BRPI0610201B8 - método para a purificação de anticorpo monoclonal a partir de agregados do mesmo - Google Patents
método para a purificação de anticorpo monoclonal a partir de agregados do mesmoInfo
- Publication number
- BRPI0610201B8 BRPI0610201B8 BRPI0610201A BRPI0610201A BRPI0610201B8 BR PI0610201 B8 BRPI0610201 B8 BR PI0610201B8 BR PI0610201 A BRPI0610201 A BR PI0610201A BR PI0610201 A BRPI0610201 A BR PI0610201A BR PI0610201 B8 BRPI0610201 B8 BR PI0610201B8
- Authority
- BR
- Brazil
- Prior art keywords
- aggregates
- monoclonal antibody
- ion exchange
- purifying monoclonal
- immunoglobulin
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 4
- 108060003951 Immunoglobulin Proteins 0.000 abstract 3
- 102000018358 immunoglobulin Human genes 0.000 abstract 3
- 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 abstract 2
- 238000010828 elution Methods 0.000 abstract 2
- 239000003456 ion exchange resin Substances 0.000 abstract 2
- 229920003303 ion-exchange polymer Polymers 0.000 abstract 2
- 238000000746 purification Methods 0.000 abstract 2
- 238000004587 chromatography analysis Methods 0.000 abstract 1
- 229940072221 immunoglobulins Drugs 0.000 abstract 1
- 238000004255 ion exchange chromatography Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
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
-
- 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
- B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
- B01D15/424—Elution mode
- B01D15/426—Specific type of solvent
-
- 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
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—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 cytokines, lymphokines, interferons
-
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/96—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Physics & Mathematics (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
método para a purificação de anticorpos. a presente invenção refere-se a método para a purificação de imunoglobulinas através de cromatografia de troca de íon que é descrito. o método cromatográfico usa uma resina de troca de íon fraca e um processo de eluição de etapa única para a purificação de uma imunoglobulina. adicionalmente um método para a determinação da concentração de sal para a eluição de etapa única de uma imunoglobulina a partir de uma resina de troca de íon é descrito.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05011302 | 2005-05-25 | ||
| EP05011302.6 | 2005-05-25 | ||
| PCT/EP2006/004863 WO2006125599A2 (en) | 2005-05-25 | 2006-05-23 | Method for the purification of antibodies |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BRPI0610201A2 BRPI0610201A2 (pt) | 2010-06-01 |
| BRPI0610201B1 BRPI0610201B1 (pt) | 2020-12-29 |
| BRPI0610201B8 true BRPI0610201B8 (pt) | 2021-05-25 |
Family
ID=34936911
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0610201A BRPI0610201B8 (pt) | 2005-05-25 | 2006-05-23 | método para a purificação de anticorpo monoclonal a partir de agregados do mesmo |
Country Status (18)
| Country | Link |
|---|---|
| US (3) | US20090098660A1 (pt) |
| EP (2) | EP2261252B2 (pt) |
| JP (1) | JP4852602B2 (pt) |
| KR (1) | KR100967778B1 (pt) |
| CN (1) | CN101180317B (pt) |
| AT (1) | ATE525087T1 (pt) |
| AU (1) | AU2006251307B2 (pt) |
| BR (1) | BRPI0610201B8 (pt) |
| CA (1) | CA2607375C (pt) |
| DK (1) | DK1888636T4 (pt) |
| ES (2) | ES2373402T5 (pt) |
| FI (1) | FI1888636T4 (pt) |
| IL (2) | IL186338A (pt) |
| MX (1) | MX2007014269A (pt) |
| NO (1) | NO345362B1 (pt) |
| PL (1) | PL1888636T5 (pt) |
| TW (2) | TWI391399B (pt) |
| WO (1) | WO2006125599A2 (pt) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
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| TWI391399B (zh) | 2005-05-25 | 2013-04-01 | Hoffmann La Roche | 測定溶離多肽之鹽濃度之方法 |
| BRPI0812288A2 (pt) | 2007-06-01 | 2014-11-25 | Hoffmann La Roche | Purificação de imunoglobulina. |
| AR067536A1 (es) * | 2007-07-17 | 2009-10-14 | Hoffmann La Roche | Metodo para obtener una eritropoyetina mono-pegilada en una forma sustancialmente homogenea |
| AR067537A1 (es) * | 2007-07-17 | 2009-10-14 | Hoffmann La Roche | Purificacion de polipeptidos pegilados |
| SG2013061528A (en) * | 2008-08-14 | 2015-03-30 | Merck Sharp & Dohme | Methods for purifying antibodies using protein a affinity chromatography |
| MX348739B (es) | 2010-03-10 | 2017-06-27 | F Hoffmann-La Roche Ag * | Metodo para purificar soluciones de inmunoglobulina. |
| CN102884080A (zh) * | 2010-04-14 | 2013-01-16 | 弗·哈夫曼-拉罗切有限公司 | 移除免疫球蛋白聚集物 |
| MX344268B (es) * | 2010-10-11 | 2016-12-09 | Abbvie Inc * | Proceso para purificacion de proteinas. |
| KR101574864B1 (ko) * | 2010-12-21 | 2015-12-11 | 에프. 호프만-라 로슈 아게 | 이소폼이 농축된 항체 제제 및 그의 제조 방법 |
| WO2012123488A1 (en) * | 2011-03-16 | 2012-09-20 | F. Hoffmann-La Roche Ag | Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase |
| JP6292718B2 (ja) * | 2011-07-01 | 2018-03-14 | エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft | 凝集ポリペプチドから単量体ポリペプチドを分離するための方法 |
| US10481164B2 (en) * | 2012-03-26 | 2019-11-19 | Amgen Inc. | Method for using light scattering in real time to directly monitor and control impurity removal in purification processes |
| JPWO2015041218A1 (ja) * | 2013-09-17 | 2017-03-02 | 株式会社カネカ | 新規抗体精製方法及びそれから得られる抗体(NovelAntibodyPurificationMethodandAntibodyobtainedtherefrom)、並びに陽イオン交換基を用いた新規抗体精製法及びそれから得られる抗体(NovelAntibodyPurificationmethodusingCationExchangerandAntibodyobtainedtherefrom) |
| KR101700580B1 (ko) | 2013-10-30 | 2017-02-13 | (주)셀트리온 | 양이온 교환 크로마토그래피를 이용한 항체의 아형 분리 방법 |
| CN106103478B (zh) | 2014-03-21 | 2020-04-03 | 豪夫迈·罗氏有限公司 | 抗体体内半寿期的体外预测 |
| RU2714116C2 (ru) | 2014-11-06 | 2020-02-11 | Ф. Хоффманн-Ля Рош Аг | ВАРИАНТЫ Fc-ОБЛАСТИ С МОДИФИЦИРОВАННЫМ СВЯЗЫВАНИЕМ FcRn И СПОСОБЫ ИХ ПРИМЕНЕНИЯ |
| GB2539420B (en) * | 2015-06-16 | 2021-01-13 | Cytiva Sweden Ab | Determination of chromatography conditions |
| MX2018005831A (es) * | 2015-11-18 | 2018-08-01 | Merck Patent Gmbh | Gradientes de ph-sal opuestos para separaciones de proteina mejoradas. |
| WO2017084737A1 (en) * | 2015-11-18 | 2017-05-26 | Merck Patent Gmbh | Improved protein separation in ion exchange chromatography |
| 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 |
| WO2019192877A1 (en) * | 2018-04-03 | 2019-10-10 | Merck Patent Gmbh | Cex chromatography media and low salt elution of target proteins from biopharmaceutical feeds |
| CN111068361B (zh) * | 2018-10-22 | 2022-02-11 | 中国石油化工股份有限公司 | 一种己内酰胺离子交换装置及其再生方法 |
| CN110066314B (zh) * | 2019-04-01 | 2023-10-27 | 上海药明生物技术有限公司 | 一种高效提高多聚体分离分辨率的亲和纯化工艺 |
| TW202128264A (zh) * | 2019-09-25 | 2021-08-01 | 瑞士商赫孚孟拉羅股份公司 | 使用經預測之溶離緩衝鹽濃度的陽離子層析法 |
| JP2023511946A (ja) * | 2020-01-24 | 2023-03-23 | アルカームス ファーマ アイルランド リミテッド | 精製方法 |
| CN115728433B (zh) * | 2021-08-27 | 2024-11-15 | 联邦生物科技(珠海横琴)有限公司 | IgG4型单克隆抗体电荷异质性的离子交换色谱检测方法 |
| CN116295834A (zh) * | 2022-01-05 | 2023-06-23 | 上海迈晋生物医药科技有限公司 | 一种生物制品在层析工艺中的表观稳定性的在线监测方法 |
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| DE59309332D1 (de) | 1993-12-27 | 1999-03-04 | Rotkreuzstiftung Zentratrallab | Verfahren zur Herstellung eines Konzentrates von Anti-D-Immunoglobulin G und pharmazeutische Zusammensetzung, die dieses enthält |
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| UA64742C2 (uk) | 1997-12-24 | 2004-03-15 | Альфа Терапевтик Корпорейшн | СПОСІБ ОДЕРЖАННЯ РОЗЧИНУ <font face="Symbol">g</font>-ГЛОБУЛІНУ, ПРИЗНАЧЕНОГО ДЛЯ ВНУТРІШНЬОВЕННОГО ВВЕДЕННЯ, І ПРОДУКТ, ЩО ОДЕРЖУЄТЬСЯ У ЦЕЙ СПОСІБ (ВАРІАНТИ) |
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| US6413427B2 (en) † | 2000-03-29 | 2002-07-02 | Ecokasa Incorporated | Nitrogen reduction wastewater treatment system |
| SE0001128D0 (sv) | 2000-03-30 | 2000-03-30 | Amersham Pharm Biotech Ab | A method of producing IgG |
| US6962700B1 (en) * | 2000-09-13 | 2005-11-08 | Atopix Pharmaceuticals Corporation | Method of manufacturing immune globulin |
| US20060234226A1 (en) * | 2002-04-26 | 2006-10-19 | Fahner Robert L | Non-affinity purification of proteins |
| US20050276812A1 (en) * | 2004-06-01 | 2005-12-15 | Genentech, Inc. | Antibody-drug conjugates and methods |
| CA2496060C (en) | 2002-09-11 | 2015-08-04 | Genentech, Inc. | Protein purification by ion exchange chromatography |
| CN1490334A (zh) * | 2002-10-18 | 2004-04-21 | 缪金明 | 基因特异性抗体的亲和纯化方法 |
| PT1601697E (pt) | 2003-02-28 | 2007-09-04 | Lonza Biologics Plc | Purificação de anticorpos através de proteína a e cromatografia de troca iónica. |
| AR045614A1 (es) | 2003-09-10 | 2005-11-02 | Hoffmann La Roche | Anticuerpos contra el recepctor de la interleuquina- 1 y los usos de los mismos |
| TWI391399B (zh) * | 2005-05-25 | 2013-04-01 | Hoffmann La Roche | 測定溶離多肽之鹽濃度之方法 |
-
2006
- 2006-05-19 TW TW098127045A patent/TWI391399B/zh active
- 2006-05-19 TW TW095118030A patent/TWI320788B/zh active
- 2006-05-23 AT AT06753791T patent/ATE525087T1/de active
- 2006-05-23 JP JP2008512752A patent/JP4852602B2/ja active Active
- 2006-05-23 US US11/920,288 patent/US20090098660A1/en not_active Abandoned
- 2006-05-23 AU AU2006251307A patent/AU2006251307B2/en active Active
- 2006-05-23 PL PL06753791.0T patent/PL1888636T5/pl unknown
- 2006-05-23 CA CA2607375A patent/CA2607375C/en active Active
- 2006-05-23 KR KR1020077027285A patent/KR100967778B1/ko active Active
- 2006-05-23 EP EP10175706.0A patent/EP2261252B2/en active Active
- 2006-05-23 MX MX2007014269A patent/MX2007014269A/es active IP Right Grant
- 2006-05-23 EP EP06753791.0A patent/EP1888636B2/en active Active
- 2006-05-23 CN CN200680017966XA patent/CN101180317B/zh active Active
- 2006-05-23 BR BRPI0610201A patent/BRPI0610201B8/pt active IP Right Grant
- 2006-05-23 WO PCT/EP2006/004863 patent/WO2006125599A2/en not_active Ceased
- 2006-05-23 DK DK06753791.0T patent/DK1888636T4/da active
- 2006-05-23 ES ES06753791T patent/ES2373402T5/es active Active
- 2006-05-23 FI FIEP06753791.0T patent/FI1888636T4/fi active
- 2006-05-23 ES ES10175706T patent/ES2389641T5/es active Active
-
2007
- 2007-10-07 IL IL186338A patent/IL186338A/en active IP Right Grant
- 2007-10-09 NO NO20075091A patent/NO345362B1/no unknown
-
2010
- 2010-07-14 IL IL206993A patent/IL206993A0/en active IP Right Grant
-
2014
- 2014-05-06 US US14/271,058 patent/US9631007B2/en active Active
-
2017
- 2017-03-14 US US15/458,368 patent/US11034754B2/en active Active
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