JP6833721B2 - バイオ医薬およびバイオ高分子製品の製造用モジュール型プラントの制御および規制のためのプロセス制御システム - Google Patents
バイオ医薬およびバイオ高分子製品の製造用モジュール型プラントの制御および規制のためのプロセス制御システム Download PDFInfo
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- JP6833721B2 JP6833721B2 JP2017559064A JP2017559064A JP6833721B2 JP 6833721 B2 JP6833721 B2 JP 6833721B2 JP 2017559064 A JP2017559064 A JP 2017559064A JP 2017559064 A JP2017559064 A JP 2017559064A JP 6833721 B2 JP6833721 B2 JP 6833721B2
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Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- 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
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/44—Multiple separable units; Modules
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- 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
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/58—Reaction vessels connected in series or in parallel
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- 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
- C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
- C12M29/10—Perfusion
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- 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
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/44—Means for regulation, monitoring, measurement or control, e.g. flow regulation of volume or liquid level
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- 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
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/48—Automatic or computerized control
-
- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B11/00—Automatic controllers
- G05B11/01—Automatic controllers electric
- G05B11/36—Automatic controllers electric with provision for obtaining particular characteristics, e.g. proportional, integral, differential
- G05B11/42—Automatic controllers electric with provision for obtaining particular characteristics, e.g. proportional, integral, differential for obtaining a characteristic which is both proportional and time-dependent, e.g. P. I., P. I. D.
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B13/00—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion
- G05B13/02—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric
- G05B13/0265—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric the criterion being a learning criterion
- G05B13/0275—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric the criterion being a learning criterion using fuzzy logic only
-
- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05D—SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES
- G05D7/00—Control of flow
- G05D7/06—Control of flow characterised by the use of electric means
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- General Health & Medical Sciences (AREA)
- General Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Sustainable Development (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Analytical Chemistry (AREA)
- Clinical Laboratory Science (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Computer Hardware Design (AREA)
- General Physics & Mathematics (AREA)
- Automation & Control Theory (AREA)
- Artificial Intelligence (AREA)
- Software Systems (AREA)
- Medical Informatics (AREA)
- Mathematical Physics (AREA)
- Computer Vision & Pattern Recognition (AREA)
- Evolutionary Computation (AREA)
- Fuzzy Systems (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Feedback Control In General (AREA)
- Testing And Monitoring For Control Systems (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Flow Control (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15167538.6A EP3093335A1 (de) | 2015-05-13 | 2015-05-13 | Prozessleitsystem zur regelung und steuerung einer modular aufgebauten anlage zur produktion von biopharmazeutischen und biologischen makromolekularen produkten |
| EP15167538.6 | 2015-05-13 | ||
| PCT/EP2016/060369 WO2016180798A1 (de) | 2015-05-13 | 2016-05-10 | Prozessleitsystem zur regelung und steuerung einer modular aufgebauten anlage zur produktion von biopharmazeutischen und biologischen makromolekularen produkten |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018524668A JP2018524668A (ja) | 2018-08-30 |
| JP2018524668A5 JP2018524668A5 (enExample) | 2019-01-17 |
| JP6833721B2 true JP6833721B2 (ja) | 2021-02-24 |
Family
ID=53177195
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017559064A Expired - Fee Related JP6833721B2 (ja) | 2015-05-13 | 2016-05-10 | バイオ医薬およびバイオ高分子製品の製造用モジュール型プラントの制御および規制のためのプロセス制御システム |
Country Status (21)
| Country | Link |
|---|---|
| US (2) | US20180127461A1 (enExample) |
| EP (2) | EP3093335A1 (enExample) |
| JP (1) | JP6833721B2 (enExample) |
| KR (1) | KR20180005225A (enExample) |
| CN (1) | CN107849506B (enExample) |
| AR (1) | AR104554A1 (enExample) |
| AU (1) | AU2016259746B2 (enExample) |
| BR (1) | BR112017024373B1 (enExample) |
| CA (1) | CA2985678A1 (enExample) |
| DK (1) | DK3294856T3 (enExample) |
| ES (1) | ES2760468T3 (enExample) |
| IL (1) | IL255556B (enExample) |
| MX (1) | MX380681B (enExample) |
| PL (1) | PL3294856T3 (enExample) |
| PT (1) | PT3294856T (enExample) |
| RU (1) | RU2724495C2 (enExample) |
| SA (1) | SA517390330B1 (enExample) |
| SG (1) | SG11201709329YA (enExample) |
| TW (1) | TWI689303B (enExample) |
| WO (1) | WO2016180798A1 (enExample) |
| ZA (1) | ZA201708418B (enExample) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3431173A1 (en) | 2017-07-19 | 2019-01-23 | Bayer Pharma Aktiengesellschaft | Continuous manufacture of guidance molecule drug conjugates |
| CN112639850A (zh) * | 2018-09-05 | 2021-04-09 | 联邦科学和工业研究组织 | 用于多参数制造过程的监视器 |
| EP3699697A1 (en) | 2019-02-25 | 2020-08-26 | Bayer Aktiengesellschaft | Automated simultaneous process control |
| CN115698881A (zh) * | 2020-05-29 | 2023-02-03 | 株式会社大赛璐 | 异常调制原因确定装置、异常调制原因确定方法以及异常调制原因确定程序 |
| DE102022208467A1 (de) | 2022-06-24 | 2024-01-04 | Bilfinger Life Science Gmbh | Modulare Vorrichtung und Verfahren zur kontinuierlichen Herstellung von biotechnologischen Produkten |
| WO2023247798A1 (de) | 2022-06-24 | 2023-12-28 | Bilfinger Life Science Gmbh | Modulare vorrichtung und verfahren zur kontinuierlichen herstellung von biotechnologischen produkten |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1994011838A1 (en) * | 1992-11-06 | 1994-05-26 | Abbott Laboratories | Process control system for biological fluid testing |
| JP2004198123A (ja) * | 2002-12-16 | 2004-07-15 | Shimadzu Corp | 分取液体クロマトグラフ質量分析装置 |
| JP3823092B2 (ja) * | 2003-03-11 | 2006-09-20 | 株式会社日立ハイテクノロジーズ | 分離分析装置 |
| JP2006018711A (ja) * | 2004-07-05 | 2006-01-19 | Earekkusu:Kk | 液体除染剤供給システム |
| KR101238798B1 (ko) | 2004-09-30 | 2013-03-04 | 바이엘 헬스케어, 엘엘씨 | 생물학적 분자의 통합된 연속 제조를 위한 장치 및 방법 |
| EP1882030B1 (en) * | 2005-05-09 | 2014-08-06 | ALPHA PLAN GmbH | Apparatus for providing media to cell culture modules |
| JP2009530615A (ja) * | 2006-03-17 | 2009-08-27 | ウオーターズ・インベストメンツ・リミテツド | 流体完全性を維持し、グラジエントを予備成形する液体クロマトグラフィ用溶媒送液システム |
| JP4831480B2 (ja) * | 2006-06-21 | 2011-12-07 | 三浦工業株式会社 | 膜濾過システム |
| CN103392124B (zh) * | 2010-12-03 | 2016-04-20 | 塞普莱有限公司 | 细胞功能的微分析 |
| JP2013544524A (ja) * | 2010-12-06 | 2013-12-19 | ターポン バイオシステムズ，インコーポレイテッド | 生物学的生成物の連続プロセス法 |
| CN103243026B (zh) * | 2012-02-14 | 2014-09-03 | 常州医凌生命科技有限公司 | 多功能全自动细胞及溶液处理仪 |
| EP2682168A1 (en) * | 2012-07-02 | 2014-01-08 | Millipore Corporation | Purification of biological molecules |
| JP5930075B2 (ja) * | 2013-01-18 | 2016-06-08 | 株式会社島津製作所 | サンプル濃縮装置 |
| HK1219964A1 (zh) | 2013-03-08 | 2017-04-21 | Genzyme Corporation | 治疗性蛋白药物物质的整合连续制造 |
| DE102013212540A1 (de) * | 2013-06-27 | 2014-12-31 | Agilent Technologies Inc. | Konditionieren eines nachfolgenden Probenpakets in einer Probentrennstufe während Prozessierens eines vorangehenden Probenpakets in einer Probenweiterverarbeitungsstufe |
| EP3186355A4 (en) * | 2014-07-31 | 2018-03-21 | Govind Rao | Microscale bioprocessing system and method for protein manufacturing from human blood |
-
2015
- 2015-05-13 EP EP15167538.6A patent/EP3093335A1/de not_active Withdrawn
-
2016
- 2016-05-06 AR ARP160101310A patent/AR104554A1/es not_active Application Discontinuation
- 2016-05-10 KR KR1020177035436A patent/KR20180005225A/ko not_active Ceased
- 2016-05-10 BR BR112017024373-3A patent/BR112017024373B1/pt not_active IP Right Cessation
- 2016-05-10 DK DK16722163T patent/DK3294856T3/da active
- 2016-05-10 JP JP2017559064A patent/JP6833721B2/ja not_active Expired - Fee Related
- 2016-05-10 WO PCT/EP2016/060369 patent/WO2016180798A1/de not_active Ceased
- 2016-05-10 MX MX2017014527A patent/MX380681B/es unknown
- 2016-05-10 CN CN201680040972.0A patent/CN107849506B/zh not_active Expired - Fee Related
- 2016-05-10 PL PL16722163T patent/PL3294856T3/pl unknown
- 2016-05-10 AU AU2016259746A patent/AU2016259746B2/en not_active Ceased
- 2016-05-10 PT PT167221639T patent/PT3294856T/pt unknown
- 2016-05-10 ES ES16722163T patent/ES2760468T3/es active Active
- 2016-05-10 EP EP16722163.9A patent/EP3294856B1/de not_active Revoked
- 2016-05-10 US US15/573,148 patent/US20180127461A1/en not_active Abandoned
- 2016-05-10 CA CA2985678A patent/CA2985678A1/en active Pending
- 2016-05-10 SG SG11201709329YA patent/SG11201709329YA/en unknown
- 2016-05-10 RU RU2017143437A patent/RU2724495C2/ru active
- 2016-05-11 TW TW105114507A patent/TWI689303B/zh not_active IP Right Cessation
-
2017
- 2017-11-09 IL IL255556A patent/IL255556B/en unknown
- 2017-11-13 SA SA517390330A patent/SA517390330B1/ar unknown
- 2017-12-12 ZA ZA2017/08418A patent/ZA201708418B/en unknown
-
2021
- 2021-03-04 US US17/192,384 patent/US20210221842A1/en not_active Abandoned
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