SI2686334T1 - Ionska izmenjevalna kromatografija z izboljšano selektivnostjo za ločevanje polipeptidnih monomerov, agregatov in fragmentov s spremembo mobilne faze - Google Patents
Ionska izmenjevalna kromatografija z izboljšano selektivnostjo za ločevanje polipeptidnih monomerov, agregatov in fragmentov s spremembo mobilne faze Download PDFInfo
- Publication number
- SI2686334T1 SI2686334T1 SI201231179T SI201231179T SI2686334T1 SI 2686334 T1 SI2686334 T1 SI 2686334T1 SI 201231179 T SI201231179 T SI 201231179T SI 201231179 T SI201231179 T SI 201231179T SI 2686334 T1 SI2686334 T1 SI 2686334T1
- Authority
- SI
- Slovenia
- Prior art keywords
- antibody
- poly
- ethylene glycol
- sorbitol
- solution
- Prior art date
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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
- C07K1/18—Ion-exchange chromatography
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- B01D15/361—Ion-exchange
- B01D15/362—Cation-exchange
-
- 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
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
-
- 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
- C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting 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
- C07K16/2866—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
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Analytical Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Endocrinology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (5)
- Ionska izmenjevalna kromatografija z izboljšano selektivnostjo za ločevanje polipeptidnih monomerov, agregatov in fragmentov s spremembo mobilne faze Patentni zahtevki1. Postopek pridobivanja protiteles razreda IgG v monomerni obliki vključuje naslednje korake: - uporaba prve raztopine, ki lahko kot izbirno možnost vključuje poli (etilenglikol) in sorbitol, na kationskem izmenjevalnem kromatografskem materialu, s čimer se material uravnoteži, - uporaba raztopine, ki vključuje protitelo razreda IgG, na uravnoteženem kromatografskem materialu in s tem polnjenje kromatografskega materiala, - pridobivanje protitelesa razreda IgG v monomerni obliki z uporabo raztopine na kromatografskem materialu, ki vključuje poli (etilenglikol) in sorbitol, in s tem desorpcijo/izpiranje protitelesa razreda IgG v monomerni obliki iz kromatografskega materiala, pri čemer ima poli (etilenglikol) koncentracijo 10 % w/w, sorbitol pa ima koncentracijo 5-20 % w/w.
- 2. Postopek pridobivanja pripravka protiteles razreda IgG z zmanjšano vsebnostjo beljakovin gostiteljske celice vključuje naslednje korake: - uporaba prve raztopine, ki lahko kot izbirno možnost vključuje poli (etilenglikol) in sorbitol, na kationskem izmenjevalnem kromatografskem materialu, s čimer se material uravnoteži, - uporaba raztopine, ki vključuje protitelo razreda IgG, na uravnoteženem kromatografskem materialu in s tem polnjenje kromatografskega materiala, - pridobivanje protitelesa razreda IgG v monomerni obliki 2* upotabo*..... raztopine na kromatografskem materialu, ki vključuje poli (etilenglikol) in sorbitol, in s tem desorpcijo/izpiranje protitelesa razreda IgG v monomerni obliki iz kromatografskega materiala, pri čemer ima poli (etilenglikol) koncentracijo 10 % w/w, sorbitol pa ima koncentracijo 5-20 % w/w.
- 3. Postopek po katerem koli od predhodnih zahtevkov, označen s tem, da ima poli (etilenglikol) molekulsko težo 3.500 Da +/-20 %.
- 4. Postopek po katerem koli od predhodnih zahtevkov, označen s tem, da ima poli (etilenglikol) molekulsko težo od 100 kDa do 200 kDa.
- 5. Postopek a pridobivanja štiriverižnega protitelesa CrossMab s polno dolžino verig v monomerni obliki, ki vključuje naslednje korake: a) gojenje sesalske celice, ki vključuje nukleinsko kislino, ki kodira protitelo, in pridobivanje protitelesa iz celice ali gojitvenega medija, b) prečiščevanje protitelsa s postopkom kationske izmenjevalne kromatografije, ki vključuje naslednje korake: - nanašanje raztopine, ki vključuje poli (etilen glikol) in sorbitol na kromatografijski material, na katerega je adsorbirano protitelo, pri čemer ostane na materialu za ionsko izmenjevalno kromatografijo adsorbirano protitelo iz štirih verig polne dolžine, in - pridobivanje protitelesa CrossMab s štirimi verigami polne dolžine v monomerni obliki iz materiala za ionsko izmenjevalno kromatografijo, z nanosom raztopine, ki vključuje poli (etilenglikol) in sorbitol, pri čemer ima poli (etilenglikol) koncentracijo 10 % w/w, sorbitol pa ima koncentracijo 5-20 % w/w, s čimer pridobimo protitelo.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11158523 | 2011-03-16 | ||
| PCT/EP2012/054449 WO2012123488A1 (en) | 2011-03-16 | 2012-03-14 | Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase |
| EP12708546.2A EP2686334B2 (en) | 2011-03-16 | 2012-03-14 | Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SI2686334T1 true SI2686334T1 (sl) | 2018-03-30 |
| SI2686334T2 SI2686334T2 (sl) | 2020-10-30 |
Family
ID=45819216
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201231907T SI3318571T1 (sl) | 2011-03-16 | 2012-03-14 | Ionska izmenjevalna kromatografija z izboljšano selektivnostjo za ločevanje polipeptidnih monomerov, agregatov in fragmentov s spremembo mobilne faze |
| SI201231179T SI2686334T2 (sl) | 2011-03-16 | 2012-03-14 | Ionska izmenjevalna kromatografija z izboljšano selektivnostjo za ločevanje polipeptidnih monomerov, agregatov in fragmentov s spremembo mobilne faze |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201231907T SI3318571T1 (sl) | 2011-03-16 | 2012-03-14 | Ionska izmenjevalna kromatografija z izboljšano selektivnostjo za ločevanje polipeptidnih monomerov, agregatov in fragmentov s spremembo mobilne faze |
Country Status (9)
| Country | Link |
|---|---|
| US (3) | US9394337B2 (sl) |
| EP (2) | EP2686334B2 (sl) |
| JP (3) | JP5984854B2 (sl) |
| ES (2) | ES2865449T3 (sl) |
| HR (2) | HRP20180028T4 (sl) |
| PL (2) | PL2686334T5 (sl) |
| SG (1) | SG193378A1 (sl) |
| SI (2) | SI3318571T1 (sl) |
| WO (1) | WO2012123488A1 (sl) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2865449T3 (es) | 2011-03-16 | 2021-10-15 | Hoffmann La Roche | Cromatografía de intercambio iónico con selectividad mejorada para la separación de monómeros, agregados y fragmentos polipeptídicos por modulación de la fase móvil |
| WO2014018420A1 (en) * | 2012-07-21 | 2014-01-30 | K-Technologies, Inc. | Processes for the removal and recovery of minor elements in wet-process phosphoric acid |
| CN105073769B (zh) | 2013-03-14 | 2019-09-10 | Emd密理博公司 | 利用基于a蛋白的色谱增加蛋白纯度的方法 |
| GB2516808A (en) * | 2013-05-31 | 2015-02-11 | Innova Biosciences Ltd | Antibody composition and buffer system therefor |
| RU2652911C2 (ru) * | 2013-08-19 | 2018-05-03 | Ф. Хоффманн-Ля Рош Аг | Разделение биспецифических антител и побочных продуктов процесса получения биспецифических антител с применением гидроксиапатитной хроматографии |
| JP2024503996A (ja) * | 2020-12-20 | 2024-01-30 | 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 | 生体分子中のスクランブルジスルフィドを同定するための方法 |
| CN113388026B (zh) * | 2021-08-03 | 2022-09-27 | 江西理工大学 | 一种螺旋藻藻蓝蛋白和藻油的同步提取方法 |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US5204244A (en) | 1987-10-27 | 1993-04-20 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5202238A (en) | 1987-10-27 | 1993-04-13 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5429746A (en) | 1994-02-22 | 1995-07-04 | Smith Kline Beecham Corporation | Antibody purification |
| ES2228052T3 (es) | 1998-06-01 | 2005-04-01 | Genentech, Inc. | Separacion demonomeros de anticuerpos de sus multimeros utilizando cromatografia de intercambio de iones. |
| SK288128B6 (sk) | 1998-06-09 | 2013-10-02 | Csl Behring Ag | Process for purifying immunoglobulin G (IgG), liquid immunoglobulin product and use thereof for the preparation of a medicament |
| DK2270044T3 (en) * | 1998-06-09 | 2015-01-26 | Csl Behring Ag | Liquid immunoglobulin G (IgG) product |
| DE19836213A1 (de) * | 1998-08-11 | 2000-02-24 | Gerhard Harry Scholz | Verfahren zur Elution von Biomolekülen von Chromatographie-Materialien |
| AU2003257188A1 (en) | 2002-08-06 | 2004-02-23 | Akzo Nobel Patent Department | Increased dynamic binding capacity in ion exchange chromatography by addition of polyethylene glycol |
| CN1208346C (zh) | 2003-04-09 | 2005-06-29 | 中国科学院过程工程研究所 | 血红蛋白－人血清白蛋白偶联物制备血液代用品及其制备方法 |
| SE0400886D0 (sv) | 2004-04-02 | 2004-04-02 | Amersham Biosciences Ab | Process of purification |
| KR100554481B1 (ko) * | 2004-06-30 | 2006-03-03 | 씨제이 주식회사 | 반코마이신 염산염의 정제방법 |
| TWI320788B (en) | 2005-05-25 | 2010-02-21 | Hoffmann La Roche | Method for the purification of antibodies |
| US8124743B2 (en) * | 2006-06-01 | 2012-02-28 | President And Fellows Of Harvard College | Purification of a bivalently active antibody using a non-chromatographic method |
| US7691980B2 (en) | 2007-01-09 | 2010-04-06 | Bio-Rad Laboratories, Inc. | Enhanced capacity and purification of antibodies by mixed mode chromatography in the presence of aqueous-soluble nonionic organic polymers |
| WO2009015063A2 (en) * | 2007-07-23 | 2009-01-29 | Centocor | Methods and compositions for treating fibrosis related disorders using il-17 antagonists |
| WO2009085200A2 (en) * | 2007-12-21 | 2009-07-09 | Amgen Inc. | Anti-amyloid antibodies and uses thereof |
| EP2287174B8 (en) | 2008-01-18 | 2016-12-07 | Bio-Rad Laboratories, Inc. | Enhanced purification of antibody fragments by apatite chromatography |
| CA2726823A1 (en) † | 2008-06-03 | 2009-12-10 | Patrys Limited | Process for purification of antibodies |
| MX2011003184A (es) | 2008-09-29 | 2011-04-21 | Roche Glycart Ag | Anticuerpos contra il17 humana y usos de los mismos. |
| US8268314B2 (en) | 2008-10-08 | 2012-09-18 | Hoffmann-La Roche Inc. | Bispecific anti-VEGF/anti-ANG-2 antibodies |
| RS57784B1 (sr) | 2009-06-16 | 2018-12-31 | Genzyme Corp | Poboljšani postupci za prečišćavanje vektora rekombinantnog aav |
| US8394922B2 (en) * | 2009-08-03 | 2013-03-12 | Medarex, Inc. | Antiproliferative compounds, conjugates thereof, methods therefor, and uses thereof |
| TW201138821A (en) * | 2010-03-26 | 2011-11-16 | Roche Glycart Ag | Bispecific antibodies |
| ES2865449T3 (es) | 2011-03-16 | 2021-10-15 | Hoffmann La Roche | Cromatografía de intercambio iónico con selectividad mejorada para la separación de monómeros, agregados y fragmentos polipeptídicos por modulación de la fase móvil |
-
2012
- 2012-03-14 ES ES17201391T patent/ES2865449T3/es active Active
- 2012-03-14 EP EP12708546.2A patent/EP2686334B2/en active Active
- 2012-03-14 SI SI201231907T patent/SI3318571T1/sl unknown
- 2012-03-14 SG SG2013067947A patent/SG193378A1/en unknown
- 2012-03-14 ES ES12708546T patent/ES2656167T5/es active Active
- 2012-03-14 JP JP2013558420A patent/JP5984854B2/ja active Active
- 2012-03-14 WO PCT/EP2012/054449 patent/WO2012123488A1/en active Application Filing
- 2012-03-14 EP EP17201391.4A patent/EP3318571B1/en active Active
- 2012-03-14 PL PL12708546T patent/PL2686334T5/pl unknown
- 2012-03-14 PL PL17201391T patent/PL3318571T3/pl unknown
- 2012-03-14 SI SI201231179T patent/SI2686334T2/sl unknown
-
2013
- 2013-09-12 US US14/025,622 patent/US9394337B2/en active Active
-
2016
- 2016-06-16 US US15/184,883 patent/US10377793B2/en active Active
- 2016-08-02 JP JP2016151624A patent/JP6273326B2/ja active Active
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2018
- 2018-01-05 JP JP2018000397A patent/JP6523491B2/ja active Active
- 2018-01-08 HR HRP20180028TT patent/HRP20180028T4/hr unknown
-
2019
- 2019-06-24 US US16/450,827 patent/US20200148719A1/en not_active Abandoned
-
2021
- 2021-04-13 HR HRP20210588TT patent/HRP20210588T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3318571B1 (en) | 2021-02-17 |
| PL2686334T5 (pl) | 2020-10-19 |
| US9394337B2 (en) | 2016-07-19 |
| ES2656167T3 (es) | 2018-02-23 |
| ES2656167T5 (es) | 2021-03-26 |
| EP3318571A1 (en) | 2018-05-09 |
| WO2012123488A1 (en) | 2012-09-20 |
| SI3318571T1 (sl) | 2021-08-31 |
| EP2686334A1 (en) | 2014-01-22 |
| US20200148719A1 (en) | 2020-05-14 |
| HRP20210588T1 (hr) | 2021-05-28 |
| PL2686334T3 (pl) | 2018-03-30 |
| HRP20180028T4 (hr) | 2020-10-02 |
| JP2018058900A (ja) | 2018-04-12 |
| JP5984854B2 (ja) | 2016-09-06 |
| JP6273326B2 (ja) | 2018-01-31 |
| SI2686334T2 (sl) | 2020-10-30 |
| US10377793B2 (en) | 2019-08-13 |
| US20140081000A1 (en) | 2014-03-20 |
| JP2014511829A (ja) | 2014-05-19 |
| JP2017019805A (ja) | 2017-01-26 |
| ES2865449T3 (es) | 2021-10-15 |
| PL3318571T3 (pl) | 2021-07-05 |
| EP2686334B1 (en) | 2017-11-15 |
| HRP20180028T1 (hr) | 2018-02-09 |
| US20170107249A1 (en) | 2017-04-20 |
| SG193378A1 (en) | 2013-10-30 |
| JP6523491B2 (ja) | 2019-06-05 |
| EP2686334B2 (en) | 2020-07-01 |
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