DK2513134T3 - Vaskeopløsning og fremgangsmåde til affinitetschromatografi - Google Patents
Vaskeopløsning og fremgangsmåde til affinitetschromatografi Download PDFInfo
- Publication number
- DK2513134T3 DK2513134T3 DK10790452.6T DK10790452T DK2513134T3 DK 2513134 T3 DK2513134 T3 DK 2513134T3 DK 10790452 T DK10790452 T DK 10790452T DK 2513134 T3 DK2513134 T3 DK 2513134T3
- Authority
- DK
- Denmark
- Prior art keywords
- protein
- arginine
- column
- wash
- matrix
- Prior art date
Links
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 - B01D15/36
- B01D15/3804—Affinity chromatography
- B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G, 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
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Biophysics (AREA)
- Medicinal Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (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)
Claims (15)
1. Fremgangsmåde til fremstilling af et oprenset antistof, antistoffragment eller Fc fusionsprotein, under anvendelse af en affinitetchromatografi-(AC)-matrix, hvortil antistoffet, antistoffragmentet eller Fc fusionsproteinet bindes, hvilken fremgangsmåde omfatter: (a) tilførsel af en blanding omfattende antistoffet, antistoffragmentet eller Fc fusionsproteinet til AC matrixen; og (b) vaskning af AC matrixen med en vaskeopløsning omfattende såvel (i) arginin eller et argininderivat valgt fra gruppen bestående af acetylarginin, N-a-butyroyl-arginin, agmatin, argininsyre og N-a-pyvaloyl-arginin ved en koncentration i området fra 0,05-0,85 M, og (ii) et ikke-buffersalt med en koncentration i området 0,1-2,0 M, hvor vaskeopløsningen fjerner urenheder fra AC matrixen; og (c) eluering af antistoffet, antistoffragmentet eller Fc fusionsproteinet fra AC matrixen; med den forudsætning, at hvis et oprenset Fc fusionsprotein fremstilles, vælges AC matrixen fra gruppen bestående af en protein A søjle, en protein G søjle, en protein A/G søjle og en protein L søjle.
2. Fremgangsmåde ifølge krav 1, hvor AC matrixen er en protein A søjle.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor ikke-buffersaltet er et halogensalt.
4. Fremgangsmåde ifølge krav 3, hvor halogensaltet er natriumchlorid.
5. Fremgangsmåde ifølge ethvert af kravene 1-4, hvor fremgangsmåden er til fremstilling af et oprenset Fc fusionsprotein og AC matrixen er en protein A søjle, en protein G søjle, en protein A/G søjle eller en protein L søjle.
6. Fremgangsmåde ifølge ethvert af kravene 1-5, hvor fremgangsmåden er til fremstilling af et oprenset antistof eller antistoffragment.
7. Fremgangsmåde ifølge ethvert af kravene 1-6, hvor argininet eller argininderivatet er med en koncentration på eller omkring 0,25 M.
8. Fremgangsmåde ifølge ethvert af kravene 1-7, hvor argininet er arginin-HCI.
9. Fremgangsmåde ifølge ethvert af kravene 1-8, hvor ikke-buffersaltet er med en koncentration på eller omkring 1 M.
10. Fremgangsmåde ifølge ethvert af kravene 1-9, hvor pH for vaskeopløsningen er større end 8,0.
11. Fremgangsmåde ifølge ethvert af kravene 1-10, hvor pH for vaskeopløsningen er i et område på omkring 8,5-9,5.
12. Fremgangsmåde ifølge krav 11, hvor pH for vaskeopløsningen er 9,0.
13. Fremgangsmåde ifølge ethvert af kravene 1-12, hvor pH for vaskeopløsningen er i det mindste 8,5.
14. Fremgangsmåde ifølge ethvert af kravene 1-13, hvor urenhederne omfatter komponenter med høj molekylvægt (HMW).
15. Fremgangsmåde ifølge ethvert af kravene 1-14, hvor urenhederne omfatter værtscelleproteiner (HCP's).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US28805909P | 2009-12-18 | 2009-12-18 | |
| PCT/EP2010/070076 WO2011073389A1 (en) | 2009-12-18 | 2010-12-17 | Wash solution and method for affinity chromatography |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2513134T3 true DK2513134T3 (da) | 2017-12-18 |
Family
ID=43598315
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10790452.6T DK2513134T3 (da) | 2009-12-18 | 2010-12-17 | Vaskeopløsning og fremgangsmåde til affinitetschromatografi |
| DK17188657.5T DK3272764T3 (da) | 2009-12-18 | 2010-12-17 | Fremgangsmåde til affinitetskromatografi |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17188657.5T DK3272764T3 (da) | 2009-12-18 | 2010-12-17 | Fremgangsmåde til affinitetskromatografi |
Country Status (18)
| Country | Link |
|---|---|
| US (3) | US9505803B2 (da) |
| EP (2) | EP2513134B1 (da) |
| JP (2) | JP5909450B2 (da) |
| KR (1) | KR101858266B1 (da) |
| CN (1) | CN102725304B (da) |
| AU (1) | AU2010332778B2 (da) |
| BR (1) | BR112012014937B1 (da) |
| CA (1) | CA2784278C (da) |
| DK (2) | DK2513134T3 (da) |
| ES (1) | ES2651065T3 (da) |
| IL (1) | IL220164B (da) |
| LT (2) | LT2513134T (da) |
| MX (1) | MX2012007103A (da) |
| PL (2) | PL3272764T3 (da) |
| PT (2) | PT3272764T (da) |
| RU (1) | RU2564569C2 (da) |
| SG (2) | SG10201408384PA (da) |
| WO (1) | WO2011073389A1 (da) |
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| US8093045B2 (en) | 2006-09-13 | 2012-01-10 | Abbott Laboratories | Fed-batch cell culture methods using non-animal-based hydrolysates |
| US8911964B2 (en) | 2006-09-13 | 2014-12-16 | Abbvie Inc. | Fed-batch method of making human anti-TNF-alpha antibody |
| NZ592095A (en) | 2008-10-20 | 2013-01-25 | Abbott Lab | Isolation and purification of il-12 and tnf-alpha antibodies using protein a affinity chromatography |
| EP2346897A2 (en) | 2008-10-20 | 2011-07-27 | Abbott Laboratories | Viral inactivation during purification of antibodies |
| MX2012007103A (es) | 2009-12-18 | 2012-07-17 | Novartis Ag | Solucion y metodo de lavado por cromatografia de afinidad. |
| EP2526114B1 (de) | 2010-01-22 | 2014-06-18 | Boehringer Ingelheim International GmbH | Chromatographisches verfahren zur aufreinigung von fc enthaltenden proteinen |
| LT2714714T (lt) * | 2011-06-01 | 2018-09-25 | Novartis Ag | Plovimo tirpalas ir afininės chromatografijos būdas |
| EP3418306B1 (en) | 2011-10-11 | 2023-12-06 | F. Hoffmann-La Roche AG | Improved assembly of bispecific antibodies |
| EP3907233A1 (en) | 2013-05-15 | 2021-11-10 | MedImmune Limited | Purification of recombinantly produced polypeptides |
| WO2015035180A1 (en) * | 2013-09-05 | 2015-03-12 | Genentech, Inc. | Method for chromatography 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 |
| EP3268100A1 (en) | 2015-03-13 | 2018-01-17 | Bristol-Myers Squibb Company | Use of alkaline washes during chromatography to remove impurities |
| WO2017032686A1 (en) | 2015-08-21 | 2017-03-02 | F. Hoffmann-La Roche Ag | Method for the reduction of host cell proteins in affinity chromatography |
| US10703774B2 (en) | 2016-09-30 | 2020-07-07 | 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 |
| EP3455241B1 (en) | 2016-05-11 | 2022-02-23 | Cytiva BioProcess R&D AB | Method of cleaning and/or sanitizing a separation matrix |
| US10889615B2 (en) | 2016-05-11 | 2021-01-12 | Cytiva Bioprocess R&D Ab | Mutated immunoglobulin-binding polypeptides |
| US10730908B2 (en) | 2016-05-11 | 2020-08-04 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| WO2017194597A1 (en) | 2016-05-11 | 2017-11-16 | Ge Healthcare Bioprocess R&D Ab | Separation matrix |
| 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 |
| CA3031028C (en) * | 2016-07-25 | 2024-02-13 | Lu Wang | Affinity chromatography wash buffer |
| KR102578087B1 (ko) | 2017-08-17 | 2023-09-18 | 저스트-에보텍 바이오로직스, 아이엔씨. | 숙주세포 갈렉틴(galectins) 및 다른 오염물(contaminant)로부터 글리코실화 단백질을 정제하는 방법 |
| 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 |
| IL311002A (en) * | 2017-12-21 | 2024-04-01 | Genzyme Corp | Methods for improved removal of impurities during protein A chromatography |
| WO2019183334A1 (en) | 2018-03-21 | 2019-09-26 | Waters Technologies Corporation | Non-antibody high-affinity-based sample preparation, sorbents, devices and methods |
| AU2019246983A1 (en) | 2018-04-02 | 2020-10-29 | 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 |
| CN114502569A (zh) * | 2019-10-08 | 2022-05-13 | 北卡罗莱纳州立大学 | 免疫球蛋白纯化肽及其用途 |
| CN115551877A (zh) * | 2020-03-27 | 2022-12-30 | 哈马洛吉克斯有限公司 | 组合物和方法 |
| 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 |
| WO2024126337A1 (en) * | 2022-12-12 | 2024-06-20 | H. Lundbeck A/S | Arginine wash in protein purification |
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| LT2714714T (lt) * | 2011-06-01 | 2018-09-25 | Novartis Ag | Plovimo tirpalas ir afininės chromatografijos būdas |
-
2010
- 2010-12-17 MX MX2012007103A patent/MX2012007103A/es unknown
- 2010-12-17 RU RU2012130151/10A patent/RU2564569C2/ru active
- 2010-12-17 EP EP10790452.6A patent/EP2513134B1/en active Active
- 2010-12-17 PT PT171886575T patent/PT3272764T/pt unknown
- 2010-12-17 WO PCT/EP2010/070076 patent/WO2011073389A1/en active Application Filing
- 2010-12-17 US US13/516,960 patent/US9505803B2/en active Active
- 2010-12-17 DK DK10790452.6T patent/DK2513134T3/da active
- 2010-12-17 DK DK17188657.5T patent/DK3272764T3/da active
- 2010-12-17 PT PT107904526T patent/PT2513134T/pt unknown
- 2010-12-17 JP JP2012543787A patent/JP5909450B2/ja active Active
- 2010-12-17 ES ES10790452.6T patent/ES2651065T3/es active Active
- 2010-12-17 LT LTEP10790452.6T patent/LT2513134T/lt unknown
- 2010-12-17 SG SG10201408384PA patent/SG10201408384PA/en unknown
- 2010-12-17 PL PL17188657.5T patent/PL3272764T3/pl unknown
- 2010-12-17 LT LTEP17188657.5T patent/LT3272764T/lt unknown
- 2010-12-17 CA CA2784278A patent/CA2784278C/en 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 CN CN201080057457.6A patent/CN102725304B/zh active Active
- 2010-12-17 SG SG2012044707A patent/SG181771A1/en unknown
- 2010-12-17 EP EP17188657.5A patent/EP3272764B1/en active Active
- 2010-12-17 PL PL10790452T patent/PL2513134T3/pl unknown
- 2010-12-17 KR KR1020127015524A patent/KR101858266B1/ko active IP Right Grant
-
2012
- 2012-06-04 IL IL220164A patent/IL220164B/en active IP Right Grant
-
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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