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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Publication number
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
Inventor
Juergen Hermann Nett
Maximiliano Vasquez
K. Dane Wittrup
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Adimab LLC
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Adimab LLC
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/16—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166—Fluid composition conditioning, e.g. gradient
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/16—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166—Fluid composition conditioning, e.g. gradient
    • B01D15/168—Fluid composition conditioning, e.g. gradient pH gradient or chromatofocusing, i.e. separation according to the isoelectric point pI
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B01D15/362—Cation-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective 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
    • B01D15/3847—Multimodal interactions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J39/00—Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
    • B01J39/26—Cation exchangers for chromatographic processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J41/00—Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/20—Anion exchangers for chromatographic processes
    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Life Sciences & Earth Sciences (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)

Application Number Priority Date Filing Date Title
AU2021225195A AU2021225195A1 (en) 2015-04-10 2021-09-01 Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
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

Related Child Applications (1)

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

Publications (2)

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

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AU2016245887A Active AU2016245887B2 (en) 2015-04-10 2016-04-08 Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species
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 (enExample)
EP (1) EP3280444B1 (enExample)
JP (3) JP6962819B2 (enExample)
CN (1) CN108472360B (enExample)
AU (2) AU2016245887B2 (enExample)
WO (1) WO2016164708A1 (enExample)

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EP4793360A2 (en) 2006-03-31 2026-08-19 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
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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
EP3280444B1 (en) 2015-04-10 2024-05-08 Adimab, LLC Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species
US20200270363A1 (en) 2015-12-25 2020-08-27 Chugai Seiyaku Kabushiki Kaisha Antibody having enhanced activity, and method for modifying same
SG11201803989WA (en) 2015-12-28 2018-06-28 Chugai Pharmaceutical Co Ltd Method for promoting efficiency of purification of fc region-containing polypeptide
AU2017255077B2 (en) 2016-04-28 2024-05-16 Chugai Seiyaku Kabushiki Kaisha Antibody-containing preparation
CA3027018A1 (en) 2016-07-29 2018-02-01 Chugai Seiyaku Kabushiki Kaisha Bispecific antibody exhibiting increased alternative fviii-cofactor-function activity
US11352438B2 (en) 2016-09-06 2022-06-07 Chugai Seiyaku Kabushiki Kaisha Methods of using a bispecific antibody that recognizes coagulation factor IX and/or activated coagulation factor IX and coagulation factor X and/or activated coagulation factor X
JP7209298B2 (ja) 2017-03-31 2023-01-20 公立大学法人奈良県立医科大学 血液凝固第ｖｉｉｉ因子の機能を代替する多重特異性抗原結合分子を含有する、血液凝固第ｉｘ因子異常症の予防および／または治療に用いられる医薬組成物
CA3071236A1 (en) 2017-09-29 2019-04-04 Chugai Seiyaku Kabushiki Kaisha Multispecific antigen-binding molecule having blood coagulation factor viii (fviii) cofactor function-substituting activity, and pharmaceutical formulation containing said moleculeas active ingredient
KR20260090008A (ko) * 2017-11-01 2026-06-16 추가이 세이야쿠 가부시키가이샤 생물 활성이 저하된 항체 배리언트 및 아이소폼
SG11202101369XA (en) * 2018-08-17 2021-03-30 Regeneron Pharma Method and chromatography system for determining amount and purity of a multimeric protein
SG11202102713TA (en) * 2018-09-21 2021-04-29 Teneobio Inc Methods for purifying heterodimeric, multispecific antibodies
US11022585B2 (en) 2019-06-09 2021-06-01 Dionex Corporation Methods and systems for optimizing buffer conditions with liquid chromatography
CN114539416B (zh) * 2020-11-26 2024-11-08 盛禾(中国)生物制药有限公司 一种双特异性抗体的层析纯化工艺

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Also Published As

Publication number Publication date
HK1246684A1 (en) 2018-09-14
EP3280444B1 (en) 2024-05-08
WO2016164708A1 (en) 2016-10-13
CN108472360A (zh) 2018-08-31
US20210047387A1 (en) 2021-02-18
EP3280444A1 (en) 2018-02-14
EP3280444A4 (en) 2019-03-27
JP2021119207A (ja) 2021-08-12
AU2016245887A1 (en) 2017-11-02
JP2018512431A (ja) 2018-05-17
JP6962819B2 (ja) 2021-11-05
CA2982131A1 (en) 2016-10-13
CN108472360B (zh) 2023-01-17
AU2021225195A1 (en) 2021-09-30
US10787500B2 (en) 2020-09-29
JP2020114881A (ja) 2020-07-30
JP7111767B2 (ja) 2022-08-02
US20180079797A1 (en) 2018-03-22

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