JP2022501357A - ヘテロ二量体多重特異性抗体を精製するための方法 - Google Patents

ヘテロ二量体多重特異性抗体を精製するための方法 Download PDF

Info

Publication number
JP2022501357A
JP2022501357A JP2021515172A JP2021515172A JP2022501357A JP 2022501357 A JP2022501357 A JP 2022501357A JP 2021515172 A JP2021515172 A JP 2021515172A JP 2021515172 A JP2021515172 A JP 2021515172A JP 2022501357 A JP2022501357 A JP 2022501357A
Authority
JP
Japan
Prior art keywords
antibody
elution buffer
binding
multispecific
elution
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.)
Pending
Application number
JP2021515172A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022501357A5 (https=
JPWO2020061478A5 (https=
Inventor
ブレット ジョーゲンセン，
ウテ シェレンベルガー，
Original Assignee
テネオバイオ， インコーポレイテッド
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 テネオバイオ， インコーポレイテッド filed Critical テネオバイオ， インコーポレイテッド
Publication of JP2022501357A publication Critical patent/JP2022501357A/ja
Publication of JP2022501357A5 publication Critical patent/JP2022501357A5/ja
Publication of JPWO2020061478A5 publication Critical patent/JPWO2020061478A5/ja
Priority to JP2024065251A priority Critical patent/JP2024099610A/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • B01D15/3804—Affinity chromatography
    • 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
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • 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
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/35—Valency
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cell Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2021515172A 2018-09-21 2019-09-20 ヘテロ二量体多重特異性抗体を精製するための方法 Pending JP2022501357A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024065251A JP2024099610A (ja) 2018-09-21 2024-04-15 ヘテロ二量体多重特異性抗体を精製するための方法

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862734566P 2018-09-21 2018-09-21
US62/734,566 2018-09-21
US201862742821P 2018-10-08 2018-10-08
US62/742,821 2018-10-08
PCT/US2019/052199 WO2020061478A2 (en) 2018-09-21 2019-09-20 Methods for purifying heterodimeric, multispecific antibodies

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024065251A Division JP2024099610A (ja) 2018-09-21 2024-04-15 ヘテロ二量体多重特異性抗体を精製するための方法

Publications (3)

Publication Number Publication Date
JP2022501357A true JP2022501357A (ja) 2022-01-06
JP2022501357A5 JP2022501357A5 (https=) 2022-09-29
JPWO2020061478A5 JPWO2020061478A5 (https=) 2022-09-29

Family

ID=68240802

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021515172A Pending JP2022501357A (ja) 2018-09-21 2019-09-20 ヘテロ二量体多重特異性抗体を精製するための方法
JP2024065251A Pending JP2024099610A (ja) 2018-09-21 2024-04-15 ヘテロ二量体多重特異性抗体を精製するための方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2024065251A Pending JP2024099610A (ja) 2018-09-21 2024-04-15 ヘテロ二量体多重特異性抗体を精製するための方法

Country Status (11)

Country Link
US (2) US20210355215A1 (https=)
EP (1) EP3853253A2 (https=)
JP (2) JP2022501357A (https=)
KR (1) KR20210063354A (https=)
CN (1) CN112839959A (https=)
BR (1) BR112021004680A2 (https=)
CA (1) CA3113057A1 (https=)
IL (1) IL281570A (https=)
MX (1) MX2021003169A (https=)
SG (1) SG11202102713TA (https=)
WO (1) WO2020061478A2 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3029209A1 (en) 2016-06-21 2017-12-28 Teneobio, Inc. Cd3 binding antibodies
IL264941B2 (en) 2016-08-24 2025-12-01 Teneobio Inc Transgenic non-human animals producing modified heavy chain-only antibodies
FI4050034T3 (fi) * 2016-09-14 2024-06-10 Teneoone Inc Cd3:een sitoutuvia vasta-aineita
NZ754713A (en) 2016-12-21 2025-11-28 Teneobio Inc Anti-bcma heavy chain-only antibodies
US11427642B2 (en) 2017-06-20 2022-08-30 Teneoone, Inc. Anti-BCMA heavy chain-only antibodies
WO2019126756A1 (en) 2017-12-22 2019-06-27 Teneobio, Inc. Heavy chain antibodies binding to cd22
JP7776987B2 (ja) 2019-04-05 2025-11-27 テネオバイオ， インコーポレイテッド Ｐｓｍａに結合する重鎖抗体
CN114206927B (zh) 2019-06-14 2025-03-21 特尼奥生物股份有限公司 与cd22和cd3结合的多特异性重链抗体
KR102153258B1 (ko) * 2020-02-21 2020-09-07 프레스티지바이오로직스 주식회사 베바시주맙 정제의 최적화된 방법
TWI838621B (zh) * 2020-04-29 2024-04-11 美商泰尼歐萬公司 具有經修飾重鏈恆定區之多特異性重鏈抗體
AU2021263448B2 (en) * 2020-04-29 2026-02-05 Teneobio, Inc. Multispecific heavy chain antibodies with modified heavy chain constant regions
KR102744698B1 (ko) * 2020-04-29 2024-12-24 테네오원, 인코포레이티드 변형된 중쇄 불변 영역을 갖는 다중특이적 중쇄 항체
CN114539417A (zh) * 2020-11-26 2022-05-27 盛禾(中国)生物制药有限公司 一种有效去除双特异性抗体同源二聚体的层析纯化工艺
WO2022222949A1 (zh) * 2021-04-23 2022-10-27 和铂医药(上海)有限责任公司 一种双特异性抗体的纯化方法
WO2025251034A1 (en) * 2024-05-31 2025-12-04 Amgen Inc. Purification method

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012531428A (ja) * 2009-06-25 2012-12-10 アムジエン・インコーポレーテツド 哺乳類以外の系で発現されるタンパク質の捕獲精製プロセス
JP2014515598A (ja) * 2011-03-10 2014-07-03 エイチシーオー アンティボディ， インク． 二重特異性三鎖抗体様分子
US20150094451A1 (en) * 2013-09-03 2015-04-02 Novimmune S.A. Readily Isolated Bispecific Binding Molecules with Native Format Having Mutated Constant Regions

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE30985E (en) 1978-01-01 1982-06-29 Serum-free cell culture media
US4560655A (en) 1982-12-16 1985-12-24 Immunex Corporation Serum-free cell culture medium and process for making same
US4657866A (en) 1982-12-21 1987-04-14 Sudhir Kumar Serum-free, synthetic, completely chemically defined tissue culture media
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US4767704A (en) 1983-10-07 1988-08-30 Columbia University In The City Of New York Protein-free culture medium
GB8516415D0 (en) 1985-06-28 1985-07-31 Celltech Ltd Culture of animal cells
US4927762A (en) 1986-04-01 1990-05-22 Cell Enterprises, Inc. Cell culture medium with antioxidant
IL85035A0 (en) 1987-01-08 1988-06-30 Int Genetic Eng Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same
AU632065B2 (en) 1988-09-23 1992-12-17 Novartis Vaccines And Diagnostics, Inc. Cell culture medium for enhanced cell growth, culture longevity and product expression
US5122469A (en) 1990-10-03 1992-06-16 Genentech, Inc. Method for culturing Chinese hamster ovary cells to improve production of recombinant proteins
EP1400536A1 (en) 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
US5534615A (en) 1994-04-25 1996-07-09 Genentech, Inc. Cardiac hypertrophy factor and uses therefor
US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
JP4046354B2 (ja) 1996-03-18 2008-02-13 ボード オブ リージェンツ，ザ ユニバーシティ オブ テキサス システム 増大した半減期を有する免疫グロブリン様ドメイン
DE19836213A1 (de) * 1998-08-11 2000-02-24 Gerhard Harry Scholz Verfahren zur Elution von Biomolekülen von Chromatographie-Materialien
CA2410551A1 (en) * 2000-06-30 2002-01-10 Vlaams Interuniversitair Instituut Voor Biotechnologie Vzw (Vib) Heterodimeric fusion proteins
WO2004042017A2 (en) 2002-10-31 2004-05-21 Genentech, Inc. Methods and compositions for increasing antibody production
CA2513113A1 (en) 2003-01-23 2004-08-05 Genentech, Inc. Methods for producing humanized antibodies and improving yield of antibodies or antigen binding fragments in cell culture
US20080286819A1 (en) 2005-11-07 2008-11-20 Ravetch Jeffrey V Reagents, Methods and Systems for Selecting a Cytotoxic Antibody or Variant Thereof
MX2008012843A (es) 2006-04-05 2009-01-19 Univ Rockefeller Polipeptidos con propiedades antiinflamatorias aumentadas y citotoxicas reducidas y metodos relacionados.
PT2825559T (pt) * 2012-03-13 2019-06-07 Novimmune Sa Anticorpos biespecíficos prontamente isolados com formato de imunoglobulina nativo
ES2936810T3 (es) * 2014-05-16 2023-03-22 Pfizer Anticuerpos biespecíficos con interfaces CH1-CL de ingeniería
AR101262A1 (es) * 2014-07-26 2016-12-07 Regeneron Pharma Plataforma de purificación para anticuerpos biespecíficos
AU2016245887B2 (en) * 2015-04-10 2021-09-23 Adimab, Llc. Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species
CN107446044B (zh) * 2016-05-30 2021-04-30 越海百奥药业(绍兴)有限公司 一种纯化抗体的方法及所用缓冲液
CA3218290A1 (en) * 2016-07-22 2018-01-25 Amgen Inc. Methods of purifying fc-containing proteins
NZ754713A (en) 2016-12-21 2025-11-28 Teneobio Inc Anti-bcma heavy chain-only antibodies
WO2019183406A1 (en) * 2018-03-21 2019-09-26 Invenra Inc. Multispecific antibody purification with ch1 resin

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012531428A (ja) * 2009-06-25 2012-12-10 アムジエン・インコーポレーテツド 哺乳類以外の系で発現されるタンパク質の捕獲精製プロセス
JP2014515598A (ja) * 2011-03-10 2014-07-03 エイチシーオー アンティボディ， インク． 二重特異性三鎖抗体様分子
US20150094451A1 (en) * 2013-09-03 2015-04-02 Novimmune S.A. Readily Isolated Bispecific Binding Molecules with Native Format Having Mutated Constant Regions

Also Published As

Publication number Publication date
EP3853253A2 (en) 2021-07-28
WO2020061478A3 (en) 2020-04-30
BR112021004680A2 (pt) 2021-08-31
KR20210063354A (ko) 2021-06-01
CN112839959A (zh) 2021-05-25
JP2024099610A (ja) 2024-07-25
AU2019343053A1 (en) 2021-04-15
IL281570A (en) 2021-05-31
MX2021003169A (es) 2021-08-11
US20250197497A1 (en) 2025-06-19
WO2020061478A2 (en) 2020-03-26
CA3113057A1 (en) 2020-03-26
US20210355215A1 (en) 2021-11-18
SG11202102713TA (en) 2021-04-29

Similar Documents

Publication Publication Date Title
US20250197497A1 (en) Methods for purifying heterodimeric, multispecific antibodies
JP2022501357A5 (https=)
KR102562519B1 (ko) IL-15/IL-15Rα FC-융합 단백질 및 PD-1 항체 단편을 포함하는 이중특이성 이종이량체 융합 단백질
US9284347B2 (en) Chromatographic method for purifying FC-containing proteins
US10363496B2 (en) Method for purification of monoclonal antibodies
KR101921767B1 (ko) 단백질 정제
TR201903707T4 (tr) Aşırı yükleme ve elüsyon kromatografisi.
JPWO2020061478A5 (https=)
KR20190037247A (ko) Fc-함유 단백질의 정제 방법
JP2026065059A (ja) 組換え抗原結合分子を製造するおよび／または濃縮するための方法
US12247065B2 (en) Method for producing a controlled mixture of two or more different antibodies
JP2025528213A (ja) 複数ドメイン結合性分子
KR20230172538A (ko) Fc-유래된 폴리펩티드
RU2820588C2 (ru) Способы очистки гетеродимерных полиспецифических антител
EP4400514A1 (en) Bispecific antibody comprising a heterodimer based on mhc proteins
AU2019343053B2 (en) Methods for purifying heterodimeric, multispecific antibodies
AU2015372801B2 (en) Method for preparing tnfr-fc fusion protein containing target content of impurities
WO2025094054A1 (en) Method for purifying small multi-domain proteins
OA21635A (en) Bispecific Antibody Comprising A Heterodimer Based On Mhc Proteins.
NZ733388B (en) Method for preparing tnfr-fc fusion protein containing target content of impurities

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220920

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220920

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230829

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20230830

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20231115

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20231219