CA2586803C - Purification d'immunoglobulines - Google Patents

Purification d'immunoglobulines Download PDF

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Publication number
CA2586803C
CA2586803C CA2586803A CA2586803A CA2586803C CA 2586803 C CA2586803 C CA 2586803C CA 2586803 A CA2586803 A CA 2586803A CA 2586803 A CA2586803 A CA 2586803A CA 2586803 C CA2586803 C CA 2586803C
Authority
CA
Canada
Prior art keywords
separation matrix
antibodies
protein
matrix according
chromatography
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
CA2586803A
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English (en)
Other versions
CA2586803A1 (fr
Inventor
Hans Berg
Hans J. Johansson
Gunnar Malmquist
Per-Mikael Aberg
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cytiva Bioprocess R&D AB
Original Assignee
GE Healthcare Bio Sciences Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36588164&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2586803(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from SE0403057A external-priority patent/SE0403057D0/sv
Application filed by GE Healthcare Bio Sciences Corp filed Critical GE Healthcare Bio Sciences Corp
Publication of CA2586803A1 publication Critical patent/CA2586803A1/fr
Application granted granted Critical
Publication of CA2586803C publication Critical patent/CA2586803C/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • 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
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/28Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties
    • B01J20/28002Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties characterised by their physical properties
    • B01J20/28004Sorbent size or size distribution, e.g. particle size
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/281Sorbents specially adapted for preparative, analytical or investigative chromatography
    • B01J20/286Phases chemically bonded to a substrate, e.g. to silica or to polymers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30Processes for preparing, regenerating, or reactivating
    • B01J20/32Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3231Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the coating or impregnating layer
    • B01J20/3242Layers with a functional group, e.g. an affinity material, a ligand, a reactant or a complexing group
    • B01J20/3244Non-macromolecular compounds
    • 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
    • B01D15/32Bonded phase chromatography
    • B01D15/325Reversed phase
    • B01D15/327Reversed phase with hydrophobic interaction
    • 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
    • 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
    • G01N30/38Flow patterns
    • G01N30/46Flow patterns using more than one column
    • G01N30/461Flow patterns using more than one column with serial coupling of separation columns

Landscapes

  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)
  • Fodder In General (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

L'invention concerne une matrice de séparation comprenant des particules poreuses sur lesquelles ont été immobilisées des ligands de protéine de liaison aux anticorps, sachant que la densité de ligand se situe dans la gamme 5-10 mg/ml ; le coefficient de distribution de phase de gel des particules exprimé par Kav pour un dextrane ayant une taille de 110 kDa est supérieur à 0,65, et le diamètre de particule moyen se situe dans la gamme 65 - 84 ?m. De préférence, le matériau en hydrate de carbone est de l'agarose hautement réticulé.
CA2586803A 2004-12-14 2005-12-12 Purification d'immunoglobulines Expired - Lifetime CA2586803C (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
SE0403057A SE0403057D0 (sv) 2004-12-14 2004-12-14 Purification of immunoglobulins
SE0403057-3 2004-12-14
US63831604P 2004-12-22 2004-12-22
US60/638,316 2004-12-22
PCT/SE2005/001900 WO2006065208A1 (fr) 2004-12-14 2005-12-12 Purification d'immunoglobulines

Publications (2)

Publication Number Publication Date
CA2586803A1 CA2586803A1 (fr) 2006-06-22
CA2586803C true CA2586803C (fr) 2012-12-11

Family

ID=36588164

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2586803A Expired - Lifetime CA2586803C (fr) 2004-12-14 2005-12-12 Purification d'immunoglobulines

Country Status (5)

Country Link
EP (1) EP1830947A4 (fr)
JP (1) JP5787461B2 (fr)
AU (1) AU2005317279C1 (fr)
CA (1) CA2586803C (fr)
WO (1) WO2006065208A1 (fr)

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EP3050963B1 (fr) 2005-03-31 2019-09-18 Chugai Seiyaku Kabushiki Kaisha Procédé pour la production de polypeptide au moyen de la régulation d'un ensemble
ES2892925T3 (es) 2006-03-31 2022-02-07 Chugai Pharmaceutical Co Ltd Métodos para controlar la farmacocinética en sangre de anticuerpos
US9670269B2 (en) 2006-03-31 2017-06-06 Chugai Seiyaku Kabushiki Kaisha Methods of modifying antibodies for purification of bispecific antibodies
EP2066419B1 (fr) 2006-09-29 2015-11-11 GE Healthcare Bio-Sciences AB Ligand de chromatographie comprenant un domaine c issu de la protéine a de staphylococcus aureus pour l'isolement d'anticorps
SG149759A1 (en) * 2007-07-10 2009-02-27 Millipore Corp Media for affinity chromatography
CN101874042B9 (zh) 2007-09-26 2019-01-01 中外制药株式会社 利用cdr的氨基酸取代来改变抗体等电点的方法
AU2008304748C1 (en) 2007-09-26 2014-06-12 Chugai Seiyaku Kabushiki Kaisha Modified antibody constant region
US8277649B2 (en) * 2009-12-14 2012-10-02 General Electric Company Membranes and associated methods for purification of antibodies
JP5889181B2 (ja) 2010-03-04 2016-03-22 中外製薬株式会社 抗体定常領域改変体
JP5917417B2 (ja) * 2010-03-05 2016-05-11 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 抗体の選択的強化
US8859294B2 (en) 2010-03-17 2014-10-14 Panasonic Corporation Method for binding a protein consisting of protein A or consisting of at least one domain of the A to E domains of the protein A to the substrate
WO2011114405A1 (fr) * 2010-03-17 2011-09-22 Panasonic Corporation Méthode de liaison au substrat d'une protéine constituée de la protéine a ou constituée d'au moins un domaine des domaines a à e de la protéine a
JP5998050B2 (ja) 2010-03-31 2016-09-28 Jsr株式会社 アフィニティークロマトグラフィー用充填剤
WO2011125673A1 (fr) 2010-03-31 2011-10-13 Jsr株式会社 Charge pour chromatographie d'affinité
PH12016502073B1 (en) 2010-11-17 2024-04-05 Chugai Pharmaceutical Co Ltd Multi-specific antigen-binding molecule having alternative function to function of blood coagulation factor viii
RS67768B1 (sr) 2010-11-30 2026-03-31 Chugai Pharmaceutical Co Ltd Terapijski agens koji indukuje citotoksičnost
WO2015030094A1 (fr) 2013-08-30 2015-03-05 株式会社カネカ PEPTIDE SE LIANT À LA RÉGION Fab
EP3042192A4 (fr) * 2013-09-04 2017-04-26 Sten Ohlson Chromatographie à faible affinité
JP6230853B2 (ja) * 2013-09-06 2017-11-15 株式会社日立製作所 タンパク質の精製方法及び精製装置
JP6534615B2 (ja) 2013-09-27 2019-06-26 中外製薬株式会社 ポリペプチド異種多量体の製造方法
US20170043320A1 (en) 2013-11-27 2017-02-16 Jsr Corporation Solid-phase carrier, production method for solid-phase carrier, carrier for affinity refining, production method for filler for affinity chromatography, filler for affinity chromatography, chromatography column, and refining method
US10610807B2 (en) 2014-01-17 2020-04-07 Repligen Corporation Sterilizing chromatography columns
CN106795215A (zh) 2014-06-24 2017-05-31 通用电气医疗集团生物工艺研发股份公司 层析方法
EP3162809B1 (fr) 2014-06-27 2021-08-04 JSR Corporation Support pour chromatographie d'affinité
WO2016031902A1 (fr) * 2014-08-28 2016-03-03 株式会社カネカ MATRICE DE SÉPARATION PAR AFFINITÉ POUR UN PEPTIDE CONTENANT UNE RÉGION Fab
WO2016121701A1 (fr) 2015-01-26 2016-08-04 株式会社カネカ Matrice pour séparation par affinité destinée à la purification de protéines contenant la région variable de la chaîne kappa des immunoglobulines
JP6663360B2 (ja) 2015-01-26 2020-03-11 株式会社カネカ 変異型免疫グロブリンκ鎖可変領域結合性ペプチド
JP7082484B2 (ja) 2015-04-01 2022-06-08 中外製薬株式会社 ポリペプチド異種多量体の製造方法
CN108368166B (zh) * 2015-12-28 2023-03-28 中外制药株式会社 提高含fc区多肽纯化效率的方法
MA44780A (fr) 2016-04-28 2019-03-06 Chugai Pharmaceutical Co Ltd Préparation contenant un anticorps
WO2017195638A1 (fr) 2016-05-09 2017-11-16 株式会社カネカ Procédé de purification d'un anticorps ou d'un fragment d'anticorps comportant une région variable de chaîne κ
WO2017195641A1 (fr) * 2016-05-11 2017-11-16 株式会社カネカ Matrice de séparation par affinité, et procédé de fabrication de celle-ci
GB201703116D0 (en) * 2017-02-27 2017-04-12 Ge Healthcare Bioprocess R&D Ab A seperation matrix and a method of seperating antibodies
CN110461358A (zh) 2017-03-31 2019-11-15 公立大学法人奈良县立医科大学 可用于预防和/或治疗凝血因子ⅸ异常、包含代替凝血因子ⅷ的功能的多特异性抗原结合分子的药物组合物
AU2018361430B2 (en) 2017-11-01 2025-08-14 Chugai Seiyaku Kabushiki Kaisha Antibody variant and isoform with lowered biological activity

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Also Published As

Publication number Publication date
WO2006065208A1 (fr) 2006-06-22
AU2005317279A1 (en) 2006-06-22
EP1830947A4 (fr) 2012-04-18
AU2005317279B2 (en) 2011-02-24
JP5787461B2 (ja) 2015-09-30
JP2008523140A (ja) 2008-07-03
CA2586803A1 (fr) 2006-06-22
AU2005317279C1 (en) 2014-07-17
EP1830947A1 (fr) 2007-09-12

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