DK4014034T3 - Fremgangsmåde til oprensning af monoklonale antistoffer - Google Patents

Fremgangsmåde til oprensning af monoklonale antistoffer

Info

Publication number
DK4014034T3
DK4014034T3 DK20754810.8T DK20754810T DK4014034T3 DK 4014034 T3 DK4014034 T3 DK 4014034T3 DK 20754810 T DK20754810 T DK 20754810T DK 4014034 T3 DK4014034 T3 DK 4014034T3
Authority
DK
Denmark
Prior art keywords
purification
monoclonal antibodies
monoclonal
antibodies
Prior art date
Application number
DK20754810.8T
Other languages
English (en)
Inventor
Tibor Nagy
Jonathan Haigh
Charles Heise
Andrew Topping
James Pullen
Original Assignee
Fujifilm Diosynth Biotechnologies Uk Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fujifilm Diosynth Biotechnologies Uk Ltd filed Critical Fujifilm Diosynth Biotechnologies Uk Ltd
Application granted granted Critical
Publication of DK4014034T3 publication Critical patent/DK4014034T3/da

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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/14Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the introduction of the feed to the apparatus
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1864Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
    • B01D15/1871Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in series
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/362Cation-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/363Anion-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804Affinity chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804Affinity chromatography
    • B01D15/3809Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14Ultrafiltration; Microfiltration
    • B01D61/145Ultrafiltration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/34Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/26Conditioning of the fluid carrier; Flow patterns
    • G01N30/28Control of physical parameters of the fluid carrier
    • G01N30/34Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2311/00Details relating to membrane separation process operations and control
    • B01D2311/26Further operations combined with membrane separation processes
    • B01D2311/2623Ion-Exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2311/00Details relating to membrane separation process operations and control
    • B01D2311/26Further operations combined with membrane separation processes
    • B01D2311/2626Absorption or adsorption
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2315/00Details relating to the membrane module operation
    • B01D2315/16Diafiltration

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
DK20754810.8T 2019-08-15 2020-08-06 Fremgangsmåde til oprensning af monoklonale antistoffer DK4014034T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1911685.4A GB201911685D0 (en) 2019-08-15 2019-08-15 Process for purifying monoclonal antibodies
PCT/GB2020/051882 WO2021028658A1 (en) 2019-08-15 2020-08-06 Process for purifying monoclonal antibodies

Publications (1)

Publication Number Publication Date
DK4014034T3 true DK4014034T3 (da) 2026-03-23

Family

ID=68099517

Family Applications (1)

Application Number Title Priority Date Filing Date
DK20754810.8T DK4014034T3 (da) 2019-08-15 2020-08-06 Fremgangsmåde til oprensning af monoklonale antistoffer

Country Status (8)

Country Link
US (1) US12559519B2 (da)
EP (1) EP4014034B1 (da)
JP (1) JP7660557B2 (da)
CN (1) CN114555794A (da)
DK (1) DK4014034T3 (da)
FI (1) FI4014034T3 (da)
GB (1) GB201911685D0 (da)
WO (1) WO2021028658A1 (da)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201911686D0 (en) * 2019-08-15 2019-10-02 Fujifilm Diosynth Biotechnologies Uk Ltd Process for purifying target substances
GB201911687D0 (en) * 2019-08-15 2019-10-02 Fujifilm Diosynth Biotechnologies Uk Ltd Apparatus for purifying a liquid comprising a target substance
WO2022251261A1 (en) * 2021-05-25 2022-12-01 Boehringer Ingelheim International Gmbh A method and system for integrated and continuous viral filtration, concentration and buffer exchange
CN117377875A (zh) * 2021-05-25 2024-01-09 勃林格殷格翰国际公司 用于连续生物生产的使用紫外测量的滴定法
WO2023152145A1 (en) * 2022-02-11 2023-08-17 Merck Patent Gmbh Sensor measurement compensation in bioprocessing systems
CN118209721A (zh) * 2023-02-28 2024-06-18 山东博科快速检测技术有限公司 一种甲型流感病毒胶体金诊断检测试纸及其制备方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4802981A (en) * 1987-11-04 1989-02-07 Oros Systems Limited Automatic chromatography apparatus
US6365395B1 (en) 2000-11-03 2002-04-02 Millipore Corporation Process for removing protein aggregates and virus from a protein solution
WO2009058737A1 (en) * 2007-10-29 2009-05-07 Pain Therapeutics, Inc. Disposable column system for purification of radiolabeled polypeptides
BRPI0823046B1 (pt) * 2008-08-14 2021-12-14 Genentech, Inc Método para purificar um anticorpo monoclonal de uma composição compreendendo o anticorpo monoclonal e pelo menos uma proteína de ovário de hamster chinês (chop)
US9527010B2 (en) * 2009-09-25 2016-12-27 Ge Healthcare Bio-Sciences Corp. Separation system and method
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
EP2578286A1 (en) 2011-10-04 2013-04-10 Merck Patent GmbH Method and apparatus for chromatographic purification
GB201600290D0 (en) 2016-01-07 2016-02-24 Fujifilm Diosynth Biotechnologies Uk Ltd Process
GB201600287D0 (en) 2016-01-07 2016-02-24 Fujifilm Diosynth Biotechnologies Uk Ltd Process
GB201911686D0 (en) * 2019-08-15 2019-10-02 Fujifilm Diosynth Biotechnologies Uk Ltd Process for purifying target substances
GB201911687D0 (en) * 2019-08-15 2019-10-02 Fujifilm Diosynth Biotechnologies Uk Ltd Apparatus for purifying a liquid comprising a target substance

Also Published As

Publication number Publication date
CN114555794A (zh) 2022-05-27
FI4014034T3 (fi) 2026-03-13
GB201911685D0 (en) 2019-10-02
US20220275024A1 (en) 2022-09-01
EP4014034A1 (en) 2022-06-22
WO2021028658A1 (en) 2021-02-18
EP4014034B1 (en) 2026-01-28
JP2022544526A (ja) 2022-10-19
JP7660557B2 (ja) 2025-04-11
US12559519B2 (en) 2026-02-24

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