a first end 216 of each of the swing arms 204 through the swing arms 204 and connect to the biological processing units 102 at a second end 218 of the swing arms 204. It is further envisioned that the electrical system 108 and gas supply system 110 may be positioned within the housing 206.
[0051] The housing 206 can contain all the components necessary for the movable support structure 204 to move the automated biological processing unit 102, as well as any resources necessary for the automated biological processing unit 102 to function properly. For example, the housing 206 can contain the mechanical and electrical components necessary to operate the multiple movable support structures 204, such as motors, pulleys, processors, electrical wires, etc. Additionally, an interface device 114 can be positioned on or on the housing 206 to allow a user to interact with the systems of the automated selection and support system 200. The housing 206 can incorporate the interface device 114 in order to present information to the user regarding the automated biological processing unit 102 and the systems of the automated selection and support system 200. The housing 206 is configured to allow a user to access the internal systems and components contained by the housing 206.
[0052] During operation, a user can interact with the interface device 114 (e.g., a computer, tablet, mobile device, etc.) to select an automated biological processing unit 102. The interface device 114 then engages the motor 424 associated with the designated automated biological processing unit 102. The motor 424, via the belt drive 428, begins to rotate the second end 218 and the first gear 320, causing the swing arm 204 to rotate. Once the swing arm 204 is located in the second position 120b, the user can interact with the biological processing unit 102. When the user has completed interacting with the biological processing unit 102, the user can interact with the interface device 114 to return the swing arm 204 to the first position 120a. The configuration shown in Figures 2-5 moves each automated biological processing unit 102 independently such that failure or error of any movement within the automated support and selection structure 200 does not result in failure or damage to each of the other automated biological processing units 102.
[0053] The thermal management system 112 may be positioned either internally or externally to the automated support and selection structure 200, and the thermal management system 112 is configured to keep each of the automated biological processing units 102 at a relatively consistent temperature (e.g., ±5° C.). As mentioned above, the automated biological processing units 102 require a consistent temperature to operate properly. It is contemplated that each automated biological processing unit 102 may generate heat, and in some embodiments, the thermal management system 112 may be used to remove heat from each of the automated biological processing units 102. As mentioned above, the thermal management system 112 may be housed in each of the automated selection and support systems 100 or may be positioned externally to the automated biological processing units 102. For example, multiple automated selection and support systems 100 may be positioned in a temperature-controlled room, and the thermal management system 112 may be configured to control the temperature of the room or provide live data regarding the temperature of the units 102 to an external ventilation system. If positioned internally, the ventilation system 112 can use multiple fans to either push or pull ambient air across the surfaces of each of the automated biological treatment units 102. The ambient air may then be counter-circulated to the surrounding ambient air or may be cooled by an internal or external temperature interface device such as an air conditioner. The thermal management system 112 can also include a fluid cooling system, where tubing or similar structures can pass over or near the surfaces of the automated biological treatment units 102 or through the units to cool the units. Furthermore, the thermal management system 112, if positioned internally or externally, can be controlled or communicated with by a central computer system or by a separate computer system specifically configured for the thermal management system 112. Additionally, it is envisioned that the temperature of each of the biological treatment units 102 is monitored to provide the user and computer system with information regarding whether the biological treatment units 102 are out of an acceptable temperature range and to make any necessary corrections to bring the biological treatment units 102 back into the acceptable temperature range.
[0054] In an alternative embodiment of the automated selection and support system 600, as shown in FIG. 6, the automated selection and support system 600 is configured to support a plurality of automated biological processing units 102 that can be positioned in either a first position 120a for storage or a second position 120b for presenting the automated biological processing units 102 to a user. The system 600 includes a plurality of holding shelves 604, a housing 606, and a movable gantry 708, each of the plurality of holding shelves 604 configured to hold and couple to one of the plurality of automated biological processing units 102. Further, the movable gantry 708 can selectively couple to each of the holding shelves 604, the movable gantry 708 configured to move a selected holding shelf 604 between the first position 120a and the second position 120b.
[0055] More specifically, each holding shelf 604 is configured to support one of the automated biological processing units 102, and is shown in FIG. 7, where the automated selection and support system 600 is shown with the housing 606 removed. Each holding shelf 604 couples to the automated biological processing unit 102, either at the base of the automated biological processing unit 102 or at one end of the automated biological processing unit 102, specifically at the rear end of the automated biological processing unit 102. The coupling points of each holding shelf 604 provide electricity, gas, and in some embodiments ventilation to the biological processing unit 102. More specifically, the coupling points of the holding shelves 604, in addition to the coupling mechanism, may have openings that provide the biological processing unit 102 with access to resources required for proper operation.
[0056] The movable gantry 708 is shown in FIG. 7 and is configured to move vertically between the plurality of holding shelves 604 and can be selectively coupled to each of the plurality of holding shelves 604 to selectively transition the automated biological processing unit 102 between the first position 120a and the second position 120b. The movable gantry 708 is positioned on a series of rails 710 that extend vertically from the base 607 of the housing 606 to the upper holding shelves 604. The movable gantry 708 is configured to be operably coupled to the series of rails 710 to selectively move vertically up and down the series of rails 710. Additionally, the gantry 708 has a pair of horizontal sliders 714, each of which has a first end and a second end operably coupled to the front rail 711 and the back rail 712. As shown in FIG. 7, the gantry 708 is operably coupled to the four corners of the pair of horizontal sliders 714.
[0057] During operation, a user can interact with the interface device 114 (e.g., a computer, tablet, mobile device, etc.) to select the automated biological processing unit 102. The interface device 114 controls the movement and speed of the movable gantry 708 and horizontal slider 714 to transition the biological processing unit 102 from the first position 120a to the second position 120b. As mentioned above, the interface device 114, in some embodiments, allows the user to monitor the status of each of the automated biological processing units 102. When the user has completed interacting with the automated biological processing unit 102, the user can again interact with the interface device 114 to return the automated biological processing unit 102 to the first position 120a (e.g., for storage and maintenance).
[0058] The horizontal slider 714 is configured to move vertically up and down with the movable gantry 708, and the horizontal slider 714 has clips or mounting structures 716 adapted to grip or couple to each of the holding shelves 604, as shown in Figure 8. When the mounting structures 716 grip the holding shelves 604, the horizontal slider 714 moves the holding shelves 604, and subsequently the automated biological processing unit 102, horizontally forward, as seen in Figure 9. The gantry 708 then moves vertically to a position where it presents the holding shelves 604 and the automated biological processing unit 102 to the user (i.e., final position). Various motors and gears are utilized to move the movable gantry 708 and the horizontal slider 714.
[0059] 6, the housing 606 contains the moveable gantry 708, the horizontal slider 714, and any systems necessary to support the automated biological processing unit 102. The housing 606 includes a base 607 located at the bottom of the housing 606. The position of the housing 606 allows the moveable gantry 708 and the horizontal slider 714 to be completely contained by the housing 606. Additionally, the retention shelf 604 may be positioned completely outside of the housing 606 to allow the retention shelf 604 to move horizontally relative to the housing 606.
[0060] 8, the housing 606 (removed in FIG. 8 for clarity) suitably contains an electrical system 108 and a gas supply system 110 operably coupled (i.e., connected to enable power, control, data transfer, and gas supply and return) to each of the processing units 102 through a series of conduits or other similar structures. As shown, in an embodiment, one or more of the electrical system 108 and the gas supply system 110 can move upwardly, including in one or more of rails 710. As shown, each processing unit 102 is supplied by its own electrical system 108 and gas supply system 110, such that appropriate changes can be made to the electricity and / or gas provided to the individual processing units 102, as desired or needed.
[0061] As described herein, the thermal management system 112 for the automated selection and support system 600 may be positioned either internally or externally to the automated support and selection structure 600, and the thermal management system 112 is configured to keep each of the automated biological processing units 102 at a relatively consistent temperature (e.g., ±5° C.). As mentioned above, the automated biological processing units 102 require a consistent temperature to operate properly. It is contemplated that each automated biological processing unit 102 may generate heat, and in some embodiments, the thermal management system 112 may be used to remove heat from a surface of each of the automated biological processing units 102. As mentioned above, the thermal management system 112 may be positioned within the housing 606 of each of the automated selection and support systems 600, or may be located externally. For example, multiple automated selection and support systems 600 may be positioned in a temperature-controlled room, and the thermal management system 112 may be configured to control the temperature of the room or provide live data regarding the temperature of the units 102 to an external ventilation system. If positioned internally, the ventilation system 112 may either use multiple fans to push or pull ambient air across each surface of the automated biological treatment unit 102, or a fluid cooling system as described herein may be used.
[0062] The process of using the automated selection and support system 600 to move one of the multiple automated biological processing units 102 between the first position 120a and the second position 120b is shown in FIG. 9. To move the biological processing unit 102, a user may first select one of the multiple automated biological processing units 102 via the interface device 114. As described above, the horizontal sliders 714 are each associated with a holding shelf 604. The movable gantry 708 then moves vertically up and down the series of rails 710 until the movable gantry 708 reaches the vertical position of the biological processing unit 102. When the movable gantry 708 is positioned on the selected automated biological processing unit 102, the horizontal slider 714 is positioned on the holding shelf 604, allowing the mounting structure or clip 716 to engage and couple with the holding shelf 604. The horizontal slider 714 of the movable gantry 708 then slides the holding shelf 604 away from the other holding shelves, as shown in FIG. 9. As the holding shelf 604 and subsequently the biological treatment unit 102 are moved horizontally, the movable gantry 708 moves the selected holding shelf 604 vertically (either up or down) to a position (second position 120b) where the biological treatment unit 102 is accessible by the user.
[0063] When the user is finished using the automated biological processing unit 102, the movable gantry 708 can be moved vertically to return the holding shelf 604 to the first position 120a. The horizontal slider 714 can then be moved horizontally to return the holding shelf 604 and the automated biological processing unit 102 to the first position 120a. The movable gantry 708 can then be disengaged from the holding shelf 604 to allow the user to access another biological processing unit 102.
[0064] An additional embodiment of an automated selection and support structure 1000 is shown in FIG. The automated selection and support system 1000 is configured to support a plurality of automated biological processing units 102, and the structure 1000 is capable of positioning the automated biological processing units 102 in either a first position 120a for storage and maintenance or a second position 120b for presenting the automated biological processing units 102 to a user. The structure 1000 generally includes a plurality of vertically stacked modular holding cells 1004, a housing 1006, a shuttle 1008, and a plurality of chassis 1010. Each of the holding cells 1004 has one of the plurality of chassis 1010 positioned therein, and each of the chassis 1010 is configured to support and secure one of the plurality of automated biological processing units 102.
[0065] More specifically, as shown in FIG. 11, each holding cell 1004 is sized to fit into both one of the chassis 1010 and one of the automated biological processing units 102. The embodiment shown in FIG. 11 has multiple holding cells 1004 stacked vertically on top of one another, with each holding cell 1004 configured to be an open cell. More specifically, the open sides of each of the cells 1004 allow airflow to move more easily across each of the automated biological processing units 102. Although the exemplary system 1000 shows five holding cells 1004 stacked vertically, this is merely exemplary and several alternative configurations are envisioned.
[0066] One of the multiple chassis 1010 is positioned within each holding cell 1004, and each chassis 1010 is configured to move both the chassis 1010 and the automated biological processing units 102 from the interior to the exterior of the holding cell 1004. The chassis 1010 connects the automated biological processing units 102 to the housing 1006 and can provide each of the automated biological processing units 102 with the necessary resources (i.e., gas, electricity) to operate and successfully complete their intended functions.
[0067] The movable shuttle 1008 is configured to move vertically across the surface of the holding cell 1004 to selectively couple and subsequently move the automated biological processing unit 102 from the first position 120a to the second position 120b. The movable shuttle 1008 may be selectively coupled to each of the chassis 1010 using a series of motors and gears. When the movable shuttle 1008 is coupled to the chassis 1010, the shuttle 1008 can move the chassis 1010 and then move the automated biological processing unit 102 horizontally out of the cell, and the movable shuttle 1008 can move the chassis 1010 and then move the automated biological processing unit 102 vertically to allow them to be presented to a user.
[0068] During operation, a user can interact with an interface device 114 (e.g., a computer, tablet, mobile device, etc.) to select one of the multiple automated biological processing units 102. The interface device 114 will control the movement and speed of the shuttle 1008 and the coupling and movement of the chassis 1010. As mentioned above, the interface device 114 allows the user to monitor the status of each of the automated biological processing units 102. When the user has completed interacting with the automated biological processing units 102, the user can again interact with the interface device 114 to return the automated biological processing unit 102 to the first position 120a. As shown in FIG. 10, the interface device 114 is positioned on the shuttle 1008, but this is by way of example only and the interface device may be located on any portion of the automated selection and support structure 1000 or may be located remotely from the automated selection and support system 100.
[0069] As shown in Figure 12, the housing 1006 contains the mechanisms required to move the shuttle 1008, the electronic systems, the gas supply, and any ventilation or thermal management components that may be required. The housing 1006 includes a base 1007 located at the bottom of the housing 1006. As shown in Figure 12, the housing 1006 suitably contains an electrical system 108 and a gas supply system 110 operably coupled (i.e., connected to enable power, control, data transfer, and gas supply and return) to each of the processing units 102 through a series of conduits or other similar structures. As shown, each processing unit 102 is supplied by its own electrical system 108 and gas supply system 110, such that appropriate modifications can be made to the electricity and / or gas provided to the individual processing units 102 as desired or required. When the shuttle 1008 selects a particular chassis 1010 to move the processing unit 102 from the first location 120a to the second location 120b, the associated electrical system 108 and gas supply system 110 also move with the shuttle 1008 accordingly.
[0070] Similar to that described above, the thermal management system 112 for the automated selection and support system 1000 may be positioned either internally or externally to the automated support and selection structure 1000, and the thermal management system 112 may be configured to keep each of the automated biological processing units 102 at a relatively consistent temperature (e.g., ±5°C). As described above, the automated biological processing units 102 require a consistent temperature to operate properly. It is contemplated that each automated biological processing unit 102 may generate heat, and in some embodiments, the thermal management system 112 may be used to remove heat from each of the automated biological processing units 102. As described above, the thermal management system 112 may be located within the housing 1006 of each of the automated selection and support systems 1000, or may be located externally. For example, multiple automated selection and support systems 1000 may be positioned in a temperature-controlled room, and the thermal management system 112 may be configured to control the temperature of the room or provide live data regarding the temperature of the units 102 to an external ventilation system. If positioned internally, the ventilation system 112 may either use multiple fans to push or pull ambient air across each surface of the automated biological treatment unit 102, or a fluid cooling system as described herein may be used.
[0071] The process of using the automated selection system 1000 to move a biological processing unit 102 between a first position 120a and a second position 120b is shown in FIG. 13. To move a biological processing unit 102, a user may first select one of the multiple automated biological processing units 102 via the interface device 114. As described above, once a particular automated biological processing unit 102 is selected, a shuttle 1008 navigates to a holding cell 1004 associated with the selected automated biological processing unit. The shuttle 1008 is coupled to a chassis 1010 positioned within the holding cell 1004. The shuttle 1008 then removes both the chassis 1010 and subsequently the automated biological processing unit 102 from the selected holding cell 1004 by sliding out of the holding cell 1004, and once removed, the shuttle 1008 moves vertically up and down across the multiple holding cells 1004 until the automated biological processing unit 102 reaches the second position 120b. The biological treatment unit 102 can then be accessed by a user.
[0072] When the user is finished using the automated biological processing unit 102, the shuttle 1008 can travel through the series of holding cells 1004 to return the chassis 1010 and automated biological processing unit 102 to the original holding cell 1004. The shuttle 1008 can then return the chassis 1010 and automated biological processing unit 102 to the original holding cell 1004 before the shuttle 1008 decouples from the chassis 1010. The shuttle 1008 is then free again to allow the user to access another biological processing unit 102.
[0073] A further embodiment of an automated selection and support structure 1400 is shown in Figures 14-15. The automated selection and support structure 1400 is configured to support a plurality of automated biological processing units 102, and the structure 1400 is capable of positioning each of the plurality of automated biological processing units 102 in either a first position 120a for storage and maintenance or a second position 120b for presenting the automated biological processing units 102 to a user. The automated selection and support structure 1400 includes a housing 1402, a plurality of transport blocks 1404, a first track 1406, a second track 1408, and a coupler 1410. Each of the transport blocks 1404 is positioned and coupled to one of the automated biological processing units 102, and each block 1404 is configured to selectively mate with the coupler 1410. During operation, a user selects one of the multiple automated biological processing units 102, and the coupler 1410 navigates to the location of the transport block 1404 of the selected automated biological processing unit 102 using the first track 1406 and the second track 1408. Once positioned, the coupler 1410 engages with the transport block 1404 associated with the selected automated biological processing unit 102. The automated biological processing unit 102 is then transferred from the first position 120a to the second position 120b using the first track 1406 and the second track 1408. Each biological processing unit 102 operates independently and may be translated between the first position 120a and the second position 120b, allowing for optimization of space utilization while simultaneously maintaining the utility of the biological processing unit 102.
[0074] One of the multiple transport blocks 1404 is positioned for each of the automated biological processing units 102. As shown in FIG. 15, each transport block 1404 is positioned internally relative to a housing 1402 of the automated biological processing unit 102 (not shown in FIG. 15), while each automated biological processing unit 102 is positioned externally relative to the housing 1402. The automated biological processing units 102 can be attached to and detached from each of the transport blocks 1404 to allow each of the automated biological processing units 102 to be removed from the automated selection and support structure 1400 (e.g., for cleaning, sterilization, repair, etc.). Furthermore, each of the transport blocks 1404 is configured to selectively mate with a coupler 1410 to move both the transport block 1404 and the selected automated biological processing unit 102 from one position to a further position (e.g., the first position 120a and the second position 120b) within the automated selection and support structure 1400.
[0075] 15, the first track 1406 includes a belt 1407 that surrounds the periphery of the first track 1406, and the belt 1407 is configured to move the second track 1408. In an embodiment, the second track 1408 may be moved by a structure other than the belt 1407, such as a chain, rope, band, pulley, ball screw, roller screw, ACME screw, etc. The second track 1408 is coupled to a portion of the belt 1407 such that the position of the second track 1408 relative to the first track 1406 can be controlled as the belt 1407 is rotated around the circumference of the first track 1406. The belt 1407 may include any suitable mechanism to enable movement of the first track 1406 and the second track 1408, including a pulley system, a gear system, a drive belt, bands, spoked wheels and corresponding chains, ball screws, roller screws, ACME screws, etc. In one exemplary embodiment, as shown in FIG. 15, the belt 1407 of the first track 1406 is used to control the height or vertical position of the second track 1408 as it is moved along the first track 1406. Similarly, the second track 1408 includes a belt 1409 that encircles the periphery of the second track 1408. A coupler 1410 is coupled to the belt 1409 of the second track such that the position of the coupler 1410 is controlled as the belt 1409 rotates around the periphery of the second track 1408. In the exemplary embodiment shown in FIG. 15, the belt 1409 controls the horizontal position of the coupler 1410. Thus, the combination of the first track 1406 and the second track 1408 controls both the vertical and horizontal positions of the coupler 1410 and thus the vertical and horizontal movement of the biological processing unit 102 within the support structure 1400. The configurations shown in Figures 14-17 are merely exemplary and other configurations of the first track 1406 and second track 1408 are contemplated.
[0076] FIG. 15 shows the transfer block 1404, the first track 1406, the second track 1408, and the coupler 1410 in more detail. In the exemplary illustration, the first track 1406 and the second track 1408 are positioned perpendicular to one another to move a selected automated biological processing unit 102 in both a first direction (e.g., horizontally) and a second direction (e.g., vertically). The first track 1406 is stationary relative to the housing 1402 of the automated selection and support structure 1400, and the second track 1408 is positioned at least partially perpendicular to the first track 1406. The first track 1406 can move the second track 1408 along the length of the first track 1406, allowing an operator to selectively control the position of the second track 1408 relative to the first track. Additionally, the coupler 1410 is positioned in the second track 1408, and similar to the relationship between the first track 1406 and the second track 1408, the second track 1408 can move the coupler 1410 along the length of the second track. In the exemplary embodiment shown in both FIG. 14 and FIG. 15, the first track 1406 is positioned vertically relative to the base 1403 of the housing 1402, and the second track 1408 is positioned in the first track 1406 and oriented parallel to the base. Thus, as explained above, the second track 1408 can move vertically up and down along the length of the first track 1406. Similarly, the coupler 1410 is positioned in the second track 1408 and can move horizontally along the length of the second track 1408. The speed at which the biological processing unit 102 is moved along the first track 1406 and / or the second track 1408 can be controlled to ensure smooth movement and minimize disturbance to the activation, transduction, proliferation, enrichment, and / or harvesting steps of the cell cultures therein.
[0077] In operation, a user can interact with an interface device 114 (e.g., a computer, tablet, mobile device, etc.) positioned on the housing 1402 to select one of the multiple automated biological processing units 102. The interface device 114 can be physically coupled to the system 1400 or remote from the system 1400 (i.e., handheld or otherwise movable) as described herein. The interface device 114 navigates the coupler 1410 to the location of the selected automated biological processing unit using the first track 1406 and the second track 1408. Once positioned, the coupler 1410 mates with the transport block 1404 associated with the selected automated processing unit 102. The second track 1408 then navigates the coupler 1410, the transport block 1404, and the automated biological processing unit 102 horizontally until they are aligned with the first track 1406. The first track 1406 then vertically translates the second track 1408, which then translates the automated biological processing unit 102 to the second position 120b, which is presented to the user (see 1440 in FIG. 14). To return the automated processing unit 102 from the second position 120b to the first position 120a, the described process can be reversed.
[0078] The housing 1402 contains the mechanisms required to operate and move the first track 1406, the second track 1408, the coupler 1410, the electronic system as described in the previous embodiment, the gas supply system as described in the previous embodiment, and any ventilation or thermal management components that may be required. The housing 1402 includes a base 1403 located at the bottom of the housing 1402. As shown in Figures 16 and 17, the housing 1402 includes an electrical system 108 and a gas supply system 110 operably coupled (i.e., connected to enable power, control, data transfer, and gas supply and return) to each of the multiple biological treatment units 102 via connecting conduits 1405. The connecting conduits 1405 are configured to move and remain attached to and follow each of the automated biological treatment units 102 as the automated biological treatment units transition from the first position 120a to the final position. 16 and 17 show the configuration of the electrical system 108 and gas supply system 110 for a single biological treatment unit 102. Additional electrical and gas supply systems for additional biological treatment units 102 can be similarly arranged.
[0079] In an embodiment, the electrical system 108 and / or the gas system 110 can be connected to each of the multiple biological treatment units 102 via a single connecting axis. For example, FIG. 16 shows a connecting conduit 1405 connecting the electrical system and the gas supply system connected to a single biological treatment unit 102 in a first position 120a, while FIG. 17 shows a connecting conduit 1405 connecting a single biological treatment unit 102 in a second position 120b. As shown, the connecting conduit 1405 maintains the connection between the biological treatment unit 102, the electrical system 108, and the gas supply system 110 while the automated biological treatment unit 102 transitions between the first position 120a and the final position. In an embodiment, each biological treatment unit 102 is coupled to the electrical system 108 and the gas supply system 110 by the connecting conduit 1405 in a manner similar to that shown in FIG. 16 and FIG. 17. As mentioned, each processing unit 102 may be supplied by its own electrical and gas supply systems, so that appropriate modifications can be made to the electricity and / or gas provided to individual processing units 102 as desired or required.
[0080] As shown throughout Figures 16-17, when a biological treatment unit 102 translates from a first position 120a to a second position 120b, a connecting conduit 1405 connected to the biological treatment unit 102 moves with it. For example, the connecting conduit 1405 can be pulled along with the biological treatment unit 102 by moving the biological treatment unit 102 through the first track 1406 and the second track 1408. As shown in Figure 16, a first guide 1401a is disposed adjacent to the transport block 1404 of a desired biological treatment unit 102 that is translated from the first position 120a to the second position 120b. As the transport block 1404 translates, it pulls the connecting conduit 1405 with it, which is directed through the first guide 1401a and the second guide 1401b disposed within the housing 1402. As the transport block 1404 continues to pull on the connecting conduit 1404, the second guide 1401b begins to translate in a direction towards the first guide 1401a to provide sufficient slack in the connecting conduit 1405 to allow the biological treatment unit 102 to complete its movement towards the second position 120b without excessive tension building up in the connecting conduit 1405, as illustrated in Figure 17. The first track 1406 and the second track 1408 may thus receive the connecting conduit 1405 on, within, or around themselves in a manner that would prevent any interruption in the connections from the electrical supply system 108 and the gas supply system 110 to the biological treatment unit 102. For example, the connecting conduit 1405 can be pulled through or across the first track 1406 and the second track 1408 via the first guide 1401a and the second guide 1401b to allow easier translation of the connecting conduit 1405 and prevent pinching, kinking, breaking, or general damage to the connecting conduit 1405.
[0081] Similar to the embodiments described above, a thermal management system 112, as shown in FIGS. 14-17, may be included in the automated selection and support system 1400. The thermal management system 112 may be positioned either internally or externally relative to the automated selection and support structure 1400. The thermal management system 112 is configured to keep each of the automated biological processing units 102 at a relatively consistent temperature (e.g., ±5° C.). As previously described, the automated biological processing units 102 require a consistent temperature to operate properly. It is contemplated that each automated biological processing unit 102 may generate heat, and in some embodiments, the thermal management system 112 may be used to remove any heat from each of the automated biological processing units 102. As previously described, the thermal management system 112 may be positioned externally relative to the automated support and selection structure 1400. For example, multiple automated selection and support systems 1400 may be positioned in a temperature-controlled room, and the thermal management system 112 may be configured to control the temperature of the room or provide live data regarding the temperature of the units 102 to an external ventilation system. If positioned internally, the ventilation system 112 may use multiple fans to either push or pull ambient air across the surfaces of each of the automated biological treatment units 102, or may use a fluid-based thermal management system with fluid paths from each biological treatment unit 102 to each other connecting via conduits 1405, as described herein.
[0082] 18 illustrates an end user 1500 interacting with the fifth embodiment of the automated selection and support system 1400. The end user 1500 interacts with an interface device 114 (or, in an embodiment, a remote / separate interface device 114 (not shown)) disposed on the housing 1402 to input commands and translate the biological processing unit 102 from the first position 120a to the second position 120b, consistent with the embodiments described herein. In the second position 120b, the biological processing unit 102 is positioned in a manner that allows easy access by the end user 1500, i.e., at a position level at a point between the knees and head of the end user 1500. The end user 1500 can then perform a desired task on the biological processing unit 102 while in the second position 120b, and upon completion, input a command via the interface device to return the biological processing unit 102 to the first position 120a, as illustrated in FIG. 19. Throughout this procedure of translating the biological treatment unit 102 from the first position 120a to the second position 120b and then back to the first position 120a, the biological treatment unit 102 can maintain its automated functions as directed by the thermal management system 112, the interface device 114, and / or the system architecture 800, as described in more detail herein.
[0083] 19 and 20 further show a transport platform 1502 disposed on the base 1403 of the housing 1402. In an embodiment, the transport platform 1502 can incorporate elements for moving the entire housing 1402 of the automated selection and support system 1400, such as, but not limited to, wheels, tracks, ball bearings, etc. The transport platform 1502 can be raised or lowered from a rest position to a moving position, where the elements are not in contact with the ground / are in contact with the ground, respectively. In the moving position, the transport platform 1502 allows for easy relocation of the housing 1402 within a clinical or hospital environment, or other cell therapy operation manufacturing environment. Once at the desired location, the transport platform 1502 can be raised to a rest position to secure the housing 1402 in place and prevent any undesired movement from the desired location. The transport platform 1502 can also include elements for locking or securing the housing to a floor, including various screws, pins, etc. In an embodiment, the transport platform 1502 may be completely removable or detached from the base 1403 of the housing 1402 once the housing 1402 is in a desired location. Once the transport platform 1502 is removed, the base 1403 may include elements for anchoring or securing the housing 1402 to a floor, including various screws, pins, etc.
[0084] 20 further illustrates a side view of the automated selection and support system 1400 with the internal components partially exposed. The first track 1406 and belt 1407 are shown engaged with the second track 1408, all within the housing 1402. The second track 1408 is shown disposed near the top of the first track 1406 for either engaging the transport block 1404 of the desired biological processing unit 102 to be translated to the second position 120b, or for returning the desired biological processing unit 102 to the first position 120a. This position of the second track 1408 is consistent with the track positioning shown in FIG. 17 and described in further detail herein. A push button housing 1504 may be disposed on the side of or within the housing 1402 and may include multiple means of hardware interactivity such as a main power switch, a seal release switch, a cassette release switch, a power outlet, a data outlet (such as a coaxial or Ethernet connection), a USB port, a fiber optic port, a gas connection port, etc. A chassis 1506 may be further provided on or within the housing 1402 and may provide additional Ethernet, gas, or electrical connection capabilities. In an embodiment, the chassis 1506 may house a breaker switch, a motherboard, a processing unit, a router, a modem, or a means for data storage (e.g., HDD, SSD, etc.).
[0085] 21 and 22 show further elevation and perspective views, respectively, of the automated selection and support system 1400 with multiple biological treatment units 102 in a first position 120a. Each biological treatment unit 102 may operate independently and be translated between a first position 120a and a second position 120b (as previously shown in FIGS. 18 and 19), allowing for optimization of space utilization while simultaneously maintaining the availability of the biological treatment units 102. The thermal management system 112 may be disposed on or in the housing 1402, or may be disposed as a separate component (not shown) outside the housing 1402. FIGS. 21 and 22 show an embodiment of a transport platform 1502 connected to the base 1402 in a resting position retracted within the base 1402 (not visible in FIGS. 21 and 22).
[0086] 23A and 23B show one embodiment of a system architecture 800 for an automated selection and support system 100 / 200 / 600 / 1000 / 1400 described herein, divided by line AA. In an embodiment, the system architecture 800 includes a housing centralized functionality 810 and a biological treatment unit centralized functionality 830. The housing centralized functionality 810 can include a rack mount 812 disposed on the housing 106 / 206 / 606 / 1006 / 1402 of the respective automated selection and support system 100 / 200 / 600 / 1000 / 1400 described herein to receive / hold various components and technologies such as a power distribution unit 814, a power supply 816, a tree (system) motor driver 818, a fan controller / monitor 820, and / or an interface device 114, among others. In an embodiment, the electrical system 108 may include a power distribution unit 814, a power source 816, and / or an interface device 114 operably connected to and responsible for providing electrical energy to each of the multiple biological treatment units 102, the tree motor driver 818 and / or the tree motor, the fan controller / monitor 820 and / or the cooling fan, the interface device 114, and / or any other electrical device disposed on, in, or near the housing 106 / 206 / 606 / 1006 / 1402 of each automatic selection and support system 100 / 200 / 600 / 1000 / 1400 described herein.
[0087] In an embodiment, the gas supply system 110 may include a gas input 828 for providing gas to each of the multiple biological treatment units 102 through the housing 106 / 206 / 606 / 1006 / 1402 of the respective automated selection and support system 100 / 200 / 600 / 1000 / 1400 described herein. In an embodiment, the interface device 114 may include a serial communicator 822, including but not limited to a CAN bus or an RS-485 bus, a network adapter / connector 824 (such as a PCIe card), and / or a storage device 826, including but not limited to an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a solid state storage device, or any suitable combination thereof. The storage devices may form, for example, a computer diskette, a hard disk drive (HDD), a solid state drive (SDD), a random access memory (RAM), a read only memory (ROM), an erasable programmable read only memory (EPROM or flash memory), a static random access memory (SRAM), a portable compact disk read only memory (CD-ROM), a digital versatile disk (DVD), and / or a memory stick. In an embodiment, the storage device 826 may include data storage virtualization technologies such as a redundant array of independent disks (RAID).
[0088] In general, the housing centralized functionality 810 may provide energy, communications, data, and / or any other necessary resources to the biological processing unit centralized functionality 830. In an embodiment, the biological processing unit centralized functionality 830 may include a power regulator 834, a gas regulator 836, and / or a multipoint control unit (MPU) 832. For example, the MPU 832 of each individual biological processing unit 102 may include or be capable of performing / controlling multiple functions on or within the respective biological processing unit 102, including, but not limited to, heating / cooling control, gas control, tilt control (for each orientation of the multiple biological processing units 102), fan control, data memory (i.e., non-volatile), pump control, valve actuator control, seal control, door control, magnetic separation control, and / or elapse time indication, among other functions. These functions / features of each biological treatment unit 102 may be autonomous, such that each biological treatment unit 102 may individually regulate and adjust these various characteristics to maintain a desired environment within the biological treatment unit 102.
[0089] As the biological processing units 102 are automatically adjusted over time, data is generated and stored in a data memory. The data collected and stored by the memory of each of the centralized functionality 830 of the multiple biological processing units 102 may be updated in real time and accessible remotely via the interface device 114 or via a wired or wireless LAN connection, as described further herein. In embodiments, the data may include measured power (e.g., in watts), measured gas supply (e.g., in cubic feet or cubic meters), gas concentration, status of the cell sample, number of cells in the sample, measured volume of sample (e.g., in liters), temperature within the biological processing unit 102, automatic temperature adjustment, automatic power adjustment, automatic gas supply adjustment, status of pumps, valves, seals, doors, fan(s), motors, motor drivers, gas regulators, electroporation activity, and / or magnets (e.g., on or off, open or closed, active or inactive, etc.), logged end user input, tilt angle of the biological processing unit 102, elapse time, and / or any other information regarding the biological processing unit 102, the cell sample, the respective automated selection and housing 106 / 206 / 606 / 1006 / 1402 of the support system 100 / 200 / 600 / 1000 / 1400, and its various components described herein.
[0090] In an embodiment, the electrical system 108 and / or the gas system 110 can be connected to each of the multiple biological treatment units 102 via a single connection axis. For example, electricity and gas may be provided to each of the multiple biological treatment units 102 from the housing centralized functionality 810 at or through a single point, such as at the location of each biological treatment unit 102's respective transport block 1404 or coupler 1410. In an embodiment, the single connection axis can be established anywhere on or within the body of the biological treatment unit 102.
[0091] In an exemplary embodiment shown in FIG. 24, the automated selection or support system 100 / 200 / 600 / 1000 / 1400 may further include a centralized analytical structure 840 for collection, analysis, and presentation of data from each individual biological processing unit 102 in an automated manner. Each biological processing unit 102 may be connected to the centralized analytical structure 840 via sterile closed fluid tubing that will transport samples of cells, cellular material, and / or culture medium to the centralized analytical structure 840 platform for processing and evaluation. In an embodiment, the centralized analytical structure 840 may be disposed inside each of the biological processing units 102. The transported samples may then be analyzed to provide metrics for variables including, but not limited to, cell counts, cell viability, cell phenotype, dissolved gas concentrations, cell activation status, transduction efficiency, transfection efficiency, potency, cytokine secretion, metabolites, sterility, and / or endotoxin analysis. Exemplary analytical structures include various instruments such as spectrometers (UV / VIS, mass, etc.), particle size analyzers, fluorescence-based analyses (e.g., fluorometers, FACS, etc.), absorbance spectrometers, etc. These generated metrics can be automatically provided as data to a centralized computer system that includes or is separate from the interface device 114 for display to an end user. Thus, the interface device 114 can provide automatically updating data regarding the above determined metrics for each sample provided from each of the multiple biological processing units 102. In an embodiment, the centralized computer system or interface device 114 may be integral with the centralized analytical structure 840 (not shown). The centralized computer system or interface device 114 may further include connectivity to the housing centralized functionality 810.
[0092] A standard in-line analytical configuration may require a 1:1 ratio of manufacturing platforms (e.g., biological processing units 102) to centralized analytical structures 840. For example, each biological processing unit 102 may require its own separate analytical structure 840 to monitor and provide the metrics / data previously described herein, or analytical structures can be used for multiple biological processing units. Alternatively, the present invention presents a centralized analytical structure 840 (or, in an embodiment, housing centralized functions 810) configured to provide an X:1 ratio of biological processing units 102 (represented as a value X, where value X can be 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) to centralized analytical structure 840 or housing centralized functions 810. Advantages of integrating a centralized analytical structure 840 may include reduced hardware and / or software costs, improved ease of hardware / software maintenance, improved batch consistency, reduced chance of batch failure, and simplified release testing process, among other benefits.
[0093] It should be understood that the various aspects disclosed herein may be combined in different combinations than those specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, added, merged, or omitted entirely (e.g., not all described acts or events may be necessary to practice the present technology). Furthermore, although certain aspects of the present disclosure are described as being performed by a single module or unit for clarity, it should be understood that the technology of the present disclosure may be performed by any combination of units or modules associated therewith.
[0094] Further embodiments include the following.
[0095] Embodiment 1 is an automated selection and support system comprising: a plurality of automated biological processing units, each of the plurality of automated biological processing units being translatable between at least a first position for storing and maintaining the plurality of automated biological processing units and a second position for presenting at least one or more of the plurality of automated biological processing units; a movable support structure for transitioning each of the plurality of automated biological processing units between the first position and the second position; an electrical system including a power source and an interface device, both of which are operably connected to each of the plurality of automated biological processing units and the movable support structure; and a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological processing units.
[0096] Embodiment 2 is the system of embodiment 1, wherein the supply system and the gas-electric system are both operatively connected to each of the automated biological treatment units via a single connecting axis.
[0097] Embodiment 3 is a system described in embodiment 1 or embodiment 2, in which the multiple biological processing units are translatable to multiple positions between a first position for storage and maintenance and a second position for presenting at least one or more of the multiple automated biological processing units.
[0098] Embodiment 4 is a system described in any one of embodiments 1 to 3, wherein the multiple biological processing units are autonomous such that each of the multiple biological processing units individually regulates and adjusts various functions and controls to maintain a desired environment within each of the multiple automated biological processing units in real time.
[0099] Embodiment 5 is the system of embodiment 4, wherein the various functions and controls include heating control, cooling control, gas control, tilt control, fan control, data memory, pump control, valve actuator control, seal control, door control, magnetic separation control, and / or eruption time display.
[0100] Embodiment 6 is a system described in any one of embodiments 1 to 5, wherein translating at least one of the multiple automated biological processing units does not affect the activation, transduction, expansion, enrichment, and / or harvesting steps of the cell culture in the remaining multiple automated biological processing units.
[0101] Embodiment 7 is the system of embodiment 1, further comprising a thermal management system configured to circulate a fluid to heat or cool each of the plurality of automated biological treatment units.
[0102] Embodiment 8 is the system of embodiment 7, wherein the thermal management system circulates fluid within each of the multiple automated biological treatment units.
[0103] Embodiment 9 is a system described in any one of embodiments 1 to 8, wherein the interface device is a separate unit that allows remote access / connection.
[0104] A tenth embodiment is a system according to any one of the first to eighth embodiments, wherein the interface device is physically coupled to the system.
[0105] Embodiment 11 is a system described in any one of embodiments 1 to 10, wherein the electrical system operatively controls the movable support structure so that the automated biological treatment unit is maintained in a horizontal position while transitioning between the first position and the second position.
[0106] Embodiment 12 is a system described in embodiment 11, wherein the electrical system operatively controls the movable support structure such that any fluid within the biological treatment chamber inside the automated biological treatment unit is maintained in a static or laminar flow state during transition from the first position to the second position.
[0107] Embodiment 13 is an automated selection and support system comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the plurality of automated biological treatment units and a second position for presenting the automated biological treatment units to a user; a plurality of swing arms, each swing arm including a first end operably coupled to one of the plurality of automated biological treatment units and a second end operably coupled to a drive motor configured to rotate the swing arm to transition the automated biological treatment unit between the first position and the second position, the swing arms maintaining the automated biological treatment units rotationally horizontal; an electrical system including a power source and an interface device, both of which are operably coupled to each of the plurality of automated biological treatment units and the drive motor; and a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units.
[0108] Example 14 is the system described in example 13, wherein the drive motor is operably coupled to the second end of the swing arm via the active control device, and the second end further includes a gear.
[0109] Embodiment 15 is the system of embodiment 13 or embodiment 14, wherein the first end of the swing arm includes a pivot point for maintaining the automated biological treatment unit rotationally level.
[0110] Embodiment 16 is any one of the systems described in embodiments 13 to 15, further comprising a thermal management system configured to circulate a fluid to heat or cool each of the plurality of automated biological treatment units.
[0111] Example 17 is the system of any one of Examples 13-16, wherein the electrical system, the gas supply system, and / or the thermal management system are positioned within a housing that supports the multiple swing arms.
[0112] Embodiment 18 is the system of embodiment 16, wherein the thermal management system circulates fluid within each of the plurality of automated biological treatment units.
[0113] Embodiment 19 is a system described in any one of embodiments 13 to 16, wherein both the electrical system and the gas supply system are operably connected to each of the automated biological treatment units via a single connection axis.
[0114] Embodiment 20 is an automated selection and support system comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the plurality of automated biological treatment units and a second position for presenting the automated biological treatment units to a user; a plurality of vertical rails; a gantry configured to move on the vertical rails and select one of the automated biological treatment units and transition the automated biological treatment unit between the first position and the second position; an electrical system including a power source and an interface device, both of which are operably coupled to each of the plurality of automated biological treatment units; and a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units, wherein the vertical rails, the electrical system, the gas supply system, and / or the thermal management system are contained within a housing.
[0115] Embodiment 21 is a system described in embodiment 20, wherein the gantry includes at least two horizontal sliders.
[0116] Embodiment 22 is a system described in embodiment 20 or embodiment 21, comprising four vertical rails.
[0117] Embodiment 23 is a system described in any one of embodiments 20 to 22, further comprising a plurality of holding shelves configured to hold each of the automated biological processing units, and the gantry is further configured to selectively couple to a single holding shelf among the plurality of holding shelves.
[0118] Embodiment 24 is the system described in embodiment 23, wherein the gantry is further configured to move the single holding cell independently both horizontally and vertically.
[0119] Embodiment 25 is an automated selection and support system comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the plurality of automated biological treatment units and a second position for presenting the automated biological treatment units to a user; a plurality of modular holding cells configured to hold one of the automated biological treatment units, respectively; a shuttle configured to move between each of the modular holding cells to select one of the automated biological treatment units and transition the automated biological treatment unit between the first position and the second position; an electrical system including a power source and an interface device, both of which are operably coupled to each of the automated biological treatment units; and a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units, wherein the electrical system, the gas supply system, and / or the thermal management system are contained within a housing.
[0120] Embodiment 26 is the system described in embodiment 25, further including a plurality of chassis, each chassis positioned within a single holding cell, supporting one of the automated biological processing units, and configured to transition the automated biological processing units between the first position and the second position.
[0121] Embodiment 27 is the system described in embodiment 26, wherein the shuttle is configured to selectively couple to each of the chassis.
[0122] Embodiment 28 is the system described in embodiment 27, wherein the shuttle is configured to independently move the chassis both horizontally and vertically relative to the modular holding cells.
[0123] Embodiment 29 is the system of any one of embodiments 25 to 28, wherein the electrical system interface device is positioned within the shuttle.
[0124] Embodiment 30 is an automated selection and support system comprising a plurality of automated biological processing units, each of the plurality of automated biological processing units having a first position for storing and maintaining the plurality of automated biological processing units and a second position for presenting the automated biological processing units to a user, a plurality of transport blocks, each transport block configured to couple to one of the plurality of automated biological processing units, a coupler configured to mate with one of the blocks of the plurality of blocks, a first track configured to move the coupler in a first direction, and a first transport block configured to couple to one of the plurality of transport blocks. An automated selection and support system comprising: a second track configured to move the track in a second direction, the second track being substantially perpendicular to the first track; an electrical system including a power source and an interface device, both of which are operably connected to each of the plurality of automated biological processing units and the transport block; and a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological processing units, wherein the first track and the second track are configured to move one of the plurality of automated biological processing units from a first position to a second position.
[0125] Embodiment 31 is the system described in embodiment 30, further comprising a housing having a first guide and a second guide disposed therein for guiding at least one of the power supply and / or gas lines connected to each of the plurality of automated biological processing units through the housing.
[0126] Embodiment 32 is a system according to embodiment 30 or embodiment 31, wherein the power supply line and the gas line are connected to each of the multiple automated biological treatment units via a single connecting axis.
[0127] Embodiment 33 is a system described in any one of embodiments 30 to 32, wherein moving one of the multiple automated biological processing units from a first position to a second position does not affect the activation, transduction, expansion, enrichment, and / or harvesting steps of the cell culture in the remaining multiple automated biological processing units.
[0128] Embodiment 34 is the system of any one of embodiments 30 to 33, further comprising a thermal management system configured to circulate fluid to each of the plurality of automated biological treatment units.
[0129] Embodiment 35 is the system of embodiment 34, wherein the thermal management system circulates fluid within each of the plurality of automated biological treatment units.
[0130] Embodiment 36 is a system described in any one of embodiments 30 to 35, wherein the interface device is a separate unit that allows remote access / connection.
[0131] Embodiment 37 is a system according to any one of embodiments 30 to 35, wherein the interface device is physically associated with the system.
[0132] Embodiment 38 is a system described in any one of embodiments 30 to 37, wherein the multiple biological processing units are translatable to multiple positions or nth positions between a first position for storage and maintenance and a final position for presenting at least one or more of the multiple automated biological processing units.
[0133] Embodiment 39 is a system described in any one of embodiments 30 to 38, wherein the multiple biological processing units are autonomous such that each of the multiple biological processing units individually regulates and adjusts various functions and controls to maintain a desired environment within each of the multiple automated biological processing units in real time.
[0134] Embodiment 40 is a system described in any one of the preceding embodiments, wherein each of the multiple biological processing units connects to a centralized analytical structure for collection, analysis, and presentation of metrics regarding samples transported from each of the multiple biological processing units to the centralized analytical structure.
[0135] Embodiment 41 is a method for presenting an automated biological treatment unit to a user, comprising: selecting an automated biological treatment unit from an automated selection and storage system, the automated selection and storage system including a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the automated biological treatment unit and a second position for presenting the automated biological treatment unit to a user; a movable support structure for transitioning each of the plurality of automated biological treatment units between the first position and the second position; an electrical system including a power source and an interface device, both of which are operably connected to each of the plurality of automated biological treatment units and the movable support structure; and a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units; transitioning the selected automated biological treatment unit from the first position to the second position using the movable support structure; and returning the selected automated biological treatment unit from the second position to the first position.
Claims
1. 1. An automated selection and support system, comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units being translatable between at least a first position for storing and maintaining the plurality of automated biological treatment units and a second position for presenting at least one or more of the plurality of automated biological treatment units; a movable support structure for transitioning each of the plurality of automated biological treatment units between the first position and the second position; an electrical system including a power source and an interface device, both of which are operably connected to each of the plurality of automated biological treatment units and to the movable support structure; a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units; An automated selection and support system comprising:
2. 10. The system of claim 1, wherein both the electrical system and the gas supply system are operatively connected to each of the automated biological treatment units via a single connecting axis.
3. 3. The system of claim 1 or 2, wherein the plurality of biological treatment units are translatable to a plurality of positions between the first position for storage and maintenance and the second position for presenting the at least one or more of the plurality of automated biological treatment units.
4. The system of any one of claims 1 to 3, wherein the plurality of biological treatment units are autonomous such that each of the plurality of biological treatment units individually regulates and adjusts various functions and controls to maintain a desired environment within each of the plurality of automated biological treatment units in real time.
5. 5. The system of claim 4, wherein the various functions and controls include heating control, cooling control, gas control, tilt control, fan control, data memory, pump control, valve actuator control, seal control, door control, magnetic separation control, and / or eruption time display.
6. The system of any one of claims 1 to 5, wherein translating at least one of the plurality of automated biological processing units does not affect activation, transduction, expansion, enrichment, and / or harvesting steps of cell cultures in the remaining plurality of automated biological processing units.
7. a thermal management system configured to circulate a fluid to heat or cool each of the plurality of automated biological treatment units; The system of claim 1 further comprising:
8. The system of claim 7 , wherein the thermal management system circulates the fluid within each of the plurality of automated biological treatment units.
9. A system according to any preceding claim, wherein the interface device is a separate unit allowing remote access / connection.
10. The system of any one of claims 1 to 8, wherein the interface device is physically coupled to the system.
11. The system of any one of claims 1 to 10, wherein the electrical system operatively controls the movable support structure such that the automated biological treatment unit is maintained in a horizontal position while transitioning between the first and second positions.
12. The system of claim 11, wherein the electrical system operatively controls the movable support structure such that any fluid within a biological treatment chamber within the automated biological treatment unit is maintained in a static or laminar flow state during the transition from the first position to the second position.
13. 1. An automated selection and support system, comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the plurality of automated biological treatment units and a second position for presenting the plurality of automated biological treatment units to a user; A plurality of swing arms, each swing arm comprising: a first end operably coupled to an automated biological treatment unit of the plurality of automated biological treatment units; a second end operably coupled to a drive motor, the drive motor configured to rotate the swing arm to transition the automated biological treatment unit between the first position and the second position; The swing arm maintains the automated biological treatment unit rotationally level; an electrical system including a power source and an interface device, both of which are operably coupled to each of the automated biological treatment units and to the drive motor; a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units; An automated selection and support system comprising:
14. 14. The system of claim 13, wherein the drive motor is operatively coupled to the second end of the swing arm via an active control device, the second end further including a gear.
15. 15. The system of claim 13 or 14, wherein the first end of the swing arm includes a pivot point for maintaining the automated biological treatment unit rotationally level.
16. a thermal management system configured to circulate a fluid to heat or cool each of the plurality of automated biological treatment units; The system according to any one of claims 13 to 15, further comprising:
17. The system of any one of claims 13 to 16, wherein the electrical system, the gas supply system, and / or the thermal management system are positioned within a housing that supports the plurality of swing arms.
18. 17. The system of claim 16, wherein the thermal management system circulates the fluid within each of the plurality of automated biological treatment units.
19. The system of any one of claims 13 to 16, wherein both the electrical system and the gas supply system are operatively connected to each of the automated biological treatment units via a single connecting axis.
20. 1. An automated selection and support system, comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the plurality of automated biological treatment units and a second position for presenting the plurality of automated biological treatment units to a user; A plurality of vertical rails; a gantry configured to move on the vertical rail to select one of the automated biological processing units and to transition the automated biological processing unit between the first position and the second position; an electrical system including a power source and an interface device, both of which are operably coupled to each of the automated biological treatment units; a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units; Equipped with The automated selection and support system, wherein the vertical rails, the electrical system, the gas supply system, and / or the thermal management system are contained within a housing.
21. The system of claim 20 , wherein the gantry comprises at least two horizontal sliders.
22. 22. A system according to claim 20 or 21, comprising four vertical rails.
23. The system of any one of claims 20 to 22, further comprising a plurality of holding shelves configured to hold each of the automated biological processing units, the gantry further configured to selectively couple to a single holding shelf of the plurality of holding shelves.
24. 24. The system of claim 23, wherein the gantry is further configured to independently move a single holding cell both horizontally and vertically.
25. 1. An automated selection and support system, comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the plurality of automated biological treatment units and a second position for presenting the plurality of automated biological treatment units to a user; a plurality of modular holding cells, each configured to hold one of the automated biological treatment units; a shuttle configured to move between each of the modular holding cells to select one of the automated biological treatment units and transition the automated biological treatment unit between the first position and the second position; an electrical system including a power source and an interface device, both of which are operably coupled to each of the automated biological treatment units; a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units; Equipped with The automated selection and support system, wherein the electrical system, the gas supply system, and / or the thermal management system are contained within a housing.
26. 26. The system of claim 25, further comprising a plurality of chassis, each chassis positioned within a single holding cell and configured to support one of the automated biological processing units and to transition the automated biological processing unit between the first position and the second position.
27. 27. The system of claim 26, wherein the shuttle is configured to selectively couple to each of the chassis.
28. 30. The system of claim 27, wherein the shuttle is configured to independently move the chassis both horizontally and vertically relative to the modular holding cells.
29. A system according to any one of claims 25 to 28, wherein the interface device of the electrical system is positioned within the shuttle.
30. 1. An automated selection and support system, comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the plurality of automated biological treatment units and a second position for presenting the plurality of automated biological treatment units to a user; a plurality of transport blocks, each transport block configured to couple to one of the plurality of automated biological processing units; a coupler configured to mate with one of the blocks; and a first track configured to move the coupler in a first direction; a second track configured to move the first track in a second direction, the second track being substantially perpendicular to the first track; and an electrical system including a power source and an interface device, both of which are operably connected to each of the plurality of automated biological processing units and the transfer block; a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units; Equipped with The automated selection and support system, wherein the first truck and the second truck are configured to move one of the plurality of automated biological processing units from the first location to the second location.
31. 31. The system of claim 30, further comprising a housing having a first guide and a second guide disposed therein for guiding at least one of the power sources and / or the gas lines connected to each of the plurality of automated biological treatment units through the housing.
32. 32. The system of claim 30 or 31, wherein the power and gas lines are connected to each of the plurality of automated biological treatment units via a single connecting axis.
33. The system of any one of claims 30 to 32, wherein moving one of the plurality of automated biological processing units from the first position to the second position does not affect activation, transduction, expansion, enrichment, and / or harvesting steps of cell cultures in the remaining plurality of automated biological processing units.
34. a thermal management system configured to circulate fluid through each of the plurality of automated biological treatment units; The system of any one of claims 30 to 33, further comprising:
35. 35. The system of claim 34, wherein the thermal management system circulates the fluid within each of the plurality of automated biological treatment units.
36. A system according to any one of claims 30 to 35, wherein the interface device is a separate unit allowing remote access / connection.
37. A system according to any one of claims 30 to 35, wherein the interface device is physically associated with the system.
38. The system of any one of claims 30 to 37, wherein the plurality of biological processing units are translatable to a plurality of positions or nth positions between the first position for storage and maintenance and a final position for presenting the at least one or more of the plurality of automated biological processing units.
39. The system of any one of claims 30 to 38, wherein the plurality of biological treatment units are autonomous such that each of the plurality of biological treatment units individually regulates and adjusts various functions and controls to maintain a desired environment within each of the plurality of automated biological treatment units in real time.
40. 11. The system of any one of the preceding claims, wherein each of the plurality of biological processing units connects to a centralized analytical structure for collection, analysis, and presentation of metrics related to samples transported from each of the plurality of biological processing units to the centralized analytical structure.
41. 1. A method for presenting an automated biological processing unit to a user, comprising: selecting an automated biological treatment unit from an automated selection and storage system, the automated selection and storage system comprising: a plurality of automated biological treatment units, each of the plurality of automated biological treatment units having a first position for storing and maintaining the automated biological treatment unit and a second position for presenting the automated biological treatment unit to a user; a movable support structure for transitioning each of the plurality of automated biological treatment units between the first position and the second position; an electrical system including a power source and an interface device, both of which are operably connected to each of the plurality of automated biological treatment units and to the movable support structure; a gas supply system including a gas line fluidly coupled to each of the plurality of automated biological treatment units; transitioning the selected automated biological processing unit from the first position to the second position using the movable support structure; returning the selected automated biological processing unit from the second position to the first position; A method comprising:
Citation Information
Patent Citations
Culture apparatus and culture method
JP2019000043A
End-to-End Cell Therapy Automation
JP2020528284A
Method and system for bioreaction
US20100316446A1
Carousel for modular biologic production units
US20200200781A1