CN112839959A - 用于纯化异源二聚多特异性抗体的方法 - Google Patents
用于纯化异源二聚多特异性抗体的方法 Download PDFInfo
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- CN112839959A CN112839959A CN201980066235.1A CN201980066235A CN112839959A CN 112839959 A CN112839959 A CN 112839959A CN 201980066235 A CN201980066235 A CN 201980066235A CN 112839959 A CN112839959 A CN 112839959A
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- Prior art keywords
- antibody
- elution buffer
- multispecific
- binding
- heavy chain
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- 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
-
- 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
- C07K16/2878—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
-
- 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)
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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112839959A true CN112839959A (zh) | 2021-05-25 |
Family
ID=68240802
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201980066235.1A Pending CN112839959A (zh) | 2018-09-21 | 2019-09-20 | 用于纯化异源二聚多特异性抗体的方法 |
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)
| 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 (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19836213A1 (de) * | 1998-08-11 | 2000-02-24 | Gerhard Harry Scholz | Verfahren zur Elution von Biomolekülen von Chromatographie-Materialien |
| AU2001270609A1 (en) * | 2000-06-30 | 2002-01-14 | Vlaams Interuniversitair Instituut Voor Biotechnologie Vzw | Heterodimeric fusion proteins |
| US20140056897A1 (en) * | 2011-03-10 | 2014-02-27 | Hco Antibody, Inc. | Bispecific three-chain antibody-like molecules |
| EP2825559A2 (en) * | 2012-03-13 | 2015-01-21 | Novimmune SA | Readily isolated bispecific antibodies with native immunoglobulin format |
| WO2015033223A2 (en) * | 2013-09-03 | 2015-03-12 | Novimmune S.A. | Readily isolated bispecific binding molecules with native format having mutated constant regions |
| US20160024147A1 (en) * | 2014-07-26 | 2016-01-28 | Regeneron Pharmaceuticals, Inc. | Purification Platform for Bispecific Antibodies |
| CN107446044A (zh) * | 2016-05-30 | 2017-12-08 | 上海迈泰君奥生物技术有限公司 | 一种纯化抗体的方法及所用缓冲液 |
| WO2018018011A2 (en) * | 2016-07-22 | 2018-01-25 | Amgen Inc. | Methods of purifying fc-containing proteins |
| US20180079797A1 (en) * | 2015-04-10 | 2018-03-22 | Adimab, Llc | Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species |
| US20180179285A1 (en) * | 2014-05-16 | 2018-06-28 | Pfizer Inc. | Bispecific antibodies |
| WO2019183406A1 (en) * | 2018-03-21 | 2019-09-26 | Invenra Inc. | Multispecific antibody purification with ch1 resin |
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| 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 |
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| NZ754713A (en) | 2016-12-21 | 2025-11-28 | Teneobio Inc | Anti-bcma heavy chain-only antibodies |
-
2019
- 2019-09-20 CN CN201980066235.1A patent/CN112839959A/zh active Pending
- 2019-09-20 CA CA3113057A patent/CA3113057A1/en active Pending
- 2019-09-20 SG SG11202102713TA patent/SG11202102713TA/en unknown
- 2019-09-20 EP EP19787122.1A patent/EP3853253A2/en active Pending
- 2019-09-20 WO PCT/US2019/052199 patent/WO2020061478A2/en not_active Ceased
- 2019-09-20 MX MX2021003169A patent/MX2021003169A/es unknown
- 2019-09-20 BR BR112021004680-1A patent/BR112021004680A2/pt unknown
- 2019-09-20 US US17/278,268 patent/US20210355215A1/en not_active Abandoned
- 2019-09-20 JP JP2021515172A patent/JP2022501357A/ja active Pending
- 2019-09-20 KR KR1020217010141A patent/KR20210063354A/ko not_active Ceased
-
2021
- 2021-03-16 IL IL281570A patent/IL281570A/en unknown
-
2024
- 2024-04-15 JP JP2024065251A patent/JP2024099610A/ja active Pending
-
2025
- 2025-01-17 US US19/030,905 patent/US20250197497A1/en active Pending
Patent Citations (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19836213A1 (de) * | 1998-08-11 | 2000-02-24 | Gerhard Harry Scholz | Verfahren zur Elution von Biomolekülen von Chromatographie-Materialien |
| AU2001270609A1 (en) * | 2000-06-30 | 2002-01-14 | Vlaams Interuniversitair Instituut Voor Biotechnologie Vzw | Heterodimeric fusion proteins |
| US20140056897A1 (en) * | 2011-03-10 | 2014-02-27 | Hco Antibody, Inc. | Bispecific three-chain antibody-like molecules |
| EP2825559A2 (en) * | 2012-03-13 | 2015-01-21 | Novimmune SA | Readily isolated bispecific antibodies with native immunoglobulin format |
| WO2015033223A2 (en) * | 2013-09-03 | 2015-03-12 | Novimmune S.A. | Readily isolated bispecific binding molecules with native format having mutated constant regions |
| US20150094451A1 (en) * | 2013-09-03 | 2015-04-02 | Novimmune S.A. | Readily Isolated Bispecific Binding Molecules with Native Format Having Mutated Constant Regions |
| US20180179285A1 (en) * | 2014-05-16 | 2018-06-28 | Pfizer Inc. | Bispecific antibodies |
| US20160024147A1 (en) * | 2014-07-26 | 2016-01-28 | Regeneron Pharmaceuticals, Inc. | Purification Platform for Bispecific Antibodies |
| US20180079797A1 (en) * | 2015-04-10 | 2018-03-22 | Adimab, Llc | Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species |
| CN108472360A (zh) * | 2015-04-10 | 2018-08-31 | 阿迪马布有限责任公司 | 从亲代同源二聚抗体种类中纯化异源二聚多特异性抗体的方法 |
| CN107446044A (zh) * | 2016-05-30 | 2017-12-08 | 上海迈泰君奥生物技术有限公司 | 一种纯化抗体的方法及所用缓冲液 |
| WO2018018011A2 (en) * | 2016-07-22 | 2018-01-25 | Amgen Inc. | Methods of purifying fc-containing proteins |
| WO2019183406A1 (en) * | 2018-03-21 | 2019-09-26 | Invenra Inc. | Multispecific antibody purification with ch1 resin |
Non-Patent Citations (6)
| Title |
|---|
| EDMUND A. ROSSI ET AL.: "Pretargeting of carcinoeembryonic antigen-expressing cancers with a trivalent bispecific fusion protein produced in myeloma cells", 《PRETARGETING STUDIES》, vol. 11, no. 19, 1 October 2005 (2005-10-01), pages 7122 - 7129 * |
| JENNIFER BRATT ET AL.: "Therapeutic lg G-like bispecific antibodies :modular versatility and manufacturing challengers", 《2017BIOPROCESS INTERNATIONAL》, vol. 15, no. 11, 16 February 2018 (2018-02-16), pages 1 - 14, XP055562245 * |
| STARLYNN C. CLARKE ET AL.: "multispecific antiboday development platform based on human heavy chain antibodies", 《FRONTIERS IN IMMUNOLOGY》, vol. 9, 7 January 2019 (2019-01-07), pages 1 - 13 * |
| YANLI WANG ET AL.: "Application of enhanced electronegative multimodal chromatography as the primary capture step for immunoglobulin G purifcation", 《AMB EXPRESS》, vol. 93, no. 8, 31 August 2018 (2018-08-31), pages 1 - 7 * |
| 吴梧桐主编: "《生物制药工艺学》", 31 August 2015, 中国医药科技出版社, pages: 541 * |
| 杨玉丹: "新型抗CD133xCD3双特异性抗体治疗晚期结直肠癌的基础研究", 《中国博士学位论文全文数据库 医药卫生科技辑》, no. 2017, 15 August 2017 (2017-08-15), pages 072 - 175 * |
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 |
| JP2022501357A (ja) | 2022-01-06 |
| 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 |
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