HRP20200589T1 - Redukcija ispiranja proteina a za vrijeme afinitetne kromatografije proteina a - Google Patents
Redukcija ispiranja proteina a za vrijeme afinitetne kromatografije proteina a Download PDFInfo
- Publication number
- HRP20200589T1 HRP20200589T1 HRP20200589TT HRP20200589T HRP20200589T1 HR P20200589 T1 HRP20200589 T1 HR P20200589T1 HR P20200589T T HRP20200589T T HR P20200589TT HR P20200589 T HRP20200589 T HR P20200589T HR P20200589 T1 HRP20200589 T1 HR P20200589T1
- Authority
- HR
- Croatia
- Prior art keywords
- antibody
- protein
- hccf
- preparation
- chromatography
- Prior art date
Links
- 102000004169 proteins and genes Human genes 0.000 title claims 13
- 108090000623 proteins and genes Proteins 0.000 title claims 13
- 238000001042 affinity chromatography Methods 0.000 title claims 4
- 238000002386 leaching Methods 0.000 title claims 2
- 238000000034 method Methods 0.000 claims 13
- 239000012561 harvest cell culture fluid Substances 0.000 claims 11
- 238000002360 preparation method Methods 0.000 claims 11
- 238000004587 chromatography analysis Methods 0.000 claims 6
- 210000004027 cell Anatomy 0.000 claims 4
- 239000006143 cell culture medium Substances 0.000 claims 3
- 229960004641 rituximab Drugs 0.000 claims 2
- 229960000575 trastuzumab Drugs 0.000 claims 2
- 108091005804 Peptidases Proteins 0.000 claims 1
- 239000004365 Protease Substances 0.000 claims 1
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 claims 1
- 238000005119 centrifugation Methods 0.000 claims 1
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 1
- 238000009295 crossflow filtration Methods 0.000 claims 1
- 230000003247 decreasing effect Effects 0.000 claims 1
- 229940042399 direct acting antivirals protease inhibitors Drugs 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 238000010828 elution Methods 0.000 claims 1
- 239000012535 impurity Substances 0.000 claims 1
- 239000000137 peptide hydrolase inhibitor Substances 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
Classifications
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- 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
-
- 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
- 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
-
- 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
- C07K16/2839—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 integrin superfamily
- C07K16/2845—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 integrin superfamily against integrin beta2-subunit-containing molecules, e.g. CD11, CD18
-
- 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
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Medicinal Chemistry (AREA)
- Genetics & Genomics (AREA)
- General Health & Medical Sciences (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Peptides Or Proteins (AREA)
- Enzymes And Modification Thereof (AREA)
Claims (13)
1. Postupak za redukciju ispiranja proteina A kod pročišćavanja antitijela koje sadrži regiju CH2/CH3 kromatografijom proteina A, naznačen time, da obuhvaća:
razdvajanje rekombinantnih stanica domaćina koje eksprimiraju antitijelo od medija za staničnu kulturu kako bi se dobila prikupljena tekućina stanične kulture (HCCF, prema engl. harvested cell culture fluid) koja sadrži antitijelo i jednu ili više nečistoća;
smanjivanje temperature pripravka HCCF koji se podvrgava kromatografiji proteina A na temperaturu u rasponu od 3°C do 18°C; i
podvrgavanje pripravka HCCF koji je na temperaturi u rasponu od 3°C do 18°C kromatografiji proteina A kako bi se dobio pročišćeni pripravak antitijela;
gdje smanjivanje temperature pripravka HCCF reducira ispiranje proteina A u pročišćenom pripravku antitijela tijekom kromatografije proteina A i antitijelo se odabire iz humaniziranog anti-HER2 antitijela trastuzumaba, humaniziranog 2C4 anti-HER2 antitijela, humaniziranog anti-CD11a antitijela, humaniziranog anti-VEGF antitijela ili Rituksimaba (kimernog anti-CD20 antitijela „C2B8“).
2. Postupak prema patentnom zahtjevu 1, naznačen time, da smanjivanje temperature pripravka HCCF koji se podvrgava kromatografiji proteina A i podvrgavanje pripravka HCCF kromatografiji proteina A smanjuje temperaturu pripravka HCCF na onu u rasponu od 10°C do 18°C.
3. Postupak prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, naznačen time, da se rekombinantne stanice domaćina razdvajaju od medija za staničnu kulturu centrifugiranjem.
4. Postupak prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, naznačen time, da se rekombinantne stanice domaćina razdvajaju od medija za staničnu kulturu tangencijalnom protočnom filtracijom.
5. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da nadalje obuhvaća dodavanje jednog ili više inhibitora proteaze u pripravak HCCF koji se podvrgava afinitetnoj kromatografiji proteina A kako bi se smanjila aktivnost proteaze.
6. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da nadalje obuhvaća snižavanje pH pripravka HCCF koji se podvrgava afinitetnoj kromatografiji proteina A.
7. Postupak prema patentnom zahtjevu 6, naznačen time, da se pH pripravka HCCF koji se podvrgava afinitetnoj kromatografiji proteina A snižava na pH u rasponu od oko 2,5 do oko 3,5.
8. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest humanizirano anti-HER2 antitijelo trastuzumab.
9. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest humanizirano 2C4 anti-HER2 antitijelo.
10. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest humanizirano anti-CD11a antitijelo.
11. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest humanizirano anti-VEGF antitijelo.
12. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest Rituksimab (kimerno anti-CD20 antitijelo „C2B8“).
13. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da su stanice domaćina stanice CHO.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US49050003P | 2003-07-28 | 2003-07-28 | |
EP16164203.8A EP3095793B1 (en) | 2003-07-28 | 2004-06-24 | Reducing protein a leaching during protein a affinity chromatography |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20200589T1 true HRP20200589T1 (hr) | 2020-07-10 |
Family
ID=34193088
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20200589TT HRP20200589T1 (hr) | 2003-07-28 | 2020-04-14 | Redukcija ispiranja proteina a za vrijeme afinitetne kromatografije proteina a |
Country Status (14)
Country | Link |
---|---|
US (2) | US7485704B2 (hr) |
EP (3) | EP3095793B1 (hr) |
JP (1) | JP4599355B2 (hr) |
AU (1) | AU2004265253B2 (hr) |
CA (1) | CA2531595C (hr) |
DK (2) | DK1648940T3 (hr) |
ES (1) | ES2786568T3 (hr) |
HR (1) | HRP20200589T1 (hr) |
HU (2) | HUE029951T2 (hr) |
LT (1) | LT3095793T (hr) |
PL (2) | PL1648940T3 (hr) |
PT (1) | PT3095793T (hr) |
SI (2) | SI3095793T1 (hr) |
WO (1) | WO2005016968A2 (hr) |
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DK3095793T3 (da) | 2020-05-25 |
US7807799B2 (en) | 2010-10-05 |
US20050038231A1 (en) | 2005-02-17 |
PL1648940T3 (pl) | 2016-12-30 |
JP4599355B2 (ja) | 2010-12-15 |
AU2004265253A1 (en) | 2005-02-24 |
WO2005016968A3 (en) | 2005-04-21 |
EP1648940B1 (en) | 2016-04-27 |
HUE029951T2 (en) | 2017-04-28 |
PT3095793T (pt) | 2020-05-04 |
EP3095793B1 (en) | 2020-03-25 |
US20090099344A1 (en) | 2009-04-16 |
US7485704B2 (en) | 2009-02-03 |
AU2004265253B2 (en) | 2011-09-01 |
EP1648940A2 (en) | 2006-04-26 |
CA2531595C (en) | 2015-12-08 |
DK1648940T3 (en) | 2016-08-15 |
LT3095793T (lt) | 2020-07-10 |
JP2007526897A (ja) | 2007-09-20 |
CA2531595A1 (en) | 2005-02-24 |
HUE050171T2 (hu) | 2020-11-30 |
EP3095793A1 (en) | 2016-11-23 |
SI1648940T1 (sl) | 2016-08-31 |
PL3095793T3 (pl) | 2020-09-07 |
ES2786568T3 (es) | 2020-10-13 |
WO2005016968A2 (en) | 2005-02-24 |
EP3722309A1 (en) | 2020-10-14 |
SI3095793T1 (sl) | 2020-07-31 |
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