JP5786432B2 - Manufacturing schedule management system for regenerative medical products - Google Patents

Description

  The present invention relates to a production schedule management system for a regenerative medical product, and more specifically, a production process of a regenerative medical product produced by culturing a first cell collected from a living body, and a second cell necessary for the production process. The present invention relates to a production schedule management system for a regenerative medical product that manages a production schedule associated with a culture process for the purpose.

Today, autologous transplantation in which cells collected from patients are cultured and transplanted into patients is performed, and in order to perform this autotransplantation, cells collected in a manufacturing facility that specializes in cell culture are cultured. At the same time, the cultured cells are made into a shape suitable for transplantation and shipped as a regenerative medical product.
Here, for example, when culturing epidermal cells as first cells, it is known to use another cell called a feeder cell (supporting cell) as a second cell (Patent Document 1).
On the other hand, when culturing cells, there are operations such as seeding the cells in the medium in the container, replacing the medium, and subculturing the cultured cells into a plurality of containers. Necessary.
Since a plurality of the regenerative medical products are performed in parallel at the manufacturing facility, a regenerative medical product manufacturing schedule management system that manages the schedules of workers engaged in the culture process is used (Cited document 2). ).

Japanese Patent No. 3043727 JP 2011-13752 A

Here, when accepting the first cell newly collected from the patient in the manufacturing facility and setting the manufacturing process of a new regenerative medical product, the operator uses the first cell to be used in the manufacturing process of the new regenerative medical product. The required quantity of 2 cells must be calculated to reset the culture process for the second cell, and whether or not the set culture process for the second cell is actually established must also be examined.
However, in the production schedule management system for regenerative medical products described in Patent Document 2 above, each cell culturing process is individually managed, and therefore the regenerative medical product production process and the second cell culturing process are related. It is not designed to let you manage.
In view of such problems, when a manufacturing process for a new regenerative medical product is set, the present invention resets the culture process of the second cell, and further sets the manufacturing schedule based on the reset culture process of the second cell. The present invention provides a production schedule management system for regenerative medical products that determines whether or not the whole is actually established.

That is, the production schedule management system for regenerative medical products according to claim 1 is a method for producing regenerative medical products produced by culturing first cells collected from a living body, and culturing second cells necessary for the production steps. A production schedule management system for regenerative medical products that manages a production schedule associated with a culture process for
An input means for inputting delivery date information and quantity information of the regenerative medical product;
A manufacturing process setting unit for setting the manufacturing process of the regenerative medical product by calculating backward from the delivery date information and the quantity information input to the input means;
A second cell required quantity calculating unit for calculating a required quantity of second cells necessary for the manufacturing process of the regenerative medical product set by the manufacturing process setting unit;
A second cell culture process setting unit that resets the culture process of the second cells that has already been set according to the required number of second cells calculated by the second cell required quantity calculation unit;
Judgment whether or not the second cell can actually be cultured by the second cell culturing process reset by the second cell culturing process setting unit, and thereby judging whether or not the manufacturing schedule is established e Bei and parts, and re-setting the second cell culturing process in accordance with addition or change of regenerative medicine products of the manufacturing process, associating the steps of culturing the manufacturing process and the second cell of the plurality of regenerative medicine products It is characterized by managing the production schedule .

According to the above invention, when the delivery date information and the required quantity of the first cell are input to the input means, the manufacturing process of the regenerative medical product is set by calculating backward from the delivery date information and the required quantity. The necessary quantity of the second cells required according to the manufacturing process and the culture process of the second cells are automatically reset.
And about the culture | cultivation process of the reset 2nd cell, since the determination part determines whether a 2nd cell can actually be cultured, it becomes possible to determine whether the whole culture schedule is materialized. .

Configuration diagram of the manufacturing facility according to this example Flow chart showing regenerative medicine product manufacturing process and feeder cell culture process Table of work room usage status stored in the equipment information management department Table of incubator usage status stored in the equipment information management department Table of worker work status stored in the worker information management department Flowchart for explaining the operation of the production schedule management system for regenerative medical products Flow chart explaining operation of epidermal cell culture process setting unit

The illustrated embodiment will be described below. FIG. 1 shows the structure of a manufacturing facility 1 for manufacturing an autologous cultured epidermis as a regenerative medical product used for autotransplantation. In order to produce the cultured epidermis, the production schedule is managed by the production schedule management system 2 described below.
The autologous cultured epidermis is produced by culturing epidermal cells as first cells collected from a living body such as a patient. When culturing the epidermal cells, the epidermal cells are used as feeder cells (3T3). Cells can be efficiently cultured, and the above-mentioned epidermal cells are seeded in a container containing feeder cells to proliferate the epidermal cells to the number required for transplantation. Can do.
The cultured epidermal cells are then formed into a shape suitable for transplantation, packed in a required container, and shipped as a regenerative medical product from the manufacturing facility 1 to the hospital.
And in the said manufacturing facility 1, while culturing the epidermis cell of many patients, in order to maintain the state which can accept an epidermis cell at any time, it culture | cultivates a feeder cell continuously.

Hereinafter, a manufacturing schedule in which a manufacturing process of a regenerative medical product manufactured by culturing epidermal cells performed in the manufacturing facility 1 and a culture process of feeder cells will be described with reference to FIG.
First, the feeder cell culturing process will be described. An operator performs a seeding operation (A1) in which a feeder cell that has been frozen and stored in advance is thawed in a storage container such as a flask in which a required medium is stored, and this is seeded. .
Feeder cells are cultured by the seeding operation (A1), and while the feeder cells grow, the operator performs a medium exchange operation (A2) for exchanging the medium in the container at a predetermined interval.
When the feeder cells are cultured inside the storage container, the operator takes out a part of the feeder cells in the storage container and performs a subculture operation (A3) for seeding the feeder cells in another storage container.
When performing the above-mentioned subculture operation, it becomes possible to obtain a plurality of feeder cell storage containers by seeding the grown feeder cells in a plurality of storage containers. It is used respectively when the cell culture is continued and when it is used for culturing the epidermal cells.
The above subculture can be repeated to further proliferate the feeder cells ((A4) to (An)), and although not shown between the subcultures, the medium is not shown. Replacement work is performed.
In addition, when the feeder cell has a passage limit (can be passaged only a predetermined number of times), the production facility 1 needs to perform thawing and seeding of the new feeder cell in parallel while performing the passage work. However, in order to explain simply in FIG. 2, it is described that the feeder cells are proliferated by repeating the passage work.
In the manufacturing facility 1 of the present embodiment, the above-described subculture work, thawing of new feeder cells, and seeding work are performed at predetermined intervals every predetermined number of days.

Next, the manufacturing process of the regenerative medical product which culture | cultivates the said epidermal cell and packs this is demonstrated. First, when an epidermis is collected from a patient in a hospital, the epidermis is transported to the manufacturing facility 1 and a required inspection is performed by an operator (B1).
Subsequently, the operator performs a separation operation for separating the epidermis to the state of epidermal cells (B2), and performs a seeding operation for seeding the separated epidermal cells in a feeder cell storage container obtained in the feeder cell culture step. (B3).
By seeding the epidermal cells on feeder cells, primary culture of the epidermal cells is performed, and in this case, a plurality of feeder cell storage containers are used according to the number of epidermal cells to be seeded.
Next, the operator examines the epidermal cells at a required interval, and at the same time, performs a medium exchange operation for exchanging the medium in the container (B4).
Then, when the epidermal cells are propagated inside the storage container, the operator takes out a part of the epidermal cells in the storage container and seeds them in the feeder cell storage container obtained in the feeder cell culture step. A subculture work is performed (B5).
The passaging operation is performed on a plurality of feeder cell storage containers, whereby a plurality of storage containers storing the epidermal cells are obtained, and the number of epidermal cells necessary for transplantation can be grown.
And after the said subculture operation | work, an operator performs the culture medium exchange operation | work which test | inspects an epidermal cell again and replaces | exchanges a culture medium at a predetermined interval (B6). As the epidermal cells grow, the feeder cells are gradually expelled from the container.
Note that the above subculture work can be repeated several times according to the required number of epidermal cells, that is, the number of epidermal cells required for transplantation. A container is used.

Next, if there is a considerable number of days between the receipt of the epidermal cells and the shipment date of the cultured epidermal cells, a freezing operation is performed to freeze the cultured epidermal cells as necessary (B7). Then, a defrosting operation is performed (B8).
When performing the above thawing operation, it is necessary to seed the thawed epidermal cells in a feeder cell container, and a plurality of feeder cell containers are also used in this case.

Subsequently, whether or not the freezing operation is performed, a sheet culture operation is performed to culture the cultured epidermal cells into a sheet suitable for transplantation (B9).
When a predetermined number of days have passed since the sheet culture operation, an autologous epidermis in which epidermal cells are arranged in a sheet form is formed inside the container, and subsequently, it is inspected whether the autologous cultured epidermis can be shipped. The shipping inspection work (B10), and the packing / shipping work for packing the self-cultured epidermis into a predetermined container and shipping it as a regenerative medical product (B11).
The self-cultured epidermis as a regenerative medical product shipped from the manufacturing facility 1 in this way is transplanted to the patient in the hospital.

As shown in FIG. 2, in the manufacturing facility 1, the epidermis cells of a plurality of patients are cultured in parallel. In this case, from the culture process of the feeder cells, the culture process of the plurality of epidermal cells is performed. Each time they need it, they must provide the required quantity of feeder cells.
Specifically, in FIG. 2, when it is necessary to perform the thawing operation (B8) of the production process A and the subculture operation (B5) of the production process B at the same time, the feeder cell is used for each of these operations. On the other hand, a predetermined number is required.
Therefore, in order to obtain a necessary amount of feeder cells when these operations are performed, the culture process of the feeder cells must be reset in advance. Here, in the subculture operation (A6), the necessary amount of feeder cells is removed. It is necessary to prepare a container for storing a plurality of feeder cells.

The manufacturing facility 1 will be described. The manufacturing facility 1 includes a plurality of working chambers 3 for performing each operation of the manufacturing process, and a plurality of incubators 4 for culturing epidermal cells and feeder cells. The production schedule management system 2 is provided in order to manage these uses and the above-described production process and feeder cell culture process.
The inside of the work chamber 3 is kept clean, and a set of equipment and instruments necessary for the culture process such as a safety cabinet is prepared.
Further, when using the work room 3, the epidermis cells of one patient are handled in order to prevent cross contamination, and after the work room 3 is used, the inside of the work room 3 is cleaned. It has become so.
Further, in the manufacturing process of the epidermal cells, when the shipping inspection work and the packing / shipping work need to be performed at the same time, the two working chambers 3 are used simultaneously for performing these work.
The incubator 4 is provided for feeder cell culture and epidermal cell culture, respectively. In the epidermal cell culture, one incubator 4 accommodates one patient's epidermal cells in order to prevent cross-contamination. It is supposed to be.

The manufacturing schedule management system 2 includes a conventionally known server 11 and a client 12 installed in each room of the manufacturing facility 1. The server 11 and the client 12 are communicably connected by a communication means 13 such as a LAN. ing.
Each of the server 11 and the client 12 includes an input unit 14 such as a mouse and a keyboard and a display unit 15 such as a monitor, and the server 11 can be operated by the input unit 14 of the client 12 via the communication unit 13. In addition, the data in the server 11 can be displayed on the display means 15 of the client 12.
The server 11 includes a storage unit 16 such as a hard disk in which data described below is stored, and a calculation unit 17 such as a CPU that performs calculations based on the data stored in the storage unit 16.
The configurations of the server 11 and the client 12 are well known in the art and will not be described in detail.

The storage unit 16 of the server 11 stores a schedule management unit 21 in which a production schedule related to the regenerative medical product is registered, a manufacturing pattern management unit 22 in which a pattern of a production process of the regenerative medical product is registered, and the work room. 3 and the incubator 4 are registered in the facility information management unit 23, the worker information management unit 24 in which information on the worker is registered, and the culture result storage unit 25 in which past culture results are registered. Is set.
The schedule management unit 21 is registered with a manufacturing schedule in which a feeder cell culturing process and a plurality of regenerative medical product manufacturing processes as shown in FIG. 2 are associated with each other. When a manufacturing process is added or a change in schedule or a culture failure is input, the contents are updated.
In the pattern management unit 22, a plurality of patterns of feeder cell culture processes and regenerative medical product manufacturing processes are registered in advance. For example, the number of subculture operations is increased or decreased according to the number of days required for the regenerative medical product manufacturing process. And the patterns such as the presence or absence of the freezing operation are registered. The registered contents can be freely changed.

The facility information management unit 23 manages the use status of the work chamber 3 and the incubator 4, and the implementation status of the epidermis cell passage work in the predetermined work chamber 3 as shown in FIGS. 3 and 4. In addition, identification symbols of epidermal cells cultured in a predetermined incubator 4 are registered.
As described above, since the work chamber 3 and the incubator 4 can only bring in cells of one patient in order to prevent cross contamination, for example, all of the five work chambers 3 shown in FIG. If the above work is being performed, a new work cannot be set at the same time any more.
In addition, since the two work rooms 3 are used simultaneously for the shipping inspection work and the packing / shipping work in the manufacturing process of the regenerative medical product, only the remaining three work rooms 3 can be used when performing these work. Become.
Furthermore, for example, when epidermal cells and feeder cells are cultured in all of the five incubators 4 shown in FIG. 4, a new regenerative medical product manufacturing process cannot be performed.

The worker information management unit 24 manages data related to workers engaged in the manufacturing process of regenerative medical products and the feeder cell culturing process in the manufacturing facility 1, and each worker's name and each worker has it. Skills, work status of each worker, etc. are managed.
The skill of the worker refers to, for example, the ability required for each work such as seeding work and subculture work in the manufacturing process of the regenerative medical product. Information indicating that inspection work and packing / shipping work cannot be performed is registered.
FIG. 5 shows a table of worker work status, and shows which work each worker performs on which date and time. Although not shown here, it is possible to refer to which work chamber 3 the work for which the worker is in charge and which cell of the incubator 4 is handled.
For example, when only the worker A can perform the shipping inspection work, when the worker A performs the shipping inspection work at a certain time, the shipping inspection work cannot be performed at the same time. .

In the culture record storage unit 25, the record of the culture related to the culture process performed in the past is registered. The date and time of each work in the culture process performed, the number of storage containers processed at that time, and each work are performed. Data on registered workers and equipment used are registered and can be used for traceability after regenerative medical products are shipped.
In particular, the culture record storage unit 25 functions as a culturable quantity storage unit in which past culturable quantities of feeder cells are registered, and is obtained by actually culturing in the feeder cell culturing process. When the cultured quantity of feeder cells exceeds the stored culturable quantity, the cultured quantity is updated as a new culturable quantity.
The culturable quantity can be set and stored based on various conditions, not limited to past culture results.

The calculation means 17 includes a manufacturing process setting unit 31 that sets a manufacturing process of a newly added regenerative medical product, and a second cell required quantity that calculates a required quantity of feeder cells used in the manufacturing process of the new regenerative medical product. Necessary for each of the calculation unit 32, the second cell culture process setting unit 33 for resetting the feeder cell culture process according to the required quantity of the feeder cells, and the regenerative medical product manufacturing process and the feeder cell culture process. A facility allocation unit 34 for allocating various facilities, a worker allocation unit 35 for allocating necessary workers to the regenerative medical product manufacturing process and the feeder cell culturing process, and whether or not the manufacturing schedule is actually established. A determination unit 36 for determination is provided.
Hereinafter, the function of each part constituting the computing means 17 will be described with reference to FIG. 6 together with the procedure for managing the production schedule in which the production schedule management system 2 associates the production process of the regenerative medical product and the feeder cell culture process. To do.
First, when an inquiry is made from the hospital to the manufacturing facility 1 regarding the manufacturing request of the regenerative medical product, the operator uses the input device of the manufacturing schedule management system 2 to receive the epidermis information and the regenerative medical treatment necessary for the treatment. Product delivery date information and quantity information are input (C1).
Then, the manufacturing process setting part 31 which comprises the said calculating means 17 sets back the manufacturing process of the said regenerative medical product by calculating backward from the delivery date information and quantity information input into the said input means 14 (C2).

Here, the setting procedure of the manufacturing process of the regenerative medical product by the manufacturing process setting unit 31 will be described in detail with reference to FIG.
When the delivery date information and quantity information about the regenerative medical product to be manufactured are input to the input unit 14 (D1), the manufacturing process setting unit 31 refers to the manufacturing pattern management unit 22 in the storage unit 16 (D2). ).
Since the manufacturing process of the regenerative medical product of various patterns is registered in the pattern management unit 22, the manufacturing process setting unit 31 responds to the number of days from the current date to the delivery date and the quantity information of the regenerative medical product. Then, the available manufacturing process pattern is displayed on the display means 15 (D3).
The worker selects an appropriate manufacturing process from the displayed manufacturing processes (in some cases, one manufacturing process) of the plurality of regenerative medical products (D4).
For example, if the number of days from the current date to the above is long, the manufacturing process in which the collection time of the epidermis and the treatment start date are delayed, the manufacturing process in which the culture (manufacturing) period is extended instead of reducing the epidermis to be collected, and the above It is possible to select a manufacturing process for cryopreserving epidermal cells by freezing.
When the worker selects an appropriate manufacturing process in this way, the manufacturing process setting unit 31 newly registers the manufacturing process of the selected regenerative medical product in the schedule management unit 21 (D5).

In this way, when a new regenerative medical product manufacturing process is set, the manufacturing process setting unit 31 further includes the delivery date information and quantity information input to the input means 14 and the new regenerative medical product manufacturing process. The amount of epidermal cells collected for the seeding operation, in other words, the area of the epidermis to be collected from the patient is calculated (C3).
For the calculation of the amount of epidermal cells collected, a pre-registered prediction formula for the proliferation of epidermal cells can be used, and the amount of epidermal cells to be collected is calculated back from the manufacturing process of the new regenerative medical product. Is to be calculated.

When the manufacturing process of a new regenerative medical product is set in this way, the second cell required quantity calculating unit 32 calculates the required quantity of feeder cells used in the manufacturing process of the new regenerative medical product (C4). ).
Specifically, from the manufacturing process of the new regenerative medical product and the amount of epidermal cells collected from the patient, it is determined in each of the seeding and subculture operations in the manufacturing process of the regenerative medical product. Whether only epidermal cells are cultured is predicted using a pre-registered prediction formula.
At this time, from the cultured quantity of epidermal cells cultured in each operation of the production process of the regenerative medical product, the necessary quantity of feeder cells used in each of the operations, in other words, using the prediction formula registered in advance. The number of feeder cell storage containers is calculated.
And the 2nd cell required quantity calculation part 32 recognizes also the delivery date information (required time) of each operation | work which uses the said feeder cell from the manufacturing process of the said regenerative medical product.

When the necessary quantity of feeder cells is calculated in this way, the second cell culture process setting unit 33 sets the existing feeder cells already set in the schedule management unit 21 according to the necessary quantity of the feeder cells. The culture process is reset to a new feeder cell culture process (C5).
Specifically, by setting the manufacturing process of the new regenerative medical product, in addition to the number of feeder cells cultured by the existing feeder cell culture process, a new regenerative medical product manufacturing process The number of feeder cells to be used is increased, and the increased feeder cells must be prepared by each operation in the manufacturing process of the new regenerative medical product.
Therefore, the second cell culturing process setting unit 33 performs the operations in the regenerative medical product manufacturing process so that the necessary number of feeder cells can be obtained by the operations in the new regenerative medical product manufacturing process. In the subculture operation in the feeder cell culture process, the number of storage containers used in the subculture operation is increased.
For example, in FIG. 2, when the thawing operation (B8) in the production process A of the regenerative medical product and the subculture operation (B5) in the production process B of the regenerative medical product are performed at the same time, In the passage work (A6), the contents of the passage work (A6) are changed so that the feeder cells necessary for the work can be obtained.
In this way, the second cell culture process setting unit 33 resets a new feeder cell culture process from the required quantity of the feeder cells that are newly required and the delivery date information (required time). The feeder cell culture process is registered in the schedule management unit 21.

When the new feeder cell culturing process is reset, the determination unit 36 determines whether the feeder cell can be actually cultured by the new feeder cell culturing process, and as a result, the manufacturing schedule is established. It is determined whether or not to perform (C6).
Specifically, in the second cell culture process setting unit 33, a change is made to increase the number of storage containers used in a predetermined passage operation, but the increased number of storage containers is the above passage operation. When the number of feeder cells used for the passage work is insufficient, in other words, the necessary number of feeder cells calculated above cannot be obtained.
The determination unit 36 refers to the culture results of the feeder cells stored in the culture result storage unit 25 to determine whether or not the subculture work can be performed, and performs the subculture work in the new feeder cell culture process. When the number of feeder cells cultured in (1) exceeds the past culture results, it is determined that the feeder cell culture step is not established.
If the feeder cell culturing process is not established, the manufacturing process of the new regenerative medical product is naturally not established, so that the entire production schedule registered in the schedule management unit 21 is not established.
If it is determined by the determination unit 36 that the new feeder cell culturing process is established, the process proceeds to the facility allocation procedure described below, and it is determined that the feeder cell culturing process is not established. In this case, the determination unit 36 displays on the display means 15 that the production schedule is not established and the regenerative medical product cannot be shipped.
At this time, the manufacturing process of the regenerative medical product can be reviewed, and the manufacturing process setting unit 31 presents a culture process having a pattern different from the previously proposed manufacturing process of the regenerative medical product, and then the procedure described above. By repeating the above, it is possible to establish a feeder cell culture step.

When the determination unit 36 determines that the feeder cell culturing process is established, the facility allocation unit 34 allocates necessary facilities for the regenerative medical product manufacturing process and the feeder cell culturing process (C7).
Specifically, since the required work room 3 and incubator 4 are already allocated in the existing manufacturing schedule set in the schedule management unit 21 in the past, the facility allocation unit 34 refers to the facility information management unit 23. Then, while recognizing the availability of the work room 3 and the incubator 4, facilities necessary for the manufacturing process of a new regenerative medical product are allocated.
At this time, since the inspection work and the packing / shipping work in the manufacturing process of the regenerative medical product need to be performed at the same time, it is necessary to use the two working chambers 3 simultaneously when performing these work.
And the determination part 36 determines whether the said equipment allocation part 34 can allocate both the said working room 3 and the incubator 4 to the manufacturing process of a new regenerative medical product (C8).
If the determination unit 36 determines that each facility can be assigned, the procedure proceeds to the worker assignment procedure described below. If it is determined that the assignment cannot be made, a manufacturing schedule is established on the display unit 15. Display that the product cannot be shipped without it.

When the determination unit 36 determines that each facility can be allocated, the worker allocation unit 35 allocates workers suitable for the regenerative medical product manufacturing process and the feeder cell culture process (C9).
Specifically, since a required worker has already been assigned in the existing manufacturing schedule set in the schedule management unit 21 in the past, the worker assignment unit 35 refers to the worker information management unit 24 described above. Then, while recognizing the working hours and skills of the workers, the workers in charge of each work in the manufacturing process of the new regenerative medical product are assigned.
At this time, for example, in the manufacturing process of two regenerative medical products in parallel, it is necessary to perform the inspection work at the same time, and only one of the workers has the skill of the inspection work. Since the inspection work in the manufacturing process of one regenerative medical product cannot be performed, an operator cannot be assigned in that case.
And the determination part 36 determines whether the said worker allocation part 35 can allocate the said worker to the manufacturing process of a new regenerative medical product (C10).
When the determination unit 36 determines that the worker cannot be assigned, the display unit 15 displays that the manufacturing schedule is not established, and displays that the manufacturing request for the regenerative medical product should be rejected.
On the other hand, when the determination unit 36 determines that the manufacturing schedule is established, the display means 15 displays that the epidermal cells can be shipped, and the operator can notify the hospital to that effect. Yes (C11).

As described above, according to the production schedule management system 2 according to the present embodiment, a new regenerative medical product can be produced even when feeder cells are cultured in parallel in order to culture the epidermal cells. It is possible to automatically set the process and automatically reset the culture process of feeder cells used in the manufacturing process of the regenerative medical product.
In addition, since the determination unit 36 determines whether the feeder cells can actually be cultured by the reset feeder cell process, it is not necessary for the operator to review the feeder cell culture process. When a plurality of regenerative medical products are manufactured in parallel, an appropriate amount of feeder cells can be prepared in accordance with the required delivery date, and therefore the feeder cell culture process can be set efficiently.
Furthermore, according to the manufacturing schedule management system 2, the manufacturing instruction, the instruction of each operation, the preparation document of the medicine to be used, the operation record, the manufacturing report regarding the manufacturing process of the set regenerative medical product and the culture process of the feeder cell. It is also possible to create and output various forms.

In the above embodiment, the case where the epidermal cell is cultured as the first cell and the feeder cell is cultured as the second cell has been described. However, the present invention is not limited to this combination, and the first cell and the second cell are shared. In the case of a manufacturing process including a culture process for culturing, the culture management system can be used.
For example, when co-culturing melanocytes and epidermal cells in a specific ratio, it is necessary to culture melanocytes in parallel with the epidermal cells, and the melanocytes are related to the culture quantity of the epidermal cells. Since the epidermal cells are the first cells and the melanocytes are the second cells, the production schedule management system for the regenerative medical product according to the present invention is used to efficiently perform these cultures. Can do.

DESCRIPTION OF SYMBOLS 1 Manufacturing facility 2 Manufacturing schedule management system of regenerative medicine product 3 Work room 4 Incubator 11 Server 12 Client 14 Input means 15 Display means 16 Storage means 17 Calculation means 31 Manufacturing process setting part 32 2nd cell required quantity calculation part 33 2nd cell Incubation process setting unit 34 Equipment allocation unit 35 Worker allocation unit 36 Judgment unit

Claims (4)

Regeneration, managing a production schedule that associates a production process of a regenerative medical product produced by culturing first cells collected from a living body and a culture process for culturing second cells necessary for the production process A manufacturing schedule management system for medical products,
An input means for inputting delivery date information and quantity information of the regenerative medical product;
A manufacturing process setting unit for setting the manufacturing process of the regenerative medical product by calculating backward from the delivery date information and the quantity information input to the input means;
A second cell required quantity calculating unit for calculating a required quantity of second cells necessary for the manufacturing process of the regenerative medical product set by the manufacturing process setting unit;
A second cell culture process setting unit that resets the culture process of the second cells that has already been set according to the required number of second cells calculated by the second cell required quantity calculation unit;
Judgment whether or not the second cell can actually be cultured by the second cell culturing process reset by the second cell culturing process setting unit, and thereby judging whether or not the manufacturing schedule is established for example Bei and parts, and re-setting the second cell culturing process in accordance with addition or change of regenerative medicine products of the manufacturing process, associating the steps of culturing the manufacturing process and the second cell of the plurality of regenerative medicine products A production schedule management system for regenerative medical products characterized by managing a production schedule. An equipment information management unit for storing the usage status of equipment necessary for each of the production process of the regenerative medical product and the culture process of the second cell;
The manufacturing process of the regenerative medical product set by the manufacturing process setting unit and the second cell culture reset by the second cell culturing process setting unit according to the usage status of the equipment stored in the equipment information management unit An equipment allocating section that assigns necessary equipment to each process,
The said determination part determines that the said manufacturing schedule is not materialized, when the said equipment allocation part cannot allocate the said equipment to the manufacturing process of a regenerative medical product, and the culture | cultivation process of a 2nd cell. Item 10. A manufacturing schedule management system for regenerative medical products according to Item 1. An operator who performs the manufacturing process of the regenerative medical product and the culture process of the second cell, an operator information management unit that stores information on the skill of the operator,
According to the worker stored in the worker information management unit and the skill of the worker, the manufacturing process of the regenerative medical product set in the manufacturing process setting unit and the resetting in the second cell culture process setting unit A worker assigning unit for assigning workers suitable for the second cell culture step,
The determining unit determines that the manufacturing schedule is not established when the worker allocating unit cannot allocate the worker to the regenerative medical product manufacturing process and the second cell culturing process. The manufacturing schedule management system of the regenerative medical product according to claim 1 or 2. A culturable quantity storage unit for storing the culturable quantity of the second cell;
The determination unit is configured to culture the second cell in which the culture quantity of the second cell cultured in the second cell culture process reset by the second cell culture process setting unit is stored in the culturable quantity storage unit. The production schedule management system for regenerative medical products according to any one of claims 1 to 3, wherein if the quantity exceeds the possible quantity, it is determined that the second cell cannot be cultured depending on the culturing step.

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