BR112012014937B1 - método de produção de um anticorpo, fragmento de anticorpo ou proteína de fusão fc purificada usando uma matriz de cromatografia de afinidade - Google Patents
método de produção de um anticorpo, fragmento de anticorpo ou proteína de fusão fc purificada usando uma matriz de cromatografia de afinidade Download PDFInfo
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- BR112012014937B1 BR112012014937B1 BR112012014937-7A BR112012014937A BR112012014937B1 BR 112012014937 B1 BR112012014937 B1 BR 112012014937B1 BR 112012014937 A BR112012014937 A BR 112012014937A BR 112012014937 B1 BR112012014937 B1 BR 112012014937B1
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- Prior art keywords
- washing
- protein
- arginine
- column
- matrix
- Prior art date
Links
- 238000001042 affinity chromatography Methods 0.000 title claims abstract description 72
- 238000000034 method Methods 0.000 title claims abstract description 48
- 108010021625 Immunoglobulin Fragments Proteins 0.000 title claims description 16
- 102000008394 Immunoglobulin Fragments Human genes 0.000 title claims description 16
- 108091006020 Fc-tagged proteins Proteins 0.000 title claims description 8
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- 239000004475 Arginine Substances 0.000 claims abstract description 83
- 150000003839 salts Chemical class 0.000 claims abstract description 80
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims abstract description 79
- 239000012535 impurity Substances 0.000 claims abstract description 38
- 229960003121 arginine Drugs 0.000 claims description 82
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- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical group OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims description 11
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- SEQKRHFRPICQDD-UHFFFAOYSA-N N-tris(hydroxymethyl)methylglycine Chemical compound OCC(CO)(CO)[NH2+]CC([O-])=O SEQKRHFRPICQDD-UHFFFAOYSA-N 0.000 description 3
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- ODKSFYDXXFIFQN-SCSAIBSYSA-N D-arginine Chemical compound OC(=O)[C@H](N)CCCNC(N)=N ODKSFYDXXFIFQN-SCSAIBSYSA-N 0.000 description 2
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- JOCBASBOOFNAJA-UHFFFAOYSA-N N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid Chemical compound OCC(CO)(CO)NCCS(O)(=O)=O JOCBASBOOFNAJA-UHFFFAOYSA-N 0.000 description 2
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- 239000008351 acetate buffer Substances 0.000 description 2
- SNEIUMQYRCDYCH-UHFFFAOYSA-N acetylarginine Chemical compound CC(=O)NC(C(O)=O)CCCN=C(N)N SNEIUMQYRCDYCH-UHFFFAOYSA-N 0.000 description 2
- 230000002776 aggregation Effects 0.000 description 2
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- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- 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
- 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
- C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
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- Chemical & Material Sciences (AREA)
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- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Virology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Applications Claiming Priority (3)
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| US28805909P | 2009-12-18 | 2009-12-18 | |
| US61/288,059 | 2009-12-18 | ||
| PCT/EP2010/070076 WO2011073389A1 (en) | 2009-12-18 | 2010-12-17 | Wash solution and method for affinity chromatography |
Publications (2)
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| BR112012014937A2 BR112012014937A2 (pt) | 2016-03-08 |
| BR112012014937B1 true BR112012014937B1 (pt) | 2021-01-19 |
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| SG10201702951RA (en) | 2008-10-20 | 2017-06-29 | Abbvie Inc | Viral inactivation during purification of antibodies |
| PL3272764T3 (pl) * | 2009-12-18 | 2024-06-10 | Novartis Ag | Sposób chromatografii powinowactwa |
| JP5567691B2 (ja) * | 2010-01-22 | 2014-08-06 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | Ｆｃ含有タンパク質を精製するためのクロマトグラフィー法 |
| WO2012164046A1 (en) * | 2011-06-01 | 2012-12-06 | Novartis Ag | Wash solution and method for affinity chromatography |
| KR102492792B1 (ko) | 2011-10-11 | 2023-01-30 | 제넨테크, 인크. | 이중특이적 항체의 개선된 어셈블리 |
| CA2910065C (en) * | 2013-05-15 | 2023-09-19 | Medimmune Limited | Purification of recombinantly produced polypeptides |
| EP3041593B1 (en) * | 2013-09-05 | 2025-01-29 | F. Hoffmann-La Roche AG | Method of cleaning a chromatography material for its reuse |
| US9546208B2 (en) | 2014-01-03 | 2017-01-17 | Bio-Rad Laboratories, Inc. | Removal of impurities from protein A eluates |
| US11566082B2 (en) | 2014-11-17 | 2023-01-31 | Cytiva Bioprocess R&D Ab | Mutated immunoglobulin-binding polypeptides |
| EA035635B1 (ru) | 2015-03-13 | 2020-07-17 | Бристол-Маерс Сквибб Компани | Использование щелочных промывочных растворов во время хроматографии для удаления примесей |
| CN107849122B (zh) * | 2015-08-21 | 2022-01-25 | 豪夫迈·罗氏有限公司 | 用低电导率洗涤缓冲液进行亲和层析纯化 |
| AU2016312909B2 (en) | 2015-08-21 | 2022-12-08 | F. Hoffmann-La Roche Ag | Method for the reduction of host cell proteins in affinity chromatography |
| US11753438B2 (en) | 2016-05-11 | 2023-09-12 | Cytiva Bioprocess R&D Ab | Method of cleaning and/or sanitizing a separation matrix |
| JP7031934B2 (ja) | 2016-05-11 | 2022-03-08 | サイティバ・バイオプロセス・アールアンドディ・アクチボラグ | 分離マトリックス |
| US10513537B2 (en) | 2016-05-11 | 2019-12-24 | Ge Healthcare Bioprocess R&D Ab | Separation matrix |
| US10730908B2 (en) | 2016-05-11 | 2020-08-04 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| US10654887B2 (en) | 2016-05-11 | 2020-05-19 | Ge Healthcare Bio-Process R&D Ab | Separation matrix |
| US10889615B2 (en) | 2016-05-11 | 2021-01-12 | Cytiva Bioprocess R&D Ab | Mutated immunoglobulin-binding polypeptides |
| US10703774B2 (en) | 2016-09-30 | 2020-07-07 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| JP7106187B2 (ja) | 2016-05-11 | 2022-07-26 | サイティバ・バイオプロセス・アールアンドディ・アクチボラグ | 分離マトリックスを保存する方法 |
| ES2994244T3 (en) * | 2016-07-25 | 2025-01-21 | Cephalon Llc | Affinity chromatography wash buffer |
| US12448411B2 (en) | 2016-09-30 | 2025-10-21 | Cytiva Bioprocess R&D Ab | Separation method |
| CN111344410B (zh) | 2017-08-17 | 2023-09-15 | 济世易为生物有限公司 | 从宿主细胞半乳糖凝集素和其他污染物中纯化糖基化蛋白的方法 |
| CN107793469B (zh) * | 2017-10-16 | 2021-07-30 | 上海药明生物技术有限公司 | 一种去除宿主细胞蛋白含量的亲和纯化工艺 |
| EP3728288B1 (en) * | 2017-12-21 | 2022-01-19 | Genzyme Corporation | Methods for enhanced removal of impurities during protein a chromatography |
| CN119881293A (zh) | 2018-03-21 | 2025-04-25 | 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 |
| US11407838B2 (en) | 2018-04-02 | 2022-08-09 | Amgen Inc. | Erenumab compositions and uses thereof |
| CN112105927B (zh) * | 2018-05-08 | 2024-06-25 | 沃特世科技公司 | 可用于pH梯度阳离子交换色谱法的方法、组合物和试剂盒 |
| WO2021072005A1 (en) * | 2019-10-08 | 2021-04-15 | North Carolina State University | Immunoglobulin purification peptides and their use |
| CA3176109A1 (en) * | 2020-03-27 | 2021-09-30 | Haemalogix Pty Ltd | Composition and method |
| JP2023523324A (ja) * | 2020-04-27 | 2023-06-02 | アレクシオン ファーマシューティカルズ， インコーポレイテッド | 抗体のプロテインａクロマトグラフィー精製 |
| CN112827217A (zh) * | 2020-12-29 | 2021-05-25 | 苏州良辰生物医药科技有限公司 | 一种层析柱清洗液及其应用 |
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| WO2024233992A2 (en) * | 2023-05-11 | 2024-11-14 | Trophogen, Inc. | Methods of manufacturing highly glycosylated glycoprotein hormones and their analogs |
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| EP2321338A1 (en) | 2008-08-14 | 2011-05-18 | Merck Sharp & Dohme Corp. | Methods for purifying antibodies using protein a affinity chromatography |
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| WO2012164046A1 (en) * | 2011-06-01 | 2012-12-06 | Novartis Ag | Wash solution and method for affinity chromatography |
-
2010
- 2010-12-17 PL PL17188657.5T patent/PL3272764T3/pl unknown
- 2010-12-17 PL PL10790452T patent/PL2513134T3/pl unknown
- 2010-12-17 ES ES17188657T patent/ES2982297T3/es active Active
- 2010-12-17 AU AU2010332778A patent/AU2010332778B2/en active Active
- 2010-12-17 BR BR112012014937-7A patent/BR112012014937B1/pt active IP Right Grant
- 2010-12-17 CA CA2784278A patent/CA2784278C/en active Active
- 2010-12-17 SG SG10201408384PA patent/SG10201408384PA/en unknown
- 2010-12-17 CN CN201080057457.6A patent/CN102725304B/zh active Active
- 2010-12-17 WO PCT/EP2010/070076 patent/WO2011073389A1/en not_active Ceased
- 2010-12-17 US US13/516,960 patent/US9505803B2/en active Active
- 2010-12-17 RU RU2012130151/10A patent/RU2564569C2/ru active
- 2010-12-17 LT LTEP17188657.5T patent/LT3272764T/lt unknown
- 2010-12-17 SG SG2012044707A patent/SG181771A1/en unknown
- 2010-12-17 DK DK17188657.5T patent/DK3272764T3/da active
- 2010-12-17 KR KR1020127015524A patent/KR101858266B1/ko active Active
- 2010-12-17 ES ES10790452.6T patent/ES2651065T3/es active Active
- 2010-12-17 PT PT107904526T patent/PT2513134T/pt unknown
- 2010-12-17 PT PT171886575T patent/PT3272764T/pt unknown
- 2010-12-17 DK DK10790452.6T patent/DK2513134T3/en active
- 2010-12-17 EP EP17188657.5A patent/EP3272764B1/en active Active
- 2010-12-17 LT LTEP10790452.6T patent/LT2513134T/lt unknown
- 2010-12-17 JP JP2012543787A patent/JP5909450B2/ja active Active
- 2010-12-17 EP EP10790452.6A patent/EP2513134B1/en not_active Revoked
- 2010-12-17 MX MX2012007103A patent/MX2012007103A/es unknown
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2012
- 2012-06-04 IL IL220164A patent/IL220164B/en active IP Right Grant
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2016
- 2016-02-08 JP JP2016021798A patent/JP2016128495A/ja active Pending
- 2016-10-28 US US15/336,878 patent/US20170044211A1/en not_active Abandoned
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2019
- 2019-03-25 US US16/363,170 patent/US20190233469A1/en not_active Abandoned
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