A fully enclosed and fully automated device and method for dispensing cells

Abstract

This invention relates to a fully enclosed and fully automated apparatus and method for dispensing cells. Specifically, the invention provides a fully enclosed and fully automated apparatus for dispensing cells, comprising a sample introduction module, a fluid replenishment module, and a fluid dispensing module. The apparatus of this invention enables cell dispensing under enclosed conditions, reducing the risk of infection from contact with the external environment, ensuring the survival rate of dispensed cells, and achieving high precision in the dispensed cells, thereby improving the quality of the dispensed cells.

Description

Technical Field

[0001] This invention relates to the field of biotechnology, and more specifically, to a fully enclosed and fully automated apparatus and method for dispensing cells. Background Technology

[0002] Cellular immunotherapy is a cell therapy that collects a patient's own immune cells, modifies them, and expands them in vitro to enhance their targeting, killing power, and durability. In recent years, it has shown promising results in clinical tumor immunotherapy, bringing hope for a clinical cure of cancer. However, the prepared immune cells need to be washed, concentrated, and aliquoted into multiple cryopreservation bags. Any intermediate step in the cell aliquoting process, including the equipment and reagent selection, can affect the quality of the aliquoted cells, thus impacting clinical efficacy. Therefore, a fully enclosed and automated aliquoting process for immune cells can ensure product safety and batch-to-batch stability, reduce the impact of personnel and the environment, and improve the quality of immunotherapy products. Traditional cell aliquoting can only be performed manually and under non-enclosed conditions, increasing the risk of infection from contact with the external environment and significantly affecting product safety.

[0003] Therefore, there is a need in this field to develop a fully enclosed, automated method for dispensing immune cells that can rapidly obtain high-quality immune cells for clinical use. Summary of the Invention

[0004] The purpose of this invention is to provide a fully enclosed, automated method for dispensing immune cells, which can rapidly obtain high-quality immune cells for clinical use.

[0005] In a first aspect, the present invention provides a fully enclosed and fully automated device for dispensing cells, the device comprising a sample injection module, a liquid replenishment module, and a liquid dispensing module;

[0006] The sample introduction module includes a cell sample bag;

[0007] The fluid replenishment module includes multiple fluid replenishment devices, and each fluid replenishment device includes multiple fluid replenishment bags (8-1, 8-2).

[0008] The liquid distribution module includes a liquid distributor, which is provided with an inlet tube, an outlet tube, an extraction tube, a waste liquid tube and a replenishment tube connected together. The inlet tube, outlet tube, extraction tube, waste liquid tube and replenishment tube are interconnected, and each of the inlet tube, outlet tube, extraction tube, waste liquid tube and replenishment tube is provided with a valve.

[0009] The sample inlet tube is connected to the cell sample bag, the liquid outlet tube is connected to the cell freezing bag (7), the extraction tube is connected to the extraction device (1), the waste liquid tube is connected to the waste liquid bag (6), and the replenishment tube is connected to multiple replenishment bags in sequence through multiple branch tubes, and each branch tube is equipped with a valve.

[0010] In another preferred embodiment, the number of the fluid replenishment bags is 1, 2, 3, 4, 5, 6, 7, and 8.

[0011] In another preferred embodiment, there are two rehydration bags, each containing rehydration component 1 and rehydration component 2. Rehydration component 1 includes compound electrolyte injection and human serum albumin aqueous solution, and rehydration component 2 includes CS10 cryopreservation solution.

[0012] In another preferred embodiment, the cell sample bag contains a cell sample.

[0013] In another preferred embodiment, the compound electrolyte injection solution comprises 3-7 parts by weight of sodium chloride, 3-7 parts by weight of sodium gluconate, 2-6 parts by weight of sodium acetate, 0.1-0.8 parts by weight of potassium chloride, 0.1-0.6 parts by weight of magnesium chloride, and 950-1050 parts by weight of water.

[0014] In another preferred embodiment, the concentration of human serum albumin in the aqueous solution of human serum albumin is 15-25% (w / v), more preferably 18-22% (w / v).

[0015] In another preferred embodiment, the volume ratio of the compound electrolyte injection to the human serum albumin aqueous solution is 80-120:1, more preferably 90-110:1, and even more preferably 95-105:1.

[0016] In another preferred embodiment, the CS10 cryopreservation solution comprises an aqueous solution of DMSO.

[0017] In another preferred embodiment, the CS10 cryopreservation solution comprises an 8-12% (v / v) aqueous solution of DMSO.

[0018] In another preferred embodiment, the extraction device is capable of drawing in liquid and expelling liquid.

[0019] A second aspect of the present invention provides a method for preparing a cell suspension using the apparatus described in the first aspect of the present invention, the method comprising the steps of:

[0020] (1) The cell sample bag contains cell samples, and the two different rehydration bags contain rehydration component 1 and rehydration component 2 respectively, wherein,

[0021] The rehydration component 1 includes compound electrolyte injection and human serum albumin aqueous solution, and the rehydration component 2 includes CS10 cryopreservation solution;

[0022] (2) The cell sample in the cell sample bag is drawn into the extraction device through the sample inlet tube and the extraction tube by the suction of the extraction device, and then the cell sample is drawn into the waste liquid bag through the extraction tube and the waste liquid tube by the discharge of the extraction device, thereby rinsing the sample inlet tube, the extraction tube and the waste liquid tube.

[0023] (3) The cell sample in the cell sample bag is drawn into the extraction device through the sample inlet tube and the extraction tube by the suction of the extraction device, and then the cell sample is drawn into the cell freezing bag through the extraction tube and the liquid outlet tube by the discharge of the extraction device.

[0024] (4) The replenishment component 1 in the replenishment bag is drawn into the extraction device through the replenishment tube and the extraction tube by the suction of the extraction device, and then the replenishment component 1 is drawn into the cell freezing bag through the extraction tube and the liquid outlet tube by the discharge of the extraction device.

[0025] The replenishment component 2 in the replenishment bag is drawn into the extraction device through the replenishment tube and the extraction tube by the suction of the extraction device, and then the replenishment component 2 is drawn into the cell freezing bag through the extraction tube and the liquid outlet tube by the discharge of the extraction device.

[0026] In step (4), replenishment component 1 and replenishment component 2 are sequentially introduced into the cell freezing bag, and the volume ratio of replenishment component 1 to replenishment component 2 is 1:1.

[0027] In another preferred embodiment, the method further includes step (5): counting the cells in the cell freezing bag described in step (4), and if the cell density is high, replenishing the fluid according to step (4) above; if the cell density is low, replenishing the cell sample according to step (2) above, thereby obtaining a cell suspension with the required cell density.

[0028] In another preferred embodiment, the method further includes a dispensing step (6), which includes connecting a cell freezing bag containing the cell suspension to a sample inlet tube and connecting a waste liquid tube to a dispensing bag;

[0029] The cell suspension in the cell freezing bag is drawn into the extraction device through the sample inlet and extraction tubes. Then, the cell suspension is discharged through the extraction device through the extraction tube and waste tube into the dispensing bag. The cell suspension can be dispensed multiple times by changing the dispensing bag.

[0030] In another preferred embodiment, the dispensing step (6) is performed after step (5).

[0031] In another preferred embodiment, the compound electrolyte injection solution comprises 3-7 parts by weight of sodium chloride, 3-7 parts by weight of sodium gluconate, 2-6 parts by weight of sodium acetate, 0.1-0.8 parts by weight of potassium chloride, 0.1-0.6 parts by weight of magnesium chloride, and 950-1050 parts by weight of water.

[0032] It should be understood that, within the scope of this invention, the above-described technical features of this invention and the technical features specifically described below (such as in the embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, they will not be described in detail here. Attached Figure Description

[0033] The accompanying drawings are for illustrative purposes only and should not be construed as limiting the invention. To better illustrate this embodiment, some components in the drawings may be omitted, enlarged, or reduced, and do not represent the actual product dimensions. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings. The same or similar reference numerals correspond to the same or similar components. The terms describing positional relationships in the drawings are for illustrative purposes only and should not be construed as limiting the invention.

[0034] Figure 1 This is a schematic diagram of a fully enclosed and fully automated cell dispensing device, in which 8-1 and 8-2 are replenishment bags, 5 is a sample inlet tube, 1 is an extraction device, 6 is a waste bag, and 7 is a cell freezing bag. Detailed Implementation

[0035] Through extensive and in-depth research, the inventors have unexpectedly developed a fully enclosed and fully automated device and method for dispensing cells. The method allows for cell dispensing under enclosed conditions, reducing the risk of infection from contact with the external environment. The fully enclosed and fully automated cell dispensing device and method of this invention ensures the survival rate of the dispensed cells and produces cells with high precision, thereby improving the quality of the dispensed cells. Based on this, the inventors completed this invention.

[0036] the term

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0038] As used herein, the terms “comprising,” “including,” and “containing” are used interchangeably and include not only open-ended definitions but also semi-closed and closed definitions. In other words, the terms include “consisting of” and “substantially consisting of”.

[0039] Device

[0040] For ease of explanation, please refer to the appendix below. Figure 1The fully enclosed and fully automated cell dispensing device described in this invention is further described below. It should be understood in the invention that the accompanying drawings do not limit the scope of the invention.

[0041] Typically, the fully enclosed and fully automated cell dispensing device of the present invention includes a sample injection module, a liquid replenishment module, and a liquid dispensing module;

[0042] The sample introduction module includes a cell sample bag;

[0043] The fluid replenishment module includes multiple fluid replenishment devices, and each fluid replenishment device includes multiple fluid replenishment bags (8-1, 8-2).

[0044] The liquid distribution module includes a liquid distributor, which is provided with an inlet tube, an outlet tube, an extraction tube, a waste liquid tube and a replenishment tube connected together. The inlet tube, outlet tube, extraction tube, waste liquid tube and replenishment tube are interconnected, and each of the inlet tube, outlet tube, extraction tube, waste liquid tube and replenishment tube is provided with a valve.

[0045] The sample inlet tube is connected to the cell sample bag, the liquid outlet tube is connected to the cell freezing bag (7), the extraction tube is connected to the extraction device (1), the waste liquid tube is connected to the waste liquid bag (6), and the replenishment tube is connected to multiple replenishment bags in sequence through multiple branch tubes, and each branch tube is equipped with a valve.

[0046] In a preferred embodiment of the present invention, the number of the rehydration bags is 1, 2, 3, 4, 5, 6, 7, and 8.

[0047] In another preferred embodiment of the present invention, there are two rehydration bags, and the two different rehydration bags contain rehydration component 1 and rehydration component 2 respectively. The rehydration component 1 includes compound electrolyte injection and human serum albumin aqueous solution, and the rehydration component 2 includes CS10 cryopreservation solution.

[0048] Preferably, the compound electrolyte injection solution comprises 3-7 parts by weight of sodium chloride, 3-7 parts by weight of sodium gluconate, 2-6 parts by weight of sodium acetate, 0.1-0.8 parts by weight of potassium chloride, 0.1-0.6 parts by weight of magnesium chloride, and 950-1050 parts by weight of water.

[0049] In another preferred embodiment, the concentration of human serum albumin in the aqueous solution of human serum albumin is 15-25% (w / v), more preferably 18-22% (w / v).

[0050] In another preferred embodiment, the volume ratio of the compound electrolyte injection to the human serum albumin aqueous solution is 80-120:1, more preferably 90-110:1, and even more preferably 95-105:1.

[0051] In another preferred embodiment, the CS10 cryopreservation solution comprises an aqueous solution of DMSO.

[0052] In another preferred embodiment, the CS10 cryopreservation solution comprises an 8-12% (v / v) aqueous solution of DMSO.

[0053] In another preferred embodiment of the invention, the cell sample bag contains a cell sample.

[0054] method

[0055] The present invention also provides a method for dispensing cells using a fully enclosed and fully automated cell dispensing device as described herein, the method comprising the steps of:

[0056] (1) The cell sample bag contains cell samples, and the two different rehydration bags contain rehydration component 1 and rehydration component 2 respectively, wherein,

[0057] The rehydration component 1 includes compound electrolyte injection and human serum albumin aqueous solution, and the rehydration component 2 includes CS10 cryopreservation solution;

[0058] (2) The cell sample in the cell sample bag is drawn into the extraction device through the sample inlet tube and the extraction tube by the suction of the extraction device, and then the cell sample is drawn into the waste liquid bag through the extraction tube and the waste liquid tube by the discharge of the extraction device, thereby rinsing the sample inlet tube, the extraction tube and the waste liquid tube.

[0059] (3) The cell sample in the cell sample bag is drawn into the extraction device through the sample inlet tube and the extraction tube by the suction of the extraction device, and then the cell sample is drawn into the cell freezing bag through the extraction tube and the liquid outlet tube by the discharge of the extraction device.

[0060] (4) The replenishment component 1 in the replenishment bag is drawn into the extraction device through the replenishment tube and the extraction tube by the suction of the extraction device, and then the replenishment component 1 is drawn into the cell freezing bag through the extraction tube and the liquid outlet tube by the discharge of the extraction device.

[0061] The replenishment component 2 in the replenishment bag is drawn into the extraction device through the replenishment tube and the extraction tube by the suction of the extraction device, and then the replenishment component 2 is drawn into the cell freezing bag through the extraction tube and the liquid outlet tube by the discharge of the extraction device.

[0062] In step (4), replenishment component 1 and replenishment component 2 are sequentially introduced into the cell freezing bag, and the volume ratio of replenishment component 1 to replenishment component 2 is 1:1.

[0063] In a preferred embodiment of the present invention, the compound electrolyte injection solution comprises 3-7 parts by weight of sodium chloride, 3-7 parts by weight of sodium gluconate, 2-6 parts by weight of sodium acetate, 0.1-0.8 parts by weight of potassium chloride, 0.1-0.6 parts by weight of magnesium chloride, and 950-1050 parts by weight of water.

[0064] In a preferred embodiment of the present invention, the method further includes step (5): counting the cells in the cell freezing bag described in step (4), and if the cell density is high, replenishing the fluid according to step (4) above; if the cell density is low, replenishing the cell sample according to step (2) above, thereby obtaining a cell suspension with the required cell density.

[0065] In a preferred embodiment of the present invention, the method further includes a dispensing step (6), which includes connecting a cell freezing bag containing the cell suspension to a sample inlet tube, and connecting a waste liquid tube to a dispensing bag;

[0066] The cell suspension in the cell freezing bag is drawn into the extraction device through the sample inlet and extraction tubes. Then, the cell suspension is discharged through the extraction device through the extraction tube and waste tube into the dispensing bag. The cell suspension can be dispensed multiple times by changing the dispensing bag.

[0067] In another preferred embodiment, the dispensing step (6) is performed after step (5).

[0068] The main advantages of this invention include:

[0069] The fully enclosed and fully automated cell dispensing device and method of the present invention can perform cell dispensing under closed conditions, reducing the risk of infection from contact with the external environment. The fully enclosed and fully automated cell dispensing device and method of the present invention can ensure the survival rate of dispensed cells and obtain cells with high precision, thereby improving the quality of dispensed cells.

[0070] The cell preparation method of the present invention can rapidly prepare immune cells, reduce enterprise costs, increase production capacity, and is suitable for industrial production. At the same time, the immune cells prepared by the cell preparation method of the present invention are of high quality and can guarantee clinical efficacy.

[0071] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed under conventional conditions or as recommended by the manufacturer. Unless otherwise stated, percentages and parts are by weight.

[0072] Example 1

[0073] 1. Experimental Design

[0074] a) Required cryopreserved cell count: 150 × 10⁶ positive T cells in the final product bag. 6 Cells, frozen in 40 ml volume; the number of positive T cells in the cell bag used for detection was 37.5 × 10⁻⁶. 6 Cells, cryopreserved in 10 ml volume; cell positivity rate 20.71%; theoretical cryopreservation density 19.918 × 10⁻⁶ cells / ml. 6 cells / ml.

[0075] b) Reagent preparation:

[0076] i. Component 1: Add a 20% (w / v) HSA (human serum albumin) aqueous solution to the compound electrolyte injection solution (containing 5.26g sodium chloride, 5.02g sodium gluconate, 3.68g sodium acetate, 0.37g potassium chloride, and 0.30g magnesium chloride per 1000ml of water), and then fill it into Component 1 bags; the volume ratio of the 20% (w / v) HSA aqueous solution to the compound electrolyte injection solution is 1:100.

[0077] ii. Component 2: Fill the CS10 cryopreservation solution into the Component 2 bag, wherein the CS10 cryopreservation solution is an aqueous solution of DMSO with a volume fraction of 10%.

[0078] c) Piping preparation before dispensing

[0079] i. Open Kit CT-49.1 (a fully enclosed and automated cell dispensing device) in the biosafety cabinet and close the clamps. Using a sterile tubing connector, connect the harvested cell sample bag to position 5, the 250ml cell cryopreservation bag to position 7, component 1 bag to position 8-1, component 2 bag to position 8-2, and the waste bag to position 6. See the Kit CT-49.1 tubing layout diagram below. Figure 1 ;

[0080] ii. According to Figure 1 Install the above piping onto Sepax;

[0081] d) Culture Wash procedure to concentrate cell suspension

[0082] i. Cell counting: After concentrating the cell suspension, connect a 5ml syringe to a 250ml cryopreservation bag containing the cell suspension, shake the cryopreservation bag well, and then draw out about 0.2ml of the cell suspension for cell counting.

[0083] e) Dilution (dispensing) procedure for preparing the final product: The final cryopreservation solution is added in the ratio of component 1: component 2 = 50%: 50%.

[0084] i. Component Volume Calculation: Based on the cell counting results, cell suspension volume, final product filling density, and final product cell quantity, calculate the required volume of each component (Component 1 and Component 2). Wherein, the required volume of Component 1 = cell suspension volume in the cryopreservation bag + the remaining volume of Component 1 to be added;

[0085] ii. Tubing rinse: Input component 1 rinse volume 10ml, open the tubing clamp, and start the program;

[0086] iii. Dispensing Component 1: Enter the dispensing volume = the volume of Component 1 to be added, click "√", open the tubing clamp, and start the program;

[0087] iv. Tubing rinse: Input component 2 rinse volume 10ml, open the tubing clamp, and start the program;

[0088] v. Dispense Component 2: Enter dispensing volume = total volume to be added for Component 2, click "√", open the tubing clamp, and start the program;

[0089] f) Final product repackaging

[0090] i. Tubing rinse: Enter the final product rinse volume of 10ml, open the tubing clamp, and start the program;

[0091] ii. Dispensing of cell bags for testing: Before dispensing, calculate the dispensing volume based on the cell volume and cryopreservation density of the cell bags. Then, connect a 50ml cell cryopreservation bag to position 6, enter the calculated dispensing volume, click "√", open the tubing clamp, and start the program. Repeat this step twice to obtain three cell bags for testing.

[0092] iii. Final product dispensing: Before dispensing, calculate the dispensing volume based on the cell volume and cryopreservation density of the final product. Then, connect a 250ml cell cryopreservation bag to position 6, enter the calculated dispensing volume, click "√", open the tubing clamp, and start the program. One bag of final product will then be obtained.

[0093] iv. Remove the air from the three cell bags and one final product bag, and seal the bags.

[0094] v. Transfer the sealed bag to a programmed cooling system for freezing, and then transfer it to a liquid nitrogen freezer for storage.

[0095] 2. Experimental Results

[0096] a) Counting of concentrated cell suspensions

[0097] Cell density and viability within the concentrated cell sample bags were determined using a cell counter, as shown in Table 1. The concentrated cell volume was 181.5 × 10⁻⁶. 6cells / ml×(12.2ml-0.2ml)=2178×10 6 cells.

[0098] Table 1. Count of concentrated cell suspension

[0099]

[0100] b) Final product formulation

[0101] The calculated component volumes are shown in Table 2, with a total volume of 54.7 ml + 54.7 ml = 109.4 ml.

[0102] Table 2. Component Volume

[0103]

[0104] c) Final product repackaging

[0105] Cell density and viability were measured using a cell counter in three test cell bags and one final product bag, as shown in Tables 4, 5, 6, and 7. The number of positive cells in test cell bag 1 was 19.25 × 10⁻⁶. 6 cells / ml×10ml×20.71%=39.87×10 6 Cells; the number of positive cells in cell bag 2 used for detection was 18.8 × 10⁻⁶. 6 cells / ml×10ml×20.71%=38.93×10 6 Cells; the number of positive cells in cell bag 3 for detection was 16.5 × 10⁻³. 6 cells / ml×10ml×20.71%=34.17×10 6 The number of positive cells in the final product bag was 20.033 × 10⁻⁶. 6 cells / ml×40ml×20.71%=165.95×10 6 Cells. The cell aliquoting results are summarized in Table 8. Compared with the theoretical cryopreservation density, the cell densities of the three bags of cells used for testing and one bag of final product were not significantly different, with a maximum difference of 17.16%; compared with the theoretical positive cell count, the maximum difference was 10.63%, all within acceptable ranges, and the cell viability of each bag was almost identical. Therefore, the final product volume and total cell count prepared using Sepax in this process are accurate, with almost no cell loss, indicating that using Sepax for aliquoting harvested cells into final products is feasible, achieving a fully enclosed and automated aliquoting process for immune cell aliquoting.

[0106] Table 4. Cell count in cell bag 1 for detection

[0107]

[0108] Table 5. Cell counts in cell bags used for detection

[0109]

[0110] Table 6. Cell counts in cell bags used for detection

[0111]

[0112] Table 7. Cell count of final product

[0113]

[0114] Table 8. Summary Results of Cell Dispensing

[0115]

[0116] All documents mentioned in this invention are incorporated herein by reference as if each document were individually incorporated by reference. Furthermore, it should be understood that after reading the foregoing teachings of this invention, those skilled in the art can make various alterations or modifications to this invention, and these equivalent forms also fall within the scope defined by the appended claims.

Claims

1. A method for preparing cell suspensions using a fully enclosed and fully automated cell dispensing device, characterized in that, The device includes a sample injection module, a liquid replenishment module, and a liquid dispensing module; The sample introduction module includes a cell sample container; The fluid replenishment module includes multiple fluid replenishment devices, and each fluid replenishment device includes multiple fluid replenishment containers; The liquid distribution module includes a liquid distributor, which is provided with an inlet tube, an outlet tube, an extraction tube, a waste liquid tube and a replenishment tube connected together. The inlet tube, outlet tube, extraction tube, waste liquid tube and replenishment tube are interconnected, and each of the inlet tube, outlet tube, extraction tube, waste liquid tube and replenishment tube is provided with a valve. The sample inlet tube is connected to the cell sample container, the liquid outlet tube is connected to the cell freezing container, the extraction tube is connected to the extraction device, the waste liquid tube is connected to the waste liquid container, and the replenishment tube is connected to multiple replenishment containers sequentially via multiple branch tubes, each branch tube being equipped with a valve. The method includes the following steps: (1) The cell sample container contains a cell sample, and the two different replenishment containers contain replenishment component 1 and replenishment component 2 respectively, wherein, The rehydration component 1 includes compound electrolyte injection and human serum albumin aqueous solution, and the rehydration component 2 includes CS10 cryopreservation solution; (2) The cell sample in the cell sample container is drawn into the extraction device through the sample inlet tube and the extraction tube by the suction of the extraction device, and then the cell sample is drawn into the waste liquid container through the extraction tube and the waste liquid tube by the discharge of the extraction device, thereby rinsing the sample inlet tube, the extraction tube and the waste liquid tube. (3) The cell sample in the cell sample container is drawn into the extraction device through the sample inlet tube and the extraction tube by the suction of the extraction device, and then the cell sample is drawn into the cell freezing container through the extraction tube and the liquid outlet tube by the discharge of the extraction device. (4) The replenishment component 1 in the replenishment container is drawn into the extraction device through the replenishment tube and the extraction tube by the suction of the extraction device, and then the replenishment component 1 is drawn into the cell freezing container through the extraction tube and the liquid outlet tube by the discharge of the extraction device. The replenishment component 2 in the replenishment container is drawn into the extraction device through the replenishment tube and the extraction tube by the suction of the extraction device, and then the replenishment component 2 is drawn into the cell freezing container through the extraction tube and the liquid outlet tube by the discharge of the extraction device. In step (4), replenishment component 1 and replenishment component 2 are sequentially introduced into the cell freezing container, and the volume ratio of replenishment component 1 to replenishment component 2 is 1:

1.

2. The method as described in claim 1, characterized in that, The compound electrolyte injection solution comprises 3-7 parts by weight of sodium chloride, 3-7 parts by weight of sodium gluconate, 2-6 parts by weight of sodium acetate, 0.1-0.8 parts by weight of potassium chloride, 0.1-0.6 parts by weight of magnesium chloride, and 950-1050 parts by weight of water.

3. The method as described in claim 1, characterized in that, The concentration of human serum albumin in the aqueous solution of human serum albumin is 15-25% (w / v).

4. The method as described in claim 1, characterized in that, The extraction device is capable of drawing in and expelling liquid.

5. The method as described in claim 1, characterized in that, The volume ratio of the compound electrolyte injection to the human serum albumin aqueous solution is 80-120:

1.

6. The method as described in claim 5, characterized in that, The volume ratio of the compound electrolyte injection to the human serum albumin aqueous solution is 90-110:

1.

7. The method as described in claim 5, characterized in that, The volume ratio of the compound electrolyte injection to the human serum albumin aqueous solution is 95-105:

1.

8. The method as described in claim 1, characterized in that, The CS10 cryopreservation solution comprises 8-12% (v / v) DMSO aqueous solution.

9. The method as described in claim 1, characterized in that, The method further includes step (5): counting the cells in the cell freezing container described in step (4), and if the cell density is high, replenishing the fluid according to the steps in step (4) above; if the cell density is low, replenishing the cell sample according to the steps in step (2) above, thereby obtaining a cell suspension with the required cell density.

10. The method as described in claim 1, characterized in that, The method further includes a dispensing step (6), which includes connecting a cell freezing container containing the cell suspension to a sample inlet tube and connecting a waste liquid tube to a dispensing bag; The cell suspension in the cell freezing container is drawn into the extraction device through the sample inlet and extraction tubes. Then, the cell suspension is discharged through the extraction device through the extraction tube and waste liquid tube into the dispensing bag. The cell suspension can be dispensed multiple times by changing the dispensing bag.

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