HRP20190846T1 - Postupak proizvodnje g-csf - Google Patents
Postupak proizvodnje g-csf Download PDFInfo
- Publication number
- HRP20190846T1 HRP20190846T1 HRP20190846TT HRP20190846T HRP20190846T1 HR P20190846 T1 HRP20190846 T1 HR P20190846T1 HR P20190846T T HRP20190846T T HR P20190846TT HR P20190846 T HRP20190846 T HR P20190846T HR P20190846 T1 HRP20190846 T1 HR P20190846T1
- Authority
- HR
- Croatia
- Prior art keywords
- temperature
- nucleic acid
- csf
- polypeptide
- seq
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 15
- 229920001184 polypeptide Polymers 0.000 title claims 4
- 108090000765 processed proteins & peptides Proteins 0.000 title claims 4
- 102000004196 processed proteins & peptides Human genes 0.000 title claims 4
- 150000007523 nucleic acids Chemical class 0.000 claims 10
- 108010017080 Granulocyte Colony-Stimulating Factor Proteins 0.000 claims 6
- 102000004269 Granulocyte Colony-Stimulating Factor Human genes 0.000 claims 6
- 230000001580 bacterial effect Effects 0.000 claims 6
- 210000004027 cell Anatomy 0.000 claims 6
- 108020004707 nucleic acids Proteins 0.000 claims 5
- 102000039446 nucleic acids Human genes 0.000 claims 5
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 4
- 241001515965 unidentified phage Species 0.000 claims 4
- 102000004163 DNA-directed RNA polymerases Human genes 0.000 claims 3
- 108090000626 DNA-directed RNA polymerases Proteins 0.000 claims 3
- 239000000411 inducer Substances 0.000 claims 3
- 238000004113 cell culture Methods 0.000 claims 2
- 210000000349 chromosome Anatomy 0.000 claims 2
- 230000001939 inductive effect Effects 0.000 claims 2
- 230000003287 optical effect Effects 0.000 claims 2
- 101000746370 Bos taurus Granulocyte colony-stimulating factor Proteins 0.000 claims 1
- 241000588724 Escherichia coli Species 0.000 claims 1
- 101000746367 Homo sapiens Granulocyte colony-stimulating factor Proteins 0.000 claims 1
- 125000000539 amino acid group Chemical group 0.000 claims 1
- 239000013604 expression vector Substances 0.000 claims 1
- 210000003000 inclusion body Anatomy 0.000 claims 1
- BPHPUYQFMNQIOC-NXRLNHOXSA-N isopropyl beta-D-thiogalactopyranoside Chemical group CC(C)S[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O BPHPUYQFMNQIOC-NXRLNHOXSA-N 0.000 claims 1
- 230000001320 lysogenic effect Effects 0.000 claims 1
- 229930182817 methionine Natural products 0.000 claims 1
- 125000001360 methionine group Chemical group N[C@@H](CCSC)C(=O)* 0.000 claims 1
- 239000013598 vector Substances 0.000 claims 1
Classifications
-
- 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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/53—Colony-stimulating factor [CSF]
- C07K14/535—Granulocyte CSF; Granulocyte-macrophage CSF
-
- 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
- C12P21/02—Preparation of peptides or proteins having a known sequence of two or more amino acids, e.g. glutathione
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Medicinal Chemistry (AREA)
- Toxicology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biotechnology (AREA)
- General Chemical & Material Sciences (AREA)
- Microbiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Peptides Or Proteins (AREA)
Claims (13)
1. Postupak proizvodnje rekombinantnog polipeptida G-CSF u inkluzijskim tijelima, naznačen time što se postupak sastoji u
(a) uzgoju bakterijske stanice domaćina na prvoj temperaturi između 36 °C i 38° C, gdje stanica domaćin sadrži nukleinsku kiselinu koja kodira navedeni rekombinantni polipeptid G-CSF,
(b) snižavanju temperature uzgoja od prve temperature do druge temperature između 30 °C i 35 °C, i
(c) uzgoju bakterijske stanice domaćina na drugoj temperaturi,
gdje je nukleinska kiselina operabilno spregnuta s inducibilnim T7 promotorom i gdje se snižavanje temperature provodi kada kultura stanica dosegne optičku gustoću na 600 nm između 10 i 50, te gdje kromosom bakterijske stanice domaćina sadrži nukleinskokiselinski slijed koji kodira RNA polimerazu iz bakteriofaga operabilno spregnut s lac promotorom.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što je bakterijski domaćin E. coli.
3. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je prva temperatura 37 °C.
4. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je druga temperatura između 31 °C i 33 °C.
5. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je pH tijekom uzgoja na prvoj temperaturi i/ili drugoj temperaturi između 6 i 8.
6. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je pH tijekom uzgoja na prvoj temperaturi i/ili drugoj temperaturi između 6,8 i 7,2.
7. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se snižavanje temperature provodi kada kultura stanica dosegne optičku gustoću na 600 nm između 27 i 33.
8. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je G-CSF ljudski ili goveđi G-CSF, uz odgovarajući mogući početni ostatak aminokiseline metionina na položaju –1.
9. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što koracima (a) do (c) prethodi korak unosa u bakterijsku stanicu domaćina ekspresijskog vektora koji sadrži nukleinsku kiselinu koja kodira navedeni rekombinantni polipeptid G-CSF, gdje je nukleinska kiselina operabilno spregnuta s inducibilnim promotorom.
10. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što kromosom bakterijske stanice domaćina sadrži nukleinskokiselinski slijed koji kodira RNA polimerazu iz bakteriofaga, operabilno spregnut s lac promotorom, te ne sadrži nukleinskokiselinske sljedove lizogenih bakteriofaga, gdje RNA polimeraza iz bakteriofaga može biti polimeraza T7.
11. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se eksprimiranje polipeptida G-CSF provodi uz dodatak induktora, gdje se induktor može dodati istodobno s ili nakon snižavanja temperature, gdje induktor može biti IPTG.
12. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što vektor sadrži slijed SEQ ID NO:4.
13. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se nukleinsku kiselinu koja kodira navedeni rekombinantni polipeptid G-CSF bira iz skupine koju čine
(i) nukleinskokiselinski slijed koji kodira polipeptid sa SEQ ID NO:3 ili SEQ ID NO:1; i
(ii) nukleinskokiselinski slijed koji kodira polipeptid čini slijed najmanje 90 % istovjetan slijedu opisanom u SEQ ID NO:3.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| HU1200171A HUP1200171A1 (hu) | 2012-03-19 | 2012-03-19 | Módszerek polipeptidek elõállítására |
| EP13709469.4A EP2828396B1 (en) | 2012-03-19 | 2013-03-18 | Method for the production of g-csf |
| PCT/EP2013/055529 WO2013068602A2 (en) | 2012-03-19 | 2013-03-18 | Method for the production of polypeptides |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20190846T1 true HRP20190846T1 (hr) | 2019-08-09 |
Family
ID=89990648
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20190846TT HRP20190846T1 (hr) | 2012-03-19 | 2019-05-07 | Postupak proizvodnje g-csf |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US9416164B2 (hr) |
| EP (2) | EP2828396B1 (hr) |
| JP (1) | JP6154885B2 (hr) |
| KR (1) | KR101949556B1 (hr) |
| CN (1) | CN104603280A (hr) |
| CA (1) | CA2867794C (hr) |
| DK (1) | DK2828396T3 (hr) |
| ES (1) | ES2732374T3 (hr) |
| HR (1) | HRP20190846T1 (hr) |
| HU (2) | HUP1200171A1 (hr) |
| LT (1) | LT2828396T (hr) |
| PL (1) | PL2828396T3 (hr) |
| SI (1) | SI2828396T1 (hr) |
| TR (1) | TR201907221T4 (hr) |
| WO (1) | WO2013068602A2 (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUP1200172A2 (en) | 2012-03-19 | 2013-10-28 | Richter Gedeon Nyrt | Methods for refolding g-csf from inclusion bodies |
| HUP1200171A1 (hu) | 2012-03-19 | 2013-09-30 | Richter Gedeon Nyrt | Módszerek polipeptidek elõállítására |
| JP6697383B2 (ja) * | 2014-06-09 | 2020-05-20 | 株式会社カネカ | 組換えブレビバチルス属細菌を用いた組換え蛋白質の製造方法 |
| EP3902820A2 (en) * | 2018-12-28 | 2021-11-03 | Coherus Biosciences, Inc. | Process for producing, isolating, and purifying modified recombinant proteins |
| WO2020234742A1 (en) * | 2019-05-20 | 2020-11-26 | Lupin Limited | Granulocyte colony stimulating factor purification |
Family Cites Families (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61227526A (ja) | 1984-07-25 | 1986-10-09 | Chugai Pharmaceut Co Ltd | 新規なコロニー刺激因子 |
| US4810643A (en) | 1985-08-23 | 1989-03-07 | Kirin- Amgen Inc. | Production of pluripotent granulocyte colony-stimulating factor |
| DE3537708A1 (de) | 1985-10-23 | 1987-04-23 | Boehringer Mannheim Gmbh | Verfahren zur aktivierung von t-pa nach expression in prokaryonten |
| JPH0618780B2 (ja) * | 1986-01-22 | 1994-03-16 | 中外製薬株式会社 | 骨髄性白血病抑制剤 |
| US5714581A (en) | 1986-12-23 | 1998-02-03 | Kyowa Hakko Kogyo Co., Ltd. | Polypeptide derivatives of human granulocyte colony stimulating factor |
| EP0719860B1 (en) | 1988-05-13 | 2009-12-16 | Amgen Inc. | Process for isolating and purifying G-CSF |
| DE3835350A1 (de) | 1988-10-17 | 1990-04-19 | Boehringer Mannheim Gmbh | Aktivierung von gentechnologisch hergestellten, in prokaryonten exprimierten antikoerpern |
| CA2006596C (en) | 1988-12-22 | 2000-09-05 | Rika Ishikawa | Chemically-modified g-csf |
| US5055555A (en) | 1989-01-05 | 1991-10-08 | Helmut Sassenfeld | Purification of G-CSF |
| FR2669646A1 (fr) | 1990-11-23 | 1992-05-29 | Lorraine Laminage | Procede de traitement d'un effluent aqueux issu d'un procede d'electrozingage, ainsi que procede et installation en comportant application. |
| DE4114575C1 (hr) | 1991-05-04 | 1992-05-14 | Fa. Carl Freudenberg, 6940 Weinheim, De | |
| KR100241257B1 (ko) | 1997-05-22 | 2000-02-01 | 한승수 | 인체 과립구 콜로니 자극 인자 활성물질 및 그것의 제조방법 |
| AU4975699A (en) | 1998-07-09 | 2000-02-01 | University Technology Corporation | High pressure refolding of protein aggregates and inclusion bodies |
| FR2796071B1 (fr) | 1999-07-08 | 2001-09-07 | Hoechst Marion Roussel Inc | Procede de purification de facteur de stimulation de colonies de granulocytes |
| EP1284987B1 (en) | 2000-05-16 | 2007-07-18 | Bolder Biotechnology, Inc. | Methods for refolding proteins containing free cysteine residues |
| SI21102A (sl) | 2001-12-19 | 2003-06-30 | LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. | Postopek za izolacijo biološko aktivnega granulocitne kolonije stimulirajočega dejavnika |
| AU2002345829A1 (en) | 2002-06-24 | 2004-01-06 | Dr. Reddy's Laboratories Ltd. | Process for preparing g-csf |
| SI21273A (sl) | 2002-07-31 | 2004-02-29 | LEK farmacevtska dru�ba d.d. | Priprava inkluzijskih teles z visokim deležem pravilno zvitega prekurzorja heterolognega proteina |
| KR100484653B1 (ko) * | 2004-05-06 | 2005-04-20 | 주식회사 대웅 | 원핵세포에서 활성형의 가용성 단백질을 제조하는 방법 및 이를 위한 폴리시스트론 벡터 |
| DE102004041639A1 (de) | 2004-08-27 | 2006-03-02 | Bioceuticals Arzneimittel Ag | Verfahren zur Gewinnung von biologisch aktivem humanen G-CSF aus Inclusion Bodies |
| EP1869078A2 (en) | 2005-03-17 | 2007-12-26 | Zenotech Laboratories Limited | Process for the purification of recombinant granulocyte-colony stimulating factor |
| KR100694994B1 (ko) | 2005-06-13 | 2007-03-14 | 씨제이 주식회사 | 사람 과립구 콜로니 형성인자 동종체 |
| GB0605684D0 (en) | 2006-03-21 | 2006-05-03 | Sicor Biotech Uab | Method For Purifying Granulocyte-Colony Stimulating Factor |
| WO2008009368A1 (en) | 2006-07-21 | 2008-01-24 | Sony Service Centre (Europe) N.V. | System and method of prioritising tasks |
| WO2008096370A2 (en) | 2007-02-05 | 2008-08-14 | Natco Pharma Limited | An efficient and novel purification method of recombinant hg-csf |
| WO2008096368A2 (en) * | 2007-02-05 | 2008-08-14 | Natco Pharma Limited | A novel process for production of recombinant human g-csf |
| CN101358196A (zh) | 2008-08-29 | 2009-02-04 | 浙江理工大学 | 利用家蚕后部丝腺体外表达系统合成蛋白质的方法 |
| CN101691560B (zh) | 2008-12-19 | 2011-08-31 | 华南理工大学 | 大肠杆菌及其可溶性表达转谷氨酰胺酶酶原的方法 |
| JP2012530131A (ja) | 2009-06-16 | 2012-11-29 | ルピン・リミテッド | 組み換えヒト顆粒球コロニー刺激因子の精製のための方法 |
| HUP1200171A1 (hu) | 2012-03-19 | 2013-09-30 | Richter Gedeon Nyrt | Módszerek polipeptidek elõállítására |
| HUP1200172A2 (en) | 2012-03-19 | 2013-10-28 | Richter Gedeon Nyrt | Methods for refolding g-csf from inclusion bodies |
-
2012
- 2012-03-19 HU HU1200171A patent/HUP1200171A1/hu unknown
-
2013
- 2013-03-18 EP EP13709469.4A patent/EP2828396B1/en not_active Revoked
- 2013-03-18 US US14/386,081 patent/US9416164B2/en not_active Expired - Fee Related
- 2013-03-18 ES ES13709469T patent/ES2732374T3/es active Active
- 2013-03-18 JP JP2015500866A patent/JP6154885B2/ja not_active Expired - Fee Related
- 2013-03-18 CN CN201380015530.7A patent/CN104603280A/zh active Pending
- 2013-03-18 TR TR2019/07221T patent/TR201907221T4/tr unknown
- 2013-03-18 DK DK13709469.4T patent/DK2828396T3/da active
- 2013-03-18 LT LTEP13709469.4T patent/LT2828396T/lt unknown
- 2013-03-18 KR KR1020147029031A patent/KR101949556B1/ko active IP Right Grant
- 2013-03-18 HU HUE13709469A patent/HUE045310T2/hu unknown
- 2013-03-18 EP EP19161593.9A patent/EP3517621A1/en not_active Withdrawn
- 2013-03-18 SI SI201331434T patent/SI2828396T1/sl unknown
- 2013-03-18 PL PL13709469T patent/PL2828396T3/pl unknown
- 2013-03-18 WO PCT/EP2013/055529 patent/WO2013068602A2/en active Application Filing
- 2013-03-18 CA CA2867794A patent/CA2867794C/en active Active
-
2019
- 2019-05-07 HR HRP20190846TT patent/HRP20190846T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JP2015514398A (ja) | 2015-05-21 |
| TR201907221T4 (tr) | 2019-06-21 |
| EP2828396B1 (en) | 2019-04-24 |
| KR20140144705A (ko) | 2014-12-19 |
| ES2732374T3 (es) | 2019-11-22 |
| KR101949556B1 (ko) | 2019-02-18 |
| HUP1200171A1 (hu) | 2013-09-30 |
| CA2867794A1 (en) | 2013-05-16 |
| EP2828396A2 (en) | 2015-01-28 |
| SI2828396T1 (sl) | 2019-06-28 |
| JP6154885B2 (ja) | 2017-06-28 |
| WO2013068602A2 (en) | 2013-05-16 |
| HUE045310T2 (hu) | 2019-12-30 |
| CN104603280A (zh) | 2015-05-06 |
| DK2828396T3 (da) | 2019-05-27 |
| US20150044721A1 (en) | 2015-02-12 |
| LT2828396T (lt) | 2019-05-27 |
| EP3517621A1 (en) | 2019-07-31 |
| WO2013068602A3 (en) | 2013-08-01 |
| CA2867794C (en) | 2020-06-09 |
| PL2828396T3 (pl) | 2019-08-30 |
| US9416164B2 (en) | 2016-08-16 |
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