# US 2019/0313633 A1 · Stem cell manufacturing system, stem cell information management system, cell transport apparatus, and stem cell frozen storage apparatus

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- Number: US 2019/0313633 A1
- Document ID: US20190313633A1
- Status: Published application
- Kind: A1
- Application number: 16/455,753
- Filed: 2019-06-28
- Published: 2019-10-17
- Earliest claimed: 2016-08-04
- Assignees: Fanuc Corporation; I Peace, Inc.
- Applicants: Fanuc Corporation; I Peace, Inc.
- Inventors: Koji TANABE; Kiyonori INABA; Masaru ODA
- Web page: https://patentgrep.com/patent/US20190313633A1

## CPC

- A01N 1/142: Apparatus
- A01N 1/145: Stationary or portable vessels generating cryogenic temperatures, e.g. liquid nitrogen baths
- A01N 1/147: Carriers for immersion in cryogenic fluid for slow freezing or vitrification
- C12M 33/00: {Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus (chemical or physical laboratory apparatus in general B01L, devices for taking cell samples A61B10/0045, withdrawing or distributing predetermined quantities of fluid B01L99/00)}
- C12M 41/12: {of temperature (controlling the temperature of chemical or physical processes B01J19/0013, heating or cooling apparatus for laboratory use B01L7/00)}
- C12M 41/44: {of volume or liquid level}
- C12M 41/48: {Automatic or computerized control (automatic analysis G01N35/00)}
- C12M 45/20: {Heating; Cooling (heating or cooling apparatus for laboratory uses B01L7/00)}
- C12M 45/22: {Means for packing or storing viable microorganisms (casings for storing cell samples A61B10/0096, preservation of living parts of the human or animal body A01N1/10)}
- G16B 25/00: ICT specially adapted for hybridisation; ICT specially adapted for gene or protein expression
- G16B 25/10: Gene or protein expression profiling; Expression-ratio estimation or normalisation
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 40/63: for local operation
- C12M 1/02: with agitation means; with heat exchange means
- Y02P 90/30: Computing systems specially adapted for manufacturing
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- Y02P: CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS

## Abstract

A stem cell manufacturing system for manufacturing stem cells from somatic cells includes: one or more closed production device(s) configured to produce stem cells from somatic cells; one or more drive device(s) configured to be connected with the production device(s) and drive the production device(s) in such a manner as to maintain the production device(s) in an environment suitable for producing stem cells; one or more cryopreservation device(s) configured to cryopreserve the produced stem cells; a first memory device configured to store whether or not somatic cells have been introduced to the production device(s), as a first state; a second memory device configured to store whether or not the production device(s) is/are connected with the drive device(s), as a second state; and a third memory device configured to store whether or not the produced stem cells can be placed in the cryopreservation device(s), as a third state.

## Claims

### Claim at position 1

1-32. (canceled)

### Claim 33

A stem cell information management system for performing an integrated management of information in an entry process of receiving a manufacturing request for manufacturing stem cells from somatic cells, a transport process of transporting somatic cells collected from a somatic cell donor or stem cells produced from the somatic cells, an examination process of examining the somatic cells or the stem cells, a manufacturing process of manufacturing the stem cells from the somatic cells, and a stock process of stocking the stem cells, the system comprising:
a memory unit configured to store a collection schedule for collecting the somatic cells from the somatic cell donor, an examination schedule for examining the somatic cells, a production schedule for one or more production device(s) configured to produce the stem cells from the somatic cells, a cryopreservation schedule for one or more cryopreservation device(s) configured to cryopreserve the produced stem cells, and a stock schedule for a stock site at which the cryopreservation device(s) is/are stocked; and
a determination unit configured to determine at least a collection date for collecting the somatic cells from the somatic cell donor, based on the stored collection schedule, the examination schedule, the production schedule, the cryopreservation schedule, and the stock schedule.

### Claim 34 (depends on 33)

A stem cell information management system according to claim 33, wherein the determination unit determines a transport date on which to transport a somatic cell collection kit for collecting somatic cells to the somatic cell donor, based on the collection date of the somatic cells.

### Claim 35 (depends on 34)

The stem cell information management system according to claim 34, wherein the somatic cell collection kit comprises a somatic cell collection vial for containing collected somatic cells, and wherein the somatic cell collection vial comprises a first individual identification device containing donor identification information for identifying the somatic cell donor and production device identification information for identifying the production device.

### Claim 36 (depends on 35)

The stem cell information management system according to claim 35, wherein, when the request for manufacturing stem cells is received, the memory unit stores donor information including at least one of informed consent, nationality, address, sex, age, blood type, anamnesis, prescription history, health check results, and family members from whom stem cells are produced in the past, of the somatic cell donor, in association with the donor identification information.

### Claim 37 (depends on 36)

The stem cell information management system according to claim 36, wherein the memory unit stores collection locations at which the somatic cells can be collected, and the determination unit determines the collection date of the somatic cells based on the collection location most closely located to the stored address of the somatic cell donor and a collection schedule of the collection location.

### Claim 38 (depends on 37)

The stem cell information management system according to claim 37, further comprising a transport container configured to contain one or more of the somatic cell collection vials,
wherein the transport container comprises at least one of:
a heating and cooling device comprising a temperature estimation unit configured to estimate temperature of the somatic cells in the transport container, and a heating and cooling unit configured to automatically perform heating or cooling in conjunction with temperature data from the temperature estimation unit so that the temperature may be kept constant;
an accumulated time measurement device configured to measure accumulated transportation time of the transport container;
a coagulation monitoring device configured to monitor coagulation state of the somatic cells in the somatic cell collection vial; and
a vibration sensor configured to detect vibration of the transport container;
wherein the memory unit stores transport information including at least one of the temperature data, the accumulated transportation time, a numerical value representing the coagulation state, a numerical value representing the vibration; and
wherein the determination unit determines to output an alarm for an abnormality at a time of transport and modify a schedule, based on the stored transport information.

### Claim 39 (depends on 38)

The stem cell information management system according to claim 38, further comprising a first examination device configured to perform examination as to whether or not the somatic cells can be easily reprogrammed, wherein the memory unit stores examination information from the first examination device, and wherein the determination unit determines to output an alarm for an abnormality at a time of examination and modify a schedule, based on the stored examination information.

### Claim 40 (depends on 39)

The stem cell information management system according to claim 39, wherein the first examination device comprises at least one of a somatic cell counting device for counting the somatic cells and a gene expression level measurement device for measuring gene expression level.

### Claim 41 (depends on 40)

The stem cell information management system according to claim 40, wherein the determination unit determines whether or not the somatic cells can be easily reprogrammed, based on at least one of age, anamnesis, family members from whom stem cells are produced in the past, of the somatic cell donor, the cell count of the somatic cells, presence or absence of a particular gene, and gene expression level of a particular gene.

### Claim 42 (depends on 39)

The stem cell information management system according to claim 39, further comprising a vision sensor configured to acquire data in the production device, wherein the memory unit stores data from the vision sensor, and wherein the determination unit determines production information including at least one of size or growth speed of stem cell clusters, ratio between stem cell clusters of different sizes, cell count of the stem cells, shape of the stem cells, color tone or pH of culture reagent, and presence or absence of differentiated cells having differentiated from the stem cells, based on the stored data from the vision sensor, and determines to output an alarm for an abnormality at a time of production and modify a schedule, based on the production information.

### Claim 43 (depends on 42)

The stem cell information management system according to claim 42, further comprising a second examination device configured to examine genomic information of the somatic cells and genomic information of the stem cells, wherein the memory unit stores examination information from the second examination device, and wherein the determination unit determines whether or not the genomic information of the somatic cells is identical to the genomic information of the stem cells and determines to output an alarm for an abnormality at a time of examination and modify a schedule, based on the stored examination information.

### Claim 44 (depends on 42)

The stem cell information management system according to claim 42, further comprising a third examination device configured to examine HLA types of the somatic cells and HLA types of the stem cells, wherein the memory unit stores examination information from the third examination device, and wherein the determination unit determines whether or not the HLA types of the somatic cells are identical to the HLA types of the stem cells and determines to output an alarm for an abnormality at a time of examination and modify a schedule, based on the stored examination information.

### Claim 45 (depends on 35)

The stem cell information management system according to claim 35, further comprising one or more conveyer device(s) configured to convey the somatic cell collection vial to the production device(s), based on production device identification information contained in the first individual identification device, wherein the determination unit determines to convey the somatic cell collection vial, based on the stored production schedule of the production device(s).

### Claim 46 (depends on 45)

The stem cell information management system according to claim 45, wherein the conveyer device conveys at least one of a stem cell production material and a culture reagent to the production device, wherein the memory unit stores inventory information of the stem cell production material and the culture reagent, and wherein the determination unit determines to convey at least one of the stem cell production material and the culture reagent, based on the stored inventory information.

### Claim 47 (depends on 45)

The stem cell information management system according to claim 45, further comprising a stem cell freezing vial for containing stem cells frozen after having been produced, wherein the determination unit determines, based on the stored production schedule, a predicted release date and time when the stem cell freezing vial will be released from the production device.

### Claim 48 (depends on 47)

The stem cell information management system according to claim 47, wherein the determination unit determines to modify the predicted release date and time, based on a result of monitoring of the production device, and wherein the conveyer device conveys the stem cell freezing vial released from the production device to the cryopreservation device, based on the modified predicted release date and time.

### Claim 49 (depends on 47)

The stem cell information management system according to claim 47, wherein the stem cell freezing vial is equipped with a second individual identification device containing donor identification information for identifying the somatic cell donor, production device identification information for identifying the production device, and cryopreservation device identification information for identifying the cryopreservation device.

### Claim 50 (depends on 49)

The stem cell information management system according to claim 49, further comprising a reader device configured to read information included in at least one of the first individual identification device and the second individual identification device.

### Claim 51 (depends on 47)

The stem cell information management system according to claim 47, wherein the memory unit stores a cryopreservation date and time on which the stem cell freezing vial is stored in the cryopreservation device, and wherein the determination unit determines a cryopreservation period of the stem cell freezing vial, based on the stored cryopreservation date and time.

### Claim 52 (depends on 33)

The stem cell information management system according to claim 33, further comprising:
a control device comprising interface software and work software; and
an input device in wired or wireless communication with the control device and configured to input information in respective processes;
wherein the interface software converts information formatted in a data format unique to the input device into information formatted in a data format unique to the work software.

### Claim 53 (depends on 42)

The stem cell information management system according to claim 42, wherein at least one of the collection location and collection date, the transport information and abnormality alarm, the examination information and abnormality alarm, and the production information and abnormality alarm is transmitted to a mobile terminal in a remote location by wireless communication.

### Claim 54 (depends on 33)

The stem cell information management system according to claim 33, wherein the somatic cells are blood cells or fibroblasts.

### Claim 55 (depends on 33)

The stem cell information management system according to claim 33, wherein the stem cells are iPS cells.

### Claim at position 25

56-82. (canceled)