TWI596107B - 單株抗體之新穎純化方法 - Google Patents
單株抗體之新穎純化方法 Download PDFInfo
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- TWI596107B TWI596107B TW103121726A TW103121726A TWI596107B TW I596107 B TWI596107 B TW I596107B TW 103121726 A TW103121726 A TW 103121726A TW 103121726 A TW103121726 A TW 103121726A TW I596107 B TWI596107 B TW I596107B
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- 238000000746 purification Methods 0.000 title description 27
- 238000000034 method Methods 0.000 claims description 55
- 108090000623 proteins and genes Proteins 0.000 claims description 54
- 102000004169 proteins and genes Human genes 0.000 claims description 54
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- 229960002964 adalimumab Drugs 0.000 claims description 23
- 235000002639 sodium chloride Nutrition 0.000 claims description 21
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- 239000000654 additive Substances 0.000 claims description 4
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 claims description 4
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- 238000000926 separation method Methods 0.000 claims description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 3
- 239000004475 Arginine Substances 0.000 claims description 3
- 239000004471 Glycine Substances 0.000 claims description 3
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 3
- 239000008351 acetate buffer Substances 0.000 claims description 3
- 230000000996 additive effect Effects 0.000 claims description 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 3
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- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims description 2
- 239000007983 Tris buffer Substances 0.000 claims description 2
- 235000019270 ammonium chloride Nutrition 0.000 claims description 2
- 125000002347 octyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 2
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- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
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- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 description 4
- 239000003729 cation exchange resin Substances 0.000 description 4
- 239000006228 supernatant Substances 0.000 description 4
- UHOVQNZJYSORNB-UHFFFAOYSA-N Benzene Chemical compound C1=CC=CC=C1 UHOVQNZJYSORNB-UHFFFAOYSA-N 0.000 description 3
- 238000005277 cation exchange chromatography Methods 0.000 description 3
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
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- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 238000011091 antibody purification Methods 0.000 description 1
- 229960000397 bevacizumab Drugs 0.000 description 1
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Classifications
-
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
-
- 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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
-
- 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
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Oncology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cell Biology (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2145MU2013 IN2013MU02145A (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) | 2013-06-25 | 2014-06-25 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| TW201512217A TW201512217A (zh) | 2015-04-01 |
| TWI596107B true TWI596107B (zh) | 2017-08-21 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW103121726A TWI596107B (zh) | 2013-06-25 | 2014-06-24 | 單株抗體之新穎純化方法 |
Country Status (19)
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI738054B (zh) * | 2018-09-21 | 2021-09-01 | 南韓商綠十字股份有限公司 | 高效率的抗tfpi抗體組成物 |
Families Citing this family (55)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH088818Y2 (ja) | 1989-12-21 | 1996-03-13 | 株式会社イナックス | タイル用捺印装置 |
| TWI398554B (zh) * | 2010-07-29 | 2013-06-11 | Zhen Ding Technology Co Ltd | 電鍍裝置 |
| WO2012149197A2 (en) | 2011-04-27 | 2012-11-01 | Abbott Laboratories | Methods for controlling the galactosylation profile of recombinantly-expressed proteins |
| WO2013158273A1 (en) | 2012-04-20 | 2013-10-24 | Abbvie Inc. | Methods to modulate c-terminal lysine variant distribution |
| US9067990B2 (en) | 2013-03-14 | 2015-06-30 | Abbvie, Inc. | Protein purification using displacement chromatography |
| US9334319B2 (en) | 2012-04-20 | 2016-05-10 | Abbvie Inc. | Low acidic species compositions |
| US9249182B2 (en) | 2012-05-24 | 2016-02-02 | Abbvie, Inc. | Purification of antibodies using hydrophobic interaction chromatography |
| US9512214B2 (en) | 2012-09-02 | 2016-12-06 | Abbvie, Inc. | Methods to control protein heterogeneity |
| SG11201507230PA (en) | 2013-03-12 | 2015-10-29 | Abbvie Inc | Human antibodies that bind human tnf-alpha and methods of preparing the same |
| US10023608B1 (en) | 2013-03-13 | 2018-07-17 | Amgen Inc. | Protein purification methods to remove impurities |
| US9017687B1 (en) | 2013-10-18 | 2015-04-28 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same using displacement chromatography |
| US9499614B2 (en) | 2013-03-14 | 2016-11-22 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides |
| AR096713A1 (es) | 2013-06-25 | 2016-01-27 | Cadila Healthcare Ltd | Proceso de purificación para anticuerpos monoclonales |
| WO2015051293A2 (en) | 2013-10-04 | 2015-04-09 | Abbvie, Inc. | Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins |
| WO2015057910A1 (en) | 2013-10-16 | 2015-04-23 | Oncobiologics, Inc. | Buffer formulations for enhanced antibody stability |
| US9181337B2 (en) | 2013-10-18 | 2015-11-10 | Abbvie, Inc. | Modulated lysine variant species compositions and methods for producing and using the same |
| US9085618B2 (en) | 2013-10-18 | 2015-07-21 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same |
| US20150139988A1 (en) | 2013-11-15 | 2015-05-21 | Abbvie, Inc. | Glycoengineered binding protein compositions |
| TW201628649A (zh) | 2014-10-09 | 2016-08-16 | 再生元醫藥公司 | 減少醫藥調配物中微可見顆粒之方法 |
| WO2016118707A1 (en) * | 2015-01-21 | 2016-07-28 | Oncobiologics, Inc. | Modulation of charge variants in a monoclonal antibody composition |
| CA2978095C (en) | 2015-03-13 | 2022-02-15 | Bristol-Myers Squibb Company | Use of alkaline washes during chromatography to remove impurities |
| EP3337818A1 (en) * | 2015-08-21 | 2018-06-27 | H. Hoffnabb-La Roche Ag | Affinity chromatography purification with low conductivity wash buffer |
| CN107849087B (zh) | 2015-08-21 | 2022-09-06 | 豪夫迈·罗氏有限公司 | 在亲和层析中减少宿主细胞蛋白的方法 |
| HK1251583A1 (zh) | 2015-08-21 | 2019-02-01 | F. Hoffmann-La Roche Ag | 在亲和层析中减少宿主细胞蛋白的方法 |
| WO2017136433A1 (en) | 2016-02-03 | 2017-08-10 | Oncobiologics, Inc. | Buffer formulations for enhanced antibody stability |
| EP4183414A1 (en) | 2016-08-16 | 2023-05-24 | Regeneron Pharmaceuticals, Inc. | Methods for quantitating individual antibodies from a mixture |
| JP7102401B2 (ja) | 2016-10-25 | 2022-07-19 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | クロマトグラフィーデータ解析のための方法およびシステム |
| US12162938B2 (en) | 2016-10-28 | 2024-12-10 | Merck Sharp & Dohme Llc | Purification process for removal of tyrosine sulfation antibody variants; purified compositions |
| EP4467565A3 (en) | 2016-12-21 | 2025-03-12 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| CR20190291A (es) | 2016-12-23 | 2019-11-05 | Serum Institute Of India Pvt Ltd | Métodos mejorados para estimular la productividad de anticuerpos en el cultivo de células de mamiferos y reducir la agregación durante los procesos de formulación post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos |
| AR111761A1 (es) * | 2017-05-16 | 2019-08-14 | Cj Healthcare Corp | Un método para purificar un anticuerpo o un fragmento de anticuerpo de este usando cromatografía de afinidad |
| EP3431168A1 (en) * | 2017-07-19 | 2019-01-23 | Bayer Aktiengesellschaft | Élimination de médicament non lié après couplage conjugué anticorps-médicament |
| BR112020005335A2 (pt) | 2017-09-19 | 2020-09-24 | Regeneron Pharmaceuticals, Inc. | métodos para reduzir a formação de partículas e composições formadas pelos mesmos |
| CN108101987A (zh) * | 2017-11-17 | 2018-06-01 | 安徽未名生物医药有限公司 | 一种重组抗TNF-α全人源单克隆抗体的纯化方法 |
| CN110128538B (zh) * | 2018-02-09 | 2022-08-26 | 鲁南制药集团股份有限公司 | 一种纯化抗cd20人鼠嵌合单克隆抗体的方法 |
| CN111902720B (zh) | 2018-03-21 | 2025-02-07 | 沃特世科技公司 | 基于非抗体高亲和力的样品制备、吸附剂、装置和方法 |
| TWI853823B (zh) | 2018-07-02 | 2024-09-01 | 美商里珍納龍藥品有限公司 | 自混合物製備多肽之系統及方法 |
| EP4559485A3 (en) * | 2018-07-19 | 2025-08-06 | Ichnos Sciences S.A. | Liquid antibody formulation |
| CN111072773A (zh) * | 2018-10-19 | 2020-04-28 | 菲鹏生物股份有限公司 | 抗体的纯化方法、抗体和应用 |
| EP3643322A1 (en) * | 2018-10-26 | 2020-04-29 | Mabion SA | Low aggregate anti cd20 ligand formulation |
| WO2020084503A1 (en) | 2018-10-26 | 2020-04-30 | Cadila Healthcare Limited | A composition comprising antibody with reduced level of basic variants thereof |
| CN109320611B (zh) * | 2018-10-31 | 2022-06-03 | 鼎康(武汉)生物医药有限公司 | 一种人鼠嵌合单克隆抗体生物类似药的纯化方法 |
| CN111153993B (zh) * | 2018-11-07 | 2024-06-28 | 正大天晴药业集团南京顺欣制药有限公司 | 抗TNF-α单克隆抗体的制备方法 |
| CN109336969B (zh) * | 2018-11-09 | 2021-02-12 | 杭州奕安济世生物药业有限公司 | 一种抗体的纯化方法 |
| CN111269316B (zh) * | 2018-12-04 | 2024-06-28 | 正大天晴药业集团南京顺欣制药有限公司 | 抗her2单克隆抗体的纯化方法 |
| WO2020153390A1 (ja) * | 2019-01-23 | 2020-07-30 | 第一三共株式会社 | 活性炭材料を使用する工程を含む抗体精製方法 |
| KR20220101168A (ko) * | 2019-11-22 | 2022-07-19 | 모르포시스 아게 | 이온 교환 크로마토그래피 동안 항체의 수율을 증가시키는 방법 |
| CN114929725A (zh) * | 2020-01-08 | 2022-08-19 | 信达生物制药(苏州)有限公司 | 阿达木单抗纯化方法及其稳定组合物 |
| KR102154952B1 (ko) * | 2020-02-21 | 2020-09-10 | 프레스티지바이오로직스 주식회사 | 아달리무맙의 Non-Protein A 정제방법 |
| WO2022245306A1 (en) * | 2021-05-20 | 2022-11-24 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Protein purification by affinity chromatography |
| US20240262890A1 (en) * | 2021-07-27 | 2024-08-08 | Ariel Scientific Innovations Ltd. | Large scale purification of antibodies |
| CN114133446A (zh) * | 2021-12-31 | 2022-03-04 | 方坦思(上海)生物医药有限公司 | 单克隆抗体的纯化方法 |
| CN115491328A (zh) * | 2022-08-31 | 2022-12-20 | 深圳市卫光生物制品股份有限公司 | 一种大肠杆菌表达蛋白及其表达纯化方法 |
| EP4335869A1 (en) | 2022-09-07 | 2024-03-13 | Bio T Biyoteknoloji Cozumleri Ve Uretim Anonim | Resin and chromatography column that purifies antibodies with protease resistant small peptides |
| CN118725127A (zh) * | 2024-07-11 | 2024-10-01 | 信立泰(苏州)药业有限公司 | 一种抗pcsk9单克隆抗体的分离纯化方法 |
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| TWI738054B (zh) * | 2018-09-21 | 2021-09-01 | 南韓商綠十字股份有限公司 | 高效率的抗tfpi抗體組成物 |
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| AU2014300486A1 (en) | 2015-11-26 |
| AU2014300486B2 (en) | 2016-06-30 |
| CA2911874A1 (en) | 2014-12-31 |
| MX2015016586A (es) | 2016-03-16 |
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| NZ714079A (en) | 2017-05-26 |
| HK1217344A1 (zh) | 2017-01-06 |
| AR096713A1 (es) | 2016-01-27 |
| TW201512217A (zh) | 2015-04-01 |
| CN105263947A (zh) | 2016-01-20 |
| WO2014207763A1 (en) | 2014-12-31 |
| KR101683415B1 (ko) | 2016-12-06 |
| IN2013MU02145A (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) | 2015-06-05 |
| KR20160003311A (ko) | 2016-01-08 |
| US20160115195A1 (en) | 2016-04-28 |
| SG11201509502XA (en) | 2015-12-30 |
| EA201592192A1 (ru) | 2016-07-29 |
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| US9708365B2 (en) | 2017-07-18 |
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| EP3013849A1 (en) | 2016-05-04 |
| ZA201508258B (en) | 2017-03-29 |
| BR112015031196A2 (pt) | 2017-07-25 |
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