ME02162B - Proces prečišćavanja proteina - Google Patents
Proces prečišćavanja proteinaInfo
- Publication number
- ME02162B ME02162B MEP-2015-94A MEP9415A ME02162B ME 02162 B ME02162 B ME 02162B ME P9415 A MEP9415 A ME P9415A ME 02162 B ME02162 B ME 02162B
- Authority
- ME
- Montenegro
- Prior art keywords
- host cell
- recombinant
- recombinant protein
- seq
- extract
- 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
- C07K1/30—Extraction; Separation; Purification by precipitation
-
- 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
- C07K1/107—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
-
- 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
-
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/475—Growth factors; Growth regulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/90—Isomerases (5.)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
- C12P21/00—Preparation of peptides or proteins
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
- C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Analytical Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- General Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Toxicology (AREA)
- Gastroenterology & Hepatology (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Enzymes And Modification Thereof (AREA)
- Peptides Or Proteins (AREA)
Claims (25)
1. Metod za prečišćavanje rekombinantnog proteina iz gram-negativnog bakterijskog uzorka ćelije domaćina ili njegovog ekstrakta pri čemu navedena ćelija domaćina eksprimira rekombinantni protein i rekombinantnu disulfid izomerazu DsbC; pri čemu metoda sadrži: a) podešavanje pH uzorka ćelije domaćina, ili njegovog ekstrakta do pH 5 ili manje da se istaloži rekombinantna disulfid izomeraza; i b) odvajanje istaložene rekombinantne disulfid izomeraze iz rekombinantnog proteina da se proizvede uzorak rekombinantnog proteina.
2. Metod prema patentnom zahtevu 1, pri čemu je pH uzorka ćelije domaćina ili njegovog ekstrakta podešena na pH od 4.5 ili manje.
3. Metod prema patentnom zahtevu 2, pri čemu je pH uzorka ćelije domaćina ili njegovog ekstrakta podešena na pH od 4.5 do 3.0.
4. Metod prema patentnom zahtevu 2, pri čemu je pH uzorka ćelije domaćina ili njegovog ekstrakta podešena na pH od 3 ili manje.
5. Metod prema patentnom zahtevu 4, pri čemu se u koraku a) dipeptid ćelije domaćina vezujućeg proteina je dalje istaložen i ukoraku b) dipeptid ćelije domaćina je dalje odvojen od rekombinantnog proteina.
6. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu disulfid izomeraza sadrži dodatak histidina.
7. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu je gram-negativna bakterijska ćelija domaćina E. koli.
8. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu ćelija domaćina sadrži Fkpa i/ili Skp.
9. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu u koraku a) pH uzorka ćelije domaćina ili njegov ekstrakt je podešen na pH od manje od 5 upotrebom glacijalne-ledene sirćetne kiseline.
10. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu uzorak ćelije domaćina ili njegov ekstrakt se drži na pH od 5 ili manje tokom jednog sata ili manje.
11. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu separacija u koraku b) sadrži centrifugiranje i/ili filtriranje.
12. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu nakon koraka b) metod sadrži dalji korak podvrgavanja prečišćavanju uzorka rekombinantnog proteina do hromatografije.
13. Metod prema patentnom zahtevu 11, pri čemu je hromatografija hromatografija jonske izmene.
14. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu nakon koraka b) pH uzorka rekombinantnog proteina je podešena na pH od 5 do 7.
15. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu pre koraka a) pufer za ekstrakciju je dodat uzorku ćelije domaćina ili njegovom ekstraktu i uzorak ćelije domaćina ili njegov ekstrakt je podvrgnut koraku termičke obrade.
16. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu rekombinantni protein ima pl od 6 do 9.
17. Metod prema patentnom zahtevu 16, pri čemu rekombinantni protein ima pl od 8 do 9.
18. Metod prema bilo kojem od prethodnih patentnih zahteva, pri čemu rekombinantni protein je rekombinantno antitelo.
19. Metod prema patentnom zahtevu 18, pri čemu je rekombinantno antitelo monoklonalno, humanizovano ili himerno antitelo, ili fragment od njih, kao što je vezujući fragment od njih.
20. Metod prema patentnom zahtevu 18 ili zahtevu 19, pri čemu je rekombinantno antitelo Fab ili Fab-ov fragment.
21. Metod prema bilo kojem od patentnih zahteva 18 do 20, pri čemu je rekombinantno antitelo specifično za humani TNFɑ.
22. Metod prema patentnom zahtevu 21, pri čemu antitelo sadrži teški lanac gde varijabilni domen sadrži CDR koji ima sekvencu datu u SEQ ID NO:1 za CDRH1, SEQ ID NO:2, za CDRH2 i SEQ ID NO:3 za CDRH3 i laki lanac pri čemu varijabilni domen sadrži CDR koji ima sekvencu datu u SEQ ID NO:4 za CDRL1, SEQ ID NO:5 za CDRL2 i SEQ ID NO:6 za CDRL3.
23. Metod prema patentnom zahtevu 22, pri čemu antitelo sadrži sekvencu varijabilne regije lakog lanca datu u SEQ ID NO: 7 i varijabilna regija teškog lanca je data u SEQ ID NO: 8.
24. Metod prema patentnom zahtevu 23, pri čemu je antitelo Fab fragment i sadrži teški lanac koji ima sekvencu datu u SEQ ID NO: 10 i laki lanac koji ima sekvencu datu u SEQ ID NO: 9.
25. Upotreba koraka podešavanja pH od gram-negativnog bakterijskog uzorka ćelije domaćina ili njegovog ekstrakta transformisanog ekspresonim vektorom koji kodira rekombinantni protein na pH 5 ili manje da se istaloži rekombinantna disulfid izomeraza ćelije domaćina, odvoji precipitirana rekombinantna disulfid izomeraza ćelije domaćina iz rekombinantnog proteina i proizvede prečišćeni uzorak rekombinantnog proteina.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1012599.5A GB201012599D0 (en) | 2010-07-27 | 2010-07-27 | Process for purifying proteins |
| PCT/GB2011/001129 WO2012013930A2 (en) | 2010-07-27 | 2011-07-27 | Process for purifying proteins |
| EP11745810.9A EP2598516B8 (en) | 2010-07-27 | 2011-07-27 | Process for purifying proteins |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME02162B true ME02162B (me) | 2015-10-20 |
Family
ID=42752868
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2015-94A ME02162B (me) | 2010-07-27 | 2011-07-27 | Proces prečišćavanja proteina |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US9751930B2 (me) |
| EP (1) | EP2598516B8 (me) |
| JP (1) | JP5935222B2 (me) |
| KR (1) | KR101944121B1 (me) |
| CN (1) | CN103189385B (me) |
| AU (1) | AU2011284548B2 (me) |
| BR (1) | BR112013000177B1 (me) |
| CA (1) | CA2804099C (me) |
| CY (1) | CY1116526T1 (me) |
| DK (1) | DK2598516T3 (me) |
| ES (1) | ES2537877T3 (me) |
| GB (1) | GB201012599D0 (me) |
| HR (1) | HRP20150639T1 (me) |
| HU (1) | HUE026049T2 (me) |
| IL (1) | IL224044A (me) |
| ME (1) | ME02162B (me) |
| MX (1) | MX337184B (me) |
| PL (1) | PL2598516T3 (me) |
| PT (1) | PT2598516E (me) |
| RS (1) | RS54085B1 (me) |
| SG (2) | SG186974A1 (me) |
| SI (1) | SI2598516T1 (me) |
| SM (1) | SMT201500142B (me) |
| WO (1) | WO2012013930A2 (me) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2480661A1 (en) | 2009-09-24 | 2012-08-01 | UCB Pharma, S.A. | Bacterial host strain |
| GB201000587D0 (en) | 2010-01-14 | 2010-03-03 | Ucb Pharma Sa | Bacterial hoist strain |
| GB201000591D0 (en) | 2010-01-14 | 2010-03-03 | Ucb Pharma Sa | Bacterial hoist strain |
| GB201000590D0 (en) | 2010-01-14 | 2010-03-03 | Ucb Pharma Sa | Bacterial host strain |
| GB201001791D0 (en) | 2010-02-03 | 2010-03-24 | Ucb Pharma Sa | Process for obtaining antibodies |
| HRP20180226T1 (hr) | 2011-07-13 | 2018-03-09 | Ucb Biopharma Sprl | Bakterijski soj domaćina koji eksprimira rekombinantnu dsbc |
| GB201208367D0 (en) * | 2012-05-14 | 2012-06-27 | Ucb Pharma Sa | Biological product |
| SG11201407801VA (en) | 2012-05-31 | 2014-12-30 | Agency Science Tech & Res | Methods for use of mixed multifunctional surfaces for reducing aggregate content in protein preparations |
| CN104507955A (zh) | 2012-05-31 | 2015-04-08 | 新加坡科技研究局 | 采用具有多形式官能性的颗粒对免疫球蛋白g制备物的色谱纯化 |
| US10112994B2 (en) * | 2014-11-05 | 2018-10-30 | Genentech, Inc. | Methods of producing two chain proteins in bacteria |
| BR112017013394B1 (pt) * | 2014-12-22 | 2024-02-06 | Ucb Biopharma Sprl | Método para fabricar proteína de interesse |
| KR102537099B1 (ko) | 2014-12-22 | 2023-05-25 | 유씨비 바이오파마 에스알엘 | 단백질 제조 방법 |
| KR20170122216A (ko) * | 2015-03-06 | 2017-11-03 | 제넨테크, 인크. | 초순수화 dsba 및 dsbc와 이를 제조하고 사용하는 방법 |
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| CN110272491B (zh) * | 2018-03-13 | 2023-01-24 | 江苏恒瑞医药股份有限公司 | 一种抗pd-1抗体的纯化工艺 |
| KR102718712B1 (ko) * | 2019-08-05 | 2024-10-17 | 와커 헤미 아게 | 발효 방법에서 재조합 단백질 방출용 박테리아 균주 |
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| GB8422238D0 (en) | 1984-09-03 | 1984-10-10 | Neuberger M S | Chimeric proteins |
| GB8719042D0 (en) | 1987-08-12 | 1987-09-16 | Parker D | Conjugate compounds |
| US5030570A (en) | 1988-06-30 | 1991-07-09 | The Eunice Kennedy Shriver Center For Mental Retardation | DNA encoding and method of expressing human monoamine oxidase type A |
| US5530101A (en) | 1988-12-28 | 1996-06-25 | Protein Design Labs, Inc. | Humanized immunoglobulins |
| GB8907617D0 (en) | 1989-04-05 | 1989-05-17 | Celltech Ltd | Drug delivery system |
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| US5508192A (en) | 1990-11-09 | 1996-04-16 | Board Of Regents, The University Of Texas System | Bacterial host strains for producing proteolytically sensitive polypeptides |
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| GB9215540D0 (en) | 1992-07-22 | 1992-09-02 | Celltech Ltd | Protein expression system |
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| AU8867501A (en) | 2000-09-01 | 2002-03-13 | Biogen Inc | Co-crystal structure of monoclonal antibody 5c8 and cd154, and use thereof in drug design |
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| US7041479B2 (en) * | 2000-09-06 | 2006-05-09 | The Board Of Trustess Of The Leland Stanford Junior University | Enhanced in vitro synthesis of active proteins containing disulfide bonds |
| PL205897B1 (pl) | 2000-12-14 | 2010-06-30 | Genentech Inc | Komórka gospodarza E. coli i sposób wytwarzania polipeptydu |
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| TWI334439B (en) | 2001-08-01 | 2010-12-11 | Centocor Inc | Anti-tnf antibodies, compositions, methods and uses |
| KR100968664B1 (ko) | 2001-08-27 | 2010-07-06 | 제넨테크, 인크. | 항체 발현 및 조립을 위한 시스템 |
| GB0124317D0 (en) | 2001-10-10 | 2001-11-28 | Celltech R&D Ltd | Biological products |
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| US8470552B2 (en) | 2009-10-12 | 2013-06-25 | Keck Graduate Institute | Strategy to reduce lactic acid production and control PH in animal cell culture |
| BR112012010153B1 (pt) | 2009-11-05 | 2022-05-03 | Genentech, Inc | Método de produção de um anticorpo |
| GB201000590D0 (en) | 2010-01-14 | 2010-03-03 | Ucb Pharma Sa | Bacterial host strain |
| GB201000587D0 (en) | 2010-01-14 | 2010-03-03 | Ucb Pharma Sa | Bacterial hoist strain |
| GB201000588D0 (en) * | 2010-01-14 | 2010-03-03 | Ucb Pharma Sa | Bacterial host strain |
| GB201000591D0 (en) | 2010-01-14 | 2010-03-03 | Ucb Pharma Sa | Bacterial hoist strain |
| GB201001791D0 (en) | 2010-02-03 | 2010-03-24 | Ucb Pharma Sa | Process for obtaining antibodies |
| EP2546267A1 (en) | 2011-07-13 | 2013-01-16 | UCB Pharma S.A. | Bacterial host strain expressing recombinant DsbC |
| HRP20180226T1 (hr) | 2011-07-13 | 2018-03-09 | Ucb Biopharma Sprl | Bakterijski soj domaćina koji eksprimira rekombinantnu dsbc |
| GB201208367D0 (en) | 2012-05-14 | 2012-06-27 | Ucb Pharma Sa | Biological product |
-
2010
- 2010-07-27 GB GBGB1012599.5A patent/GB201012599D0/en not_active Ceased
-
2011
- 2011-07-27 JP JP2013521208A patent/JP5935222B2/ja active Active
- 2011-07-27 DK DK11745810.9T patent/DK2598516T3/da active
- 2011-07-27 HR HRP20150639TT patent/HRP20150639T1/hr unknown
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