JP7674875B2 - Transportation status management system - Google Patents

Description

The present invention relates to a management system for transport status using sensor data.

Regenerative medicine involves culturing cells taken from a patient to produce cellular medicine, which is then transplanted back into the patient's body. During transport between the hospital and the manufacturing facility, a specified temperature range must be maintained to prevent the cells and cellular medicine from deteriorating. This calls for a system to manage the transport conditions.

Patent Document 1 discloses a stem cell manufacturing system for manufacturing stem cells from somatic cells, a receiving process for receiving manufacturing requests for manufacturing stem cells from somatic cells, a transporting process for transporting somatic cells collected from somatic cell donors or stem cells created from the somatic cells, an inspection process for inspecting the somatic cells or stem cells, a manufacturing process for manufacturing the stem cells from the somatic cells, and a stem cell information management system for centrally managing information in a storage process for storing the stem cells.

Patent document 2 discloses a measurement unit that is attached to a cell culture vessel that contains cells to be cultured and a culture medium, and that includes a measurement section that measures information about the cells and the culture medium in a non-contact manner, and a sensor that detects at least one of position, posture, impact, and vibration.

Patent Publication 2018-19685 Patent Publication 2013-202030

Patent Document 1 and Patent Document 2 each have a sensor that detects vibrations of the transport container. Furthermore, Patent Document 1 also describes that the transport container stores transport information including at least one of the temperature data, the accumulated transport time, the value obtained by quantifying the coagulation state, and the value obtained by quantifying the vibration in memory in association with at least the donor ID, and transmits the transport information to a server device, which is a higher-level computer. The server device determines whether to output an abnormality warning during transport and revise the schedule if at least one of the temperature data, the accumulated transport time, the value obtained by quantifying the coagulation state, and the value obtained by quantifying the vibration is not within a normal range, and transmits the abnormality warning during transport and the transport information to a mobile terminal in a remote location (paragraph 0083).

However, cells that fall outside the rules for transport conditions are usually discarded, and even cells that are actually of good quality are discarded, which requires cells to be obtained again, leading to increased lead times for administering cell medicines to patients and increased pharmaceutical costs.

In addition, there is a risk that products that meet the rules for transport conditions may actually have quality problems and be used. Patent Documents 1 and 2 do not take into consideration the issue of solving the lead time for administering cell medicines to patients and the increase in pharmaceutical costs.

The object of the present invention is to provide a transportation status management system that avoids increases in lead time and pharmaceutical costs before administering cellular medicine to patients.

A preferred example of the present invention is a transportation status management system having a transportation container, a terminal, and a notification device that communicates with the transportation container and the terminal,
The transport container has a temperature sensor, a humidity sensor, a vibration sensor, and a communication unit,
The notification device includes:
a receiving interface unit that receives information on temperature, humidity, and vibration inside the transport container from the transport container;
an information storage unit that stores information on the temperature, the humidity, and the vibration;
an alert determination unit that determines whether or not a notification for changing the inspection process is required based on the temperature, humidity, and vibration information read from the information storage unit and on determination information;
an external communication interface unit for transmitting the notification when it is determined that the notification is necessary,
The terminal that has received the notification
If there is no problem in the result of the inspection process for the cells or cellular medicine in the transport container, a process for accepting the cells or cellular medicine in the transport container is performed;
If there is a problem with the results, the system for managing the transport state discards the cells or the cellular medicine.

The present invention makes it possible to avoid increases in lead time and pharmaceutical costs before administering a cell medicine to a patient.

A conceptual diagram outlining the entire cell culture process. FIG. 2 is a diagram showing functional blocks of the transportation status management system according to the first embodiment. FIG. 13 shows a system screen displayed on the hospital's incoming inspection terminal or the manufacturing plant's incoming inspection terminal. FIG. 1 is a functional block diagram of a transport container and a diagram showing the relationship with other functions. 4 is a flowchart showing the process of the transportation status management system according to the first embodiment. FIG. 11 is a diagram showing functional blocks of a transportation status management system according to a second embodiment. FIG. 11 is a diagram showing functional blocks of a transportation status management system according to a third embodiment.

The following describes the examples using the drawings.

Figure 1 is a conceptual diagram overlooking the entire cell culture process. In recent years, clinical trials have been started for new treatments, such as cell therapy using the cells themselves and regenerative medicine that aims to regenerate tissues and organs, and efforts are underway to put these treatments into practical use. Medicines manufactured from cells are called cellular medicines. The process from manufacturing to administration to patients is as follows. In other words, cells are collected from the patient at the hospital and placed in a transport container, which is then transported by vehicle to the manufacturing plant. The manufacturing plant then undergoes cultivation and other processes to produce the cellular medicine. The cellular medicine is then placed in a transport container, which is then transported again by vehicle to the hospital and administered to the patient.

In this embodiment, we will show a system and method for monitoring the temperature of cells and cell medicines during transportation, detecting abnormal conditions, and notifying the receiving inspection terminal at the manufacturing plant or hospital, thereby utilizing the system and method for the inspection process at the manufacturing plant or hospital.

Figure 2 is a diagram showing the functional blocks of the transport status management system of the first embodiment. Figure 4 is a diagram showing the functional blocks inside the transport container and the communication relationships between the transport container, the host computer 20 (notification device), the hospital's incoming inspection terminal 30, and the manufacturing plant's incoming inspection terminal 40.

The transport container 10 loaded onto the transport vehicle in Figures 2 and 4 is loaded onto a transport company's vehicle and contains cells or cell medicine. As shown in Figure 4, the transport container 10 has a communication unit 11, a temperature sensor 12, a humidity sensor 13, and an acceleration sensor 14, and uploads sensor data from the communication unit 11 to the receiving interface unit 21 of the host computer 20 via the network.

The host computer 20 in FIG. 2 is a communication device that communicates with the transport container 10, the hospital's acceptance inspection terminal 30, and the manufacturing plant's acceptance inspection terminal 40. In the host computer 20, the uploaded data is first received and processed by the reception interface (I/F) unit 21, passes through the data conversion unit 22, and is stored in the sensor information accumulation database (DB) 23.

The alert determination unit 24 processes the stored data. The alert determination unit 24 compares the threshold value in the determination master 25 with the sensor information and determines whether or not a notification such as an alert notification is required. If it is determined that a notification is required, a notification such as an alert is sent to the hospital's acceptance inspection terminal 30 and the manufacturing plant's acceptance inspection terminal 40 via the hospital interface (I/F) 26 and the manufacturing plant interface (I/F) 27, which serve as external communication interfaces. The hospital's acceptance inspection terminal 30 is connected to a patient information database (DB) 31. The manufacturing plant's acceptance inspection terminal 40 is connected to a manufacturing information database (DB) 41.

The host computer (notification device) 20, the hospital's acceptance inspection terminal 30, and the manufacturing plant's acceptance inspection terminal 40 each have a processor such as a CPU and a storage device, and the processor reads out the programs stored in the storage device to execute the functions shown in FIG. 5, etc.

In the cell culture process management solution of this embodiment, physical quantities such as temperature are measured during transportation, and if the physical quantity deviates from the appropriate value, a notification is issued to change the inspection process in the subsequent process.

There are two types of notifications: alert range notifications and tolerance range notifications. The alert range is a range that does not pose a quality problem, but is close to a deviation value. The tolerance range is a range that slightly exceeds the normal range, which is the appropriate value. If it is within the normal range, no notification is necessary. Alert range notifications and tolerance range notifications are between the abnormal range and the normal range, and can be considered a gray range that could fall into either.

Figure 3 shows a system screen 50 displayed on the hospital's receiving and testing terminal 30 or the manufacturing facility's receiving and testing terminal 40. Users at the hospital or manufacturing facility can check the receipt date and time, processing date and time, and whether or not a notification of an alert range has been made for each cell or cell medicine identified by an identification ID.

Figure 5 shows a flowchart of the processing of the transportation status management system in Example 1.

The receiving interface unit 21 of the notification device (host computer) 20 receives sensor information such as temperature data, humidity data, and acceleration data from the transport container 10 and starts determining whether there are abnormal values (step 101).

The sensor information is converted into data that can be processed by the notification device 20 via a data conversion unit 22 such as an AD conversion unit, and the converted sensor information is stored in a sensor information storage DB 23 that serves as a recording unit.

The alert determination unit 24 reads the data stored in the information storage DB 23 and determines whether the data is within an alert range that is close to a deviation value but does not pose a quality problem, or whether the data is within an acceptable range that is slightly beyond the normal range.

If it is determined that a notification is necessary, an alert notification or a notification of the acceptable range is sent via the external communication interface to the hospital's acceptance inspection terminal 30 or the manufacturing plant's acceptance inspection terminal 40. If the abnormal range is problematic, the alert determination unit 24 may send a notification of the abnormality to the hospital's acceptance inspection terminal 30 or the manufacturing plant's acceptance inspection terminal 40.

The alert determination unit 24 determines whether the temperature data is within a normal range including an appropriate value (step 102). If it is within the normal range, the process proceeds to step 103. If not, the process proceeds to step 105.

The alert determination unit 24 determines whether the humidity data is within the normal range (step 103). If it is within the normal range, proceed to step 104. If not, proceed to step 105.

The alert determination unit 24 determines whether the acceleration data is within the normal range (step 104). If it is within the normal range, proceed to step 108. If not, proceed to step 105.

If steps 102, 103, and 104 are within the normal range, the notification device (host computer) 20 does not issue a notification.

The alert determination unit 24 determines whether the temperature, humidity, and acceleration are all within the notification range (alert/tolerance) (step 105). If they are within the notification range, the alert determination unit 24 sends an alert notification or a notification of the tolerance range to the hospital's receiving inspection terminal 30 or the manufacturing plant's receiving inspection terminal 40, and proceeds to step 106. If the result is NO, proceeds to step 109. If any one of them is outside the alert range (NG range), the result is NO.

When the hospital's incoming inspection terminal 30 or the manufacturing facility's incoming inspection terminal 40 receives an alert notification or a notification of the acceptable range, a detailed inspection with changed inspection content is performed, such as an inspection of the deterioration state of the cells at the manufacturing facility or an inspection of the deterioration state of the cell medicine at the hospital (step 106). Then, the process proceeds to step 107.

For the above reasons, when the notification device 20 (host computer) issues an alert notification or a notification of an acceptable range, the hospital or manufacturing facility changes the subsequent process so that detailed inspection can be performed. If even one of the notification contents is outside the alert range (NG range), the cells or cell medicine will be discarded.

Step 107: An inspector at the hospital or manufacturer determines whether there are any problems with the test results in step 106. If there are no problems, proceed to step 108. If not, proceed to step 109.

The hospital's acceptance inspection terminal 30 or the manufacturing plant's acceptance inspection terminal 40 receives an instruction from the inspector to process the acceptance of the cells or cellular medicine as being of normal quality, and performs the predetermined acceptance process for the cells or cellular medicine (step 108). Then, the process proceeds to step 110.

The hospital's receiving and testing terminal 30 or the manufacturing facility's receiving and testing terminal 40 receives an instruction from the inspector to discard the cells or cell medicine, and performs the disposal process, such as inputting the disposal data into the patient information DB 31 or manufacturing information DB 41 (step 109). Then, the process proceeds to step 110. In step 110, the abnormal value determination of the sensor information is completed.

According to the first embodiment, for cells and cellular medicines for which a notification has been issued, the inspection contents at the time of acceptance at the manufacturing facility or hospital are changed (for example, to more detailed inspections). For example, if an alert or other notification occurs during transportation from the hospital to the manufacturing facility, the manufacturing facility can be notified at the time the notification occurs, and preparations can be made to change the inspection contents. This has the following effects compared to the conventional method in which safety was prioritized when the tolerance range was exceeded, and even products that were not actually problematic in terms of quality were discarded. In other words, in this embodiment, when a notification is issued, the inspection of the subsequent process can be changed early. Also, if there are no problems in the inspection results of the inspection process, there is no need to obtain cells again. Therefore, the lead time until the administration of the cellular medicine to the patient can be shortened. Also, since the discarded cells and cellular medicines can be utilized, an increase in pharmaceutical costs can be prevented. Also, if there is a problem in the inspection results of the inspection process, the cells and cellular medicines are discarded, so the risk of using cells and cellular medicines with quality problems can be reduced.

Figure 6 is a diagram showing the functional blocks of the transportation status management system of the second embodiment. The second embodiment is configured to change the judgment master 25 depending on the inspection results. Explanations of the same matters as in the first embodiment will be omitted.

If any cell or cellular medicine is found to have deteriorated during testing within the alert range, the threshold value in the judgment master 25 is updated. For example, if cells or cellular medicine that were within the alert range are found to have deteriorated during testing, the set range is narrowed so as not to include values that were within the alert range.

For temperature, humidity, and vibration, the alert range may be set to the top 10% and bottom 10% of the set range. In that case, if the set temperature is -5.0°C to 5.0°C, the alert range will be -4.0 or below and 4.0°C or above, but if an inspection within the alert range shows deterioration, the set temperature will be narrowed to -4.0°C to 4.0°C, for example, so that the deterioration result is not included in the alert range. The thresholds for alerts, etc. will be changed depending on the change in the set range.

According to this embodiment, if deterioration is found when the cells or cell medicine for which a notification has been issued is inspected at a manufacturing facility or hospital, the preset ranges, such as the temperature range, can be updated.

Figure 7 is a diagram showing the functional blocks of the transport status management system of Example 3. In Example 3, the hospital's acceptance testing terminal 30 uploads the effect results of patients who have been administered a cellular medicine from the hospital to the host computer 20. The host computer 20 stores the patient effect result data in a follow-up observation result database (DB) 29. Here, explanations of matters that are the same as those in Examples 1 and 2 will be omitted.

In this embodiment, the correlation diagram creation process 28 executes the correlation diagram creation process at any time based on the data in the sensor information accumulation database (DB) 23 and the progress observation result database (DB) 29.

The correlation diagram creation process 28 creates a correlation diagram by combining the effect after administration of the cellular medicine with the transport state (including the presence or absence of notification). An example of a correlation diagram is one that indicates how many seconds or more the time in the alert range must be before it will affect the patient's effect. The host computer 20 may have a time measurement function and determine the time in the alert range from the time when a notification that the alert range is received, or the transport container 10 may have a time measurement function and notify the host computer 20 of the time in the alert range.

The results of the correlation diagram are sent to the hospital's acceptance inspection terminal 30 and the manufacturing plant's acceptance inspection terminal 40 via the hospital interface (I/F) 26 and the manufacturing plant interface (I/F) 27.

According to this embodiment, it is possible to obtain a correlation between the effect after administration of a cell medicine and the transport state, for example, how many seconds the time in the alert range must be to affect the effect of the product. This can be used to improve transport rules.

10 Transport container 20 Host computer 21 Receiving interface unit 23 Sensor information accumulation database 24 Alert determination unit 25 Determination master 26 Hospital interface 27 Manufacturing facility interface 30 Hospital receiving inspection terminal 40 Manufacturing facility receiving inspection terminal

Claims (5)

A transportation status management system having a transportation container, a terminal, and a notification device that communicates with the transportation container and the terminal,
The transport container has a temperature sensor, a humidity sensor, a vibration sensor, and a communication unit,
The notification device includes:
a receiving interface unit that receives information on temperature, humidity, and vibration inside the transport container from the transport container;
an information storage unit that stores information on the temperature, the humidity, and the vibration;
an alert determination unit that determines whether or not a notification is required to change the inspection process for the deterioration state of the cells, which is performed at the time of receiving the cells, based on the temperature, humidity, and vibration information read from the information storage unit and the determination information;
and an external communication interface unit in the terminal that transmits the notification when it is determined that the notification is necessary;
The terminal that has received the notification
If there is no problem in the result of the inspection process for the cells or cellular medicine in the transport container, a process for accepting the cells or cellular medicine in the transport container is performed;
A transportation status management system that disposes of the cells or the cellular medicine if there is a problem with the results. 2. The transportation status management system according to claim 1,
The notification device includes:
a determination master for recording a threshold value for determining whether or not the notification is necessary;
A transportation status management system that receives, from the terminal, information on a threshold value for judgment based on the inspection results and changes the threshold value. 2. The transportation status management system according to claim 1,
The notification device includes:
The receiving interface unit receives effect information after administration of the cellular medicine to a patient from the front terminal,
A transportation state management system having a correlation creation unit that creates a correlation between the effect of the cellular medicine and the temperature, humidity, or vibration information based on the effect information and the information in the information storage unit. 2. The transportation status management system according to claim 1,
A transport status management system in which, when the judgment information defines a set range, if the temperature, humidity, and vibration information is included in an upper range and a lower range of the set range, an alert judgment unit judges that an alert notification is necessary. 2. The transportation status management system according to claim 1,
The terminal includes:
A transport status management system having a display unit that displays the identification number of the transport container, the date and time of receipt and processing, and whether or not an alert has occurred.

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