Control method of cell therapy device

Abstract

The present application discloses a control method for a cell therapy device. The control method for the cell therapy device includes: injecting a cell solution containing a culture medium into a first container, and activating cells in the first container; releasing the cell solution in the first container into a second container for filtration, releasing the cell solution after filtering out the culture medium into a third container, and injecting a virus solution and a new culture medium into the third container for gene transduction of cells; releasing the cell solution after gene transduction into a fourth container for filtration, and releasing the cell solution after filtering out the culture medium into a fifth container for cell amplification, and regularly checking whether the amplified cells in the fifth container are qualified. The present application can solve the problem that the device used for CAR T cell preparation in the prior art is time-consuming and labor-intensive, and has a relatively low yield when preparing CAR T cells.

Description

Technical Field

[0001] The present application relates to the field of medical device control technology, and in particular, to a control method for a cell therapy device. Background Art

[0002] Recent successful clinical results from immunotherapy trials using chimeric antigen receptor (CAR) T cells have brought new hope to patients with previously incurable cancers. As these novel therapies progress from the clinical trial stage to commercial scale-up, challenges associated with cell manufacturing have emerged.

[0003] CAR T (Chimeric Antigen Receptor T-Cell immunotherapy) is a new type of precision targeted therapy for treating tumors. In recent years, it has achieved good results in clinical tumor treatment through optimization and improvement, especially in the treatment of malignant blood diseases. Therefore, CAR T cell therapy is a very promising new tumor immunotherapy method that is accurate, fast, efficient, and has the potential to cure cancer.

[0004] The CAR T cell therapy process mainly includes the extraction of patient blood samples, separation of T cells, cell activation, gene transduction, cell expansion, cell concentration, cell collection, automated cell processing, etc. At present, some devices used for CAR T cell therapy on the market integrate several of the above steps, but most of them are completed manually, lacking a reasonable control method to control the operation of the device. The cell preparation process is time-consuming and labor-intensive, and the yield rate is relatively low. Summary of the invention

[0005] The main purpose of the present application is to provide a control method for a cell therapy device to solve the problem that the devices used for CAR T cell preparation in the prior art are time-consuming, labor-intensive and have a relatively low yield when preparing CAR T cells.

[0006] According to one aspect of the present application, a control method for a cell therapy device is provided, and the control method for the cell therapy device is used to control the cell therapy device, the cell therapy device includes a main body, a cell therapy mechanism, a collection rack and a collection bag; the main body is provided with a first working chamber, a second working chamber, a cell outlet pipe and a collection bin at intervals; the cell therapy mechanism includes a rotating shaft, a first fixed seat, a second fixed seat, a first container, a second container, a third container, a fourth container, a fifth container, a sixth container, a seventh container and an eighth container, the rotating shaft is rotatably arranged in the first working chamber and the second working chamber, the first fixed seat is arranged in the first working chamber and fixed on the rotating shaft, and a first accommodating cavity is arranged on the first fixed seat, the second fixed seat is arranged in the second working chamber and fixed on the rotating shaft, a second accommodating cavity is arranged on the second fixed seat, and the second accommodating cavity is connected to the first accommodating cavity; the first container, The second container, the third container, the fourth container and the fifth container can be detachably fixed on the first fixing seat, and the first container, the second container, the third container, the fourth container and the fifth container are all provided with a first connecting channel communicating with the first accommodating cavity, and each of the first connecting channels is provided with a first control valve for controlling the opening and closing of the corresponding first connecting channel; the sixth container, the seventh container and the eighth container are detachably fixed on the second fixing seat, and the sixth container, the seventh container and the eighth container are all provided with a second connecting channel communicating with the second accommodating cavity, and each of the second connecting channels is provided with a second control valve for controlling the opening and closing of the corresponding second connecting channel; one end of the cell outlet pipeline is communicated with the fifth container, and the other end of the cell outlet pipeline extends to the collection bin, the collection rack is provided in the collection bin, and the collection bag is detachably mounted on the collection rack;

[0007] The control method of the cell therapy device comprises:

[0008] Step S1: injecting a cell solution containing a culture medium into a first container, and performing cell activation in the first container;

[0009] Step S2: releasing the cell solution in the first container into the second container for filtration, releasing the cell solution after filtering out the culture medium into the third container, and injecting the virus solution and new culture medium into the third container for gene transduction of the cells;

[0010] Step S3: releasing the cell solution that has completed gene transduction into the fourth container for filtration, and releasing the cell solution after filtering out the culture medium into the fifth container for cell amplification, and regularly checking whether the amplified cells in the fifth container are qualified.

[0011] Furthermore, in the step S1, after the cell solution containing the culture medium is injected into the first container, the controller is used to control the rotating shaft of the cell therapy device to drive the first container to reciprocate at a first predetermined speed for a first predetermined time to complete cell activation.

[0012] Furthermore, the first predetermined time is 44 hours to 54 hours.

[0013] Furthermore, in step S2, after the virus solution and new culture medium are injected into the third container, the controller is used to control the rotating shaft of the cell therapy device to drive the third container to swing at a second predetermined speed for a second predetermined time to complete gene transduction.

[0014] Furthermore, the second predetermined time is from 20 hours to 28 hours.

[0015] Furthermore, in step S3, after the cell solution after filtering out the culture medium is released into the fifth container, the controller is used to control the rotating shaft of the cell therapy device to drive the fifth container to swing at a third predetermined speed for a third predetermined time to complete cell expansion.

[0016] Furthermore, the third predetermined time is 7 days to 10 days.

[0017] Further, in step S3, when it is detected that the culture medium in the fifth container is lower than a predetermined amount, the culture medium in the sixth container is released into the fifth container.

[0018] Furthermore, the control method of the cell therapy device further includes:

[0019] Step S4: using a collection bag to collect the qualified cell solution in the fifth container.

[0020] Furthermore, the control method of the cell therapy device further includes:

[0021] Step S5: releasing the unqualified cell solution in the fifth container into the seventh container, and releasing the cleaning solution in the eighth container into the seventh container to clean and filter the cell solution in the seventh container.

[0022] Compared with the prior art, the technical solution of this application has at least the following technical effects:

[0023] The control method of the cell therapy device of the present application can perform highly automated and highly integrated control of processes such as cell activation, cell gene transduction, cell expansion, cell collection, cell cleaning and discharge, greatly reducing the intensity of manual labor, shortening the cell preparation process, and improving the efficiency and yield of cell preparation. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0025] Figure 1 This is a schematic diagram of the structure of the cell therapy device disclosed in this application;

[0026] Figure 2 It is a front view of the cell therapy device disclosed in this application;

[0027] Figure 3 An exploded view of the cell therapy device disclosed in this application;

[0028] Figure 4 It is a schematic diagram of the structure of each container of the cell therapy device disclosed in the present application when it is at a first viewing angle;

[0029] Figure 5 This is a schematic diagram of the structure of a container disclosed in this application;

[0030] Figure 6 This is a schematic diagram of the structure of another container disclosed in this application;

[0031] Figure 7 This is a schematic diagram of the structure of the collection chamber of the cell therapy device disclosed in this application;

[0032] Figure 8 This is a schematic diagram of the working process of the cell therapy device disclosed in this application;

[0033] Fig. 9 This is a flow chart of the control method of the cell therapy device disclosed in this application.

[0034] The above drawings include the following reference numerals:

[0035] 10. Main body; 101. Working chamber; 101a. First working chamber; 101b. Second working chamber; 12. Cell outlet pipe; 13. Collection chamber; 20. Cell therapy mechanism; 21. Rotating shaft; 22. Fixed seat; 221. First fixed seat; 222. Second fixed seat; 23. Container; 230. Semicircular main body; 231. Accommodating chamber; 234. Cover; 236. Filter partition; 23a. First container; 23b. Second container; 23c. Third container; 23d. Fourth container; 23e. Fifth container; 23f. Sixth container; 23g. Seventh container; 23h. Eighth container; 30. Connecting part; 40. Collection rack; 50. Collection bag. DETAILED DESCRIPTION

[0036] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0037] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0038] Unless otherwise specifically stated, the relative arrangement, numerical expressions and numerical values ​​of the parts and steps set forth in these embodiments do not limit the scope of the present application. At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, methods and equipment known to those of ordinary skill in the relevant art may not be discussed in detail, but in appropriate cases, the technology, methods and equipment should be considered as a part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as being merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, and therefore, once a certain item is defined in an accompanying drawing, it does not need to be further discussed in subsequent drawings.

[0039] See also Figures 1 to 3 , Figure 8 According to an embodiment of the present application, a control method for a cell therapy device is provided. The control method for a cell therapy device is used to Figures 1 to 3 Control of cell therapy devices in the

[0040] See also Figures 1 to 3 , Figure 8 As shown, the cell therapy device described in this embodiment includes a main body 10 and a cell therapy mechanism 20.

[0041] The main body 10 is provided with two working chambers 101. For the convenience of distinction, the two working chambers 101 are respectively identified as a first working chamber 101a and a second working chamber 101b. The two working chambers 101 are arranged at intervals along the length direction of the main body 10. In actual operation, the temperature in the first working chamber 101a is controlled at 37 degrees Celsius, which is convenient for cell activation, gene transduction, cell amplification and other operations in the first working chamber 101a; the temperature in the second working chamber 101b is controlled at 4 degrees Celsius, which is convenient for storing culture medium, cleaning fluid and other substances.

[0042] Furthermore, the cell therapy mechanism 20 in this embodiment includes a rotating shaft 21, a fixing seat 22 and a container assembly.

[0043] The rotating shaft 21 is rotatably disposed in the first working chamber 101a and the second working chamber 101b. The fixing seat 22 includes a first fixing seat 221 and a second fixing seat 222. The first fixing seat 221 is disposed in the first working chamber 101a and fixed on the rotating shaft 21, and a first accommodating cavity is disposed in the first fixing seat 221; the second fixing seat 222 is disposed in the second working chamber 101b and fixed on the rotating shaft 21, and a second accommodating cavity is disposed in the second fixing seat 222.

[0044] The container assembly includes 8 independent containers 23, specifically, the 8 containers 23 include a first container 23a, a second container 23b, a third container 23c, a fourth container 23d, a fifth container 23e, a sixth container 23f, a seventh container 23g and an eighth container 23g which are sequentially arranged along the length direction of the rotating shaft 21. The first container 23a, the second container 23b, the third container 23c, the fourth container 23d and the fifth container 23e can be detachably mounted on the first fixing seat 221, and the first container 23a, the second container 23b, the third container 23c, the fourth container 23d and the fifth container 23e are all provided with a first connecting channel for communicating with the first accommodating cavity, and each first connecting channel is provided with a first control valve for controlling the opening and closing of the corresponding first connecting channel. The sixth container 23f, the seventh container 23g and the eighth container 23g can all be detachably mounted on the second fixed seat 222, and the sixth container 23f, the seventh container 23g and the eighth container 23g are each provided with a second connecting channel for communicating with the second accommodating cavity, and each second connecting channel is provided with a second control valve for controlling the opening and closing of the corresponding second connecting channel.

[0045] In this embodiment, the first container 23a is used for cell activation, the second container 23b is used for filtering the activated cells, the third container 23c is used for gene transduction of the cells filtered by the second container 23b, the fourth container 23d is used for filtering the gene transduced cells, the fifth container 23e is used for amplifying the gene transduced cells, the sixth container 23f is used for storing culture medium, the seventh container 23g is used for cleaning and filtering the cells that fail to be cultured, and the eighth container 23g is used for storing cleaning solution. Figure 5As shown, in the actual design process, the structures of the first container 23a, the second container 23b, the third container 23c, the fourth container 23d, the fifth container 23e, the sixth container 23f, the seventh container 23g and the eighth container 23g are basically the same. Specifically, the first container 23a, the second container 23b, the third container 23c, the fourth container 23d, the fifth container 23e, the sixth container 23f, the seventh container 23g and the eighth container 23g all include a semicircular body 230, a cover 234 and a sealing ring (not shown in the figure). Among them, the semicircular body 230 is surrounded to form a receiving cavity 231, and an opening (i.e., an opening at the end of the receiving cavity 231) communicating with the receiving cavity 231 is provided on the semicircular body 230, and a connecting portion 30 is provided on the semicircular body 230, and the connecting portion 30 is used to detachably mount the semicircular body 230 on the first fixing seat 221 or the second fixing seat 222. Optionally, the connecting portion 30 can be a buckle, or a magnetic structure, etc. The cover body 234 is detachably covered on the semicircular body 230 to open or close the opening. The sealing ring is sleeved on the cover body 234 to seal the opening. In actual use, the cover body 234 is covered on the semicircular body 230 to close the opening to prevent the cell solution and the like from leaking out of the receiving cavity 231 during the culture process, and the connecting portion 30 is connected to the fixing seat 22. After use, the connecting portion 30 is disassembled from the fixing seat 22, so that the container 23 can be disassembled from the cell therapy device, and the disassembled cell container can be discarded after being processed.

[0046] In order to facilitate filtering and washing the cell solution, the structures of the second container 23b, the fourth container 23d and the seventh container 23f in this embodiment are different from those of the first container 23a, the third container 23c, the fifth container 23e, the sixth container 23f and the eighth container 23h. Figure 6 As shown, the second container 23b, the fourth container 23d and the seventh container 23f are all provided with a filter partition 236. The filter partition 236 is arranged in the second container 23b, the fourth container 23d and the seventh container 23f, so as to separate the internal cavity of the second container 23b, the fourth container 23d and the seventh container 23f into two independent chambers, so as to store the substances before and after filtration.

[0047] Combination Figures 1 to 8 As shown, the cell therapy device in this embodiment is also provided with a collection rack 40 and a controller (not shown in the figure). The main body 10 is provided with a collection chamber 13 and a cell outlet pipe 12 (as shown in the figure). Figure 8As shown in FIG. 1 , one end of the cell outlet pipe 12 is connected to the fifth container 23e, and the other end extends into the collection chamber 13. The collection rack 40 is slidably installed in the collection chamber 13, and a collection bag 50 is detachably provided on the collection rack 40. The collection bag 50 can be used to communicate with the cell outlet pipe 12 to collect the cell solution.

[0048] Optionally, a driving motor (not shown in the figure) is provided on the main body 10 in this embodiment, and the driving motor is connected to the rotating shaft 21 and is electrically connected to the controller. During actual operation, the driving motor drives the rotating shaft 21 to swing under the control of the controller.

[0049] See also Figures 1 to 9 As shown, in order to control the above-mentioned cell therapy device, the present application provides a control method for a cell therapy device.

[0050] Specifically, the control method of the cell therapy device includes the following steps:

[0051] Step S1: injecting a cell solution containing a culture medium into the first container 23a, and performing cell activation in the first container 23a.

[0052] Before performing step S1, first install the first container 23a, the second container 23b, the third container 23c, the fourth container 23d, the fifth container 23e, the sixth container 23f, the seventh container 23g and the eighth container 23g mentioned above on the first fixing seat 221 and the second fixing seat 222 respectively.

[0053] After completing the assembly of the first container 23a, the second container 23b, the third container 23c, the fourth container 23d, the fifth container 23e, the sixth container 23f, the seventh container 23g and the eighth container 23g, the preparation process of the CAR T cells can be performed.

[0054] Specifically, when preparing CAR T cells, T cells separated from human blood and culture medium for culturing T cells are first injected into the first container 23a, and at the same time, activation substances such as immunomagnetic beads are added to the first container. Specifically, they can be injected into the first container 23a through an injection port reserved on the first container 23a using a syringe or the like.

[0055] After the injection is completed, the controller is used to control the driving motor provided on the main body 10 to work, so as to drive the rotating shaft 21 to rotate, and then drive the first container 23a to swing back and forth at a first predetermined speed for a first predetermined time, so as to activate the cells uniformly. In this step, the rotation angle of the rotating shaft 21 is 0° to 270°, and the specific swing angle can be adjusted according to the mixing and activation of the cell solution.

[0056] The first predetermined speed in this embodiment can also be adjusted according to the activation of the cells and the mixing of the cells with the culture medium and other substances. Optionally, the first container 23a or the first fixed seat 221 in this embodiment is provided with a sensor for detecting the temperature, cell activation status, etc. in the first container 23a, and the detected signal is transmitted to the controller by the sensor, so that the controller can control the driving motor to adjust the rotation angle and rotation speed of the rotating shaft 21. In view of the different activation conditions of the cells, the first predetermined speed and the rotation angle of the rotating shaft 21 are not limited in this application. The specific values ​​can be set on the controller by using the control program after experimental verification, and will not be specifically introduced in this application.

[0057] Furthermore, in this embodiment, the first predetermined time is 44h to 54h, such as 44h, 46h, 48h, 50h or 54h. It can be selected and set according to the properties of the cells to be activated. Taking the preparation of CAR T cells as an example, the first predetermined time is usually 48h.

[0058] Step S2: Release the cell solution in the first container 23a into the second container 23b for filtration, release the cell solution after filtering out the culture medium into the third container 23c, and inject the virus solution and new culture medium into the third container 23c for cell gene transduction.

[0059] Since the culture medium will change or deteriorate during the cell activation process, after completing the cell activation, it is necessary to filter out the culture medium in the first container 23a. The specific operation is that when the driving motor drives the rotating shaft 21 to work for a first predetermined time, the controller controls the first control valve in the first connecting channel on the first container 23a to open, and releases the cell solution in the first container 23a into the first accommodating cavity of the first fixing seat 221, and at the same time controls the first control valve in the first connecting channel on the second container 23b to open, so that the cell solution in the first accommodating cavity is released into the second container 23b. After the cell solution enters the second container 23b, the culture medium in the cell solution can be filtered out through the filtering effect of the filtering partition 236. After completing the filtration of the culture medium, the controller controls the first control valve in the first connecting channel on the second container 23b to open, and releases the filtered cell container into the first accommodating cavity, and at the same time controls the first control valve in the first connecting channel on the third container 23c to open, and releases the filtered cell solution into the third container 23c.

[0060] At this time, the third container 23c is provided with an injection port, through which the virus solution used for gene transduction of cells and new culture medium can be injected into the third container 23c, so that the culture medium, virus solution and activated cell solution can coexist in the third container 23c for gene transduction.

[0061] It is understandable that, in this step, the virus solution and the culture medium may be pre-loaded into the third container 23c, or may be injected after the cell solution enters the third container 23c.

[0062] After the virus solution, cell solution and new culture medium are mixed, the controller is used to control the driving motor to drive the rotating shaft 21 to rotate, thereby driving the third container 23c to swing at a second predetermined speed for a second predetermined time, so that the culture medium, virus solution and cell solution can be effectively contacted, the speed of gene transduction can be accelerated, and the success rate of gene transduction can be improved.

[0063] In this step, the second predetermined speed can also be adjusted according to the cell gene transduction condition and the mixing condition with the culture medium and other substances. Optionally, the third container 23c or the first fixing seat 221 in this embodiment is provided with a sensor for detecting the temperature in the first container 23c, the cell gene transduction condition, etc., and the sensor transmits the detected signal to the controller, so that the controller can control the driving motor to adjust the rotation speed of the rotating shaft 21. In view of the different gene transduction conditions of different cells, the second predetermined speed is not limited in this application.

[0064] Furthermore, in this embodiment, the second predetermined time is 20 hours to 28 hours, for example, 20 hours, 24 hours, and 28 hours. It can be selected and set according to the properties of the cells to be gene-transduced. For example, for the preparation of CAR T cells, the second predetermined time is usually 24 hours.

[0065] Step S3: releasing the cell solution that has completed gene transduction into the fourth container 23d for filtration, and releasing the cell solution after filtering out the culture medium into the fifth container 23e for cell amplification, and regularly checking whether the amplified cells in the fifth container 23e are qualified.

[0066] In this step, after the controller controls the driving motor to work for the second predetermined time, the controller controls the first control valve in the first connecting channel of the third container 23c to open, and releases the solution in the third container 23c into the first accommodating cavity of the first fixing seat 221, and at the same time controls the first control valve in the first connecting channel of the fourth container 23d to open, so that the solution in the first accommodating cavity enters the fourth container 23d to filter out the changed or deteriorated culture medium. After the filtration is completed, the controller controls the first control valve in the first connecting channel on the fourth container 23d to open, and releases the filtered cell solution into the first accommodating cavity, and at the same time controls the first control valve in the first connecting channel on the fifth container 23e to open, so that the cell solution in the first accommodating cavity enters the fifth container 23e for amplification. At this time, a certain culture medium is contained in the fifth container 23e, which is convenient for culturing the cells after gene transduction so that the cells can be amplified.

[0067] In this step, the controller is used to control the rotation of the rotating shaft 21, thereby driving the fifth container 23e to swing at a third predetermined speed for a third predetermined time. By controlling the swing of the rotating shaft 21, the fifth container 23e can be driven to swing, and the culture medium and cell solution in the fifth container 23e can be effectively mixed, thereby improving the cell proliferation rate and the success rate of cell culture.

[0068] Similarly, the third predetermined speed can also be adjusted according to the cell proliferation conditions and the mixing conditions of the cells with the culture medium and other substances. Optionally, the fifth container 23e or the first fixing seat 221 in this embodiment is provided with a sensor for detecting the temperature, cell proliferation conditions, etc. in the fifth container 23e, and the detected signal is transmitted to the controller by the sensor, so that the controller can control the driving motor to adjust the rotation speed of the shaft 21. In view of the different gene growth conditions of different cells, the third predetermined speed is not limited in this application.

[0069] Optionally, the third predetermined time is 7d to 10d, such as 7d, 8d, 9d or 10d. It can be selected and set according to the properties of the cells to be amplified as needed. Taking the preparation of CAR T cells as an example, the third predetermined time is usually 7d.

[0070] In step S3, after a period of cell expansion, the culture medium in the fifth container 23e is insufficient to support cell expansion. When it is detected that the culture medium in the fifth container 23e is lower than a predetermined amount, the controller can be used to release the culture medium in the sixth container 23f into the fifth container 23e.

[0071] Specifically, when the sensor and other structures detect that the culture medium in the fifth container 23e is lower than a predetermined amount (the predetermined amount is related to the volume of the fifth container and the initial amount of the cell solution, and is not specifically limited in the present application), the controller is used to control the second control valve in the second connecting channel on the sixth container 23f to open, and at the same time, the first control valve in the first connecting channel on the fifth container 23e is controlled to open. Since the first accommodating cavity and the second accommodating cavity are connected, at this time, the culture medium in the sixth container 23f can pass through the second accommodating cavity on the second fixed seat 222 and the first accommodating cavity on the first fixed seat 221 in sequence and enter the fifth container 23e. The structure is simple and easy to implement.

[0072] In this embodiment, the fifth container 23e is provided with a sampling port, through which the cell solution in the fifth container 23e can be sampled and tested regularly. When the cells in the fifth container 23e are found to be qualified, they can be collected. When the cells in the fifth container 23e are always unqualified, they can be processed and discharged. The regular testing here can be, for example, sampling once a day for testing.

[0073] Step S4: using a collection bag to collect the qualified cell solution in the fifth container.

[0074] This step is used to collect the cell solution after the test is qualified. When it is necessary to collect cells, the collection bag 50 is placed on the collection rack 40, and the collection rack 40 is pushed into the collection bin 13. At this time, the hard pipe joint at the top of the collection bag 50 can open the switch at the end of the cell outlet pipe 12, and the cell solution in the fifth container 23e can flow from the cell outlet pipe into the collection bag 50 to achieve collection.

[0075] Step S5: releasing the unqualified cell solution in the fifth container 23e into the seventh container 23g, and releasing the cleaning solution in the eighth container 23h into the seventh container 23g to clean and filter the cell solution in the seventh container 23g.

[0076] This step is used to clean and filter the cell solution that fails the test. That is to say, when the cell solution is amplified in the fifth container 23e for a period of time, multiple sampling tests are unqualified (i.e., the sampling is unqualified after the third predetermined time of cultivation), the controller is used to control the first control valve in the first connecting channel on the fifth container 23e to open, and the second control valve in the second connecting channel on the seventh container 23g is controlled to open. Since the first accommodating cavity and the second accommodating cavity are connected, at this time, the cell solution in the fifth container 23e can pass through the first accommodating cavity and the second accommodating cavity in sequence and enter the seventh container 23g. After that, the controller is used to control the second control valve in the second connecting channel on the eighth container 23h and the seventh container 23g to open at the same time, so that the cleaning solution (sodium chloride solution) in the eighth container 23h enters the seventh container 23g to clean and filter the cell solution, and the cell solution after cleaning and filtration can be discharged from the discharge port reserved on the seventh container 23g.

[0077] According to the above description, the technical solution of the present application has at least the following technical effects:

[0078] The control method of the cell therapy device of the present application can perform highly automated and highly integrated control of processes such as cell activation, cell gene transduction, cell expansion, cell collection, cell cleaning and discharge, greatly reducing the intensity of manual labor, shortening the cell preparation process, and improving the efficiency and yield of cell preparation.

[0079] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0080] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. Unless otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of this application.

[0081] The above are only preferred embodiments of the present application and are not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A method for controlling a cell therapy device, characterized in that: The control method of the cell therapy device is used to control the cell therapy device, the cell therapy device comprising a main body (10), a cell therapy mechanism (20), a collection rack (40) and a collection bag (50); the main body (10) is provided with a first working chamber (101a), a second working chamber (101b), a cell outlet pipe (12) and a collection chamber (13) at intervals; the cell therapy mechanism (20) comprises a rotating shaft (21), a first fixing seat (221), a second fixing seat (222), a first container (23a), a second container (23b), a third container (23c), a fourth container (23d), a fifth container (23e), a sixth container (23e), a fifth container (23f), a sixth container (23g), a fifth container (23h), a sixth container (23h), a fifth container (23h), a sixth container (23h), a fifth container (23i), a sixth container (23j), a fifth ... 23f), a seventh container (23g) and an eighth container (23h), the rotating shaft (21) is rotatably arranged in the first working chamber (101a) and the second working chamber (101b), the first fixing seat (221) is arranged in the first working chamber (101a) and fixed on the rotating shaft (21), and a first accommodating cavity is arranged on the first fixing seat (221), the second fixing seat (222) is arranged in the second working chamber (101b) and fixed on the rotating shaft (21), a second accommodating cavity is arranged on the second fixing seat (222), and the second accommodating cavity is communicated with the first accommodating cavity; the first container The first container (23a), the second container (23b), the third container (23c), the fourth container (23d) and the fifth container (23e) are all detachably fixed on the first fixing seat (221), and the first container (23a), the second container (23b), the third container (23c), the fourth container (23d) and the fifth container (23e) are all provided with a first connecting channel connected to the first accommodating cavity, and each of the first connecting channels is provided with a first control valve for controlling the opening and closing of the corresponding first connecting channel; the sixth container (23f), the seventh container (23g) and the eighth container ( 23h) is detachably fixed on the second fixing seat (222), the sixth container (23f), the seventh container (23g) and the eighth container (23h) are all provided with a second connecting channel communicating with the second accommodating cavity, and each of the second connecting channels is provided with a second control valve for controlling the opening and closing of the corresponding second connecting channel; one end of the cell outlet pipe (12) is communicated with the fifth container (23e), and the other end of the cell outlet pipe (12) extends to the collection bin (13), the collection rack (40) is arranged in the collection bin (13), and the collection bag (50) is detachably mounted on the collection rack (40); The control method of the cell therapy device comprises: Step S1: injecting a cell solution containing a culture medium into the first container (23a), and performing cell activation in the first container (23a); Step S2: releasing the cell solution in the first container (23a) into the second container (23b) for filtration, releasing the cell solution after filtering out the culture medium into the third container (23c), and injecting the virus solution and new culture medium into the third container (23c) to perform gene transduction of the cells; Step S3: releasing the cell solution that has completed gene transduction into the fourth container (23d) for filtration, and releasing the cell solution after filtering out the culture medium into the fifth container (23e) for cell amplification, and regularly checking whether the amplified cells in the fifth container (23e) are qualified.

2. The control method of the cell therapy device according to claim 1, characterized in that: In step S1, after injecting a cell solution containing a culture medium into the first container (23a), a controller is used to control the rotating shaft (21) of the cell therapy device to drive the first container (23a) to reciprocate at a first predetermined speed for a first predetermined time to complete cell activation.

3. The control method of the cell therapy device according to claim 2, characterized in that: The first predetermined time is from 44 hours to 54 hours.

4. The control method of the cell therapy device according to claim 1, characterized in that: In step S2, after the virus solution and new culture medium are injected into the third container (23c), the controller is used to control the rotating shaft (21) of the cell therapy device to drive the third container (23c) to swing at a second predetermined speed for a second predetermined time to complete gene transduction.

5. The control method of the cell therapy device according to claim 4, characterized in that: The second predetermined time is from 20 hours to 28 hours.

6. The control method of the cell therapy device according to claim 1, characterized in that: In step S3, after the cell solution after filtering out the culture medium is released into the fifth container (23e), the controller is used to control the rotating shaft (21) of the cell therapy device to drive the fifth container (23e) to swing at a third predetermined speed for a third predetermined time to complete cell expansion.

7. The control method of the cell therapy device according to claim 6, characterized in that: The third predetermined time is from 7d to 10d.

8. The control method of the cell therapy device according to claim 1, characterized in that: In the step S3, when it is detected that the culture medium in the fifth container (23e) is lower than a predetermined amount, the culture medium in the sixth container (23f) is released into the fifth container (23e).

9. The control method of the cell therapy device according to any one of claims 1 to 8, characterized in that: The control method of the cell therapy device further comprises: Step S4: using a collection bag (50) to collect the cell solution that has passed the culture in the fifth container (23e).

10. The control method of the cell therapy device according to any one of claims 1 to 8, characterized in that: The control method of the cell therapy device further comprises: Step S5: releasing the unqualified cell solution in the fifth container (23e) into the seventh container (23g), and releasing the cleaning solution in the eighth container (23h) into the seventh container (23g) to clean and filter the cell solution in the seventh container (23g).

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