Cell-containing product, and method for producing cell-containing product

Abstract

A cell-containing product according to an embodiment of the present invention is provided with a multi-chamber container as a filling container, wherein the multi-chamber container includes: a first chamber formed inside the container; a communication port; at least one second chamber connected to the first chamber via the communication port; and closing means for closing the communication port. The first chamber and the second chamber are filled with a cell suspension, and the communication port is closed by the closing means to isolate the first chamber from the second chamber.

Description

Cell-containing product and method for producing the cell-containing product

[0001] SUMMARY OF THE INVENTION The embodiments disclosed herein and in the drawings relate to cell-containing products and methods of making cell-containing products.

[0002] In recent years, personalized medicine using cells has become widespread. In such personalized medicine, autologous products containing autologous cells are sometimes used. Typically, the number of viable cells counted by testing is indicated on the label or package insert of the autologous product.

[0003] Autologous products are generally shipped frozen and thawed at medical facilities for use. The freezing and thawing process is known to reduce the number of viable cells, which may result in a discrepancy between the number of viable cells at the time of product use and the number of viable cells labeled on the product.

[0004] Furthermore, the degree of decrease in viable cell count due to the freeze-thaw process varies depending on the type of cell (cell health, cell concentration), type and concentration of additives, storage container, freeze-thaw procedure (cooling rate, heating rate, minimum temperature reached, number of freeze-thaw cycles, etc.), etc. For this reason, it is known to be difficult to predict the viable cell count by mathematical means.

[0005] Japanese Patent Application Laid-Open No. 2021-72966

[0006] One of the problems to be solved by the embodiments disclosed in this specification and the drawings is to consider the decrease in the number of viable cells from the time of product manufacture when the product is in use. For example, to reduce the discrepancy between the number of viable cells when the product is in use and the number of viable cells displayed on the product or the number of viable cells that the user wants or should use. However, the problems to be solved by the embodiments disclosed in this specification and the drawings are not limited to the above problem. Problems corresponding to the effects of each configuration shown in the embodiments described below can also be positioned as other problems.

[0007] The cell-containing product according to the embodiment is a cell-containing product in which the filled container is a multi-chamber container having a first chamber formed inside the container, a communication port, at least one second chamber connected to the first chamber via the communication port, and a closing means for closing the communication port, and the first chamber and the second chamber are filled with a cell suspension, and the first chamber and the second chamber are isolated from each other by closing the communication port with the closing means.

[0008] FIG. 1 is a diagram showing an example of the configuration of a multi-chamber container 1 according to the first embodiment. FIG. 2 is a diagram illustrating an example of the configuration of the vicinity of a communication port according to the first embodiment. FIG. 3 is a diagram illustrating an example of the configuration of a clip according to the first embodiment. FIG. 4 is a diagram illustrating an example of the configuration of a clip according to the first embodiment. FIG. 5 is a diagram illustrating an example of the configuration of a clipped multi-chamber container 1 according to the first embodiment. FIG. 6 is a schematic diagram of an example of a cross section taken along line X-X in FIG. 5. FIG. 7 is a schematic diagram of an example of a cross section taken along line X-X in FIG. 5. FIG. 8 is a diagram illustrating an example of the configuration of the vicinity of a clipped communication port according to the first embodiment. FIG. 9 is a diagram illustrating an example of the state of a multi-chamber container when filled with a cell suspension according to the first embodiment. FIG. 10 is a diagram illustrating an example of the state of a multi-chamber container after filling with a cell suspension according to the first embodiment. FIG. 11 is a diagram illustrating an example of the state of a multi-chamber container at the time of shipping a cell suspension according to the first embodiment. FIG. 12 is a flowchart showing an example of a process from production to use of a cell-containing product according to the first embodiment. FIG. 13 is a schematic diagram illustrating an example of a process from production to use of a cell-containing product according to the first embodiment. FIG. 14 is a flowchart showing an example of a process from production to use of a cell-containing product according to the second embodiment. FIG. 15 is a schematic diagram illustrating an example of a process from production to use of a cell-containing product according to the second embodiment. FIG. 16 is a diagram showing an example of the configuration of a multi-chamber container 1 according to the third embodiment. FIG. 17 is a diagram illustrating an example of the configuration near a communication port according to the third embodiment. FIG. 18 is a flowchart showing an example of a process from production to use of a cell-containing product according to the third embodiment. FIG. 19 is a schematic diagram illustrating an example of a process from production to use of a cell-containing product according to the third embodiment. FIG. 20 is a diagram showing an example of the configuration of a multi-chamber container 1 according to Modification 1. FIG. 21 is a diagram showing an example of the configuration of a multi-chamber container 1 according to Modification 2.

[0009] Hereinafter, embodiments of a cell-containing product and a method for producing a cell-containing product will be described in detail with reference to the accompanying drawings.

[0010] First Embodiment First, a multi-chamber container 1 according to the first embodiment will be described. The multi-chamber container 1 is a filled container that is filled with a cell suspension in which cells are suspended in a liquid medium or the like. The suspended cells include, for example, induced pluripotent stem (iPS) cells, iPS cell-derived differentiated cells, mesenchymal stem cells (MSCs), etc.

[0011] The multi-chamber container 1 is a three-dimensional container with a flat shape. In other words, the multi-chamber container 1 is a container with a thickness. After being filled with the cell suspension, the multi-chamber container 1 is frozen by a known method using liquid nitrogen or the like. For this reason, the material used to form the multi-chamber container 1 is, for example, a material that can withstand the temperature of liquid nitrogen (such as polyolefin resin, ultra-high molecular weight polyethylene resin, ethylene-vinyl acetate copolymer resin, fluororesin, polyimide resin, etc.).

[0012] Fig. 1 is a diagram showing an example of the configuration of a multi-chamber container 1 according to the first embodiment. Fig. 1 is an example of a front view of the multi-chamber container 1. As shown in Fig. 1, the multi-chamber container 1 is composed of a large chamber 10, a plurality of small chambers 11, a plurality of communication ports 12, a plurality of clip fastening holes 13, a filling port 14, and an air vent port 15. In the example of Fig. 1, the multi-chamber container 1 is filled with a cell suspension liquid CL.

[0013] The large chamber 10 is an area that contains the cell suspension CL, in which a target number of viable cells is suspended, the target number being determined depending on the patient's condition at the time of filling the cell suspension CL. The large chamber 10 is an example of a first chamber. The target number of viable cells will be described later.

[0014] The multiple small chambers 11 are areas separated from the large chamber 10. The multiple small chambers 11 are areas that accommodate excess cell suspension CL when the cell suspension CL is filled. The small chamber 11 is an example of a second chamber. The excess cell suspension CL in the multiple small chambers 11 is used in a process for adjusting the number of viable cells to be administered to a patient without opening the container. The process for adjusting the number of viable cells to be administered to a patient without opening the container will be described later.

[0015] Each of the small chambers 11 is separated by a partition wall 111 (see FIG. 2 ), which will be described later. Each of the small chambers 11 has approximately the same volume. As an example, each of the small chambers 11 is configured so that the ratio of the volume of the small chamber 11 to the volume of the large chamber 10 is 5%. Note that 5% is just an example, and the ratio of the volume of the small chamber 11 to the volume of the large chamber 10 is not limited to 5%.

[0016] 1, the multi-chamber container 1 has three chambers 11, but the number of chambers is not limited to three. For example, the number of chambers 11 may be two or less, or four or more.

[0017] Although the large chamber 10 and the plurality of small chambers 11 are distinguished, they do not exist independently, but rather the large chamber 10 and the plurality of small chambers 11 together form one multi-chamber container 1.

[0018] The plurality of communication ports 12 are structured to connect the large chamber 10 with each of the plurality of small chambers 11. In this embodiment, the plurality of communication ports 12 are provided at positions lower than the liquid level of the cell suspension CL after the cell suspension CL has been filled into the multi-chamber container 1.

[0019] When the large chamber 10 is filled with the cell suspension CL, the cell suspension CL passes through each of the multiple communication ports 12 and moves to each of the multiple small chambers 11. Therefore, by filling the large chamber 10 with the cell suspension CL, it is possible to fill each of the multiple small chambers 11 with the cell suspension CL.

[0020] After the cell suspension is filled, when the plurality of communication ports 12 are pressed by a clip 2 (described later), the plurality of communication ports 12 are crushed and blocked, thereby isolating the large chamber 10 from each of the plurality of small chambers 11. The process of isolating the large chamber 10 from each of the plurality of small chambers 11 will be described later.

[0021] 2 is a diagram illustrating an example of the configuration in the vicinity of the communication port 12 according to the first embodiment. In FIG. 2, the configuration of the multi-chamber container 1 is shown in a simplified manner, and therefore may differ from the configuration in FIG. 1.

[0022] 2, the chambers 11 are separated by partition walls 111. This prevents the cell suspension CL filled in a specific chamber 11 from moving to another chamber 11. For example, the partition walls 111 are formed by thermocompression bonding the materials that make up the multi-chamber container 1.

[0023] 2, when the large chamber 10 and the small chamber 11 are in communication with each other via the communication port 12, the cell suspension CL present in the large chamber 10 moves to the small chamber 11 via the communication port 12. Therefore, the cell suspension CL can be filled into both the large chamber 10 and the small chamber 11 using a single filling port 14.

[0024] 2, the width of the communication opening 12 is smaller than the width of the small chamber 11. Furthermore, since the thickness of the multi-chamber container 1 is approximately constant, it can be said that the cross-sectional area of ​​the communication opening 12 in the horizontal direction is smaller than the cross-sectional area of ​​the small chamber 11 in the horizontal direction.

[0025] The horizontal cross-sectional area of ​​the communication port 12 is smaller than the horizontal cross-sectional area of ​​the chambers 11, so that when the communication port 12 is pressed by the clip 2, the amount of cell suspension CL pushed out from the communication port 12 into the chambers 11 is reduced. This makes it possible to suppress variation in the amount of cell suspension CL ultimately filled into each of the multiple chambers 11.

[0026] Furthermore, for example, by forming the communication port 12 so that the ratio of the volume of the communication port 12 to the volume of the small chamber 11 is less than 5%, the variation in the amount of cell suspension liquid CL ultimately filled into each of the multiple small chambers 11 can be suppressed to less than 5%.

[0027] Returning to Figure 1, the explanation will continue. The multiple clip fastening holes 13 are a structure used to close the communication openings 12 with the clip 2. The clip fastening holes 13 are an example of a through-hole. Each of the multiple clip fastening holes 13 corresponds to a respective one of the multiple communication openings 12 and is provided near the communication openings 12.

[0028] The clip fastening hole 13 and the interior of the multi-chamber container 1 are separated by a partition similar to the above-mentioned partition 111. Therefore, even if the clip fastening hole 13 is provided in the multi-chamber container 1, the cell suspension CL filled in the multi-chamber container 1 will not leak out of the multi-chamber container 1.

[0029] The clip 2 will be described below. The clip 2 closes the communication port 12. The clip 2 is an example of a closing means. Figures 3 and 4 are diagrams showing an example of the configuration of the clip 2 according to the first embodiment. Figure 3 shows an example of the clip 2 in an open state. Figure 4 shows an example of the clip 2 in a closed state.

[0030] 3 and 4 , the clip 2 has a clamping portion 21 and a fitting portion 22. The clamping portion 21 clamps the communication opening 12. The clamping portion 21 is composed of a first arm 21 a and a second arm 21 b. The clamping portion 21 clamps the communication opening 12 between the first arm 21 a and the second arm 21 b.

[0031] The fitting portion 22 prevents the clip 2 from coming off the clipped multi-chamber container 1. The fitting portion 22 is composed of a first fitting portion 22a and a second fitting portion 22b. As shown in Fig. 4, the first fitting portion 22a and the second fitting portion 22b fit together. This increases the distance between the first arm 21a and the second arm 21b that clamp the communication opening 12 (not shown in Fig. 4), preventing the clamping portion 21 from losing its clamping force on the communication opening 12.

[0032] 1 (not shown in FIGS. 3 and 4). The provision of the clipping hole 13 allows the clip 2, which is shorter than the width (horizontal length) of the multi-chamber container 1, to fasten the multi-chamber container 1 to the clip without the clamping portion 21 losing its clamping force on the communication opening 12.

[0033] Returning to Figure 1, the explanation will continue. The filling port 14 is a port for filling the large chamber 10 and the plurality of small chambers 11 with the cell suspension liquid CL. The filling port 14 is disposed in the large chamber 10. The method for filling the cell suspension liquid CL can be selected from any known method.

[0034] The air vent port 15 is a port for discharging air present in the multi-chamber container 1 (performing an air venting process). The air vent port 15 is an example of a vent port. The air vent port 15 is disposed in the large chamber 10. After filling with the cell suspension CL, the air vent port 15 discharges air generated in the large chamber 10 and the multiple small chambers 11 by the filling operation. Any known method can be selected as the method for the air venting process.

[0035] Clipping will be described below with reference to Figures 5 to 8. Clipping is a process of closing the small chamber 11 by closing the communication port 12. Figure 5 is a diagram showing an example of the configuration of a clipped multi-chamber container 1 according to the first embodiment.

[0036] As shown in Figure 5, once the filling of the multi-chamber container 1 with the cell suspension CL is complete, the manufacturer of the cell-containing product (the cell suspension CL filled in the multi-chamber container 1) plugs the filling port 14 with a plug 3a. Note that plugging may be performed by welding using a sealer instead of plugging with the plug 3a. Also, there may be multiple manufacturers.

[0037] After plugging, the manufacturer performs an air vent process using the air vent port 15. After air venting, the air vent port 15 is plugged with the plug 3b. Note that plugging may be performed by welding using a sealer instead of plugging with the plug 3b. Then, the manufacturer clips the multi-chamber container 1 with the clip 2 to close the communication port 12.

[0038] 6 and 7 are schematic diagrams of an example of a cross section taken along line X-X in Fig. 5. Fig. 6 shows an outline of the state of the multi-chamber container 1 before clipping, and Fig. 7 shows an outline of the state of the multi-chamber container 1 after clipping.

[0039] As shown in Figure 6, when the first engaging portion 22a and the second engaging portion 22b of the clip 2 are not engaged, the communication port 12 is not closed and the cell suspension liquid CL can move from the large chamber 10 to the small chamber 11.

[0040] 7, when the first fitting portion 22a and the second fitting portion 22b of the clip 2 are fitted together via the clip fastening hole 13 (not shown in FIG. 7), the communication port 12 is clamped between the first arm 21a and the second arm 21b of the clip 2. As a result, the communication port 12 is pressed and collapsed. When the communication port 12 is collapsed, the communication port 12 is blocked, and the cell suspension liquid CL cannot pass through the communication port 12.

[0041] 8 is a diagram illustrating an example of the configuration near the clipped communication port 12 according to the first embodiment. The configuration of the multi-chamber container 1 is shown in simplified form in FIG. 8 , and may differ from the configuration in FIG. 5 . As shown in FIG. 7 , when the communication port 12 is closed by being pressed by the clamping portion 21 of the clip 2, the large chamber 10 and the small chamber 11 are isolated from each other as shown in FIG. 8 .

[0042] Although the clip 2 shown in Figures 3 to 7 can only close three communication ports 12, by using a clip 2 having first arms 21a and second arms 21b of lengths corresponding to the number of communication ports 12 to be closed, any number of communication ports 12 can be closed.

[0043] In this way, by configuring any number of communication ports 12 to be closable, the manufacturer can adjust the number of viable cells to be administered to the patient (the number of viable cells in the product when it is in use) without opening the container when shipping the cell-containing product.

[0044] 9 to 11, the process of adjusting the number of viable cells to be administered to a patient will be described. For ease of explanation, the following description will be given assuming that the multi-chamber container 1 has three small chambers 11, and that the ratio of the volume of one small chamber 11 to the volume of the large chamber 10 is 5%.

[0045] 9 is a diagram illustrating an example of the state of the multi-chamber container 1 when the cell suspension CL according to the first embodiment is filled in. As shown in FIG. 9, when the cell suspension CL is filled in, the three communication ports 12 of the multi-chamber container 1 are not closed by the clips 2, and the large chamber 10 and the three small chambers 11 are in communication with each other.

[0046] The manufacturer fills the cell suspension CL, containing a number of viable cells that is 15% greater than the target number of viable cells set according to the patient's condition, through the filling port 14. As a result, the large chamber 10 is filled with the cell suspension CL containing the target number of viable cells. Also, each of the small chambers 11 is filled with the cell suspension CL containing 5% of the target number of viable cells.

[0047] When filling is complete, the manufacturer plugs the filling port 14 with plug 3a and performs an air venting process in which air generated in the multi-chamber container 1 during filling with the cell suspension CL is discharged through the air vent port 15. After air venting, the manufacturer plugs the air vent port 15 with plug 3b.

[0048] Instead of plugging the filling port 14 with the plug 3a, the filling port 14 may be plugged by welding with a sealer. Also, instead of plugging the air vent port 15 with the plug 3b, the air vent port 15 may be plugged by welding with a sealer.

[0049] 10 is a diagram illustrating an example of the state of the multi-chamber container 1 after being filled with the cell suspension CL according to the first embodiment. As shown in FIG. 10, after being filled with the cell suspension CL, the manufacturer fastens the three communication ports 12 of the multi-chamber container 1 with clips.

[0050] This separates the large chamber 10 containing the cell suspension CL containing the target number of viable cells from the three small chambers 11 containing the surplus cell suspension CL. The manufacturer freezes the multi-chamber container 1 in this state. Thereafter, the manufacturer performs a quality inspection of the product using a product for quality inspection, which is prepared by filling the multi-chamber container 1 with the same cell suspension CL using the same method, separate from the product to be shipped.

[0051] Product quality inspections include, for example, counting the number of cells (cell counting) and calculating the viability rate, which indicates the percentage of live cells in the product. Quality inspections check whether the cell number, viability rate, etc. meet the standard values. If the cell number, viability rate, etc. do not meet the standard values, the product cannot be shipped.

[0052] The quality inspection can be performed manually using a microscope or automatically using an automated analyzer such as a flow cytometer. From the results of the product quality inspection, manufacturers can determine the rate of decrease in viable cell count from the time of filling to after the freeze-thaw process. The rate of decrease in viable cell count is an example of a decrease index.

[0053] The manufacturer determines the number of chambers 11 to open based on the rate of decrease in the number of viable cells. As an example, if the rate of decrease in the number of viable cells is 9%, and the target number of viable cells is X, the number of viable cells present in one chamber 11 can be estimated to be X × 0.05 × (1 − 0.09) ≒ 0.046X.

[0054] Therefore, it can be estimated that opening one chamber 11 will add approximately 0.046X more viable cells to the number of viable cells administered to the patient, opening two chambers 11 will add approximately 0.092X more viable cells, and opening three chambers 11 will add approximately 0.138X more viable cells to the number of viable cells administered to the patient.

[0055] Since the reduction rate of viable cell count due to the freeze-thaw process is 9%, the viable cell count in the large chamber 10 after the freeze-thaw process can be estimated to be 0.91X. In other words, when two small chambers 11 are opened, the estimated viable cell count in the large chamber 10 after the freeze-thaw process is closest to the target viable cell count. Therefore, in this example, the manufacturer decides to open two small chambers 11.

[0056] As another example, if the rate of decrease in the number of viable cells is 12%, and the target number of viable cells is X, the number of viable cells present in one chamber 11 can be estimated to be X × 0.05 × (1 − 0.12) ≒ 0.044X.

[0057] Therefore, it can be estimated that opening one chamber 11 will add approximately 0.044X more viable cells to the number of viable cells administered to the patient, opening two chambers 11 will add approximately 0.088X more viable cells, and opening three chambers 11 will add approximately 0.132X more viable cells to the number of viable cells administered to the patient.

[0058] Since the reduction rate of viable cell count due to the freeze-thaw process is 12%, the viable cell count in the large chamber 10 after the freeze-thaw process can be estimated to be 0.88X. In other words, when three small chambers 11 are opened, the estimated viable cell count in the large chamber 10 after the freeze-thaw process is closest to the target viable cell count. Therefore, in this example, the manufacturer decides to open three small chambers 11.

[0059] 11 is a diagram illustrating an example of the state of the multi-chamber container 1 at the time of shipping the cell suspension CL according to the first embodiment. As shown in FIG. 11, at the time of shipping, the manufacturer fastens one of the communication ports 12 with a clip.

[0060] This isolates the large chamber 10 from one small chamber 11 whose corresponding communication port 12 is closed by the clip 2. The large chamber 10 is also in communication with the two small chambers 11 whose corresponding communication ports 12 are not closed by the clip 2. In this case, the number of live cells present in the large chamber 10 plus the two small chambers 11 will be administered to the patient.

[0061] The cell suspension CL contained in one small chamber 11 whose corresponding communication port 12 is closed becomes surplus cell suspension CL at the time of shipment, and the cell-containing product, including this surplus, is shipped from the manufacturing facility for the cell-containing product to the medical facility that uses the cell-containing product.

[0062] Next, the process from production to use (administration to a patient) of the cell-containing product according to the first embodiment will be described.

[0063] Fig. 12 is a flowchart showing an example of the process from production to use of a cell-containing product according to the first embodiment. Fig. 13 is a schematic diagram explaining an example of the process from production to use of a cell-containing product according to the first embodiment. The process up to shipping (P44) in Figs. 12 and 13 is carried out at a manufacturing facility, and the subsequent processes (M1 to M4) are carried out at a medical institution.

[0064] First, the manufacturer fills the multi-chamber container 1 with the cell suspension CL and plugs it (P1).

[0065] Here, the manufacturer sets a target viable cell count for the patient (hereinafter simply referred to as the patient) who will receive the cell-containing product before filling the cell suspension CL into the multi-chamber container 1. The target viable cell count is a target value for the number of viable cells to be filled into one multi-chamber container 1.

[0066] The target viable cell count is set according to the patient's condition. The patient's condition is, for example, the patient's weight at the time of the filling process. Note that the patient's condition is not limited to weight. For example, the target viable cell count may be set taking into consideration the patient's symptoms, the patient's cell proliferation ability, etc.

[0067] For example, the manufacturer separately counts the number of viable cells present in the cell suspension CL before filling. Based on the counting results, the manufacturer fills each of the multiple multi-chamber containers 1 with an amount of cell suspension CL that contains "the target number of viable cells plus surplus viable cells (15% of the target number of viable cells)." Note that the manufacturer may adjust the amount of cell suspension CL filled into the multiple-chamber container 1 by diluting it with a liquid medium or the like before filling.

[0068] When filling with the cell suspension CL is complete, the large chamber 10 of the multi-chamber container 1 contains an amount of cell suspension CL corresponding to the target number of viable cells. Each of the three small chambers 11 contains an amount of cell suspension CL corresponding to 5% of the target number of viable cells. After filling with the cell suspension CL is complete, the manufacturer plugs the filling ports 14 of each of the multiple multi-chamber containers 1 by welding them with a plug 3a or a sealer, as shown in Figure 13 (P1, P2).

[0069] Next, the manufacturer closes all of the small chambers 11 of each of the multiple multi-chamber containers 1 (P2). For example, as shown in Figure 13 (P1, P2), the manufacturer closes all of the small chambers 11 by closing all of the communication ports 12 of each of the multiple multi-chamber containers 1 with clips 2. The manufacturer then plugs the air vent port 15 of the multiple multi-chamber container 1 by welding it with a plug 3b or a sealer. The manufacturer then designates one of the multiple multi-chamber containers 1 filled with the cell suspension CL as a product for quality inspection 1a, and the remaining ones as products for shipment 1b.

[0070] First, the process for the quality inspection product 1a will be described. The manufacturer freezes the quality inspection product 1a (P31). For example, the manufacturer freezes the quality inspection product 1a using a known method such as liquid nitrogen. After freezing, the quality inspection product 1a is stored in a frozen state.

[0071] Next, the manufacturer thaws the frozen product for quality inspection 1a (P32). For example, the manufacturer stores the product for quality inspection 1a for a period that takes into account the shipping schedule of the cell-containing product, and then thaws the product for quality inspection 1a.

[0072] Next, the manufacturer performs a quality inspection (cell count) of the product for quality inspection 1a (P33). For example, the manufacturer counts the number of cells in the product for quality inspection 1a again, calculates the cell viability, and so on.

[0073] Next, the manufacturer calculates a reduction index of viable cells due to the freeze-thaw process (P34). For example, the manufacturer obtains the reduction rate (reduction index) of viable cell count from the time of filling to the time after the freeze-thaw process based on the re-count of the number of cells and the calculation of the viable cell rate performed in the quality inspection. P34 is an example of an obtaining step.

[0074] Next, the manufacturer determines how many small chambers 11 should be connected to the large chamber 10 (additional amount) at the time of shipment for the product 1b to be shipped (P35). For example, assume that the reduction rate in the number of viable cells is 9%. In this case, as described above, the manufacturer can estimate that the number of viable cells present in one small chamber 11 is 0.046X, where X is the target number of viable cells. Based on this estimation, the manufacturer decides to open two small chambers 11 (to connect the two small chambers 11 to the large chamber 10). P35 is an example of a calculation step.

[0075] Next, the process for the products for shipment 1b will be described. The manufacturer freezes the products for shipment 1b (P41). The manufacturer freezes the products for shipment 1b using the same procedure as for the products for quality inspection 1a, and stores them in the same environment as the products for quality inspection 1a until shipment.

[0076] Furthermore, the manufacturer adjusts the additional amount after P35 of the process related to the quality inspection product 1a (P42).

[0077] For example, if the determined additional amount is equivalent to two small chambers, as shown in Figure 13 (P42), the manufacturer removes the clips 2 that are closing the three communication ports 12. Then, the manufacturer closes one of the three communication ports 12 with the clip 2. In this case, the manufacturer performs clipping using a clip 2 having a first arm 21a and a second arm 21b of lengths corresponding to the case of closing one communication port 12.

[0078] Next, the manufacturer affixes a label to the product 1b for shipment (P43). For example, the manufacturer affixes a label to the product 1b for shipment that lists the product name, the number of viable cells in one multi-chamber container 1 at the time of filling, the serial number, the date of manufacture, the expiration date, etc. The label may be affixed to the packaging of the multi-chamber container 1 rather than to the multi-chamber container 1 itself.

[0079] The manufacturer then ships the cell-containing product to the medical facility (P44).

[0080] The cell-containing product is shipped to the medical facility after going through the above processes P1 to P44 and stored in a frozen state until administration (M1). The cell-containing product is then thawed at the medical facility (M2) and administered to the patient (M3). Note that the surplus that is not administered to the patient (cell suspension CL in the closed chamber 11) is either discarded or stored for testing, investigation, etc. (M4).

[0081] The multi-chamber container 1 according to the first embodiment described above has a large chamber 10, at least one small chamber 11, a communication port 12 that connects the large chamber 10 and the small chamber 11, and a clip 2 that closes the communication port 12. In addition, a cell-containing product using the multi-chamber container 1 as a filling container has the large chamber 10 and the small chamber 11 filled with a cell suspension CL, and the communication port 12 is closed with the clip 2, thereby isolating the large chamber 10 and the small chamber 11.

[0082] As a result, by removing the clip 2, the large chamber 10 and the small chamber 11 can be connected to each other. When the large chamber 10 and the small chamber 11 are isolated from each other, the cell suspension CL does not move from the small chamber 11 to the large chamber 10. Therefore, when the large chamber 10 is used to administer the cell suspension CL, the cell suspension CL contained in the small chamber 11 is not administered to the patient. In contrast, when the large chamber 10 and the small chamber 11 are connected to each other, the cell suspension CL can move from the small chamber 11 to the large chamber 10. Therefore, even when the large chamber 10 is used to administer the cell suspension CL, the cell suspension CL contained in the small chamber 11 can be administered to the patient. In other words, according to the cell-containing product of this embodiment, the amount of cell suspension CL to be administered to the patient can be adjusted without having to prepare a separate cell suspension CL filled with cell suspension CL.

[0083] Incidentally, cell-containing products generally display information indicating the number of viable cells in one multi-chamber container 1 at the time of filling. Furthermore, cell-containing products are typically shipped frozen from manufacturing facilities and thawed at medical facilities before being administered to patients. It is known that the number of viable cells decreases during the freeze-thaw process. Therefore, at the stage when the cell-containing product is administered to a patient, there is a possibility that the number of viable cells displayed on the cell-containing product may differ from the number of viable cells actually administered to the patient.

[0084] At the time of shipment, a cell-containing product undergoes a quality inspection to confirm whether the cell count and viability meet the specifications. The quality inspection product is manufactured using the same process as the shipping product and has undergone a freeze-thaw process. From the results, it is possible to estimate the extent to which viable cells have been reduced by the freeze-thaw process. Furthermore, by determining in advance the ratio of the volume of the small chamber 11 to the volume of the large chamber 10, it is possible to estimate the number of viable cells contained in the large chamber 10 and the small chamber 11 for the shipping product that has undergone the freeze-thaw process. For example, if (displayed number of viable cells - estimated number of viable cells contained in the large chamber 10) > (displayed number of viable cells - (estimated number of viable cells contained in the large chamber 10 + estimated number of viable cells contained in the small chamber 11)), the manufacturing facility can remove the clip 2 before shipping the cell-containing product, thereby reducing the discrepancy between the viable cell count during product use and the viable cell count displayed on the product.

[0085] Furthermore, by providing the multi-chamber container 1 with a plurality of small chambers 11 whose volume ratio to the volume of the large chamber 10 is constant, and with communicating ports 12 corresponding to each of the plurality of small chambers 11, the number of small chambers 11 (communicating ports 12) to be closed can be determined so as to come closest to the displayed cell count based on the estimated number of live cells contained in the large chamber 10 and the number of live cells contained in the small chambers 11, thereby further reducing the discrepancy between the number of live cells when the product is in use and the number of live cells displayed on the product.

[0086] Second Embodiment In the first embodiment, the adjustment of the additional amount is performed at a manufacturing facility. In the second embodiment, the adjustment of the additional amount is performed at a medical facility.

[0087] In the following, differences from the above-described embodiment will be mainly described, and detailed descriptions of commonalities with the above-described embodiment will be omitted. Furthermore, each embodiment described below may be implemented individually or in appropriate combination.

[0088] The process from production to use of the cell-containing product of the second embodiment will be described below.

[0089] Figure 14 is a flowchart showing an example of the process from production to use of a cell-containing product according to the second embodiment. Also, Figure 15 is a schematic diagram explaining an example of the process from production to use of a cell-containing product according to the second embodiment. The process up to shipping (P144) in Figures 14 and 15 is carried out at a manufacturing facility, and the subsequent processes (M11 to M16) are carried out at a medical institution.

[0090] Processes P11 to P12, P131 to P135, and P141 are similar to processes P1 to P2, P31 to P35, and P41 in FIGS. 12 and 13, and therefore description thereof will be omitted.

[0091] After the process P135 for determining the additional amount, the manufacturer prepares a package insert AD regarding the additional amount (P142). As shown in Figure 15, the package insert AD contains information indicating how many small chambers 11 should be connected to the large chamber 10 to minimize the difference between the live cell count during product use and the displayed live cell count, such as "taking into account the effects of freezing and thawing, it is appropriate to add two small chambers." P142 is an example of a printing step.

[0092] Here, the attachment AD may, for example, physically (on a physical medium) display information about the additional amount.

[0093] As an example of physically displaying information, the package insert AD may be a sheet of paper enclosed with the cell-containing product (multi-chamber container 1) on which information regarding the additional amount is printed. As another example, the package insert AD may be a sheet of paper on which information regarding the additional amount is printed on the multi-chamber container 1 itself or on a label attached to the multi-chamber container 1. As another example, the package insert AD may be a sheet of paper on which information regarding the additional amount is printed on the packaging container that contains the multi-chamber container 1 or on a label attached to the packaging container.

[0094] The package insert AD may also display information regarding the additional amount, for example electronically.

[0095] As an example of displaying information electronically, the package insert AD may be a piece of paper enclosed with the cell-containing product (multi-chamber container 1) on which a code symbol such as a one-dimensional code or a two-dimensional code encoding information about the additional amount is printed. In this case, by using a known reading device (scanner) or the like to compound the information about the additional amount, it is possible to display the information about the additional amount on a display device such as a monitor using a general information processing device such as a PC.

[0096] The information regarding the additional amount may be stored on a cloud server or the like. In this case, the code symbol may encode an address for accessing the information regarding the additional amount. In this case, a medical professional or the like who administers the cell-containing product to a patient can view the information regarding the additional amount via a network by reading the code symbol with a reading device.

[0097] As another example, a one-dimensional code or a two-dimensional code may be printed on the multi-chamber container 1 itself or on a label attached to the multi-chamber container 1. As another example, the package insert AD may be a one-dimensional code or a two-dimensional code printed on the packaging container that houses the multi-chamber container 1 or on a label attached to the packaging container.

[0098] Process P143 is similar to process P43 in Figures 12 and 13, and therefore will not be described here. After process P143, the manufacturer ships the cell-containing product to the medical institution (P144). For example, as shown in Figure 15 (P143, P144), the manufacturer ships the cell-containing product with the package insert created in process P142 and a clip 2 for adjusting the amount of additional product added, with the three communication ports 12 remaining closed.

[0099] Next, the process performed at a medical institution will be described. Process M11 is similar to process M1 in Figures 12 and 13, and therefore will not be described here. After process M11, a medical professional (e.g., a doctor or nurse) at the medical facility checks the package insert AD regarding the additional amount (M12). Note that there may be multiple medical professionals.

[0100] The medical professional then adjusts the additional amount (M13).

[0101] For example, if the package insert AD shown in Fig. 15 is attached, the medical professional removes the clips 2 closing the three communication ports 12, as shown in Fig. 15 (M13, M14).The medical professional then closes one of the three communication ports 12 with a clip 2 for adjusting the additional amount attached to the cell-containing product.

[0102] Processes M14 to M16 are similar to processes M2 to M4 in FIG. 11, and therefore a description thereof will be omitted.

[0103] In the process from manufacturing to use of the cell-containing product according to the second embodiment described above, the process of adjusting the amount of additional cells is carried out at a medical institution. Furthermore, a package insert AD regarding the amount of additional cells is attached to the cell-containing product. This allows medical personnel to reliably adjust the amount of additional cells. Furthermore, in this embodiment, the medical institution can decide whether to adjust the amount of additional cells. For example, if the medical institution believes that administering the displayed number of live cells to the patient would result in an excessive administration based on the patient's current condition, the cell suspension CL can be administered to the patient without adjustment. In other words, the discrepancy between the number of live cells at the time of product use and the number of live cells the user wants or should use can be reduced.

[0104] In the above-described first and second embodiments, an adjustment is made by adding (increasing) the cell suspension CL in accordance with the number of viable cells estimated from the results of the quality inspection in the multi-chamber container 1. In the third embodiment, an adjustment is made that takes into consideration the condition of the patient and allows not only an increase but also a decrease in the amount.

[0105] First, the configuration of the multi-chamber container 1 according to the third embodiment will be described. Fig. 16 is a diagram showing an example of the configuration of the multi-chamber container 1 according to the third embodiment. Fig. 17 is a diagram explaining an example of the configuration near the communication port according to the third embodiment. Fig. 17 shows a simplified configuration of the multi-chamber container 1, so it may differ from the configuration in Fig. 16.

[0106] The multi-chamber container 1 of the third embodiment is similar to the first and second embodiments, but differs from the first and second embodiments in that the small chamber 11 is used to form a vacant chamber 11a when filling the cell suspension CL.

[0107] The empty chamber 11a is used in a medical facility for a process of reducing the amount of cell suspension CL to be administered to a patient without opening the container. The process of reducing the amount of cell suspension CL to be administered to a patient without opening the container will be described later.

[0108] In the third embodiment, before filling with the cell suspension CL, the number of communication ports 12 corresponding to the number of empty chambers 11a to be formed (one in the example of FIG. 16) are closed with clips 2. As shown in FIG. 17 , even if the large chamber 10 is filled with the cell suspension CL, the cell suspension CL does not move to empty chambers 11a whose communication ports 12a are closed with clips 2.

[0109] On the other hand, for the small chamber 11 whose communication port 12 is not closed by the clip 2, the large chamber 10 and the small chamber 11 are in a connected state, so when the large chamber 10 is filled with the cell suspension liquid CL, the small chamber 11 is also filled with the cell suspension liquid CL.

[0110] Next, the process from production to use of the cell-containing product according to the third embodiment will be described.

[0111] Figure 18 is a flowchart showing an example of the process from production to use of a cell-containing product according to the third embodiment. Also, Figure 19 is a schematic diagram explaining an example of the process from production to use of a cell-containing product according to the third embodiment. The process up to shipping (P544) in Figures 18 and 19 is carried out at a manufacturing facility, and the subsequent processes (M51 to M54, M551 to M552, M561 to M564, M57 to M58) are carried out at a medical institution.

[0112] Processes P51 to P52, P531 to P535, P541 to P544, and M51 to M52 are similar to processes P11 to P12, P131 to P135, P141 to P144, and M11 to M12 in FIGS. 14 and 15, and therefore will not be described here.

[0113] After process M52, the medical staff obtains information indicating the patient's weight as a condition of the patient (M53). For example, the medical staff obtains information indicating the patient's most recent weight from an electronic medical record or the like.

[0114] 14 and 15, an example is described in which the cell suspension CL to be administered to a patient is adjusted using the patient's weight as an indication of the patient's condition, but the adjustment may also be made using the patient's cell proliferation ability as an indication of the patient's condition in addition to the patient's weight.

[0115] The process M53 may be performed before the process M52 or in parallel with the process M52.

[0116] Next, the medical professional calculates the number of viable cells to be administered to the patient (M54). For example, as shown in Figure 19 (M52, M53), the medical professional calculates the number of viable cells to be administered to the patient based on the package insert AD and information PI indicating the patient's condition at the time of administration. Based on the number of viable cells to be administered to the patient calculated in process M54, the medical professional determines whether to increase or decrease the amount of cell suspension CL.

[0117] If it is determined from the results of M54 that the amount of cell suspension CL should be increased, the medical staff opens the small chamber 11 (M551).

[0118] For example, the medical professional removes the clip 2 closing the chamber 11a and the small chamber 11. Then, the medical professional closes the chamber 11a and the small chamber 11 with a clip 2 of a length corresponding to the additional amount. As an example, if the additional amount is the amount for one small chamber, the medical professional clips the communication port 12 corresponding to the chamber 11a and the communication port 12 corresponding to the small chamber 11 adjacent to the chamber 11a.

[0119] The subsequent process M552 is similar to process M2 in Fig. 12, and therefore will not be described here. On the other hand, if it is determined from the results of M54 that the amount of cell suspension CL should be reduced, the frozen cell-containing product is thawed (M561), similar to process M2 in Fig. 12. Next, the medical staff opens the empty chamber 11a (M562).

[0120] For example, the medical professional removes the clip 2 that closes the communication port 12 corresponding to the chamber 11a. If there are multiple chambers 11a, the medical professional opens the chambers 11a in the number corresponding to the amount of reduction. In other words, the medical professional recloses the communication ports 12 corresponding to the chambers 11a in the number corresponding to the amount of reduction.

[0121] Next, the medical professional moves the cell suspension CL to the empty chamber 11a (M563). For example, the medical professional gently presses the cell suspension CL in the large chamber 10 to move the cell suspension CL from the large chamber 10 to the now open empty chamber 11a. This causes some of the live cells present in the large chamber 10 to move to the small chamber 11 (the space that was formerly empty chamber 11a). As a result, the number of live cells present in the large chamber 10 will be reduced compared to immediately after the cell-containing product was thawed.

[0122] Next, the medical professional recloses the small chamber 11 (M564). For example, the medical professional clips all of the communication ports 12, including the communication port 12 corresponding to the empty chamber 11a into which the cell suspension liquid CL was transferred from the large chamber 10 in M563.

[0123] The subsequent processes M57 and M58 are similar to M3 and M4 in FIG. 12, and therefore a description thereof will be omitted.

[0124] The multi-chamber container 1 according to the third embodiment described above has an empty chamber 11a that is not filled with cell suspension CL, and the empty chamber 11a is closed with a clip 2. For example, if a medical professional wishes to reduce the dosage of a patient due to weight loss or other reasons, the clip 2 closing the empty chamber 11a can be removed after thawing the cell-containing product to move the cell suspension CL from the large chamber 10 to the empty chamber 11a. This moves the viable cells present in the large chamber 10 to the empty chamber 11a, thereby reducing the number of viable cells in the large chamber 10. Closing all of the small chambers 11 with clips 2 in this state reduces the number of viable cells actually administered to the patient. In other words, the discrepancy between the number of viable cells during product use and the number of viable cells the user desires or should use can be reduced.

[0125] The above-described embodiment can be modified as needed by changing a portion of the configuration of the multi-chamber container 1. Therefore, several modifications of the above-described embodiment will be described below as other embodiments. The following mainly focuses on differences from the above-described embodiment, and detailed descriptions of commonalities with the content already described will be omitted. The modifications described below may be implemented individually or in appropriate combinations.

[0126] (Modification 1) In the above-described first to third embodiments, the multi-chamber container 1 has been described as having a communication port 12 between the large chamber 10 and the small chamber 11. In this modification, a description will be given of a multi-chamber container 1 that does not have a communication port 12.

[0127] Figure 20 is a diagram showing an example of the configuration of a multi-chamber container 1 according to Modification 1. As shown in Figure 20, the multi-chamber container 1 according to Modification 1 is composed of a large chamber 10, a plurality of small chambers 11b, a filling port 14, an air vent port 15, and a confinement section 16. In the example of Figure 20, the multi-chamber container 1 is filled with a cell suspension CL. The large chamber 10, the filling port 14, and the air vent port 15 are substantially the same as those in Figure 1, and therefore description thereof will be omitted.

[0128] The multiple chambers 11b are separated by partition walls 111 (not shown in FIG. 20) as in the first embodiment, but do not have the communication ports 12 as in the first embodiment. In other words, it can be said that the multiple chambers 11b have wide inlets for the cell suspension liquid CL.

[0129] Furthermore, in the multi-chamber container 1 of the first embodiment, the liquid level in the small chamber 11 after filling with the cell suspension CL was located below the liquid level in the large chamber 10, but in this modified example, the liquid levels in both chambers are the same after filling with the cell suspension CL. In other words, the liquid level in the small chamber 11 after filling with the cell suspension CL in modified example 1 is closer to the air vent port 15 than in the first embodiment.

[0130] The confining portion 16 is a portion for confinement by a clip 2 (not shown in FIG. 20). In this modified example, the area inside the multi-chamber container 1 that corresponds to the confining portion 16 functions as the communication port in the claims. In the example of FIG. 20, the multi-chamber container 1 does not have a clip fastening hole 13, so the first fitting portion 22a and the second fitting portion 22b of the clip 2 fit together so as to sandwich the confining portion 16.

[0131] In addition, the clip 2 may be formed so that the entire surface of the first arm 21a that contacts the multi-chamber container 1 functions as the first fitting portion 22a, and the entire surface of the second arm 21b that contacts the multi-chamber container 1 functions as the second fitting portion 22b.

[0132] This allows the entire surface of the first arm 21a that contacts the multi-chamber container 1 and the entire surface of the second arm 21b that contacts the multi-chamber container 1 to press against the confining portion 16. This increases the force with which the clip 2 presses against the confining portion 16, allowing each chamber 11 to be closed more reliably.

[0133] Furthermore, the multi-chamber container 1 according to the first modification may have a clipping hole 13. In this case, the width of the clipping hole 13 is preferably less than 50% of the width of the small chamber 11 so as not to interfere with the filling process of the cell suspension CL and the air removal process after filling.

[0134] The small chamber 11 of the multi-chamber container 1 of this modified example has a wide inlet for the cell suspension CL, so that the cell suspension CL can easily enter the small chamber 11 when the cell suspension CL is filled.

[0135] Furthermore, since the small chamber 11 has a wide inlet for the cell suspension CL, air generated in the small chamber 11 by filling the chamber 11 can easily escape to the outside of the small chamber 11. Furthermore, since the liquid level in the small chamber 11 after filling the chamber 11 with the cell suspension CL is located near the air vent port 15, air inside the container can easily escape to the outside of the container.

[0136] That is, according to this modification, the filling of the cell suspension CL and the air removal process after filling can be carried out efficiently.

[0137] (Modification 2) In the first to third embodiments described above, the multi-chamber container 1 has the large chamber 10 and the small chamber 11. In this modification, a description will be given of a multi-chamber container 1 that does not have the large chamber 10.

[0138] Fig. 21 is a diagram showing an example of the configuration of a multi-chamber container 1 according to Modification 2. As shown in Fig. 21, the multi-chamber container 1 according to Modification 1 is composed of a plurality of small chambers 11c, a filling port 14, an air vent port 15, and a confinement section 16. In the example of Fig. 20, the multi-chamber container 1 is filled with a cell suspension liquid CL. The large chamber 10, the filling port 14, the air vent port 15, and the confinement section 16 are substantially the same as those in Fig. 20, and therefore description thereof will be omitted.

[0139] The plurality of small chambers 11c are formed to have substantially the same volume. The plurality of small chambers 11c are an example of second chambers.

[0140] In this modification, when the cell suspension CL is filled into the multi-chamber container 1 through the filling port 14, the cell suspension CL moves into each of the chambers 11c through a space (corresponding to the first chamber in the claims) where no partition (partition wall 111, not shown in FIG. 21) between the chambers 11c exists. As a result, each of the chambers 11c contains cell suspension CL containing approximately the same number of viable cells.

[0141] The multi-chamber container 1 of this modified example does not have the large chamber 10, so a small chamber 11c can be formed in the area where the large chamber is formed in the multi-chamber container 1 of the first embodiment, which makes it possible to more precisely adjust the number of viable cells actually administered to a patient.

[0142] According to at least one embodiment described above, it is possible to reduce the discrepancy between the viable cell count when using a product and the viable cell count displayed on the product. Furthermore, according to at least one embodiment described above, it is possible to reduce the discrepancy between the viable cell count when using a product and the viable cell count that a user wants or should use. That is, according to at least one embodiment described above, it is possible to take into account the decrease in the viable cell count since the time of product manufacture when using a product.

[0143] Although several embodiments have been described, these embodiments are presented as examples and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, substitutions, modifications, and combinations of embodiments can be made without departing from the spirit of the invention. These embodiments and their modifications are included within the scope and spirit of the invention, as well as within the scope of the invention and its equivalents as defined in the claims.

Claims

1. A cell-containing product in which the filled container is a multi-chamber container having a first chamber formed inside the container, a communication port, at least one second chamber connected to the first chamber via the communication port, and a closing means for closing the communication port, wherein the first chamber and the second chamber are filled with a cell suspension, and the communication port is closed by the closing means, thereby isolating the first chamber and the second chamber.

2. The multi-chamber container has a filling port arranged in the first chamber, the closing means is formed to be openable and closable, and when the communication port is not closed by the closing means, the cell suspension is filled into the first chamber from outside the multi-chamber container through the filling port, thereby filling the second chamber through the communication port, and after the filling port is plugged, the communication port is closed by the closing means. A cell-containing product as described in claim 1.

3. The cell-containing product of claim 1, wherein the volume of the front second chamber of the multi-chamber container is a constant ratio to the volume of the first chamber, the horizontal cross-sectional area of ​​the communication port is smaller than the horizontal cross-sectional area of ​​the front second chamber, and the ratio of the volume of the communication port to the volume of the second chamber is less than 5%.

4. The cell-containing product described in claim 1, wherein the closing means has a clamping portion consisting of two arms, and the clamping portion closes the communication opening by clamping and pressing the communication opening with the two arms.

5. The multi-chamber container has a through-hole located near the communication port, penetrating the multi-chamber container horizontally, and separated from the inside of the container by a partition, and the closing means has a pair of fitting portions at one end of each of the two arms of the clamping portion, and the pair of fitting portions fit together through the through-hole, thereby clamping and pressing the communication port with the two arms to close the communication port, a cell-containing product as described in claim 4.

6. The cell-containing product described in claim 5, wherein the multi-chamber container has a plurality of second chambers arranged in parallel, a plurality of communication ports and a plurality of through holes arranged in parallel corresponding to each of the second chambers, and any number of the communication ports are closed by using the closing means of a length corresponding to the number of second chambers to be closed.

7. The cell-containing product according to any one of claims 1 to 6, wherein the first chamber and the second chamber are each filled with the cell suspension.

8. The cell-containing product according to claim 7, wherein the multi-chamber container has at least one empty second chamber that is not filled with the cell suspension, and the empty chamber is closed by the closing means.

9. The cell-containing product according to any one of claims 1 to 6, wherein the multi-chamber container further comprises an exhaust port for exhausting air present inside the container to the outside of the container.

10. A cell-containing product described in any one of claims 1 to 6, wherein the multi-chamber container has a plurality of second chambers, and information regarding the additional quantity indicating how many of the second chambers are to be in communication with the first chamber when the cell-containing product is used is displayed physically or electronically.

11. A method for producing a cell-containing product in which the filled container is a multi-chamber container having a first chamber formed inside the container, a communication port, at least one second chamber connected to the first chamber via the communication port, and a closing means for closing the communication port, the method comprising: a filling step for filling the first chamber and the second chamber with a cell suspension; and a closing step for isolating the first chamber and the second chamber by closing the communication port with the closing means.

12. The method for producing a cell-containing product according to claim 11, wherein the multi-chamber container has a plurality of second chambers arranged in parallel and a plurality of communication ports arranged in parallel corresponding to each of the second chambers, and the filling step further comprises: a freezing step of filling each of the first chamber and the second chamber of the multi-chamber container with the cell suspension, freezing the cell suspension filled in the multi-chamber container; an inspection step of conducting an inspection related to the number of viable cells on an inspection product obtained by filling and freezing the same cell suspension in another multi-chamber container having the same shape as the multi-chamber container in the same process; an acquisition step of obtaining a reduction index of the viable cells filled in the multi-chamber container due to freezing and thawing based on the results of the inspection; a determination step of determining the number of communication ports to close based on the reduction index; an opening step of opening the closing means that closes the communication ports; and a re-closing step of closing the determined number of communication ports with the closing means.

13. The method for producing a cell-containing product described in claim 11, wherein the multi-chamber container has a filling port arranged in the first chamber, the closing means is formed to be openable and closable, the filling step includes filling the cell suspension into the first chamber from outside the multi-chamber container through the filling port while the communication port is not closed by the closing means, thereby filling the cell suspension into the second chamber through the communication port, and further includes a plugging step of plugging the filling port, and the closing step includes closing the communication port with the closing means after the filling port has been plugged.

14. A method for producing a cell-containing product described in any one of claims 11 to 13, further comprising: an acquisition step of acquiring a reduction index of the number of live cells from the time of filling with the cell suspension to after the cell-containing product has undergone a freeze-thaw process; a calculation step of calculating an additional amount indicating how many of the second chambers should be connected to the first chamber when the cell-containing product is used based on the reduction index; and a printing step of printing a display on the multi-chamber container itself or a component attached to the multi-chamber container so that information regarding the additional amount can be viewed directly or indirectly.

Images