BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a system and a method for an iPS cell bank using media.

2. Description of the Related Art

In recent years, the iPS Cell Stock Project has progressed in regenerative medicine. In the iPS Cell Stock Project, blood is collected from healthy human leukocyte antigen (HLA) homozygous donors, and induced pluripotent stem cells (iPS cells) are generated and stocked in the Center for iPS Cell Research and Application, Kyoto University. In such a background, it is considered that business (system construction) in which regenerative medicine and clinical research are conducted using the stocked iPS cells is essential and urgently needed. In this respect, for example, literatures described below are known as the technologies of managing the inventory of medical supplies and the temperature of drugs.

Japanese Unexamined Patent Publication (Kokai) No. 2012-243324 describes the invention of a system for managing the inventory and order of expendable supplies (chemical samples and calibrators) used in a clinical analyzer for analyzing blood, tissue, and the like.

Japanese Unexamined Patent Publication (Kokai) No. 2005-112499 describes the invention of a management system for performing inventory management and ordering of expendable supplies (syringes, bandages, and rubbing alcohol) used in hospitals.

Japanese Unexamined Patent Publication (Kokai) No. 2015-202918 describes a system for performing temperature management of factories and repositories for commodities needing temperature management, such as foods and drugs, and for performing temperature management of the commodities during transporting the commodities.

SUMMARY OF THE INVENTION

The time, cost, and effort of production of iPS cells for clinical use are hurdles for practical use. This is because there is no management system capable of performing the unified management of enormous data related to production management, quality management, and the like based on regulations as described below.

There is concern that it is impossible to maintain and ensure the quality of iPS cells when appropriate management is not performed in a step of accepting somatic cells which are ingredients for producing the iPS cells, a step of producing the iPS cells, a step of stocking the iPS cells, and a step of transporting the iPS cells. Against the concern, it is preferable to perform analysis based on, for example, “Standard for Biological Ingredients” for ingredients used for producing regenerative medical products, “Ministerial Ordinance on Good Gene, Cellular and Tissue-based Products” (Ministerial Ordinance on GCTP) for production and quality management, Notifications from the Director of the Ministry of Health, Labour and Welfare “Guideline on Ensuring Quality and Safety of Drug Product, etc. Derived from Processing of Human (Autologous) iPS (-like) Cells” and “Guideline on Quality and Safety Assurance of Drug Product, etc. Derived from Human (Allogenic) iPS (-like) Cells”, Q5A and Q5D agreed in the International Conference on Harmonisation (ICH) for generation of a cell bank and for a virus free test, and the like.

It is preferable to strictly evaluate the quality of generated iPS cells for clinical use. As a manner in the whole quality management of pharmaceutical products obtained by processing human iPS cells, and the like (including iPS cells which are ingredients), there is a regulation that the standard and testing method of iPS cells are set, and the evidence thereof is provided. For example, the following quality evaluation items are demanded.

It is demanded to match various severe quality test management items such as:

1) cell count and survival rate;

2) identification test;

3) test of purity of cells;

4) process-related impurities testing;

5) sterility testing and mycoplasma negative testing;

6) endotoxin testing;

7) viral test;

8) characteristic test associated with iPS cells;

(i) having pluripotency of being capable of differentiating into various somatic cells; and

(ii) observing no gene mutation inducing cancer after transplantation, as well as low risk of tumorigenicity due to contamination of undifferentiated cells.

Construction of a foundation for stably supplying iPS cells to customers while maintaining and ensuring the quality of iPS cells is a future problem.

It is preferable to construct a management system capable of accurately and bi-directionally searching massive amounts and a wide variety of various data such as the data (sexes, ages, medical histories, health conditions, genetic backgrounds, and the like) of donors themselves, the data of acceptance of somatic cells as ingredients for generating iPS cells, the results of quality tests for generated iPS cells, and additional production and stock states.

Thus, it is demanded to construct a system for stably supplying high-quality iPS cells to a customer under accurate quality management.

A first aspect of the present invention is to provide a system for an iPS cell bank including: a entry management terminal that receives a request to produce an iPS cell from a customer; an acceptance management terminal that manages acceptance of a somatic cell including a blood cell, a skin cell, or the like as an ingredient for producing the iPS cell (hereinafter referred to as “somatic cell”); a production process management terminal that manages a step of producing the iPS cell; and a stock management terminal that manages stock of the produced iPS cell, wherein the entry management terminal includes: a first storage unit; an entry unit that makes an entry of the production request from the customer, including a desired date of collection of the somatic cell, as well as customer identification information for identifying the customer; a first determination unit that determines a date of collection of the somatic cell based on the desired collection date included in the entered production request; a first output unit that outputs the determined date of collection of the somatic cell to a first medium; and a first storage processing unit that stores, in the first storage unit, the determined date of collection of the somatic cell in association with the entered customer identification information; wherein the acceptance management terminal includes: a second storage unit that stores a collectable date on which the somatic cell can be collected; a second output unit that outputs the stored collectable date to a second medium; a second determination unit that determines a date of acceptance of the somatic cell based on the date of collection of the somatic cell, transmitted by the first medium; and a second storage processing unit that stores the determined date of acceptance of the somatic cell in the second storage unit; wherein the production process management terminal includes: a third storage unit that stores a producible period during which the iPS cell can be produced; a third determination unit that determines a period of production of the iPS cell based on the date of collection of the somatic cell, transmitted by the first medium, and on the stored producible period, and that determines a date of shipment of the produced iPS cell based on the determined period of production of the iPS cell; a third output unit that outputs the determined period of production of the iPS cell to a third medium; and a third storage processing unit that stores the determined period of production of the iPS cell and the determined date of shipment of the iPS cell in the third storage unit; wherein the stock management terminal includes: a fourth storage unit that stores a stockable location and a stockable period where the produced iPS cell can be stocked; a fourth output unit that outputs the stored stockable location and the stored stockable period to a fourth medium; and a fourth determination unit that determines a stock location and a stock period for stocking the produced iPS cell based on the period of production of the iPS cell, transmitted by the third medium and on the stored stockable location and stockable period; wherein the first determination unit determines the date of collection of the somatic cell based on the desired collection date and on the collectable date transmitted by the second medium; wherein the second determination unit determines the date of acceptance of the somatic cell based on the date of collection of the somatic cell and on the production period transmitted by the third medium; and wherein the third determination unit determines the date of shipment of the iPS cell based on the period of production of the iPS cell and on the stockable location and the stockable period transmitted by the fourth medium.

A second aspect of the present invention is to provide the system for the iPS cell bank according to the first aspect, wherein the somatic cell is a blood cell.

A third aspect of the present invention is to provide the system for the iPS cell bank according to the first or second aspect, wherein the first to fourth media are paper media.

A fourth aspect of the present invention is to provide the system for the iPS cell bank according to any one of the first to third aspects, wherein the entry management terminal, the acceptance management terminal, the production process management terminal, and the stock management terminal are connected communicatably to each other; and wherein the first to fourth media are communication media.

A fifth aspect of the present invention is to provide a method executed in a system for an iPS cell bank including: an entry management terminal that receives a request to produce an iPS cell from a customer; an acceptance management terminal that manages acceptance of a somatic cell for producing the iPS cell; a production process management terminal that manages a step of producing the iPS cell; and a stock management terminal that manages stock of the produced iPS cell, the method executed in the entry management terminal includes: a step of making an entry of the production request from the customer, including a desired date of collection of the somatic cell, as well as customer identification information for identifying the customer; a step of determining a date of collection of the somatic cell based on the desired collection date included in the entered production request; a step of outputting the determined date of collection of the somatic cell to a first medium; and a step of storing, in the first storage unit, the determined date of collection of the somatic cell in association with the entered customer identification information; the method executed in the acceptance management terminal includes: a step of storing a collectable date on which the somatic cell can be collected; a step of outputting the stored collectable date to a second medium; a step of determining a date of acceptance of the somatic cell based on the date of collection of the somatic cell, transmitted by the first medium; and a step of storing the determined date of acceptance of the somatic cell in the second storage unit; the method executed in the production process management terminal includes: a step of storing a producible period during which the iPS cell can be produced; a step of determining a period of production of the iPS cell based on the date of collection of the somatic cell, transmitted by the first medium, and on the stored cell producible period, and of determining a date of shipment of the produced iPS cell based on the determined period of production of the iPS cell; a step of outputting the determined period of production of the iPS cell to a third medium; and a step of storing the determined period of production of the iPS cell and the determined date of shipment of the iPS cell in the third storage unit; the method executed in the stock management terminal includes: a step of storing a stockable location and a stockable period where the produced iPS cell can be stocked; a step of outputting the stored stockable location and the stored stockable period to a fourth medium; and a step of determining a stock location and a stock period for stocking the produced iPS cell based on the period of production of the iPS cell, transmitted by the third medium and on the stored stockable location and stockable period; wherein the step of determining the date of collection of the somatic cell includes a step of determining the date of collection of the somatic cell based on the desired collection date and on the collectable date transmitted by the second medium; wherein the step of determining the date of acceptance of the somatic cell includes a step of determining the date of acceptance of the somatic cell based on the date of collection of the somatic cell and on the production period transmitted by the third medium; and wherein the step of determining the date of shipment of the iPS cell includes a step of determining the date of shipment of the iPS cell based on the period of production of the iPS cell and on the stockable location and the stockable period transmitted by the fourth medium.

According to one aspect of the present invention, each step is managed in consideration of the quality of a somatic cell which is an ingredient and an iPS cell to be a product, and therefore, a high-quality iPS cell can be stably supplied to a customer.

