JP2015537212A - イオン強度媒介のph勾配イオン交換クロマトグラフィー - Google Patents
イオン強度媒介のph勾配イオン交換クロマトグラフィー Download PDFInfo
- Publication number
- JP2015537212A JP2015537212A JP2015542849A JP2015542849A JP2015537212A JP 2015537212 A JP2015537212 A JP 2015537212A JP 2015542849 A JP2015542849 A JP 2015542849A JP 2015542849 A JP2015542849 A JP 2015542849A JP 2015537212 A JP2015537212 A JP 2015537212A
- Authority
- JP
- Japan
- Prior art keywords
- polypeptide
- gradient
- antibody
- ionic strength
- contaminants
- 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
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Classifications
-
- 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
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Physics & Mathematics (AREA)
- Immunology (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Food Science & Technology (AREA)
- Biotechnology (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Computational 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 |
|---|---|---|---|
| US201261727051P | 2012-11-15 | 2012-11-15 | |
| US61/727,051 | 2012-11-15 | ||
| US201361780707P | 2013-03-13 | 2013-03-13 | |
| US61/780,707 | 2013-03-13 | ||
| PCT/US2013/070415 WO2014078729A1 (en) | 2012-11-15 | 2013-11-15 | IONIC STRENGTH-MEDIATED pH GRADIENT ION EXCHANGE CHROMATOGRAPHY |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2015537212A true JP2015537212A (ja) | 2015-12-24 |
| JP2015537212A5 JP2015537212A5 (enExample) | 2016-12-28 |
Family
ID=50731733
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015542849A Pending JP2015537212A (ja) | 2012-11-15 | 2013-11-15 | イオン強度媒介のph勾配イオン交換クロマトグラフィー |
Country Status (11)
| Country | Link |
|---|---|
| US (2) | US9810670B2 (enExample) |
| EP (1) | EP2920586A4 (enExample) |
| JP (1) | JP2015537212A (enExample) |
| KR (1) | KR20150084046A (enExample) |
| CN (1) | CN105051528A (enExample) |
| BR (1) | BR112015011011A2 (enExample) |
| CA (1) | CA2890979A1 (enExample) |
| HK (1) | HK1217232A1 (enExample) |
| MX (1) | MX2015006149A (enExample) |
| RU (1) | RU2015122726A (enExample) |
| WO (1) | WO2014078729A1 (enExample) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021210662A1 (ja) * | 2020-04-17 | 2021-10-21 | 小野薬品工業株式会社 | タンパク質製剤原薬の着色除去方法 |
| JP2022547203A (ja) * | 2019-09-25 | 2022-11-10 | エフ.ホフマン-ラ ロシュ アーゲー | 予測される溶出緩衝液の塩濃度を使用するカチオンクロマトグラフィー |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014078729A1 (en) | 2012-11-15 | 2014-05-22 | Genentech, Inc. | IONIC STRENGTH-MEDIATED pH GRADIENT ION EXCHANGE CHROMATOGRAPHY |
| ES2705700T3 (es) * | 2013-07-12 | 2019-03-26 | Hoffmann La Roche | Elucidación de la optimización de entrada en cromatografía de intercambio iónico |
| EP3280444B1 (en) * | 2015-04-10 | 2024-05-08 | Adimab, LLC | Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species |
| GB2539420B (en) * | 2015-06-16 | 2021-01-13 | Cytiva Sweden Ab | Determination of chromatography conditions |
| WO2017084738A1 (en) * | 2015-11-18 | 2017-05-26 | Merck Patent Gmbh | Opposite ph-salt gradients for improved protein separations |
| KR20180083409A (ko) * | 2015-11-18 | 2018-07-20 | 메르크 파텐트 게엠베하 | 이온 교환 크로마토그래피에서의 개선된 단백질 분리 |
| CN108333264A (zh) * | 2017-01-20 | 2018-07-27 | 湖北生物医药产业技术研究院有限公司 | 检测蛋白电荷变异体的方法及确定生物制品生产工艺的方法 |
| WO2019067637A1 (en) * | 2017-09-26 | 2019-04-04 | Waters Technologies Corporation | HIGH-PURITY CHROMATOGRAPHIC MATERIALS COMPRISING AN IONIZABLE MODIFIER FOR RETENTION OF ACID ANALYTES |
| EP3791172B1 (en) | 2018-05-08 | 2023-06-28 | Waters Technologies Corporation | Methods, compositions and kits useful for ph gradient cation exchange chromatography |
| KR20200080748A (ko) * | 2018-12-27 | 2020-07-07 | 주식회사 폴루스 | 음이온 교환 크로마토그래피를 이용한 인슐린 전구체의 정제방법 |
| CN111024883B (zh) * | 2019-12-31 | 2022-12-06 | 上海博威生物医药有限公司 | 一种奥马珠单抗的电荷异质体的分离方法 |
| CN111239278B (zh) * | 2020-02-05 | 2022-11-04 | 康立泰生物医药(青岛)有限公司 | 一种检测重组人白介素-12蛋白电荷变异体的方法及应用 |
| KR102283871B1 (ko) * | 2021-03-02 | 2021-08-02 | 한국원자력연구원 | 크로마토그래피를 이용한 무담체 홀뮴-166의 분리 방법, 분리 장치 및 이에 의하여 분리된 무담체 홀뮴-166 |
| JP2024527758A (ja) * | 2021-07-13 | 2024-07-26 | 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 | 陰イオン交換クロマトグラフィー-質量分析(aex-ms)によるタンパク質の特徴付け方法 |
| WO2023107510A1 (en) * | 2021-12-06 | 2023-06-15 | Staveness Daryl | Exciplex-based methods for contaminant and disease detection and methods for use of extraction buffers |
| CN114544839B (zh) * | 2022-01-20 | 2024-08-20 | 未名生物医药有限公司 | 一种抗人神经生长因子抗体的电荷变异体检测方法 |
| WO2024134512A1 (en) * | 2022-12-20 | 2024-06-27 | Seqirus Inc. | Lipid nanoparticle composition |
| WO2024261724A1 (en) * | 2023-06-23 | 2024-12-26 | Lupin Limited | Ion-exchange chromatography for separation and analysis of charge variants |
| WO2025038736A1 (en) * | 2023-08-15 | 2025-02-20 | Gigagen, Inc. | Methods of analyzing recombinant polyclonal proteins |
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2000055203A1 (en) * | 1999-03-15 | 2000-09-21 | Novo Nordisk A/S | Ion exchange chromatographic separation of glp-1 and related peptides |
| US20060240564A1 (en) * | 2005-04-20 | 2006-10-26 | Chia-Hui Shieh | pH gradient ion exchange LC-MS and mass compatible buffers |
| WO2007075283A2 (en) * | 2005-12-06 | 2007-07-05 | Amgen Inc. | Polishing steps used in multi-step protein purification processes |
| JP2008511337A (ja) * | 2004-09-02 | 2008-04-17 | ジェネンテック・インコーポレーテッド | ヘテロ多量体分子 |
| JP2010510963A (ja) * | 2006-06-14 | 2010-04-08 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | セラミックヒドロキシアパタイトを使用する抗体の精製方法 |
| WO2011037983A1 (en) * | 2009-09-23 | 2011-03-31 | Medarex, Inc. | Cation exchange chromatography |
| WO2012084829A1 (en) * | 2010-12-21 | 2012-06-28 | F. Hoffmann-La Roche Ag | Isoform enriched antibody preparation and method for obtaining it |
| JP2013500244A (ja) * | 2009-07-24 | 2013-01-07 | エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト | 抗体製造の最適化 |
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| WO2014078729A1 (en) | 2012-11-15 | 2014-05-22 | Genentech, Inc. | IONIC STRENGTH-MEDIATED pH GRADIENT ION EXCHANGE CHROMATOGRAPHY |
-
2013
- 2013-11-15 WO PCT/US2013/070415 patent/WO2014078729A1/en not_active Ceased
- 2013-11-15 US US14/443,329 patent/US9810670B2/en active Active
- 2013-11-15 KR KR1020157015377A patent/KR20150084046A/ko not_active Withdrawn
- 2013-11-15 JP JP2015542849A patent/JP2015537212A/ja active Pending
- 2013-11-15 MX MX2015006149A patent/MX2015006149A/es unknown
- 2013-11-15 CA CA2890979A patent/CA2890979A1/en not_active Abandoned
- 2013-11-15 RU RU2015122726A patent/RU2015122726A/ru not_active Application Discontinuation
- 2013-11-15 HK HK16105250.6A patent/HK1217232A1/zh unknown
- 2013-11-15 CN CN201380070366.XA patent/CN105051528A/zh active Pending
- 2013-11-15 BR BR112015011011A patent/BR112015011011A2/pt not_active Application Discontinuation
- 2013-11-15 EP EP13855528.9A patent/EP2920586A4/en not_active Withdrawn
-
2017
- 2017-09-29 US US15/721,389 patent/US10712322B2/en active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000055203A1 (en) * | 1999-03-15 | 2000-09-21 | Novo Nordisk A/S | Ion exchange chromatographic separation of glp-1 and related peptides |
| JP2008511337A (ja) * | 2004-09-02 | 2008-04-17 | ジェネンテック・インコーポレーテッド | ヘテロ多量体分子 |
| US20060240564A1 (en) * | 2005-04-20 | 2006-10-26 | Chia-Hui Shieh | pH gradient ion exchange LC-MS and mass compatible buffers |
| WO2007075283A2 (en) * | 2005-12-06 | 2007-07-05 | Amgen Inc. | Polishing steps used in multi-step protein purification processes |
| JP2010510963A (ja) * | 2006-06-14 | 2010-04-08 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | セラミックヒドロキシアパタイトを使用する抗体の精製方法 |
| JP2013500244A (ja) * | 2009-07-24 | 2013-01-07 | エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト | 抗体製造の最適化 |
| WO2011037983A1 (en) * | 2009-09-23 | 2011-03-31 | Medarex, Inc. | Cation exchange chromatography |
| WO2012084829A1 (en) * | 2010-12-21 | 2012-06-28 | F. Hoffmann-La Roche Ag | Isoform enriched antibody preparation and method for obtaining it |
Non-Patent Citations (7)
| Title |
|---|
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| "Multiproduct High-Resolution Monoclonal Antibody Charge Variant Separations by pH Gradient Ion-Excha", ANALYTICAL CHEMISTRY, JPN6017023406, 31 August 2009 (2009-08-31), pages 8846 - 8857, ISSN: 0003752607 * |
| "Purification of ascitic fluid-derived murine monoclonal antibodies by anion-exchange and size exclus", JOURNAL OF CHROMATOGRAPHY, JPN6017023403, 7 April 1988 (1988-04-07), pages 329 - 339, ISSN: 0003752606 * |
| "Selection of pH-related parameters in ion-exchange chromatography using pH-gradient operations", JOURNAL OF CHROMATOGRAPHY, JPN6017023409, 8 December 2007 (2007-12-08), pages 22 - 29, ISSN: 0003752608 * |
| "Separation of manganese peroxidase isoenzymes on strong anion-exchange monolithic column using pH -s", JOURNAL OF CHROMATOGRAPHY, JPN6017023402, 27 October 2003 (2003-10-27), pages 343 - 347, ISSN: 0003752605 * |
| "Validation of a pH gradient-based ion-exchange chromatography method for high-resolution monoclonal", JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, JPN6017023415, 21 August 2010 (2010-08-21), pages 317 - 323, ISSN: 0003594773 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2022547203A (ja) * | 2019-09-25 | 2022-11-10 | エフ.ホフマン-ラ ロシュ アーゲー | 予測される溶出緩衝液の塩濃度を使用するカチオンクロマトグラフィー |
| JP7598929B2 (ja) | 2019-09-25 | 2024-12-12 | エフ. ホフマン-ラ ロシュ アーゲー | 予測される溶出緩衝液の塩濃度を使用するカチオンクロマトグラフィー |
| WO2021210662A1 (ja) * | 2020-04-17 | 2021-10-21 | 小野薬品工業株式会社 | タンパク質製剤原薬の着色除去方法 |
| JPWO2021210662A1 (enExample) * | 2020-04-17 | 2021-10-21 | ||
| JP7686180B2 (ja) | 2020-04-17 | 2025-06-02 | 小野薬品工業株式会社 | タンパク質製剤原薬の着色除去方法 |
Also Published As
| Publication number | Publication date |
|---|---|
| HK1217232A1 (zh) | 2016-12-30 |
| CA2890979A1 (en) | 2014-05-22 |
| US20150285771A1 (en) | 2015-10-08 |
| RU2015122726A (ru) | 2017-01-10 |
| CN105051528A (zh) | 2015-11-11 |
| BR112015011011A2 (pt) | 2019-12-17 |
| MX2015006149A (es) | 2015-08-05 |
| WO2014078729A1 (en) | 2014-05-22 |
| EP2920586A1 (en) | 2015-09-23 |
| EP2920586A4 (en) | 2017-01-04 |
| US10712322B2 (en) | 2020-07-14 |
| KR20150084046A (ko) | 2015-07-21 |
| US20180120273A1 (en) | 2018-05-03 |
| US9810670B2 (en) | 2017-11-07 |
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