KR102826635B1 - 다중 특이적 항체의 정제 - Google Patents
다중 특이적 항체의 정제 Download PDFInfo
- Publication number
- KR102826635B1 KR102826635B1 KR1020237025000A KR20237025000A KR102826635B1 KR 102826635 B1 KR102826635 B1 KR 102826635B1 KR 1020237025000 A KR1020237025000 A KR 1020237025000A KR 20237025000 A KR20237025000 A KR 20237025000A KR 102826635 B1 KR102826635 B1 KR 102826635B1
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- South Korea
- Prior art keywords
- chromatography
- mixed mode
- antibody
- buffer
- protein
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
- C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode 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
- C07K1/18—Ion-exchange 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
- 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
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
- C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
-
- 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
- C07K2317/52—Constant or Fc region; Isotype
- C07K2317/526—CH3 domain
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/54—F(ab')2
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Ophthalmology & Optometry (AREA)
- Water Supply & Treatment (AREA)
- Endocrinology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020257021158A KR20250107275A (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662351908P | 2016-06-17 | 2016-06-17 | |
| US62/351,908 | 2016-06-17 | ||
| KR1020197001176A KR20190039929A (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
| PCT/US2017/038007 WO2017218977A2 (en) | 2016-06-17 | 2017-06-16 | Purification of multispecific antibodies |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020197001176A Division KR20190039929A (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020257021158A Division KR20250107275A (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR20230113662A KR20230113662A (ko) | 2023-07-31 |
| KR102826635B1 true KR102826635B1 (ko) | 2025-06-30 |
Family
ID=59593150
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020257021158A Pending KR20250107275A (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
| KR1020197001176A Ceased KR20190039929A (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
| KR1020237025000A Active KR102826635B1 (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020257021158A Pending KR20250107275A (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
| KR1020197001176A Ceased KR20190039929A (ko) | 2016-06-17 | 2017-06-16 | 다중 특이적 항체의 정제 |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US20190256556A1 (enExample) |
| EP (2) | EP3472177B1 (enExample) |
| JP (3) | JP2019521986A (enExample) |
| KR (3) | KR20250107275A (enExample) |
| CN (1) | CN109563124A (enExample) |
| AR (1) | AR108800A1 (enExample) |
| AU (2) | AU2017286676B2 (enExample) |
| BR (1) | BR112018075516A2 (enExample) |
| CA (1) | CA3026518A1 (enExample) |
| ES (1) | ES2988363T3 (enExample) |
| HR (1) | HRP20241323T1 (enExample) |
| HU (1) | HUE068564T2 (enExample) |
| IL (1) | IL263690B2 (enExample) |
| MX (2) | MX2018015173A (enExample) |
| PL (1) | PL3472177T3 (enExample) |
| SG (1) | SG11201810777WA (enExample) |
| TW (1) | TWI798179B (enExample) |
| WO (1) | WO2017218977A2 (enExample) |
Families Citing this family (40)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US9840553B2 (en) | 2014-06-28 | 2017-12-12 | Kodiak Sciences Inc. | Dual PDGF/VEGF antagonists |
| AU2016381964B2 (en) | 2015-12-30 | 2024-02-15 | Kodiak Sciences Inc. | Antibodies and conjugates thereof |
| US11964998B2 (en) * | 2017-08-30 | 2024-04-23 | Fresenius Kabi Deutschland Gmbh | Method for purifying anti-IL-6 receptor antibodies |
| EP3728327A1 (en) * | 2017-12-22 | 2020-10-28 | F. Hoffmann-La Roche AG | Depletion of light chain mispaired antibody variants by hydrophobic interaction chromatography |
| WO2019149693A1 (en) * | 2018-01-30 | 2019-08-08 | Univercells S.A. | Protein purification process and platform |
| US20210040146A1 (en) * | 2018-01-30 | 2021-02-11 | Exothera S.A. | Protein purification process |
| CN119733046A (zh) * | 2018-02-06 | 2025-04-01 | 豪夫迈·罗氏有限公司 | 眼科疾病的治疗 |
| CN112203679A (zh) | 2018-03-02 | 2021-01-08 | 科达制药股份有限公司 | Il-6抗体及其融合构建体和缀合物 |
| US20230182041A1 (en) * | 2018-04-25 | 2023-06-15 | Medimmune, Llc | Purification of antibodies |
| CN111423512B (zh) * | 2019-01-10 | 2024-01-05 | 北京比洋生物技术有限公司 | 阻断血管内皮细胞生长且活化t细胞的多靶向融合蛋白和包含其的药物组合物 |
| TWI871300B (zh) * | 2019-01-28 | 2025-02-01 | 美商安進公司 | 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程 |
| CN113840625B (zh) | 2019-01-29 | 2024-12-31 | 武田药品工业有限公司 | 甲状旁腺激素变体 |
| AU2020268896B2 (en) * | 2019-05-03 | 2024-11-28 | F. Hoffmann-La Roche Ag | Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform |
| CN114026108B (zh) * | 2019-06-28 | 2024-09-10 | 夏尔巴生物技术(苏州)有限公司 | 无缝连续流层析方法 |
| CA3157509A1 (en) | 2019-10-10 | 2021-04-15 | Kodiak Sciences Inc. | Methods of treating an eye disorder |
| CA3160208A1 (en) * | 2019-11-07 | 2021-05-14 | Amgen Inc. | High salt washes during cation exchange chromatography to remove product-realated impurities |
| WO2021144422A1 (en) * | 2020-01-15 | 2021-07-22 | F. Hoffmann-La Roche Ag | Methods to decrease impurities from recombinant protein manufacturing processes |
| KR102154952B1 (ko) * | 2020-02-21 | 2020-09-10 | 프레스티지바이오로직스 주식회사 | 아달리무맙의 Non-Protein A 정제방법 |
| WO2021170060A1 (en) * | 2020-02-28 | 2021-09-02 | Wuxi Biologics (Shanghai) Co., Ltd. | Purification of bispeciifc antibodies |
| US20230357315A1 (en) * | 2020-03-11 | 2023-11-09 | Dr. Reddy's Laboratories Limited | METHOD OF PURIFYING AN Fc-FUSION PROTEIN |
| WO2021208839A1 (en) * | 2020-04-13 | 2021-10-21 | Wuxi Biologics (Shanghai) Co., Ltd. | Purification of bispeciifc antibodies |
| CN113563469A (zh) * | 2020-04-28 | 2021-10-29 | 江苏中新医药有限公司 | 高回收率纯化阿达木单抗的方法 |
| JP2023523823A (ja) | 2020-05-01 | 2023-06-07 | カシーヴ バイオサイエンシズ,リミテッド・ライアビリティ・カンパニー | タンパク質の精製の改善されたプロセス |
| AU2021265346A1 (en) * | 2020-05-01 | 2022-12-22 | Kashiv Biosciences, Llc | An improved process of affinity chromatography |
| EP4142905A4 (en) * | 2020-05-01 | 2024-11-13 | Kashiv Biosciences, LLC | IMPROVED PROCESS FOR PURIFICATION OF PROTEIN |
| CN114014906B (zh) * | 2020-06-24 | 2024-01-12 | 夏尔巴生物技术(苏州)有限公司 | 一种利用阳离子交换层析纯化疏水性蛋白的方法 |
| JP2023542079A (ja) * | 2020-09-21 | 2023-10-05 | ジェネンテック, インコーポレイテッド | 多重特異性抗体の精製 |
| 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 |
| CA3202339A1 (en) * | 2020-12-18 | 2022-06-23 | Mei Jang | Protein compositions and methods for producing and using the same |
| MX2023010523A (es) * | 2021-03-09 | 2023-09-20 | Japan Chem Res | Metodo para producir una proteina de fusion de anticuerpo-enzima lisosomica. |
| US20240191179A1 (en) * | 2021-04-23 | 2024-06-13 | Kyowa Kirin Co., Ltd. | Method for suppressing production of degradation products |
| CN117242095A (zh) * | 2021-04-23 | 2023-12-15 | 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 |
| US20220411811A1 (en) * | 2021-06-25 | 2022-12-29 | The Board Of Trustees Of The University Of Illinois | Synthetic toolkit for plant transformation |
| CN118414350A (zh) * | 2021-10-19 | 2024-07-30 | 阿特根公司 | 纯化具有igg fc结构域的融合蛋白的方法 |
| WO2024076990A1 (en) * | 2022-10-03 | 2024-04-11 | Therini Bio, Inc. | Multi-specific antigen binding proteins which bind human fibrin or fibrinogen ?c domain and vascular endothelial growth factor and methods of use |
| CN117990807B (zh) * | 2022-11-07 | 2024-09-24 | 北京东方百泰生物科技股份有限公司 | 一种抗tslp单克隆抗体电荷异质性的检测方法 |
| CN116769044A (zh) * | 2023-07-11 | 2023-09-19 | 康日百奥生物科技(苏州)有限公司 | 抗cd3和cd19双特异性抗体蛋白及其层析纯化方法 |
| WO2025029614A1 (en) * | 2023-07-28 | 2025-02-06 | Amgen Inc. | A method for equilibrating a chromatography medium |
| WO2025088516A1 (en) * | 2023-10-26 | 2025-05-01 | Pfizer Inc. | Method of forming multi-specific antibodies from homodimer antibodies and pharmaceutical product including multi-specific antibodies thus obtained |
| WO2025155751A1 (en) * | 2024-01-17 | 2025-07-24 | Nutcracker Therapeutics, Inc. | Improved method for isolating and characterizing proteins |
Citations (2)
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| WO2015070068A1 (en) * | 2013-11-07 | 2015-05-14 | Abbvie Inc. | Isolation and purification of antibodies |
| WO2016018740A2 (en) * | 2014-07-26 | 2016-02-04 | Regeneron Pharmaceuticals, Inc. | Purification platform for bispecific antibodies |
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