AU2016259746B2 - Process control system for regulating and controlling a modular plant for manufacturing biopharmaceutical and biological macromolecular products - Google Patents

Process control system for regulating and controlling a modular plant for manufacturing biopharmaceutical and biological macromolecular products Download PDF

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Publication number
AU2016259746B2
AU2016259746B2 AU2016259746A AU2016259746A AU2016259746B2 AU 2016259746 B2 AU2016259746 B2 AU 2016259746B2 AU 2016259746 A AU2016259746 A AU 2016259746A AU 2016259746 A AU2016259746 A AU 2016259746A AU 2016259746 B2 AU2016259746 B2 AU 2016259746B2
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AU
Australia
Prior art keywords
buffer volume
unit
units
production plant
flow rate
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Ceased
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AU2016259746A
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English (en)
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AU2016259746A8 (en
AU2016259746A1 (en
Inventor
Jens BERNSHAUSEN
Martin Lobedann
Peter Schwan
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Bayer AG
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Bayer AG
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Application filed by Bayer AG filed Critical Bayer AG
Publication of AU2016259746A1 publication Critical patent/AU2016259746A1/en
Publication of AU2016259746A8 publication Critical patent/AU2016259746A8/en
Application granted granted Critical
Publication of AU2016259746B2 publication Critical patent/AU2016259746B2/en
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Classifications

    • 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.
    • 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)
  • 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)
AU2016259746A 2015-05-13 2016-05-10 Process control system for regulating and controlling a modular plant for manufacturing biopharmaceutical and biological macromolecular products Ceased AU2016259746B2 (en)

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
AU2016259746A1 AU2016259746A1 (en) 2017-12-07
AU2016259746A8 AU2016259746A8 (en) 2018-04-05
AU2016259746B2 true AU2016259746B2 (en) 2020-12-24

Family

ID=53177195

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016259746A Ceased AU2016259746B2 (en) 2015-05-13 2016-05-10 Process control system for regulating and controlling a modular plant for manufacturing biopharmaceutical and biological macromolecular products

Country Status (21)

Country Link
US (2) US20180127461A1 (cg-RX-API-DMAC10.html)
EP (2) EP3093335A1 (cg-RX-API-DMAC10.html)
JP (1) JP6833721B2 (cg-RX-API-DMAC10.html)
KR (1) KR20180005225A (cg-RX-API-DMAC10.html)
CN (1) CN107849506B (cg-RX-API-DMAC10.html)
AR (1) AR104554A1 (cg-RX-API-DMAC10.html)
AU (1) AU2016259746B2 (cg-RX-API-DMAC10.html)
BR (1) BR112017024373B1 (cg-RX-API-DMAC10.html)
CA (1) CA2985678A1 (cg-RX-API-DMAC10.html)
DK (1) DK3294856T3 (cg-RX-API-DMAC10.html)
ES (1) ES2760468T3 (cg-RX-API-DMAC10.html)
IL (1) IL255556B (cg-RX-API-DMAC10.html)
MX (1) MX380681B (cg-RX-API-DMAC10.html)
PL (1) PL3294856T3 (cg-RX-API-DMAC10.html)
PT (1) PT3294856T (cg-RX-API-DMAC10.html)
RU (1) RU2724495C2 (cg-RX-API-DMAC10.html)
SA (1) SA517390330B1 (cg-RX-API-DMAC10.html)
SG (1) SG11201709329YA (cg-RX-API-DMAC10.html)
TW (1) TWI689303B (cg-RX-API-DMAC10.html)
WO (1) WO2016180798A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA201708418B (cg-RX-API-DMAC10.html)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012078677A2 (en) * 2010-12-06 2012-06-14 Tarpon Biosystems, Inc. Continuous processing methods for biological products
EP2682168A1 (en) * 2012-07-02 2014-01-08 Millipore Corporation Purification of biological molecules
WO2014137903A2 (en) * 2013-03-08 2014-09-12 Genzyme Corporation Integrated continuous manufacturing of therapeutic protein drug substances
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

Family Cites Families (12)

* Cited by examiner, † Cited by third party
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
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
US10203308B2 (en) * 2013-01-18 2019-02-12 Shimadzu Corporation Sample concentration device
EP3186355A4 (en) * 2014-07-31 2018-03-21 Govind Rao Microscale bioprocessing system and method for protein manufacturing from human blood

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012078677A2 (en) * 2010-12-06 2012-06-14 Tarpon Biosystems, Inc. Continuous processing methods for biological products
EP2682168A1 (en) * 2012-07-02 2014-01-08 Millipore Corporation Purification of biological molecules
WO2014137903A2 (en) * 2013-03-08 2014-09-12 Genzyme Corporation Integrated continuous manufacturing of therapeutic protein drug substances
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

Also Published As

Publication number Publication date
IL255556A (en) 2018-01-31
AR104554A1 (es) 2017-07-26
HK1252939A1 (zh) 2019-06-06
AU2016259746A8 (en) 2018-04-05
DK3294856T3 (da) 2019-12-09
PL3294856T3 (pl) 2020-04-30
ES2760468T3 (es) 2020-05-14
BR112017024373B1 (pt) 2022-08-09
CA2985678A1 (en) 2016-11-17
EP3294856B1 (de) 2019-09-18
RU2017143437A3 (cg-RX-API-DMAC10.html) 2019-08-29
MX2017014527A (es) 2018-03-12
EP3294856A1 (de) 2018-03-21
US20180127461A1 (en) 2018-05-10
TW201717886A (zh) 2017-06-01
CN107849506A (zh) 2018-03-27
TWI689303B (zh) 2020-04-01
US20210221842A1 (en) 2021-07-22
CN107849506B (zh) 2020-11-03
RU2017143437A (ru) 2019-06-13
JP6833721B2 (ja) 2021-02-24
RU2724495C2 (ru) 2020-06-23
AU2016259746A1 (en) 2017-12-07
ZA201708418B (en) 2022-08-31
KR20180005225A (ko) 2018-01-15
MX380681B (es) 2025-03-12
SG11201709329YA (en) 2017-12-28
IL255556B (en) 2022-04-01
BR112017024373A2 (pt) 2018-07-31
JP2018524668A (ja) 2018-08-30
SA517390330B1 (ar) 2021-09-22
EP3093335A1 (de) 2016-11-16
WO2016180798A1 (de) 2016-11-17
PT3294856T (pt) 2019-12-16

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Free format text: IN VOL 31 , NO 48 , PAGE(S) 6951 UNDER THE HEADING PCT APPLICATIONS THAT HAVE ENTERED THE NATIONAL PHASE - NAME INDEX UNDER THE NAME BAYER TECHNOLOGY SERVICES GMBH, APPLICATION NO. 2016259746, UNDER INID (71) CORRECT THE APPLICANT NAME TO BAYER AKTIENGESELLSCHAFT

FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired