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1. (WO2019044559) PRODUCTION DEVICE, SYSTEM, AND METHOD
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Pub. No.: WO/2019/044559 International Application No.: PCT/JP2018/030656
Publication Date: 07.03.2019 International Filing Date: 20.08.2018
IPC:
A61K 35/12 (2015.01) ,A61L 27/38 (2006.01) ,C12M 1/00 (2006.01) ,C12M 3/00 (2006.01) ,G06F 19/00 (2018.01) ,G06Q 50/22 (2018.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
35
Medicinal preparations containing material or reaction products thereof with undetermined constitution
12
Materials from mammals or birds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
L
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
27
Materials for prostheses or for coating prostheses
36
containing ingredients of undetermined constitution or reaction products thereof
38
Animal cells
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
M
APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY
1
Apparatus for enzymology or microbiology
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
M
APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY
3
Tissue, human, animal or plant cell, or virus culture apparatus
G PHYSICS
06
COMPUTING; CALCULATING; COUNTING
F
ELECTRIC DIGITAL DATA PROCESSING
19
Digital computing or data processing equipment or methods, specially adapted for specific applications
G PHYSICS
06
COMPUTING; CALCULATING; COUNTING
Q
DATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
50
Systems or methods specially adapted for a specific business sector, e.g. utilities or tourism
10
Services
22
Health care, e.g. hospitals; Social work
Applicants:
ファーマバイオ株式会社 PHARMABIO CORPORATION [JP/JP]; 愛知県名古屋市西区上名古屋四丁目14番17号 4-14-17 Kaminagoya, Nishi-ku, Nagoya City, Aichi 4510025, JP
Inventors:
宮内 英征 MIYAUCHI Hidemasa; JP
草野 仁 KUSANO Hitoshi; JP
Agent:
小野 誠 ONO Makoto; JP
金山 賢教 KANAYAMA Masakata; JP
今藤 敏和 KONDO Toshikazu; JP
岩瀬 吉和 IWASE Yoshikazu; JP
城山 康文 SHIROYAMA Yasufumi; JP
Priority Data:
2017-16528330.08.2017JP
Title (EN) PRODUCTION DEVICE, SYSTEM, AND METHOD
(FR) DISPOSITIF, SYSTÈME ET PROCÉDÉ DE PRODUCTION
(JA) 製造装置、システム及び方法
Abstract:
(EN) [Problem] To facilitate the production of "regenerative medicine products" using the Quality by Design (QbD) approach. [Solution] In one embodiment of the present invention, a production device which produces a medical product and analyzes a starting material and a central management device which determines the processing conditions in said production device are provided separately. In addition, by transmitting and receiving data pertaining to the starting material, and the like, between the production device and central management device data, the medical product is produced while the production conditions therefor are continuously optimized. Thus, it is easy to produce a medical product while reducing or eliminating the effects from changes to cells and tissue over time and from oscillation during transport and the effects from changes to the surrounding environment such as changes in temperature, and to produce the desired medical product even when there are individual differences in the starting material.
(FR) Le problème décrit par la présente invention est de faciliter la production de "produits médicaux régénératifs" à l'aide de l'approche de Qualité par Conception (QbD). Selon un mode de réalisation de la présente invention, un dispositif de production qui produit un produit médical et analyse un matériau de départ et un dispositif de gestion central qui détermine les conditions de traitement dans ledit dispositif de production sont fournis séparément. De plus, grâce à la transmission et à la réception de données se rapportant au matériau de départ, et analogues, entre le dispositif de production et les données de dispositif de gestion central, le produit médical est produit tandis que les conditions de production de celui-ci sont optimisées en continu. Ainsi, il est facile de produire un produit médical tout en réduisant ou en éliminant les effets issus de changements sur des cellules et du tissu au fil du temps et de l'oscillation pendant le transport et les effets issus de changements sur l'environnement voisin tels que des changements de température, et de produire le produit médical souhaité même lorsqu'il existe des différences individuelles dans le matériau de départ.
(JA) 【課題】クオリティ・バイ・デザイン(Quality-by-Design:QbD)の手法を用いた「再生医療等製品」の製造を容易にする。 【解決手段】本発明の一態様においては、医療用製品の製造及び原材料の分析等を行う製造装置と、当該製造装置における加工条件を決定する中央管理装置とを別個に設ける。そして、当該製造装置と当該中央管理装置データの間において当該原材料に関するデータ等を送受信することで、連続的に製造条件を最適化しながら当該医療用製品を製造する。これにより、細胞又は組織の経時変化、並びに、輸送の際の振動の影響及び温度変化等の周囲環境の変化の影響を受けずに、又は、低減して医療用製品を製造すること、及び、原材料に個体差が存在する場合であっても、所望の医療用製品を製造することが容易になる。
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Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: Japanese (JA)
Filing Language: Japanese (JA)