HRP20211737T1 - Postupak za smanjenje proteina stanice domaćina u afinitetnoj kromatografiji - Google Patents
Postupak za smanjenje proteina stanice domaćina u afinitetnoj kromatografiji Download PDFInfo
- Publication number
- HRP20211737T1 HRP20211737T1 HRP20211737TT HRP20211737T HRP20211737T1 HR P20211737 T1 HRP20211737 T1 HR P20211737T1 HR P20211737T T HRP20211737T T HR P20211737TT HR P20211737 T HRP20211737 T HR P20211737T HR P20211737 T1 HRP20211737 T1 HR P20211737T1
- Authority
- HR
- Croatia
- Prior art keywords
- aqueous solution
- antibody
- use according
- protein
- chromatography
- Prior art date
Links
- 102000004169 proteins and genes Human genes 0.000 title claims 10
- 108090000623 proteins and genes Proteins 0.000 title claims 10
- 238000000034 method Methods 0.000 title claims 6
- 238000001042 affinity chromatography Methods 0.000 title 1
- 239000007864 aqueous solution Substances 0.000 claims 15
- 238000004587 chromatography analysis Methods 0.000 claims 7
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 7
- 239000007983 Tris buffer Substances 0.000 claims 6
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 6
- 238000005406 washing Methods 0.000 claims 4
- 239000000463 material Substances 0.000 claims 3
- 102000012406 Carcinoembryonic Antigen Human genes 0.000 claims 2
- 108010022366 Carcinoembryonic Antigen Proteins 0.000 claims 2
- 102000003780 Clusterin Human genes 0.000 claims 2
- 108090000197 Clusterin Proteins 0.000 claims 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- 238000002955 isolation Methods 0.000 claims 2
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 claims 2
- 102000013455 Amyloid beta-Peptides Human genes 0.000 claims 1
- 108010090849 Amyloid beta-Peptides Proteins 0.000 claims 1
- 102100034608 Angiopoietin-2 Human genes 0.000 claims 1
- 101150029707 ERBB2 gene Proteins 0.000 claims 1
- 108010048049 Factor IXa Proteins 0.000 claims 1
- 108010014173 Factor X Proteins 0.000 claims 1
- 101000924533 Homo sapiens Angiopoietin-2 Proteins 0.000 claims 1
- 102000008212 P-Selectin Human genes 0.000 claims 1
- 108010035766 P-Selectin Proteins 0.000 claims 1
- 102000009524 Vascular Endothelial Growth Factor A Human genes 0.000 claims 1
- 108010073929 Vascular Endothelial Growth Factor A Proteins 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 102000039446 nucleic acids Human genes 0.000 claims 1
- 108020004707 nucleic acids Proteins 0.000 claims 1
- 150000007523 nucleic acids Chemical class 0.000 claims 1
- 229910000160 potassium phosphate Inorganic materials 0.000 claims 1
- 235000011009 potassium phosphates Nutrition 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
Classifications
-
- 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
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2851—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
- C07K16/2854—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
-
- 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
-
- 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
- C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
-
- 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)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Life Sciences & Earth Sciences (AREA)
- Hematology (AREA)
- Oncology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (18)
1. Uporaba vodene otopine koja sadrži histidin i Tris u koraku ispiranja proteina A za kromatografiju, naznačena time, da je za smanjenje sadržaja proteina stanice domaćina, pri čemu se kromatografija proteina A koristi za pročišćavanje humanog izotipskog protutijela IgG4 ili IgG1, pri čemu vodena otopina ima pH vrijednost 6,5 ili veću.
2. Uporaba prema patentnom zahtjevu 1, naznačena time, da vodena otopina sadrži 10 mM do 1000 mM histidin.
3. Uporaba prema bilo kojem od patentnih zahtjeva 1 do 2, naznačena time, da vodena otopina sadrži 200 mM histidin.
4. Uporaba prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, da vodena otopina sadrži 100 mM do 1500 mM Tris.
5. Uporaba prema bilo kojem od patentnih zahtjeva 1 do 4, naznačena time, da vodena otopina sadrži 200 mM histidin i 1000 mM Tris.
6. Uporaba prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time, da je protein stanice domaćina fosfolipaza slična B 2 (PLBL2) ili klasterin.
7. Uporaba prema bilo kojem od patentnih zahtjeva 1 do 6, naznačena time, da kromatografija proteina A dodatno sadrži korak ispiranja s vodenom otopinom niske vodljivosti.
8. Uporaba prema patentnom zahtjevu 7, naznačena time, da vodena otopina niske vodljivosti ima vrijednost vodljivosti od 0,5 mS/cm ili manju.
9. Uporaba prema bilo kojem od patentnih zahtjeva 7 do 8, naznačena time, da vodena otopina niske vodljivosti sadrži 0,1 do 8 mM Tris.
10. Uporaba prema patentnom zahtjevu 7, naznačena time, da vodena otopina niske vodljivosti sadrži 0,05 do 2 mM kalijev fosfat.
11. Uporaba prema bilo kojem od patentnih zahtjeva 7 do 10, naznačena time, da vodena otopina niske vodljivosti ima pH vrijednost 7 ili veću.
12. Uporaba prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time, da humano izotipsko protutijelo IgG4 je protutijelo na P-selektin ili protutijelo na faktor IXa i faktor X.
13. Uporaba prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time, da je humano izotipsko protutijelo IgG1 protutijelo na amiloid beta ili protutijelo na Her2 ili protutijelo na Ang2 i VEGF-A ili protutijelo na karcinoembrionski antigen (CEA) i CD3.
14. Postupak za dobivanje humanog izotipskog protutijela IgG4 ili IgG1, naznačen time da obuhvaća sljedeće korake
a) kultiviranje stanice koja sadrži nukleinsku kiselinu koja kodira humano izotipsko protutijelo IgG4 ili IgG1,
b) izdvajanje humanog izotipskog protutijela IgG4 ili IgG1 iz stanice ili kultivacijskog medija,
c) stavljanje u doticaj humanog izotipskog protutijela IgG4 ili IgG1 s materijalom proteina A za kromatografiju,
d) ispiranje materijala proteina A za kromatografiju vodenom otopinom koja sadrži histidin i Tris koja ima pH vrijednost 6,5 ili veću,
e) izdvajanje humanog izotipskog protutijela IgG4 ili IgG1 iz materijala proteina A za kromatografiju
i na taj način proizvodeći humano izotipsko protutijelo IgG4 ili IgG1.
15. Postupak prema patentnom zahtjevu 14, naznačen time, da vodena otopina sadrži 200 mM histidin.
16. Postupak prema bilo kojem od patentnih zahtjeva 14 do 15, naznačen time, da vodena otopina sadrži 200 mM histidin i 1 M Tris.
17. Postupak prema bilo kojem od patentnih zahtjeva 14 do 16, naznačen time, da kromatografija proteina A dodatno sadrži korak ispiranja s vodenom otopinom niske vodljivosti koja ima vrijednost vodljivosti od 0,5 mS/cm ili manju.
18. Postupak prema bilo kojem od patentnih zahtjeva 14 do 17, naznačen time, da je protein stanice domaćina fosfolipaza slična B 2 (PLBL2) ili klasterin.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15181903 | 2015-08-21 | ||
| EP16753879.2A EP3337817B1 (en) | 2015-08-21 | 2016-08-11 | Method for the reduction of host cell proteins in affinity chromatography |
| PCT/EP2016/069163 WO2017032611A1 (en) | 2015-08-21 | 2016-08-11 | Method for the reduction of host cell proteins in affinity chromatography |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20211737T1 true HRP20211737T1 (hr) | 2022-02-18 |
Family
ID=54064133
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20211737TT HRP20211737T1 (hr) | 2015-08-21 | 2016-08-11 | Postupak za smanjenje proteina stanice domaćina u afinitetnoj kromatografiji |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US20180186865A1 (hr) |
| EP (1) | EP3337817B1 (hr) |
| JP (1) | JP7073253B2 (hr) |
| CN (1) | CN107835819A (hr) |
| ES (1) | ES2897965T3 (hr) |
| HK (1) | HK1251583A1 (hr) |
| HR (1) | HRP20211737T1 (hr) |
| PL (1) | PL3337817T3 (hr) |
| SI (1) | SI3337817T1 (hr) |
| WO (1) | WO2017032611A1 (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112018001511A2 (pt) | 2015-08-21 | 2018-09-18 | Hoffmann La Roche | ?uso de solução aquosa com baixa condutividade e métodos de produção e purificação de anticorpo de isótipo igg1 ou igg4 humano |
| CN112876567A (zh) * | 2019-11-29 | 2021-06-01 | 广东菲鹏制药股份有限公司 | Fc融合蛋白及其纯化方法 |
| TWI787710B (zh) * | 2020-01-20 | 2022-12-21 | 中國大陸商上海藥明生物技術有限公司 | 用於親和層析的新型清洗緩衝液 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9203459D0 (en) * | 1992-02-19 | 1992-04-08 | Scotgen Ltd | Antibodies with germ-line variable regions |
| TWI338009B (en) * | 2001-10-29 | 2011-03-01 | Genentech Inc | Antibodies for inhibiting blood coagulation and methods of use thereof |
| SI2261230T1 (sl) * | 2002-09-11 | 2017-08-31 | Chugai Seiyaku Kabushiki Kaisha | Postopek čiščenja proteinov |
| TWI306862B (en) | 2005-01-03 | 2009-03-01 | Hoffmann La Roche | Antibodies against il-13 receptor alpha 1 and uses thereof |
| EP2824183B1 (en) * | 2005-04-08 | 2020-07-29 | Chugai Seiyaku Kabushiki Kaisha | Methods for producing bispecific antibodies |
| AU2006259298B2 (en) * | 2005-06-17 | 2012-06-14 | Wyeth Llc | Methods of purifying Fc region containing proteins |
| WO2010056550A1 (en) * | 2008-10-29 | 2010-05-20 | Wyeth Llc | Methods for purification of single domain antigen binding molecules |
| WO2011038894A1 (en) * | 2009-10-01 | 2011-04-07 | F. Hoffmann-La Roche Ag | Protein a chromatography |
| EP2583973B1 (en) | 2010-06-21 | 2018-03-21 | Kyowa Hakko Kirin Co., Ltd. | Method for purifying protein using amino acid |
| WO2012164046A1 (en) * | 2011-06-01 | 2012-12-06 | Novartis Ag | Wash solution and method for affinity chromatography |
| AR096713A1 (es) | 2013-06-25 | 2016-01-27 | Cadila Healthcare Ltd | Proceso de purificación para anticuerpos monoclonales |
| SG11201601823TA (en) | 2013-09-13 | 2016-04-28 | Genentech Inc | Methods and compositions comprising purified recombinant polypeptides |
| JP2015083558A (ja) * | 2013-09-18 | 2015-04-30 | 東ソー株式会社 | 抗体吸着剤ならびにそれを用いた抗体の精製方法および識別方法 |
| BR112018001511A2 (pt) | 2015-08-21 | 2018-09-18 | Hoffmann La Roche | ?uso de solução aquosa com baixa condutividade e métodos de produção e purificação de anticorpo de isótipo igg1 ou igg4 humano |
-
2016
- 2016-08-11 JP JP2018509841A patent/JP7073253B2/ja active Active
- 2016-08-11 SI SI201631396T patent/SI3337817T1/sl unknown
- 2016-08-11 HR HRP20211737TT patent/HRP20211737T1/hr unknown
- 2016-08-11 CN CN201680041446.6A patent/CN107835819A/zh active Pending
- 2016-08-11 PL PL16753879T patent/PL3337817T3/pl unknown
- 2016-08-11 EP EP16753879.2A patent/EP3337817B1/en active Active
- 2016-08-11 WO PCT/EP2016/069163 patent/WO2017032611A1/en unknown
- 2016-08-11 ES ES16753879T patent/ES2897965T3/es active Active
-
2018
- 2018-02-20 US US15/900,443 patent/US20180186865A1/en not_active Abandoned
- 2018-08-23 HK HK18110895.5A patent/HK1251583A1/zh unknown
-
2021
- 2021-06-01 US US17/335,680 patent/US20220119499A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| SI3337817T1 (sl) | 2021-12-31 |
| PL3337817T3 (pl) | 2022-01-17 |
| US20220119499A1 (en) | 2022-04-21 |
| CN107835819A (zh) | 2018-03-23 |
| HK1251583A1 (zh) | 2019-02-01 |
| EP3337817A1 (en) | 2018-06-27 |
| ES2897965T3 (es) | 2022-03-03 |
| JP7073253B2 (ja) | 2022-05-23 |
| EP3337817B1 (en) | 2021-09-15 |
| US20180186865A1 (en) | 2018-07-05 |
| WO2017032611A1 (en) | 2017-03-02 |
| JP2018525408A (ja) | 2018-09-06 |
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