# US 12,191,006 B2 · Production device, system, and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,191,006 B2 - Document ID: US12191006B2 - Status: Granted - Kind: B2 - Application number: 18/154,328 - Filed: 2023-01-13 - Published: 2023-05-25 - Granted: 2025-01-07 - Earliest claimed: 2017-08-30 - Assignees: Pharmabio Corporation - Applicants: PharmaBio Corporation - Inventors: Hidemasa Miyauchi; Hitoshi Kusano - Web page: https://patentgrep.com/patent/US12191006B2 ## CPC - G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis - A61K 35/12: Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00) - A61K 35/14: Blood; Artificial blood (perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42) - A61K 35/36: Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells (islets of Langerhans A61K35/39) - A61K 35/38: Stomach; Intestine; Goblet cells; Oral mucosa; Saliva - A61L 27/38: {containing added animal cells (organs or tissue containing native cells A61L27/36)} - C12M 1/00: Apparatus for enzymology or microbiology - C12M 3/00: Tissue, human, animal or plant cell, or virus culture apparatus - C12M 21/08: {for producing artificial tissue or for ex-vivo cultivation of tissue (prostheses A61F2/00, grafts A61L27/00)} - C12M 41/36: {of biomass, e.g. colony counters or by turbidity measurements (electrooptical investigation of individual particles G01N15/14, flow cytometers G01N15/1404)} - G06Q 50/22: Social work or social welfare, e.g. community support activities or counselling services - G16H 40/20: for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms - G16H 40/67: for remote operation - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - 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} - G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR ## Abstract Production of “regenerative medicine products” is facilitated using a quality by design (QbD) approach. A production device produces a medical product and analyzes a starting material and a central management device determines processing conditions in the production device. By transmitting and receiving data pertaining to the starting material between the production device and central management device data, the medical product is produced while production conditions therefor are continuously optimized. Thus, it is easy to produce a medical product while reducing or eliminating effects from changes in cells and tissues over time, from oscillation during transport, and from changes in surrounding environment such as changes in temperature, and to produce the desired medical product even when there are individual differences in the starting material. ## Claims ### Claim 1 A system including a production device comprising: an analyzer that determines a number of living cells or percentage of cells that are living in human or animal cell or tissue that is a starting material of a medical product and generates data on the basis of the analyzation; a communicator that transmits the generated data to a central management device via a network constructed by either a wired connection or a wireless connection and receives initial processing data indicating a processing condition of the starting material optimized by the central management device based on the generated data within a range of a predetermined design space as the processing condition of the starting material; and a processor that processes the starting material according to the initial processing data to produce the medical product, wherein, the central management device comprises: a central storage that records the generated data transmitted by the communicator; and a central processor that optimizes the processing condition of the starting material based on the generated data. ### Claim 2 (depends on 1) The production device according to claim 1, wherein the analyzer generates intermediate analysis data of the intermediate product obtained by processing the starting material, the communicator transmits the intermediate analysis data to the central management device and receives intermediate processing data indicating the processing condition of the intermediate product optimized by the central management device based on the intermediate analysis data within a range of a predetermined design space as the processing condition of the intermediate product, and the processor processes the intermediate product according to the intermediate processing data. ### Claim 3 (depends on 1) The production device according to claim 1, the analyzer measures at least one of the number of the viable cells and the viable cell rate. ### Claim 4 (depends on 1) The production device according to claim 1, wherein the processor cultivates the cell or tissue. ### Claim 5 (depends on 1) The production device according to claim 1, further comprising: a transfer unit that transfers the starting material from one of the analyzer and the processor to the other of the analyzer and the processor. ### Claim 6 (depends on 1) The production device according to claim 1, wherein the medical product is an autologous product. ### Claim 7 (depends on 1) The production device according to claim 1, wherein the analyzer generates final analysis data of the medical product produced from the starting material, and the communicator transmits the final analysis data to the central management device to record the final analysis data by associating the final analysis data with the generated data and the initial processing data in the central management device. ### Claim 8 (depends on 7) The plurality of production devices according to claim 7, wherein the central management device includes: a central storage that records the generated data, the initial processing data, and the final analysis data transmitted from each of the plurality of production devices in association with each other; a central analyzer that when a target production device transmits latest generated data newly generated in the target production device which is any one of the plurality of production devices, generates latest initial processing data optimal for the latest generated data by referring to the generated data, the initial processing data, and the final analysis data recorded in association with each other in the central storage; and a central communicator that transmits the latest generated data to the target production device. ### Claim 9 (depends on 1) The system according to claim 1, wherein the communicator directly transmits the generated data to the central management device. ### Claim 10 (depends on 1) The system according to claim 1, and wherein the analyzer, the communicator, and the processor are local to a collection site of the starting material and the central management device is remote to the collection site of the starting material. ### Claim 11 A system including a production device comprising: an analyzer that determines a number of living cells or percentage of cells that are living in human or animal cell or tissue that is a starting material of a medical product and generates data on the basis of the analyzation and a clinical data of the human or animal; a communicator that transmits the generated data to a central management device via a network constructed by either a wired connection or a wireless connection and receives initial processing data indicating a processing condition of the starting material optimized by the central management device based on the generated data within a range of a predetermined design space as the processing condition of the starting material; and a processor that processes the starting material according to the initial processing data to produce the medical product, wherein, the central management device comprises: a central storage that records the generated data transmitted by the communicator; and a central processor that optimizes the processing condition of the starting material based on the generated data. ### Claim 12 A method for producing a medical product in a system including a production device, the production device is controlled by a central management device, the method comprising: analyzing, by the production device, a number of living cells or percentage of cells that are living in human or animal cell or tissue that is a starting material of a medical product, and generating data on the basis of the analyzation; transmitting, by the production device, the generated data to the central management device via a network constructed by either a wired connection or a wireless connection; generating, by the central management device, initial processing data indicating a processing condition of the starting material optimized based on the generated data within a range of a predetermined design space as a processing condition of the starting material; transmitting, by the central management device, the initial processing data to the production device; and processing, by the production device, the starting material according to the initial processing data to produce the medical product.