# US 2019/0313634 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 2019/0313634 A1
- Document ID: US20190313634A1
- Status: Published application
- Kind: A1
- Application number: 16/455,754
- 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/US20190313634A1

## 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

1-55. (canceled)

### Claim 56

A cell transport apparatus for transporting somatic cells collected from a somatic cell donor(s) to one or more closed production device(s) configured to produce stem cells from somatic cells, or for transporting the stem cells to a stem cell stock site, the apparatus comprising:
a somatic cell collection vial for containing the collected somatic cells and equipped with 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, or a stem cell freezing vial for containing stem cells produced in the production device and subsequently frozen and equipped with a second individual identification device containing the donor identification information, the production device identification information, and stock site identification information for identifying a stock site for stocking the stem cells;
a transport container configured to contain one or more of the somatic cell collection vials or one or more of the stem cell freezing vials;
a reader device configured to read at least one of the donor identification information, the production device identification information, and the stock site identification information contained in the first individual identification device or the second individual identification device; and
a transport means for transporting the transport container containing the somatic cell collection vial or the stem cell freezing vial, based on the read production device identification information or stock site identification information.

### Claim 57 (depends on 56)

The cell transport apparatus according to claim 56, further comprising a heat retaining means for keeping the temperature inside the transport container constant, wherein the heat retaining means is a heating and cooling device comprising a temperature estimation unit configured to estimate temperature of the somatic cells or the stem cells in the transport container, and a heating and cooling unit configured to automatically perform heating or cooling in conjunction with temperature data outputted by the temperature estimation unit so that the temperature is kept constant.

### Claim 58 (depends on 57)

The cell transport apparatus according to claim 57, wherein the heating and cooling device stores in memory an upper temperature limit and a lower temperature limit and outputs a temperature-related abnormality alarm when the temperature data is equal to or higher than the upper temperature limit or equal to or lower than the lower temperature limit.

### Claim 59 (depends on 58)

The cell transport apparatus according to claim 58, further comprising a heat retaining means for keeping the temperature inside the transport container constant, wherein the heat retaining means comprises a refrigerant for cooling or freezing the somatic cells or the stem cells in the transport container, a refrigerant remaining amount sensor configured to detect a remaining amount of the refrigerant, a reserve tank detachably connected with the transport container and containing reserve refrigerant, and a reserve refrigerant supply device configured to supply the reserve refrigerant, based on the remaining amount of the refrigerant.

### Claim 60 (depends on 59)

The cell transport apparatus according to claim 59, further comprising a reserve refrigerant remaining amount sensor configured to detect a remaining amount of the reserve refrigerant and a memory device configured to store an upper remaining amount limit and a lower remaining amount limit of the reserve refrigerant, wherein the cell transport apparatus outputs a remaining-amount-related abnormality alarm when the remaining amount of the reserve refrigerant is equal to or more than the upper remaining amount limit or equal to or less than the lower remaining amount limit.

### Claim 61 (depends on 60)

The cell transport apparatus according to claim 60, further comprising an accumulated time measurement device configured to measure accumulated transportation time of the transport container, wherein the accumulated time measurement device measures the accumulated transportation time from a collection date and time of the somatic cells or a release date and time of the stem cell freezing vial from the production device.

### Claim 62 (depends on 61)

The cell transport apparatus according to claim 61, wherein the accumulated time measurement device stores in memory a time period during which the quality of somatic cells or stem cells can be maintained and outputs a time-related abnormality alarm when the accumulated transportation time exceeds the time period during which the quality can be maintained.

### Claim 63 (depends on 62)

The cell transport apparatus according to claim 62, further comprising a vibration monitoring device provided with a vibration sensor configured to detect vibration of the transport container, wherein the cell transport apparatus outputs an vibration-related abnormality alarm when a vibration value from the vibration sensor is out of a normal range or within an abnormal range.

### Claim 64 (depends on 63)

The cell transport apparatus according to claim 63, further comprising a wireless communication device that transmits at least one of the temperature data together with the temperature-related abnormality alarm, the remaining amount of the reserve refrigerant together with the remaining-amount-related abnormality alarm, the accumulated transportation time together with the time-related abnormality alarm, and the vibration value together with the vibration-related abnormality alarm to a mobile terminal in a remote location by wireless communication.

### Claim 65 (depends on 56)

The cell transport apparatus according to claim 56, 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 a transport process;
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 66 (depends on 56)

The cell transport apparatus according to claim 56, wherein the transport means is at least one of automobile, railway, aircraft, ship, and robot.

### Claim 67 (depends on 56)

The cell transport apparatus according to claim 56, wherein the somatic cells are blood cells or fibroblasts.

### Claim 68 (depends on 56)

The cell transport apparatus according to claim 56, wherein the stem cells are iPS cells.

### Claim at position 15

69-82. (canceled)