Method of providing cell-based therapies

Abstract

To provide, for example, methods of providing a cell medicine that save the trouble of thawing at a medical institution.SOLUTION: A method of providing a cell medicine comprises: thawing pharmaceutical raw material cells stored in a frozen state; separating an inspection sample from the thawed pharmaceutical raw material cells; and providing the pharmaceutical raw material cells enclosed in a shipping container and the results of a shipping inspection performed using the inspection sample. The results of the shipping inspection include cell viability. A dose to be administered to a patient is calculated based on the results of the shipping inspection, and information about the calculated dose is provided together with the results of the shipping inspection.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a method for providing cell drugs.

Background Art

[0002] Cell drugs in which cultured cells are administered to patients while alive are being used (Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] Cell drugs are stored in a frozen state and are delivered in the frozen state according to the requests from medical institutions. At medical institutions, the delivered cell drugs are thawed immediately before administration to patients.

[0005] However, the quality of cell drugs is easily affected by the temperature conditions during thawing. It takes time and effort to perform thawing under appropriate temperature conditions.

[0006] In one aspect, an object is to provide a method for providing cell drugs that can save the effort of thawing at medical institutions.

Means for Solving the Problems

[0007] A method for providing cell drugs thaws drug raw material cells stored in a frozen state, separates a test sample from the thawed drug raw material cells, and provides the drug raw material cells enclosed in a shipping container and the shipping inspection results obtained using the test sample. The system detects the condition of the shipping container during delivery and notifies the user if the conditions deviate during delivery. .

Effects of the Invention

[0008] In one embodiment, this method can provide a way to deliver cell-based pharmaceuticals that eliminates the need for thawing at medical institutions. [Brief explanation of the drawing]

[0009] [Figure 1] This is an explanatory diagram illustrating the general method for providing cell-based pharmaceuticals. [Figure 2] This is an explanatory diagram illustrating the configuration of a cell-based drug delivery system. [Figure 3] This is an explanatory diagram illustrating an example of a shipping container for cell-based pharmaceuticals. [Figure 4] This is an explanatory diagram illustrating the record layout of the product database. [Figure 5] This is an explanatory diagram illustrating the record layout of the database in the first stage. [Figure 6] This is an explanatory diagram illustrating the record layout of the second-stage database. [Figure 7] This is a flowchart that explains the processing flow of a program. [Figure 8] This is a flowchart illustrating the processing flow of the subroutine for creating label data. [Figure 9] This is the second label of variation 1-1. [Figure 10] This is the second label for variation 1-2. [Figure 11] This is a shipping container for modified example 1-3. [Figure 12] This is a shipping container for modified example 1-4. [Figure 13] This is an explanatory diagram illustrating the second step of the modified example 1-5. [Figure 14] This is an explanatory diagram illustrating the second step of the modified example 1-6. [Figure 15] Examples of labels for variation 1-6. [Figure 16] This is an explanatory diagram illustrating the second step of the modified example 1-7. [Figure 17] This is an explanatory diagram illustrating the outline of the cell-based drug delivery method according to Embodiment 2. [Figure 18]It is an explanatory diagram for explaining the configuration of the cell drug providing system according to Embodiment 2. [Figure 19] It is a flowchart for explaining the processing flow of the program according to Embodiment 2. [Figure 20] It is an example of a screen according to Embodiment 2. [Figure 21] It is an example of a screen according to Embodiment 2. [Figure 22] It is an example of a screen according to Embodiment 2. [Figure 23] It is an example of a label according to Modification Example 2-1. [Figure 24] It is an example of a label according to Modification Example 2-1. [Figure 25] It is an example of a screen according to Modification Example 2-2. [Figure 26] It is an example of a screen according to Modification Example 2-3. [Figure 27] It is an explanatory diagram for explaining the configuration of the cell drug providing system according to Embodiment 3. [Figure 28] It is a flowchart for explaining the processing flow of the program according to Embodiment 3. [Figure 29] It is an example of a screen according to Embodiment 3. [Figure 30] It is an explanatory diagram for explaining an example of a shipping container containing a cell drug according to Modification Example 3-1. [Figure 31] It is an explanatory diagram for explaining the configuration of the cell drug providing system according to Embodiment 4. [Figure 32] It is a functional block diagram of the cell drug providing system according to Embodiment 5.

Modes for Carrying Out the Invention

[0010] [Embodiment 1] Figure 1 is an explanatory diagram illustrating the outline of a method for providing cell-based pharmaceuticals. The cell-based pharmaceutical in this embodiment includes cells and a diluent that has a protective effect on the cells. The cells used in the cell-based pharmaceutical are, for example, somatic stem cells or mesenchymal stem cells isolated from cells collected from a healthy person. The cells used in the cell-based pharmaceutical may also be so-called pluripotent stem cells, such as iPS (induced pluripotent stem) cells established by reprogramming somatic cells collected from a healthy person. The cells used in the cell-based pharmaceutical may also be so-called autologous cells collected and cultured from the patient themselves.

[0011] In the following explanation, cells used in cell-based therapies may be referred to as pharmaceutical raw material cells. Note that during the manufacturing process of cell-based therapies, cells may undergo genetic manipulation or transformation, altering their properties. In the following explanation, cells before and after such alterations will be collectively referred to as pharmaceutical raw material cells.

[0012] The manufacturing process for cell-based pharmaceuticals in this embodiment is divided into two steps: a first step and a second step. The pharmaceutical raw material cells manufactured in the first step are stored in a frozen state. Upon receiving an order from a medical institution, the pharmaceutical raw material cells are thawed and the second step begins. In other words, the second step is performed for each shipment lot of cell-based pharmaceuticals.

[0013] The cell-based therapies completed after the second process are delivered to medical institutions at room temperature or refrigerated and administered to patients. The operations performed in the first and second manufacturing processes will be described later.

[0014] Figure 2 is an explanatory diagram illustrating the configuration of the cell therapy supply system 10. The cell therapy supply system 10 includes an information processing device 20, a cell therapy manufacturing device 30, and an order management system 18.

[0015] The information processing device 20 comprises a control unit 21, a main memory 22, an auxiliary memory 23, a communication unit 24, an output unit 25, an input unit 26, and a bus. The control unit 21 is an arithmetic control device that executes the program of this embodiment. One or more CPUs (Central Processing Units), GPUs (Graphics Processing Units), or multi-core CPUs are used in the control unit 21. The control unit 21 is connected to each hardware component of the information processing device 20 via the bus.

[0016] The main memory 22 is a storage device such as SRAM (Static Random Access Memory), DRAM (Dynamic Random Access Memory), or flash memory. The main memory 22 temporarily stores information necessary during processing performed by the control unit 21 and the program currently being executed by the control unit 21.

[0017] The auxiliary storage device 23 is a storage device such as SRAM, flash memory, hard disk, or magnetic tape. The auxiliary storage device 23 stores the first process DB61, the second process DB62, the product DB63, the program to be executed by the control unit 21, and various data necessary for the execution of the program. The first process DB61, the second process DB62, and the product DB63 may be stored in an external mass storage device connected to the information processing device 20.

[0018] The communication unit 24 is an interface for communication between the information processing device 20 and the network. The output unit 25 is an output device such as a liquid crystal display panel or an organic EL (electro-luminescence) panel. The input unit 26 is an input device such as a keyboard or mouse. The output unit 25 and the input unit 26 may be a stacked touch panel. The output unit 25 may be a speaker. The input unit 26 may be a microphone.

[0019] The information processing device 20 in this embodiment is a general-purpose personal computer, tablet, smartphone, mainframe computer, virtual machine operating on a mainframe computer, or cloud computing system. The information processing device 20 may also consist of multiple personal computers or the like performing distributed processing. The information processing device 20 may also serve as a control computer built into the cell drug manufacturing apparatus 30.

[0020] The cell therapy manufacturing apparatus 30 includes a culture device 31, an inspection device 32, an inclusion device 33, a labeling device 34, a freezing device 35, a thawing device 36, and a storage device 37. Multiple of the listed devices may be configured as a single unit. For example, the cell therapy manufacturing apparatus 30 is a fully automated apparatus in which multiple devices are connected by a transport device (not shown) and operate in conjunction with each other.

[0021] Each of the devices constituting the cell therapy manufacturing apparatus 30 may be operated by an operator. The operator removes processed cells from one device, places them in the next device to be used, and continues processing. Alternatively, a robot (not shown in the illustration) may operate each device to manufacture the cell therapy instead of an operator.

[0022] The culture device 31 is a device for culturing and growing cells. The culture device 31 is a device that automatically repeats tasks such as temperature control of the culture medium, cell selection, and subculturing to grow cells. The culture device 31 may only have the function of an incubator that maintains a temperature suitable for cell proliferation, and the operator may perform selection and subculturing manually.

[0023] The inspection device 32 includes, for example, measuring instruments such as cell counters and instruments for cell observation such as microscopes. The inspection device 32 is used in each process of manufacturing cell-based pharmaceuticals. The inspection device 32 performs tests such as viable cell rate, cell concentration, specific cell concentration, cell proliferation rate, presence or absence of foreign substances and atypical cells. Here, specific cell concentration refers to the ratio of specific cells, specifically the pharmaceutical raw material cells to the total number of cells in the culture medium.

[0024] The sealing device 33 is a device that seals the cultured cells and diluent into the shipping container 41 (see Figure 3). The sealing device 33 is, for example, an automated dispensing device. The labeling device 34 is a device that applies a predetermined label 42 (see Figure 3) to the shipping container 41. The labeling device 34 is, for example, a label printer that prints the label 42 to be affixed to the shipping container 41. The labeling device 34 may also directly print or engrave the label 42 on the surface of the shipping container 41.

[0025] The freezing device 35 is a device for freezing cells. The freezing device 35 is, for example, a speed-controlled freezer that has the function of lowering the temperature of cells at a predetermined rate. The thawing device 36 is a device for thawing frozen cells. The thawing device 36 is, for example, a water bath. The storage device 37 is a device for storing frozen cells. The storage device 37 is, for example, an ultra-low temperature deep freezer that stores cells in liquid nitrogen.

[0026] The order management system 18 is a device that manages orders from medical facilities. Based on instructions from the order management system 18, the second process begins.

[0027] Returning to Figure 1, we will now describe the process for manufacturing cell-based pharmaceuticals. The following explanation will use the case where the information processing device 20 also serves as the control device for the cell-based pharmaceutical manufacturing apparatus 30 as an example. As mentioned earlier, some or all of the operations in the manufacturing process may be performed by an operator. Since the individual steps performed during cell culture are publicly known, we will omit detailed explanations.

[0028] The control unit 21 cultures medical raw material cells using the culture device 31 (step S501). The control unit 21 takes a sample for testing from the medical raw material cells and performs testing using the testing device 32 (step S502). Although the flowchart is omitted, if the characteristics of the medical raw material cells do not meet the predetermined acceptance criteria during testing during or after the completion of culture, the manufacturing process is stopped.

[0029] The control unit 21 concentrates the medical raw material cells, for example by centrifugation, and then mixes in a diluent (step S503). The diluent preferably has the function of a cryoprotective agent to protect the medical raw material cells during freezing. Examples of diluents include DMSO (Dimethyl Sulfoxide), glycerol, polyethylene glycol, glycerin, or sorbitol. The culture apparatus 31 may also have a function to automatically execute step S503 after the completion of step S501.

[0030] The control unit 21 uses the encapsulation device 33 to divide the medical raw cells and diluent into shipping containers 41 (step S504). Step S503 described above may also be performed by the encapsulation device 33.

[0031] The control unit 21 uses the freezing device 35 to freeze the medical raw cells that have been divided into shipping containers 41 (step S505). This completes the first step. The control unit 21 stores the medical raw cells in the storage device 37 (step S506).

[0032] The order management system 18 transmits order information to the cell drug manufacturing apparatus 30, including the type, quantity, and delivery date and time of the cell drug (step S591). Upon receiving the order information, the control unit 21 starts the second process described below.

[0033] The control unit 21 removes the shipping containers 41 from the storage device 37 and thaws them using the thawing device 36 (step S511). The thawing device 36 is controlled to thaw at appropriate temperature conditions that minimize damage to the cells during thawing. In step S511, the control unit 21 thaws a number of shipping containers 41 specified in the order information, i.e., the planned number of cell therapies to be shipped, plus the number of shipping containers 41 to be used for post-thawing inspection.

[0034] The control unit 21 removes the test sample from the thawed shipping container 41 and performs the test using the testing device 32 (step S512). The test performed in step S512 is a test that can be completed in a relatively short time, such as measuring the viability of cells or the cell concentration.

[0035] The control unit 21 attaches the second label 422, which indicates the post-thawing inspection results performed in step S512, i.e., the shipping inspection results, to the shipping container 41 (step S513). With this, the second process is completed, and the cell-based pharmaceutical product is finished.

[0036] The completed cell therapy is promptly delivered to medical institutions without being refreezed (step S514). At the medical institution, the delivered cell therapy is administered to the patient (step S515). Since there is no need for thawing at the medical institution, the cell therapy can be used immediately upon arrival. Furthermore, users such as doctors or nurses can record the product ID of the cell therapy administered to the patient in the electronic medical record by scanning the barcode printed on the first label 421 (see Figure 3).

[0037] Furthermore, if the test performed in step S502 or step S512 does not damage the pharmaceutical raw material cells, the sample removed for testing may be returned and the process proceeds to the next step. For example, samples in which cell viability has been measured using polarization or Raman spectroscopy do not damage the pharmaceutical raw material cells, so there is no problem in introducing them to the next step. On the other hand, samples in which cell staining has been performed should be discarded without being introduced to the next step.

[0038] As a result, a cell-based drug delivery system 10 can be provided that minimizes the amount of drug raw material cells discarded for testing. Alternatively, instead of returning the drug raw material cells used for testing, they may be managed as a separate production lot. Even if testing is performed that raises concerns about minor impacts on drug raw material cells, they can be used without disposal by treating them as a separate production lot and implementing quality control.

[0039] For tests that do not damage the pharmaceutical raw material cells, instead of testing a sample, the entire quantity of pharmaceutical raw material cells may be tested. For example, instead of testing cell viability, viable cells may be isolated using a cell sorting device and proceeded to the next step.

[0040] Figure 3 is an explanatory diagram illustrating an example of a shipping container 41 containing cell-based therapies. Using Figure 3, an example of a vial-type shipping container 41 is explained. The main body of the shipping container 41 functions as a sealing section for enclosing the cell-based therapies. Each shipping container 41 contains an amount of cell-based therapies corresponding to the supply unit provided to a medical institution. A supply unit is, for example, the amount used for one patient. A supply unit may also be the amount used for multiple patients.

[0041] The shipping container 41 has two labels 42 affixed to it: a first label 421 and a second label 422. The two labels 42 are positioned so as not to obstruct visual confirmation of the liquid level of the cell therapy when the shipping container 41 is left standing still.

[0042] The first label 421 displays a product ID (Identifier) ​​unique to each shipping container 41, using both text and a barcode. The first label 421 is affixed to each shipping container 41 before step S504. The first label 421 may also be affixed to each shipping container 41 between step S504 and step S505.

[0043] The second label 422 is affixed to the shipping container 41 in step S513. The second label 422 includes a pass date column 423, an expiration date column 424, and a post-thawing inspection information column 425. The pass date column 423 indicates the date on which the product passed the post-thawing inspection in step S512. The expiration date column 424 indicates the expiration date calculated based on the thawing date. The post-thawing inspection information column 425 displays the results of the post-thawing inspection performed in step S512.

[0044] The shipping container 41 is an example of a cell therapy container in this embodiment. The second label 422 is an example of a label for cell therapy in this embodiment.

[0045] The positions and shapes of the first label 421 and the second label 422 shown in Figure 3 are illustrative. Both the first label 421 and the second label 422 may be positioned below the liquid level of the cell therapy. The first label 421 may be affixed, printed, or laser-marked to the lid of the vial. The first label 421 may be printed or laser-marked on the body of the vial.

[0046] By positioning the first label 421 and the second label 422 without the liquid surface in between, the cell therapy can be filled up to the top of the first label 421 without obstructing the visual inspection of the liquid surface. Reducing the amount of air inside the shipping container 41 prevents the cell therapy from foaming due to the movement of the liquid surface during delivery, which could damage the cells. Variations of the shape of each label 42 and the information to be written on the labels 42 will be described later.

[0047] Figure 4 is an explanatory diagram illustrating the record layout of product DB63. Product DB63 has a product ID field, a first lot ID field, a second process field, and a shipping field. The second process field has a second lot ID field and an inspection result field. The shipping field has a destination field and a shipping date field.

[0048] The Product ID field records the Product ID uniquely assigned to each shipping container 41. The First Lot ID field records the First Lot ID uniquely assigned to each first process as explained using Figure 1.

[0049] The second lot ID field records the second lot ID, which is uniquely assigned to each second process as explained using Figure 1. In other words, the second lot ID is an ID associated with the shipment lot of the cell therapy product.

[0050] The "Inspection Results" field records the inspection results after thawing, as performed in step S512. The "Shipping Destination" field records the recipient medical institution. The "Shipping Date" field records the shipping date. Blank entries in each field indicate that data has not yet been recorded. Product DB63 has one record for each product ID.

[0051] Let me explain with a specific example. Shipping containers 41 for product IDs 10001 to 10007 contain cells with the first lot ID "F100". Shipping container 41 for product ID 10420 does not yet contain cells, so the first lot ID field is blank.

[0052] In step S511 of the second process for lot number 2, ID "100", product ID 10001 and product ID 10002 were thawed simultaneously. Of these, product ID 10002 was opened and inspected in step S512. In Figure 4, the inspection result field for product ID 10002, abbreviated as "****", records various data such as the measurement result of the viable cell rate, the serial number of the inspection device 32 used for the measurement, and the measurement conditions.

[0053] If both the first and second processes are from the same lot, the inspection results after thawing can be expected to be the same. Therefore, the inspection result field for product ID 10001 records that the inspection results for product ID 10002 will be reused.

[0054] Similarly, in step S511 of the second process for the second lot ID "101", products ID 10003 through 10005 were simultaneously thawed. Of these, product ID 10005 was opened and inspected in step S512. The inspection result fields for product ID 10003 and product ID 10004 record that the inspection results of product ID 10005 will be reused.

[0055] The shipping fields for products ID 10001, 10003, and 10004 record the shipping destination and shipping date. Products ID 10002 and 10005 were opened and used for inspection, and therefore will not be shipped. The shipping destination field is recorded as "For Inspection," and the shipping date field is recorded as "-" to indicate that there is no shipping date.

[0056] Product IDs 10006 and 10007 remain stored in storage device 37 and the second process has not been initiated. Therefore, the second process field and the shipping field are blank.

[0057] Figure 5 is an explanatory diagram illustrating the record layout of the first process DB61. The first process DB61 has a first lot ID field, an inspection result field, and a freezing process field. The freezing process field has a start date and time field, an end date and time field, a minimum temperature field, and a maximum temperature field.

[0058] The first lot ID field records the first lot ID related to the first process as described using Figure 1. The inspection result field records the inspection result before freezing performed in step S502.

[0059] The start date and time field records the date and time the freezing process began. The end date and time field records the date and time the freezing process ended. The minimum temperature field records the lowest temperature recorded chronologically from the start time to the end time. The maximum temperature field records the highest temperature recorded chronologically from the start time to the end time. The first process DB61 has one record for each lot of the first process.

[0060] The following describes a case where cells cultured simultaneously are divided and frozen in multiple freezing devices 35. For example, the control unit 21 assigns a different first lot ID to each freezing device 35. The control unit 21 records the highest and lowest temperatures in each freezing device 35 in the lowest temperature field and the highest temperature field, respectively.

[0061] The control unit 21 may assign a common first lot ID even if different freezing devices 35 are used for freezing. In this case, the control unit 21 records a representative value of the lowest temperature for each of the multiple freezing devices 35 in the lowest temperature field, and a representative value of the highest temperature for each of the multiple freezing devices 35 in the highest temperature field. The representative value is, for example, the arithmetic mean. The control unit 21 may use any statistical value as the representative value, such as the geometric mean, maximum value, minimum value, median, or mode.

[0062] Figure 6 is an explanatory diagram illustrating the record layout of the second process DB62. The second process DB62 has a second lot ID field, a storage process field, a thawing process field, and an inspection process field. The storage process field, thawing process field, and inspection process field each have a start date and time field, an end date and time field, a minimum temperature field, and a maximum temperature field, respectively.

[0063] The second lot ID field records the lot ID of the second process as explained using Figure 1. The start date and time field records the start date and time of each process. The end date and time field records the end date and time of each process. The minimum temperature field records the lowest temperature among the temperatures recorded chronologically from the start time to the end time of each process. The maximum temperature field records the highest temperature among the temperatures recorded chronologically from the start time to the end time of each process. The second process DB62 has one record for each lot of the second process.

[0064] The following describes the case where multiple thawing devices 36 are used simultaneously. The control unit 21 assigns a different second lot ID to each thawing device 36. The control unit 21 records the highest and lowest temperatures of each thawing device 36 in the lowest temperature field and the highest temperature field, respectively.

[0065] The control unit 21 may assign a common second lot ID even if thawing is performed using different thawing devices 36. In this case, the control unit 21 records a representative value of the lowest temperature for each of the multiple thawing devices 36 in the lowest temperature field, and a representative value of the highest temperature for each of the multiple thawing devices 36 in the highest temperature field. The representative value is, for example, the arithmetic mean. The control unit 21 may use any statistical value as the representative value, such as the geometric mean, maximum value, minimum value, median, or mode.

[0066] Figure 7 is a flowchart illustrating the program's processing flow. In the flowchart of Figure 7, explanations of the work processes performed by each device constituting the cell drug manufacturing apparatus 30, such as culture (step S501) and inspection (step S502), are omitted.

[0067] The control unit 21 instructs the cell drug manufacturing apparatus 30 to start the first process based on a predetermined production plan (step S601). The cell drug manufacturing apparatus 30 starts the first process (step S701). The cell drug manufacturing apparatus 30 also transmits log data regarding the ongoing process to the information processing device 20 as needed (step S702).

[0068] The log data includes the current time and information about the ongoing process. Information about the ongoing process includes the serial number of the equipment being used, the first lot ID of the culture medium and drug used, and the temperature of the cells being processed. In the process after the cells are divided into shipping containers 41 in step S504, the product ID is also included in the log data. The log data transmitted from the inspection device 32 also includes the inspection results.

[0069] The control unit 21 records a log file in the auxiliary storage device 23 (step S602). The log file is, for example, a text file that records the received log data in chronological order. Log files that record various data acquired in the manufacturing process in chronological order have been used conventionally, so a detailed explanation is omitted. The log file may also constitute part of the GMP (Good Manufacturing Practice) documentation related to the manufacture of cell-based pharmaceuticals.

[0070] If the cell drug manufacturing apparatus 30 does not perform the first process fully automatically, the control unit 21 sequentially sends instructions to the cell drug manufacturing apparatus 30 regarding the progress of the first process. The cell drug manufacturing apparatus 30 executes the process according to the instructions and sends log data to the information processing device 20.

[0071] If the process includes an operator operating the device, the control unit 21 may output information to support the operator via the output unit 25. When an operator operates the device, the log data also includes the ID of the operator in charge, data manually entered by the operator, and comments entered by the operator.

[0072] After the completion of the first process, the cell drug manufacturing apparatus 30 notifies the information processing apparatus 20 that the first process has been completed (step S703). The control unit 21 creates a new record in the first process DB 61 and records the inspection results extracted from the log file, as well as the start date and time, end date and time, minimum temperature, and maximum temperature of the freezing process in their respective fields (step S603).

[0073] The control unit 21 stores the cells that have completed the first process in the storage device 37. During storage, log data is transmitted from the storage device 37 to the information processing device 20 as needed. The control unit 21 continues to record the log data in a log file.

[0074] The order management system 18 sends a shipping instruction to the information processing device 20 based on the order from the medical institution (step S801). After receiving the shipping instruction via interrupt processing, the information processing device 20 instructs the cell drug manufacturing device 30 to start the second process (step S611).

[0075] The cell drug manufacturing apparatus 30 starts the second process (step S711). The cell drug manufacturing apparatus 30 also transmits log data related to the ongoing process to the information processing device 20 as appropriate (step S712).

[0076] The control unit 21 records the log file in the auxiliary storage device 23 (step S612). Just before proceeding to the second labeling step (step S513), the cell drug manufacturing apparatus 30 sends the product ID and a request to transmit the data for the second label to the information processing device 20 (step S713).

[0077] The control unit 21 creates a new record in the second process DB 62. The control unit 21 records the start date and time, end date and time, minimum temperature, and maximum temperature of the storage process, thawing process, and inspection process, extracted from the log file, in their respective fields (step S613).

[0078] The control unit 21 starts the label data creation subroutine (step S614). The label data creation subroutine is a subroutine that creates the data to be used for printing the second label 422. The processing flow of the label data creation subroutine will be described later.

[0079] The control unit 21 transmits the label data to the cell drug manufacturing apparatus 30 (step S615). In step S615, the control unit 21 realizes the function of a label output unit that outputs the label data.

[0080] The cell drug manufacturing apparatus 30 receives label data (step S721). The labeling device 34 prints the second label 422 and attaches it to the shipping container 41 (step S722). The cell drug manufacturing apparatus 30 notifies the information processing device 20 that the second process has been completed (step S723).

[0081] The control unit 21 sends a shipping instruction to, for example, the delivery person (step S616). After that, the control unit 21 terminates processing. The delivery person delivers the completed cell therapy to the ordering medical institution.

[0082] Figure 8 is a flowchart illustrating the processing flow of the label data creation subroutine. The label data creation subroutine is responsible for creating the data used for printing the second label 422.

[0083] The control unit 21 searches the product database 63 using the product ID received from the cell drug manufacturing apparatus 30 as a key, and obtains the second lot ID from the second lot ID field of the extracted record (step S631). The control unit 21 obtains the inspection result from the inspection result field of the extracted record (step S632).

[0084] The control unit 21 searches the second process DB 62 using the second lot ID obtained in step S631 as a key and obtains the decompression completion date and time from the decompression process field (step S633). The control unit 21 calculates the expiration date by adding a predetermined time to the obtained decompression completion date and time (step S634). The control unit 21 generates label data to be used for printing the second label 422 (step S635). The label data is, for example, a page layout file. After that, the control unit 21 terminates the process.

[0085] The subroutine for creating label data enables the control unit 21 to extract inspection results from a database that records the product ID and the inspection results of cell-based pharmaceuticals in association with each other, thereby realizing the function of a label data generation unit that generates label data.

[0086] According to this embodiment, a method for providing cell-based pharmaceuticals that eliminates the need for medical institutions to thaw them can be realized. By thawing the cell-based pharmaceuticals in a location equipped with a thawing device 36 that thaws them under appropriate conditions, a deterioration in the quality of the cell-based pharmaceuticals during thawing can be prevented. Here, the quality of the cell-based pharmaceuticals refers, for example, to the viable cell percentage.

[0087] According to this embodiment, a cell therapy product can be provided in which the expiration date after thawing is indicated in the expiration date column 424. Medical institutions can check the expiration date after thawing and administer the cell therapy product to patients.

[0088] According to this embodiment, a cell-based pharmaceutical product can be provided in which the results of tests performed after thawing are displayed in the post-thawing test information section 425. Medical institutions can confirm the quality after thawing using the label 42 and administer the cell-based pharmaceutical product to patients.

[0089] Furthermore, the first and second processes may be carried out in different locations. For example, the location for the first process may be consolidated into one place. A mobile deep freezer is used to deliver the frozen shipping containers 41 to the second process bases located in each area. The second process bases receive orders from medical institutions within their respective service areas and provide cell-based therapies.

[0090] This enables the realization of a cell-based drug delivery system 10 that combines economies of scale achieved by performing the first process on a large scale with a reduction in the time from order to delivery.

[0091] [Variation 1-1] Figure 9 shows the second label 422 of Modification 1-1. The second label 422 of this modification has a "Pass Date" column 423 and a "Post-Thawing Test Information" column 425, but does not have an "Expiration Date" column 424. In a medical institution, the cell therapy is administered to the patient based on the "Pass Date" column 423 to determine that it is within its expiration date.

[0092] Furthermore, information such as "Use within 5 days after the passing date" may be included between the passing date column 423 and the post-thawing test information column 425. This allows users such as doctors or nurses to easily determine whether or not the product is within its expiration date.

[0093] [Variation 1-2] Figure 10 shows the second label 422 of Modification 1-2. The second label 422 of this modification has a dosage column 426 in addition to the pass date column 423, the expiration date column 424, and the post-thawing test information column 425.

[0094] The post-thawing inspection information section 425 includes, in addition to the aforementioned viable cell rate, volume, weight, foreign matter detection result, cell concentration, and specific cell concentration. Volume and weight may be measured values ​​or standard values. The foreign matter detection result indicates whether or not foreign matter was detected inside the shipping container 41. Cell concentration indicates the number of cells contained per unit volume. Specific cell concentration indicates the ratio of specific cells, specifically pharmaceutical raw material cells, to the total number of cells contained in the culture medium.

[0095] The dosage column 426 contains a table showing the relationship between the patient's weight and the amount of cell therapy drug to be administered. For example, the dosage column 426 lists standard dosages for different body weights.

[0096] The dosage column 426 may contain the dosage calculated based on the test results measured after thawing. The control unit 21 calculates the dosage to be entered in the dosage column 426 using, for example, formula (1).

[0097]

number

[0098] Based on the above, we can provide a cell-based pharmaceutical product with an appropriate dosage determined based on the viable cell rate and cell concentration after thawing, indicated on the second label 422.

[0099] [Modification 1-3] Figure 11 shows the shipping container 41 for the modified version 1-3. The shipping container 41 in this modified version is a soft bag type. The soft bag type shipping container 41 has the advantage of being thin, which allows for quick freezing and thawing. Another advantage of the soft bag type is that it is lighter than glass vial type containers. Furthermore, since it is possible to fill the container with cell pharmaceuticals so that there is no liquid surface inside, it has the advantage of preventing cell damage due to foaming during delivery.

[0100] However, trace amounts of the adhesive or bonding agent used to attach the label 42, as well as the printing ink, may penetrate into the shipping container 41 and damage the cells inside. In this modified example, to avoid such damage, the tag 428 with the label 42 attached is secured to the shipping container 41 by a ring-shaped string.

[0101] According to this modified example, cell-based pharmaceuticals can be provided using a soft bag-type shipping container 41.

[0102] Furthermore, when using a soft bag-type shipping container 41, the shipping container 41 may be equipped with a sample removal section 411, as shown by the dashed line in Figure 11. The sample removal section 411 is a tube-shaped structure with a sealed tip and communicates with the inside of the shipping container 41.

[0103] After the thawing process (step S511) described using Figure 1, the sample removal section 411 is cut and the sample for inspection is removed. The removed sample for inspection is used in the inspection process (step S512). The sample removal section 411 is sealed, for example, by heat welding.

[0104] By using the sample extraction unit 411, each shipping container 41 can be inspected. Since there is no need to thaw an additional shipping container 41 for inspection, pharmaceutical raw material cells can be used without waste.

[0105] [Modifications 1-4] Figure 12 shows the shipping container 41 of the modified example 1-4. The shipping container 41 of this modified example is also a soft bag type. The shipping container 41 is delivered to medical institutions sealed in an outer bag 43. A second label 422 is affixed to the outside of the outer bag 43. Note that the shipping container 41 is illustrated using a thin solid line instead of a dashed line.

[0106] A label attachment section 412 is attached to the shipping container 41. The label attachment section 412 is a rectangular sheet, and one of its long sides is fixed to the shipping container 41 by a method that does not produce leaching, such as heat welding. A first label 421 is affixed to the label attachment section 412.

[0107] In this modified example, the label 42 is attached via the label attachment portion 412 and the outer bag 43, thereby preventing damage to cells from adhesives or bonding agents.

[0108] [Variations 1-5] Figure 13 is an explanatory diagram illustrating the second step of Modification 1-5. In this modification, a soft bag-type shipping container 41 is used. The shipping container 41 contains a small amount of cells and diluent relative to its size and is frozen in a flat state. It has a large surface area relative to its volume, making it easy to accurately control the temperature during the freezing and thawing processes. The shipping container 41 has the aforementioned sample removal section 411.

[0109] The control unit 21 removes the shipping container 41 from the storage device 37 and thaws it using the thawing device 36 (step S511). The control unit 21 cuts the sample removal section 411 to remove the sample for inspection and performs inspection using the inspection device 32 (step S512).

[0110] The control unit 21 injects the diluent from the sample extraction unit 411 (step S521). The diluent is, for example, physiological saline. As shown in the center of Figure 13, the shipping container 41 becomes inflated. The control unit 21 seals the sample extraction unit 411 by heat welding or the like.

[0111] The control unit 21 attaches the second label 422, which indicates the results of the inspection performed in step S512, to the shipping container 41 (step S513). With this, the second process is completed, and the cell therapy product is finished.

[0112] According to this modified version, even if a diluent containing toxic substances such as DMSO is used during freezing, it can be provided to medical institutions in a diluted state suitable for direct administration to patients.

[0113] It is even more desirable that the diluent used in step S521 contains components that protect cells at room temperature or refrigerated. Using such a diluent prevents deterioration of the quality of the cell therapy between the completion of the second step and administration to the patient.

[0114] The shipping container 41 may also have a port for injecting diluent separately from the sample removal section 411. The label 42 may contain information such as the cell concentration or dilution ratio calculated from the amount of test sample removed from the shipping container 41 and the amount of diluent added in step S521.

[0115] [Variations 1-6] Figure 14 is an explanatory diagram illustrating the second step of Modification 1-6. In this modification, in the first step, the cells are divided into freezer containers containing quantities sufficient for administration to multiple patients, instead of being placed in the shipping container 41, and then stored in a frozen state.

[0116] The control unit 21 removes the frozen container from the storage device 37 and thaws it using the thawing device 36 (step S531). The control unit 21 then uses a centrifuge to centrifuge the contents of the thawed frozen container (step S532). The control unit 21 may also transfer the contents of the frozen container to a centrifuge tube between steps S531 and S532.

[0117] The control unit 21 removes the supernatant separated by centrifugation (step S533). The control unit 21 adds a diluent to the precipitate to dilute it to a predetermined concentration (step S534). Steps S533 and S534 replace the diluent used during freezing with another diluent.

[0118] The diluent used in step S534 is, for example, physiological saline. It is even more desirable that the diluent contains components that protect cells at room temperature or refrigerated. The diluent used during freezing is an example of the first diluent in this embodiment. The diluent used in step S534 is an example of the second diluent in this embodiment.

[0119] Furthermore, by adding a larger amount of the second diluent in step S534 than the amount of the first diluent removed in step S533, the concentration of the first diluent remaining in the cell therapy can be reduced. For example, even when using a first diluent that is toxic to humans, such as DMSO, the amount of the first diluent that enters the patient's body can be reduced.

[0120] The control unit 21 takes out a sample for testing and performs testing using the testing device 32 (step S535). The control unit 21 uses the encapsulation device 33 to divide the medical raw cells and diluent into shipping containers 41 (step S536).

[0121] The control unit 21 attaches a label 42, which indicates the results of the inspection performed in step S535, to the shipping container 41 (step S537). With this, the second process is completed, and the cell therapy product is finished.

[0122] In this modified example, a syringe is used as the shipping container 41. That is, the cell therapy drug is provided to the medical institution in the form of a so-called pre-filled syringe, which is already filled with the drug. At the medical institution, the cell therapy drug can be quickly administered by connecting the pre-filled syringe to an intravenous line already in place in the patient.

[0123] The syringe-type shipping container 41 reliably removes air from inside, ensuring that there is no liquid surface within the container. Therefore, it is possible to prevent the cell therapy from foaming due to fluctuations in the liquid surface during delivery, which could damage the cells.

[0124] Figure 15 shows an example of label 42 in Modification 1-6. In this modification, instead of two labels 42, the first label 421 and the second label 422, one label 42 as shown in Figure 15 is used.

[0125] Label 42 includes a field for the date of acceptance 423, an expiration date field 424, and a field for post-thawing inspection information 425, as well as the product ID, the second lot ID, and a barcode indicating the product ID. Label 42 may be affixed to the shipping container 41 or to the case containing the shipping container 41.

[0126] According to this modified method, cell-based therapies can be provided to medical institutions from which the diluent used during freezing has been removed. By removing the diluent, which has cryoprotective properties and is unnecessary after thawing, cell-based therapies can be provided that do not contain components that are unnecessary for the patient's body.

[0127] The sample for testing may be taken between steps S533 and S534. By taking the sample while the cell concentration is high, testing can be performed using a sample suitable for morphological observation under a microscope.

[0128] Between steps S531 and S532, the freezer container may be left to stand for a while to remove the supernatant. By reducing the contents of the freezer container before centrifugation, a small centrifuge can be used.

[0129] [Variations 1-7] Figure 16 is an explanatory diagram illustrating the second step of Modification 1-7. In this modification, the cells are divided into centrifugable shipping containers 41 and stored in a frozen state.

[0130] The control unit 21 removes the shipping container 41 from the storage device 37 and thaws it using the thawing device 36 (step S511). The control unit 21 opens the thawed shipping container 41, removes the test sample, and performs the test using the test device 32 (step S512).

[0131] The control unit 21 places the shipping container 41 into a centrifuge and performs centrifugation (step S541). The control unit 21 removes the supernatant separated by centrifugation (step S542). The control unit 21 adds a diluent to the precipitate and dilutes it to a predetermined concentration (step S543).

[0132] The control unit 21 seals the shipping container 41 (step S544). For example, when using a vial-type shipping container 41, the control unit 21 seals the shipping container 41 using a new rubber stopper and sealing material. For example, when using a soft bag-type shipping container 41, the control unit 21 seals the sample removal section 411 used for removing the test sample and adding / removing the diluent by heat sealing or the like.

[0133] The control unit 21 attaches the second label 422, which indicates the results of the inspection performed in step S512, to the shipping container 41 (step S513). With this, the second process is completed, and the cell therapy product is finished.

[0134] According to this modified method, cell-based therapies can be provided to medical institutions from which the diluent used during freezing has been removed. By removing the diluent, which has cryoprotective properties and is unnecessary after thawing, cell-based therapies can be provided that do not contain components that are unnecessary for the patient's body.

[0135] According to this modified version, since the container is not changed after thawing, cell-based pharmaceuticals can be provided using a process with a low environmental impact.

[0136] [Embodiment 2] This embodiment relates to a method for providing cell-based pharmaceuticals, in which relatively time-consuming tests such as culture tests are performed after the cell-based pharmaceuticals have been thawed. Parts common to Embodiment 1 will not be explained.

[0137] Figure 17 is an explanatory diagram illustrating the overview of the cell therapy delivery method of Embodiment 2. The process up to step S513 is the same as the process of Embodiment 1 described using Figure 1, so the explanation is omitted.

[0138] The control unit 21 cultures the test sample using cell proliferation medium in parallel with the inspection process in step S512 (step S551). The culture period is, for example, about 12 hours. During the culture period, the cell therapy product is delivered to the medical institution (step S514).

[0139] After the culture period ends, the control unit 21 performs a culture test (step S552). The culture test is, for example, a test of cell proliferation rate. The control unit 21 may perform multiple culture tests, for example, at 12 hours, 24 hours, 48 ​​hours, and 72 hours. The results of the culture test are sequentially appended to the test result field and log file of the product DB 63.

[0140] In medical institutions, data verification is performed before administering cell-based therapies to patients (step S555). Specifically, medical institutions use a barcode reader to read the barcode printed on label 42. In this embodiment, the barcode contains, for example, a product ID.

[0141] Medical institutions can access a webpage via a barcode to view the test results of cell-based therapies, including the results of culture tests conducted after shipment. Administration to patients is carried out only after it is confirmed that there are no abnormalities in the test results (Step S515).

[0142] Figure 18 is an explanatory diagram illustrating the configuration of the cell therapy supply system 10 of Embodiment 2. The cell therapy supply system 10 of this embodiment includes an information processing device 20, a cell therapy manufacturing device 30, and an order management system 18, in addition to a second information processing device 50.

[0143] The second information processing device 50 comprises a control unit 51, a main memory 52, an auxiliary memory 53, a communication unit 54, an output unit 55, an input unit 56, and a bus. The control unit 51 is an arithmetic control device that executes the program of this embodiment. One or more CPUs, GPUs, or multi-core CPUs are used in the control unit 51. The control unit 51 is connected to each hardware component constituting the second information processing device 50 via the bus.

[0144] The main memory 52 is a storage device such as SRAM, DRAM, or flash memory. The main memory 52 temporarily stores information necessary during processing performed by the control unit 51 and the program currently being executed by the control unit 51.

[0145] The auxiliary storage device 53 is a storage device such as SRAM, flash memory, hard disk, or magnetic tape. The auxiliary storage device 53 stores the program to be executed by the control unit 51 and various data necessary for the execution of the program.

[0146] The communication unit 54 is an interface for communication between the second information processing device 50 and the network. The output unit 55 is an output device such as a liquid crystal display panel or an organic EL panel. The input unit 56 is an input device such as a barcode reader, keyboard, and mouse. The output unit 55 and the input unit 56 may be a stacked touch panel. The output unit 55 may be a speaker. The input unit 56 may be a microphone.

[0147] The second information processing device 50 in this embodiment is a portable terminal device used by a user such as a doctor or nurse. The second information processing device 50 may also be a terminal device placed in each patient's room and treatment room, etc. The second information processing device 50 may also be an information device such as a general-purpose tablet or smartphone.

[0148] Figure 19 is a flowchart illustrating the processing flow of the program in Embodiment 2. The program described using Figure 19 is used in step S555, which was described using Figure 17.

[0149] The control unit 51 obtains the product ID via the barcode printed on the label 42 (step S901). Alternatively, the user may input the product ID by operating the input unit 56. The control unit 51 transmits the product ID to the information processing device 20 via the network (step S902).

[0150] The control unit 21 receives the product ID (step S641). The control unit 21 searches the product DB 63 using the product ID as a key and obtains the second lot ID from the second lot ID field of the extracted record (step S642). The control unit 21 obtains the inspection result from the inspection result field of the extracted record (step S643).

[0151] The control unit 21 transmits the test results to the second information processing device 50 (step S644). The test results transmitted in step S644 also include the culture test results. The control unit 51 receives the test results (step S911). The control unit 51 displays the test results (step S912).

[0152] Figures 20 to 22 show examples of screens in Embodiment 2. In step S912, the control unit 51 displays the screen shown in Figure 20 on the output unit 55. The screen shown in Figure 20 displays the first label 421, the second label 422, and the appearance sample 68. The second label 422 includes a pass date field 423, an expiration date field 424, and a post-thawing inspection information field 425. Note that the scroll bar is not shown in Figures 20 to 22.

[0153] In the post-thawing inspection information section 425 of Modification 1-2, explained using Figure 10, the post-thawing inspection information section 425 of this embodiment includes additional items for cell proliferation rate and hygiene test. The cell proliferation rate indicates the proliferation rate of the pharmaceutical raw material cells. The hygiene test indicates whether or not contaminants such as commensal bacteria proliferated during culture. "Pass" indicates that no contaminants proliferated, i.e., the cell pharmaceutical does not contain contaminants. The cell proliferation rate and hygiene test are examples of culture test results.

[0154] Figure 21 is an example of a screen that appears when a user scrolls over the screen described using Figure 20. The work history information for each process from the freezing process recorded in the first process DB61 to the storage process recorded in the second process DB62, specifically the start time, end time, minimum temperature, and maximum temperature for each process, is displayed in a list format.

[0155] Figure 22 is an example of a screen that appears when the user scrolls further on the screen described using Figure 21. The percentage of viable cells after thawing, as well as the acceptance criteria for the working time and temperature range for each step, are displayed.

[0156] Note that the screens and display items shown in Figures 20 and 21 are all examples. For example, temperature changes in each process may be displayed in graph format based on data extracted from log files. For example, buttons to display reference information such as attached files for cell therapies or related medical papers may be displayed on the screen.

[0157] According to this embodiment, it is possible to provide cell-based pharmaceuticals that can be administered to patients after confirming the results of time-consuming tests such as culture tests.

[0158] According to this embodiment, a method for providing cell-based pharmaceuticals can be realized in which the user can check the work history information and acceptance criteria at each step of the process.

[0159] [Variation 2-1] In this modified example, a web page (World Wide Web) is automatically generated for each product ID based on product DB63 and process DB62. Since the automatic generation of web pages has been performed in the past, a detailed explanation will be omitted.

[0160] Figures 23 and 24 show an example of label 42 in Modification 2-1. Label 42 displays a barcode indicating the URL (Uniform Resource Locator) of the web page assigned to each product ID, in addition to the product ID and second lot ID.

[0161] By using a barcode reader to scan the barcode on label 42, users can access a web page created for each product ID and view screens such as those described using Figures 20 to 22.

[0162] According to this modified example, using a web page can reduce the load on the processing capacity of the second information processing device 50.

[0163] [Modification 2-2] In this modified example, the user manually enters the product ID and second lot ID printed on label 42. Figure 25 shows an example screen of modified example 2-2. The user operates the input unit 56 to enter the product ID and second lot ID displayed on label 42, and then presses the display button. The control unit 51 displays the screen described using Figures 20 to 22 on the output unit 55.

[0164] If there is a discrepancy between the entered product ID and the second lot ID, the control unit 51 will display an error message and prompt the user to re-enter the information.

[0165] According to this modified example, even a second information processing device 50 without a barcode reader can provide a cell therapy supply system 10 that displays the screens shown in Figures 20 to 22. By requiring input of both the product ID and the second lot ID, the cell therapy supply system 10 can detect user input errors and prevent the display of incorrect information.

[0166] [Modification 2-3] In this modified example, the user manually enters the second lot ID. Figure 26 shows an example screen of modified example 2-3. After receiving the input of the second lot ID, the control unit 51 displays the screen shown in Figure 26 on the output unit 55.

[0167] The screen shown in Figure 26 displays a list of product IDs for cell therapy products corresponding to the second lot ID "101". The user selects the product ID of the cell therapy product for which they wish to view information. The control unit 51 displays the screen described using Figures 20 to 22 on the output unit 55.

[0168] [Embodiment 3] This embodiment relates to a cell therapy delivery system 10 that records and displays temperature changes during delivery. Parts common to Embodiment 2 will not be described.

[0169] Figure 27 is an explanatory diagram illustrating the configuration of the cell therapy delivery system 10 of Embodiment 3. A thermometer such as a thermocouple and a data logger 151 are attached to the delivery case 15 for delivering cell therapy to medical institutions. The data logger 151 records the temperature history inside the delivery case 15 in chronological order. The data logger 151 is an example of a temperature recording device in this embodiment.

[0170] The data logger 151 has a wireless communication function and, for example, transmits the temperature history recorded when the package is opened to the information processing device 20. The control unit 21 adds the received temperature history to the log file.

[0171] Figure 28 is a flowchart illustrating the processing flow of the program in Embodiment 3. The program described using Figure 28 is used in place of the program in Embodiment 2 described using Figure 19.

[0172] The data logger 151 transmits the temperature history to the information processing device 20 (step S401). The control unit 21 receives the time-series data of the temperature (step S661). The control unit 21 records the received data in a log file (step S662).

[0173] The control unit 51 obtains the product ID via the barcode printed on the label 42 (step S901). The control unit 51 transmits the product ID to the information processing device 20 via the network (step S902).

[0174] The control unit 21 receives the product ID (step S641). The control unit 21 searches the product DB 63 using the product ID as a key and obtains the second lot ID from the second lot ID field of the extracted record (step S642). The control unit 21 obtains the inspection result from the inspection result field of the extracted record (step S643).

[0175] The control unit 21 extracts the highest and lowest temperatures during delivery from the time-series temperature data received from the data logger 151 (step S665). The control unit 21 determines whether the lowest and highest temperatures during delivery meet predetermined criteria (step S666).

[0176] The control unit 21 transmits the inspection results extracted in step S643 and the determination results determined in step S666 to the second information processing device 50 (step S667). The control unit 51 receives the inspection results and the determination results (step S921). The control unit 51 displays the inspection results and the determination results (step S922).

[0177] Figure 29 shows an example screen of Embodiment 3. The screen of Embodiment 2, described using Figure 20, is shown with the addition of a delivery status field 427. In the example shown in Figure 29, it indicates that the temperature during delivery was normal. If the temperature during delivery deviates from a predetermined temperature range, this fact will be displayed in the delivery status field 427.

[0178] The data logger 151 may also transmit the measured temperature to the information processing device 20 at any time. If the control unit 21 receives data that deviates from a predetermined temperature range, it may notify the medical institution that the cell therapy product being delivered is unusable and start the second process for a substitute cell therapy product.

[0179] [Modification 3-1] In this modified example, instead of using a thermometer and data logger 151, an irreversible thermochromic material is used. Figure 30 is an explanatory diagram illustrating an example of a shipping container 41 containing cell-based pharmaceuticals in Modified Example 3-1.

[0180] A shipping status label 429 is attached to the bottom of the shipping container 41. The shipping status label 429 is a label using an irreversible temperature-indicating material, and the words "Unusable" irreversibly appear when the temperature deviates from a predetermined range. By visually inspecting the shipping status label 429, the user can determine whether or not an abnormality occurred in the temperature conditions during shipping.

[0181] [Embodiment 4] Figure 31 is an explanatory diagram illustrating the configuration of the cell-based drug delivery system 10 of Embodiment 4. This embodiment relates to a configuration in which the cell-based drug delivery system 10 of this embodiment is realized by operating a general-purpose computer 90 in combination with a program 97. Parts common to Embodiment 2 will not be described.

[0182] The computer 90 includes the aforementioned control unit 21, main memory 22, auxiliary memory 23, communication unit 24, output unit 25, input unit 26, and bus, as well as a read unit 29.

[0183] Program 97 is recorded on a portable recording medium 96. The control unit 21 reads Program 97 via the reading unit 29 and saves it to the auxiliary storage device 23. The control unit 21 may also read Program 97 stored in a semiconductor memory 98, such as flash memory, implemented in the computer 90. Furthermore, the control unit 21 may download Program 97 from another server computer (not shown) connected via the communication unit 24 and a network (not shown) and save it to the auxiliary storage device 23.

[0184] Program 97 is installed as a control program for the computer 90, loaded into the main memory 22, and executed. Furthermore, the control unit 21 distributes Program 97 to the second information processing devices 50 used by each medical institution via the network. Program 97 is installed as a control program for the second information processing devices 50, loaded into the main memory 52, and executed. Thus, the cell drug delivery system 10 described in Embodiment 2 is realized.

[0185] The control unit 51 may read the program 97 via a reading unit provided in each of the second information processing devices 50. The control unit 51 may also read the program 97 from an external storage device connected to each of the second information processing devices 50. [Embodiment 5]

[0186] Figure 32 is a functional block diagram of the cell drug delivery system 10 of Embodiment 5. The cell drug delivery system 10 comprises a cell drug manufacturing apparatus 30 and an information processing apparatus 20. The cell drug manufacturing apparatus 30 includes a thawing device 36, an inspection device 32, and a labeling device 34. The information processing apparatus 20 includes a label data generation unit 71 and a label output unit 72.

[0187] The thawing device 36 thaws the pharmaceutical raw material cells that have been stored in a frozen state. The inspection device 32 performs a shipping inspection of the thawed pharmaceutical raw material cells. The labeling device 34 applies a label 42 to the shipping container 41 containing the pharmaceutical raw material cells.

[0188] The label data generation unit 71 generates label data to be used for the label 42 based on the shipping inspection results performed by the inspection device 32. The label output unit 72 outputs the label data to the label device 34.

[0189] The technical features (constituent elements) described in each embodiment are combinable with each other, and by combining them, new technical features can be formed. The embodiments disclosed herein should be considered in all respects to be illustrative and not restrictive. The scope of the present invention is indicated by the claims, not in the sense described above, and all modifications within the sense and scope equivalent to the claims are intended to be included. [Explanation of Symbols]

[0190] 10 Cell-based drug delivery system 15 shipping cases 151 Data Logger 18. Order Management System 20 Information Processing Devices 21 Control Unit 22 Main storage 23 Auxiliary storage device 24 Communications Department 25 Output section 26 Input section 29 Reading section 30 Cell drug manufacturing equipment 31 Culture device 32 Inspection equipment 33. Sealing device 34 Labeling device 35 Freezer 36 Thawing device 37 Storage device 41 Shipping containers 411 Sample extraction section 412 Label attachment section 42 labels 421 Label 1 422 Label 2 423 Passing date column 424 Expiry date field 425 Post-thawing inspection information section 426 Dosage column 427 Delivery Status Section 428 tags 429 Delivery status label 43 Outer bag 50. Second Information Processing Device 51 Control Unit 52 Main memory 53 Auxiliary storage device 54 Communications Department 55 Output section 56 Input section 61 1st process DB 62 2nd process DB 63 Product DB 68. Exterior Sample 71 Label data generation unit 72 Label output section 90 Computer 96 Portable recording media 97 Programs 98 Semiconductor memory

Claims

1. Thaw the pharmaceutical raw material cells that have been stored in a frozen state. A sample for testing is taken from the thawed pharmaceutical raw material cells. The pharmaceutical raw material cells sealed in a shipping container and the shipping inspection results performed using the inspection sample are provided. The condition of the shipping container during delivery is detected, We will notify you if the specified conditions are not met during delivery. Methods for providing cell-based therapies.

2. The aforementioned shipment inspection results include the percentage of viable cells. A method for providing a cell-based pharmaceutical product as described in claim 1.

3. Based on the aforementioned shipment inspection results, the dosage to be administered to the patient is calculated. This provides information on the dosage calculated together with the aforementioned shipment inspection results. A method for providing a cell-based pharmaceutical product according to claim 1 or claim 2.

4. The aforementioned shipping inspection results are provided attached to the shipping container. A method for providing a cell-based pharmaceutical product according to any one of claims 1 to 3.

5. The aforementioned shipping containers are provided with an ID associated with the shipping lot, When the aforementioned ID is received via the network, the shipment inspection result is transmitted. A method for providing a cell-based pharmaceutical product according to any one of claims 1 to 3.

6. Along with the aforementioned shipment inspection results, the culture test results performed using the aforementioned inspection samples will be transmitted. A method for providing a cell-based pharmaceutical product according to claim 5.

7. The aforementioned shipping container is delivered in a delivery case equipped with a temperature recording device. The temperature history during delivery recorded by the aforementioned temperature recording device is acquired, Along with the aforementioned shipping inspection results, information regarding the temperature history during delivery is transmitted. A method for providing a cell-based pharmaceutical product according to claim 5 or claim 6.

8. The aforementioned pharmaceutical raw material cells are stored in the aforementioned shipping containers in a frozen state, in units provided. Thaw more shipping containers than the number scheduled for shipment, Some of the thawed shipping containers are used as the test samples. The shipment inspection results for the remaining shipment containers shall be based on the shipment inspection results obtained using the inspection samples. A method for providing a cell-based pharmaceutical product according to any one of claims 1 to 7.

9. The aforementioned pharmaceutical raw material cells are stored in a frozen state, with multiple supply units contained in a single container. The remaining pharmaceutical raw material cells, after the sample for testing has been separated, are divided into individual units into the shipping containers. A method for providing a cell-based pharmaceutical product according to any one of claims 1 to 7.

10. Before dividing the cells into the aforementioned shipping containers, the pharmaceutical raw material cells are diluted. A method for providing a cell-based pharmaceutical product as described in claim 9.

11. The aforementioned pharmaceutical raw material cells are stored in a frozen state, with multiple supply units contained in a single container. The first dilution solution contained in the thawed pharmaceutical raw material cells is replaced with a second dilution solution having different components from the first dilution solution. The remaining pharmaceutical raw material cells, after the sample for testing has been separated, are divided into individual units into the shipping containers. A method for providing a cell-based pharmaceutical product according to any one of claims 1 to 7.

12. The second diluent is in a larger quantity than the first diluent removed from the pharmaceutical raw material cells. A method for providing a cell-based pharmaceutical product according to claim 11.

13. Based on the concentration of the pharmaceutical raw material cells placed in the aforementioned shipping container and the results of the aforementioned shipping inspection, the dosage to be administered to the patient is calculated. This provides information on the dosage calculated together with the aforementioned shipment inspection results. A method for providing a cell-based pharmaceutical product according to any one of claims 9 to 12.

14. The expiration date is calculated based on the time of thawing. The expiration date is provided along with the results of the aforementioned shipping inspection. A method for providing a cell-based pharmaceutical product according to any one of claims 1 to 13.

15. Deliver without refreezing. A method for providing a cell-based pharmaceutical product according to any one of claims 1 to 14.

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