ES2760468T3 - Sistema de control del proceso de regulación y control de una planta de estructura modular para la producción de productos biofarmacéuticos y biológicos macromoleculares - Google Patents
Sistema de control del proceso de regulación y control de una planta de estructura modular para la producción de productos biofarmacéuticos y biológicos macromoleculares Download PDFInfo
- Publication number
- ES2760468T3 ES2760468T3 ES16722163T ES16722163T ES2760468T3 ES 2760468 T3 ES2760468 T3 ES 2760468T3 ES 16722163 T ES16722163 T ES 16722163T ES 16722163 T ES16722163 T ES 16722163T ES 2760468 T3 ES2760468 T3 ES 2760468T3
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Links
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 75
- 238000000034 method Methods 0.000 title claims abstract description 50
- 230000008569 process Effects 0.000 title claims abstract description 26
- 229960000074 biopharmaceutical Drugs 0.000 title claims abstract description 15
- 230000033228 biological regulation Effects 0.000 title claims description 55
- 239000000872 buffer Substances 0.000 claims abstract description 107
- 239000007853 buffer solution Substances 0.000 claims abstract description 50
- 238000012544 monitoring process Methods 0.000 claims abstract description 21
- 230000009471 action Effects 0.000 claims abstract description 20
- 230000001105 regulatory effect Effects 0.000 claims abstract description 20
- 238000011161 development Methods 0.000 claims abstract description 16
- 239000002699 waste material Substances 0.000 claims abstract description 6
- 238000004886 process control Methods 0.000 claims description 10
- 238000005259 measurement Methods 0.000 claims description 9
- 238000011144 upstream manufacturing Methods 0.000 claims description 9
- 230000003750 conditioning effect Effects 0.000 claims description 7
- 239000007788 liquid Substances 0.000 claims description 4
- 238000004590 computer program Methods 0.000 claims description 2
- 239000000243 solution Substances 0.000 abstract description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
- 238000004587 chromatography analysis Methods 0.000 description 27
- 241000700605 Viruses Species 0.000 description 22
- 208000004043 venous thromboembolism Diseases 0.000 description 19
- 230000009849 deactivation Effects 0.000 description 18
- 238000010924 continuous production Methods 0.000 description 12
- 230000032258 transport Effects 0.000 description 11
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- 102000004169 proteins and genes Human genes 0.000 description 3
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- 229920001296 polysiloxane Polymers 0.000 description 2
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- 244000052616 bacterial pathogen Species 0.000 description 1
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- 102000039446 nucleic acids Human genes 0.000 description 1
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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
- 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
- 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
- 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
- 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
-
- 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.
-
- 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
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Sustainable Development (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Analytical Chemistry (AREA)
- Clinical Laboratory Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- Physics & Mathematics (AREA)
- Computer Hardware Design (AREA)
- General Physics & Mathematics (AREA)
- Automation & Control Theory (AREA)
- Artificial Intelligence (AREA)
- Software Systems (AREA)
- Mathematical Physics (AREA)
- Fuzzy Systems (AREA)
- Computer Vision & Pattern Recognition (AREA)
- Evolutionary Computation (AREA)
- Medical Informatics (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Feedback Control In General (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Testing And Monitoring For Control Systems (AREA)
- Flow Control (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| 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 |
| 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 (1)
| Publication Number | Publication Date |
|---|---|
| ES2760468T3 true ES2760468T3 (es) | 2020-05-14 |
Family
ID=53177195
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES16722163T Active ES2760468T3 (es) | 2015-05-13 | 2016-05-10 | Sistema de control del proceso de regulación y control de una planta de estructura modular para la producción de productos biofarmacéuticos y biológicos macromoleculares |
Country Status (21)
Families Citing this family (7)
| 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 |
| AU2019335063A1 (en) * | 2018-09-05 | 2021-01-07 | Commonwealth Scientific And Industrial Research Organisation | "a monitor for a multi-parameter manufacturing process" |
| EP3699697A1 (en) | 2019-02-25 | 2020-08-26 | Bayer Aktiengesellschaft | Automated simultaneous process control |
| JP7604486B2 (ja) * | 2020-05-29 | 2024-12-23 | 株式会社ダイセル | 異常変調原因特定装置、異常変調原因特定方法及び異常変調原因特定プログラム |
| 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 |
| EP4711439A1 (en) | 2024-09-16 | 2026-03-18 | Sartorius Stedim Biotech GmbH | Flow system with recirculation loop |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU5546594A (en) * | 1992-11-06 | 1994-06-08 | 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 |
| CN102794109B (zh) | 2004-09-30 | 2015-10-07 | 拜耳医药保健有限公司 | 用于集成连续生产生物分子的装置和方法 |
| JP2008539738A (ja) * | 2005-05-09 | 2008-11-20 | サクソニア バイオテック ゲーエムベーハー | 細胞培養モジュール用供給システム |
| US9103814B2 (en) * | 2006-03-17 | 2015-08-11 | Waters Technologies Corporation | Solvent delivery system for liquid chromatography that maintains fluid integrity and pre-forms gradients |
| JP4831480B2 (ja) * | 2006-06-21 | 2011-12-07 | 三浦工業株式会社 | 膜濾過システム |
| US9891157B2 (en) * | 2010-12-03 | 2018-02-13 | Cellply S.R.L. | Microanalysis of cellular function |
| CN103562145B (zh) * | 2010-12-06 | 2016-09-21 | 颇尔公司 | 生物制品的连续加工方法 |
| 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 |
| US10203308B2 (en) * | 2013-01-18 | 2019-02-12 | Shimadzu Corporation | Sample concentration device |
| AU2014226126B2 (en) | 2013-03-08 | 2019-02-14 | Genzyme Corporation | Continuous purification of therapeutic proteins |
| 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 WO PCT/EP2016/060369 patent/WO2016180798A1/de not_active Ceased
- 2016-05-10 JP JP2017559064A patent/JP6833721B2/ja not_active Expired - Fee Related
- 2016-05-10 CN CN201680040972.0A patent/CN107849506B/zh not_active Expired - Fee Related
- 2016-05-10 AU AU2016259746A patent/AU2016259746B2/en not_active Ceased
- 2016-05-10 CA CA2985678A patent/CA2985678A1/en active Pending
- 2016-05-10 BR BR112017024373-3A patent/BR112017024373B1/pt not_active IP Right Cessation
- 2016-05-10 MX MX2017014527A patent/MX380681B/es unknown
- 2016-05-10 RU RU2017143437A patent/RU2724495C2/ru active
- 2016-05-10 KR KR1020177035436A patent/KR20180005225A/ko not_active Ceased
- 2016-05-10 PL PL16722163T patent/PL3294856T3/pl unknown
- 2016-05-10 PT PT167221639T patent/PT3294856T/pt unknown
- 2016-05-10 SG SG11201709329YA patent/SG11201709329YA/en unknown
- 2016-05-10 EP EP16722163.9A patent/EP3294856B1/de not_active Revoked
- 2016-05-10 DK DK16722163T patent/DK3294856T3/da active
- 2016-05-10 ES ES16722163T patent/ES2760468T3/es active Active
- 2016-05-10 US US15/573,148 patent/US20180127461A1/en not_active Abandoned
- 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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