HRP20191848T1 - Postupci odstranjivanja kontaminanta uporabom membranske kromatografije ionskom izmjenom s premještanjem autohtonog proteina - Google Patents
Postupci odstranjivanja kontaminanta uporabom membranske kromatografije ionskom izmjenom s premještanjem autohtonog proteina Download PDFInfo
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- HRP20191848T1 HRP20191848T1 HRP20191848TT HRP20191848T HRP20191848T1 HR P20191848 T1 HRP20191848 T1 HR P20191848T1 HR P20191848T T HRP20191848T T HR P20191848TT HR P20191848 T HRP20191848 T HR P20191848T HR P20191848 T1 HRP20191848 T1 HR P20191848T1
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- monoclonal antibody
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- antibodies
- antibody
- membrane
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- 238000000034 method Methods 0.000 title claims 14
- 239000000356 contaminant Substances 0.000 title claims 5
- 239000003014 ion exchange membrane Substances 0.000 title claims 2
- 102000004169 proteins and genes Human genes 0.000 title claims 2
- 108090000623 proteins and genes Proteins 0.000 title claims 2
- 238000006073 displacement reaction Methods 0.000 title 1
- 238000011140 membrane chromatography Methods 0.000 title 1
- 239000012528 membrane Substances 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 5
- 238000000746 purification Methods 0.000 claims 4
- 239000012530 fluid Substances 0.000 claims 2
- 238000004255 ion exchange chromatography Methods 0.000 claims 2
- 238000011084 recovery Methods 0.000 claims 2
- 239000002699 waste material Substances 0.000 claims 2
- 102100038080 B-cell receptor CD22 Human genes 0.000 claims 1
- 101000884305 Homo sapiens B-cell receptor CD22 Proteins 0.000 claims 1
- 239000003463 adsorbent Substances 0.000 claims 1
- 238000001042 affinity chromatography Methods 0.000 claims 1
- 239000003011 anion exchange membrane Substances 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 229960000397 bevacizumab Drugs 0.000 claims 1
- 238000005341 cation exchange Methods 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229960000470 omalizumab Drugs 0.000 claims 1
- 229960002087 pertuzumab Drugs 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000011148 porous material Substances 0.000 claims 1
- 229960004641 rituximab Drugs 0.000 claims 1
- 229960000575 trastuzumab Drugs 0.000 claims 1
Classifications
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- 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
-
- 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
-
- 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
-
- 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
- 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
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- 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
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (11)
1. Postupak za pročišćavanje monoklonskog protutijela iz sastava koji sadrži monoklonsko protutijelo i najmanje jedan kontaminant, naznačen time, da postupak obuhvaća sljedeće uzastopne korake:
a. propuštanje sastava kroz membranu kationske izmjene, pri čemu monoklonsko protutijelo i membrana imaju suprotne naboje, uz radne uvjete koji obuhvaćaju pufer koji ima pH od oko 1 do oko 5 pH jedinica ispod pI-vrijednosti od monoklonskog protutijela i provodljivost koja je ≤ od oko 40 mS/cm, što uzrokuje da membrana veže monoklonsko protutijelo i najmanje jedan kontaminant, i
b. oporavljanje pročišćenog monoklonskog protutijela iz otpadne tekućine.
2. Postupak za pročišćavanje monoklonskog protutijela iz sastava koji sadrži monoklonsko protutijelo i najmanje jedan kontaminant, naznačen time, da postupak obuhvaća sljedeće uzastopne korake:
a. propuštanje sastava kroz membranu anionske izmjene, pri čemu monoklonsko protutijelo i membrana imaju suprotne naboje, uz radne uvjete koji obuhvaćaju pufer koji ima pH od oko 1 do oko 5 pH-jedinica iznad pI-vrijednosti od monoklonskog protutijela i provodljivost koja je ≤ od oko 40 mS/cm, što uzrokuje da membrana veže monoklonsko protutijelo i najmanje jedan kontaminant, i
b. oporavljanje pročišćenog monoklonskog protutijela iz otpadne tekućine.
3. Postupak prema patentnom zahtjevu 1 ili 2, naznačen time, da membrana ionske izmjene ima veličinu pora od 0,1 do 100 μm.
4. Postupak prema patentnom zahtjevu 1, naznačen time, da pH u njemu iznosi:
(i) oko 1 do oko 4 pH-jedinice ispod pI-vrijednosti monoklonskog protutijela;
(ii) oko 1 do oko 3 pH-jedinice ispod pI-vrijednosti monoklonskog protutijela;
(iii) oko 1 do oko 2 pH-jedinice ispod pI-vrijednosti monoklonskog protutijela; ili
(iv) oko 1 pH-jedinice ispod pI-vrijednosti monoklonskog protutijela.
5. Postupak prema patentnom zahtjevu 1 ili 2, naznačen time, da provodljivost iznosi < od oko 20 mS/cm ili < od oko 10 mS/cm.
6. Postupak prema patentnom zahtjevu 2, naznačen time, da pH u njemu iznosi:
(i) oko 1 do oko 4 pH-jedinice iznad pI-vrijednosti monoklonskog protutijela;
(ii) oko 1 do oko 3 pH-jedinice iznad pI-vrijednosti monoklonskog protutijela;
(iii) oko 1 do oko 2 pH-jedinice iznad pI-vrijednosti monoklonskog protutijela; ili
(iv) oko 1 pH-jedinice iznad pI-vrijednosti monoklonskog protutijela.
7. Postupak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da membrana je adsorbent mješovitog načina rada.
8. Postupak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da nadalje obuhvaća podvrgavanje sastava koji sadrži monoklonsko protutijelo jednom ili većem broju dodatnih koraka pročišćavanja:
(i) ili prije, ili za vrijeme ili nakon koraka a do b, gdje je navedeni korak pročišćavanja afinitetna kromatografija proteina A;
(ii) ili prije, ili za vrijeme ili nakon koraka a do b, gdje je navedeni korak pročišćavanja kromatografija ionske izmjene; ili
(iii) kontinuirano se izvodi za vrijeme koraka a do b, gdje je navedeni korak pročišćavanja kromatografija ionske izmjene.
9. Postupak prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da nadalje obuhvaća proizvodnju farmaceutskog sastava pomoću miješanja pročišćenog monoklonskog protutijela s farmaceutski prihvatljivim nosačem.
10. Postupak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da je monoklonsko protutijelo, ili njegov fragment koji veže antigen, odabrano iz skupine koja se sastoji od sljedećih: HER2-protutijela, EGFR-protutijela, CD20-protutijela, CD22-protutijela, VEGF-protutijela, VEGF-receptor-protutijela, IgE-protutijela, Apo-2-receptor-protutijela, i TNF-alfa-protutijela.
11. Postupak prema patentnom zahtjevu 10, naznačen time, da je protutijelo sljedeće:
(i) HER2-protutijelo odabrano iz skupine koja se sastoji od trastuzumaba i pertuzumaba;
(ii) CD20-protutijelo koje je rituksimab;
(iii) VEGF-protutijelo koje je bevacizumab; ili
(iv) IgE-protutijelo koje je omalizumab.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2008/073179 WO2010019148A1 (en) | 2008-08-14 | 2008-08-14 | Methods for removing a contaminant using indigenous protein displacement ion exchange membrane chromatography |
| EP14189582.1A EP2848625B1 (en) | 2008-08-14 | 2008-08-14 | Methods for removing a contaminant using indigenous protein displacement ion exchange membrane chromatography |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20191848T1 true HRP20191848T1 (hr) | 2019-12-27 |
Family
ID=39899038
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240472TT HRP20240472T1 (hr) | 2008-08-14 | 2008-08-14 | Postupci za eliminaciju kontaminanta uporabom kromatografije membranske ionske izmjene s premještanjem urođenog proteina |
| HRP20191848TT HRP20191848T1 (hr) | 2008-08-14 | 2019-10-14 | Postupci odstranjivanja kontaminanta uporabom membranske kromatografije ionskom izmjenom s premještanjem autohtonog proteina |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240472TT HRP20240472T1 (hr) | 2008-08-14 | 2008-08-14 | Postupci za eliminaciju kontaminanta uporabom kromatografije membranske ionske izmjene s premještanjem urođenog proteina |
Country Status (23)
| Country | Link |
|---|---|
| US (2) | US10927144B2 (hr) |
| EP (3) | EP3604324B1 (hr) |
| JP (1) | JP5666447B2 (hr) |
| KR (3) | KR20180033311A (hr) |
| CN (1) | CN102149724B (hr) |
| AU (1) | AU2008360625C1 (hr) |
| BR (1) | BRPI0823046B1 (hr) |
| CA (1) | CA2731943C (hr) |
| CY (1) | CY1122221T1 (hr) |
| DK (2) | DK3604324T3 (hr) |
| ES (2) | ES2527943T5 (hr) |
| FI (1) | FI3604324T3 (hr) |
| HK (1) | HK1210181A1 (hr) |
| HR (2) | HRP20240472T1 (hr) |
| HU (1) | HUE047316T2 (hr) |
| IL (2) | IL210912B (hr) |
| LT (2) | LT3604324T (hr) |
| MX (1) | MX2011001506A (hr) |
| PL (1) | PL2848625T3 (hr) |
| PT (2) | PT2848625T (hr) |
| RS (1) | RS59232B1 (hr) |
| SI (2) | SI3604324T1 (hr) |
| WO (1) | WO2010019148A1 (hr) |
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