AU2016245887B2 - Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species - Google Patents

Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species Download PDF

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AU2016245887B2
AU2016245887B2 AU2016245887A AU2016245887A AU2016245887B2 AU 2016245887 B2 AU2016245887 B2 AU 2016245887B2 AU 2016245887 A AU2016245887 A AU 2016245887A AU 2016245887 A AU2016245887 A AU 2016245887A AU 2016245887 B2 AU2016245887 B2 AU 2016245887B2
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unit
units
polypeptide
antibody
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AU2016245887A1 (en
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Juergen Hermann Nett
Maximiliano Vasquez
K. Dane Wittrup
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Adimab LLC
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Adimab LLC
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • B01D15/16Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166Fluid composition conditioning, e.g. gradient
    • 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
    • B01D15/16Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166Fluid composition conditioning, e.g. gradient
    • B01D15/168Fluid composition conditioning, e.g. gradient pH gradient or chromatofocusing, i.e. separation according to the isoelectric point pI
    • 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
    • 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
    • B01D15/3847Multimodal interactions
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J39/00Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
    • B01J39/26Cation exchangers for chromatographic processes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J41/00Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/20Anion exchangers for chromatographic 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
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype

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  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
AU2016245887A 2015-04-10 2016-04-08 Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species Active AU2016245887B2 (en)

Priority Applications (1)

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AU2021225195A AU2021225195A1 (en) 2015-04-10 2021-09-01 Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species

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US201562146116P 2015-04-10 2015-04-10
US62/146,116 2015-04-10
US201562249180P 2015-10-30 2015-10-30
US62/249,180 2015-10-30
PCT/US2016/026620 WO2016164708A1 (en) 2015-04-10 2016-04-08 Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species

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AU2016245887A1 AU2016245887A1 (en) 2017-11-02
AU2016245887B2 true AU2016245887B2 (en) 2021-09-23

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AU2021225195A Abandoned AU2021225195A1 (en) 2015-04-10 2021-09-01 Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species

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US (2) US10787500B2 (https=)
EP (1) EP3280444B1 (https=)
JP (3) JP6962819B2 (https=)
CN (1) CN108472360B (https=)
AU (2) AU2016245887B2 (https=)
WO (1) WO2016164708A1 (https=)

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EP4050026A1 (en) * 2014-04-01 2022-08-31 Adimab, LLC Method of obtaining or identifying one or more common light chains for use in preparing a multispecific antibody
TWI700300B (zh) 2014-09-26 2020-08-01 日商中外製藥股份有限公司 中和具有第viii凝血因子(fviii)機能替代活性的物質之抗體
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
JP6962819B2 (ja) 2015-04-10 2021-11-05 アディマブ, エルエルシー 親ホモ二量体抗体種からのヘテロ二量体多重特異性抗体の精製方法
WO2017110980A1 (ja) 2015-12-25 2017-06-29 中外製薬株式会社 増強された活性を有する抗体及びその改変方法
AU2016381992B2 (en) 2015-12-28 2024-01-04 Chugai Seiyaku Kabushiki Kaisha Method for promoting efficiency of purification of Fc region-containing polypeptide
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US20190185578A1 (en) 2016-07-29 2019-06-20 Chugai Seiyaku Kabushiki Kaisha Bispecific antibody exhibiting increased alternative fviii-cofactor-function activity
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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
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Publication number Publication date
JP7111767B2 (ja) 2022-08-02
AU2016245887A1 (en) 2017-11-02
JP6962819B2 (ja) 2021-11-05
JP2020114881A (ja) 2020-07-30
WO2016164708A1 (en) 2016-10-13
HK1246684A1 (en) 2018-09-14
US10787500B2 (en) 2020-09-29
EP3280444A1 (en) 2018-02-14
EP3280444A4 (en) 2019-03-27
CN108472360B (zh) 2023-01-17
US20180079797A1 (en) 2018-03-22
CN108472360A (zh) 2018-08-31
JP2018512431A (ja) 2018-05-17
AU2021225195A1 (en) 2021-09-30
JP2021119207A (ja) 2021-08-12
US20210047387A1 (en) 2021-02-18
CA2982131A1 (en) 2016-10-13
EP3280444B1 (en) 2024-05-08

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