HRP20171966T1 - Postupak za proizvodnju rekombinantnih proteina s niskim razinama dhna (1,4-dihidroksi-2-naftoata) - Google Patents
Postupak za proizvodnju rekombinantnih proteina s niskim razinama dhna (1,4-dihidroksi-2-naftoata) Download PDFInfo
- Publication number
- HRP20171966T1 HRP20171966T1 HRP20171966TT HRP20171966T HRP20171966T1 HR P20171966 T1 HRP20171966 T1 HR P20171966T1 HR P20171966T T HRP20171966T T HR P20171966TT HR P20171966 T HRP20171966 T HR P20171966T HR P20171966 T1 HRP20171966 T1 HR P20171966T1
- Authority
- HR
- Croatia
- Prior art keywords
- recombinant protein
- maintained
- dhna
- levels
- homogenization
- Prior art date
Links
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 title claims 7
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 title claims 7
- VOJUXHHACRXLTD-UHFFFAOYSA-N 1,4-dihydroxy-2-naphthoic acid Chemical compound C1=CC=CC2=C(O)C(C(=O)O)=CC(O)=C21 VOJUXHHACRXLTD-UHFFFAOYSA-N 0.000 title claims 2
- 238000004519 manufacturing process Methods 0.000 title claims 2
- 238000000034 method Methods 0.000 claims 11
- 238000000265 homogenisation Methods 0.000 claims 4
- 238000002156 mixing Methods 0.000 claims 3
- VOJUXHHACRXLTD-UHFFFAOYSA-M 1,4-dihydroxy-2-naphthoate Chemical compound C1=CC=C2C(O)=CC(C([O-])=O)=C(O)C2=C1 VOJUXHHACRXLTD-UHFFFAOYSA-M 0.000 claims 2
- 108010065780 2-amino-4-hydroxy-6-hydroxymethyldihydropteridine pyrophosphokinase Proteins 0.000 claims 2
- 241000588724 Escherichia coli Species 0.000 claims 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 2
- 108010089355 dihydroneopterin aldolase Proteins 0.000 claims 2
- 238000004128 high performance liquid chromatography Methods 0.000 claims 2
- 238000004255 ion exchange chromatography Methods 0.000 claims 2
- 102000004196 processed proteins & peptides Human genes 0.000 claims 2
- 108090000765 processed proteins & peptides Proteins 0.000 claims 2
- 238000005481 NMR spectroscopy Methods 0.000 claims 1
- 238000004458 analytical method Methods 0.000 claims 1
- 238000003556 assay Methods 0.000 claims 1
- 238000001704 evaporation Methods 0.000 claims 1
- 230000008020 evaporation Effects 0.000 claims 1
- 238000004191 hydrophobic interaction chromatography Methods 0.000 claims 1
- 238000011065 in-situ storage Methods 0.000 claims 1
- 238000004949 mass spectrometry 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
- 229910052760 oxygen Inorganic materials 0.000 claims 1
- 239000001301 oxygen Substances 0.000 claims 1
- 229920001184 polypeptide Polymers 0.000 claims 1
- 238000004007 reversed phase HPLC Methods 0.000 claims 1
- 238000003860 storage Methods 0.000 claims 1
- 238000000870 ultraviolet spectroscopy Methods 0.000 claims 1
Classifications
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- 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
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/40—Means for regulation, monitoring, measurement or control, e.g. flow regulation of pressure
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/42—Means for regulation, monitoring, measurement or control, e.g. flow regulation of agitation speed
-
- 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
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12N15/70—Vectors or expression systems specially adapted for E. coli
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Sustainable Development (AREA)
- Physics & Mathematics (AREA)
- Plant Pathology (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Claims (11)
1. Postupak proizvodnje rekombinantnog proteina, uključujući peptide, polipeptide i protutijela, naznačen time, da obuhvaća sljedeće korake:
(a) fermentiranje stanice E.coli i pri čemu je stanica E.coli transformirana nukleinskom kiselinom koja kodira spomenuti rekombinantni protein; i
(b) dobivanje spomenutog rekombinantnog proteina pod uvjetima u kojima se otopljeni kisik (dO2) održava na razinama većim od 0% neprekidno putem obavljanja dobivanja iz koraka (b), pri čemu se obavljanje dobivanja sastoji od sljedećih faza homogenizacije i pri čemu se sadržaj dO2 održava:
1) prije homogenizacije na razinama većim od 75%; i/ili
2) nakon homogenizacije na otprilike 50% ili na razinama većim od 50%;
i
(c) pročišćavanje spomenutog rekombinantnog proteina u filtriranu rinfuzu za pohranu (FBS), pri čemu spomenuta filtrirana rinfuza ne sadrži detektabilni zbroj od 1,4-dihidroksi-2-naftoata (DHNA) i rekombinantnog proteina, izmjereno testom kromatografije ionske izmjene (IEC) pri 310 nm.
2. Postupak prema patentnom zahtjevu 1, naznačen time, da se spomenuti analitički test izvodi putem HPLC, RP HPLC, HIC HPLC, NMR, masene spektrometrije ili UV-spektroskopije.
3. Postupak prema patentnom zahtjevu 1, naznačen time, da korak c) obuhvaća mjerenje razina zbroja DHNA i rekombinantnog proteina u filtriranoj rinfuzi.
4. Postupak prema patentnom zahtjevu 1, naznačen time, da se spomenuti sadržaj dO2 održava pri razinama većim od 75% prije homogenizacije i u vremenskom periodu koji je dulji od ili je točno 2 sata.
5. Postupak prema patentnom zahtjevu 1, naznačen time, da se spomenuti sadržaj dO2 održava zračnim prekrivačem ili in situ isparivanjem s povećanim povratnim tlakom ili brzinom miješanja.
6. Postupak prema patentnom zahtjevu 5, naznačen time, da zračni prekrivač iznosi od 0,4 vvm do 0,8 vvm.
7. Postupak prema patentnom zahtjevu 6, naznačen time, da zračni prekrivač iznosi 0,6 vvm.
8. Postupak prema patentnom zahtjevu 5, naznačen time, da povećani povratni tlak iznosi između 1,0 i 30 psi (6 895 do 206 843 Pa).
9. Postupak prema patentnom zahtjevu 8, naznačen time, da povećani povratni tlak iznosi 19 psi (131 000 Pa).
10. Postupak prema patentnom zahtjevu 5, naznačen time, da brzina miješanja iznosi od 6 W/L do 8 W/L.
11. Postupak prema patentnom zahtjevu 10, naznačen time, da brzina miješanja iznosi oko 6 W/L.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261616297P | 2012-03-27 | 2012-03-27 | |
| PCT/US2013/031383 WO2013148249A1 (en) | 2012-03-27 | 2013-03-14 | Improved harvest operations for recombinant proteins |
| EP13713295.7A EP2831261B1 (en) | 2012-03-27 | 2013-03-14 | Method for producing recombinant proteins with low levels of DHNA (1,4-dihydroxy-2-naphthoate) |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20171966T1 true HRP20171966T1 (hr) | 2018-02-09 |
Family
ID=48040433
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20171966TT HRP20171966T1 (hr) | 2012-03-27 | 2017-12-19 | Postupak za proizvodnju rekombinantnih proteina s niskim razinama dhna (1,4-dihidroksi-2-naftoata) |
Country Status (21)
| Country | Link |
|---|---|
| US (8) | US20140080180A1 (hr) |
| EP (1) | EP2831261B1 (hr) |
| JP (4) | JP6225162B2 (hr) |
| KR (2) | KR102096678B1 (hr) |
| CN (2) | CN104350156B (hr) |
| AR (2) | AR090340A1 (hr) |
| AU (3) | AU2013240280A1 (hr) |
| BR (1) | BR112014023176B1 (hr) |
| CA (2) | CA3086730A1 (hr) |
| ES (1) | ES2654424T3 (hr) |
| HK (1) | HK1207120A1 (hr) |
| HR (1) | HRP20171966T1 (hr) |
| IL (1) | IL234377B (hr) |
| MX (3) | MX365947B (hr) |
| MY (1) | MY171729A (hr) |
| PL (1) | PL2831261T3 (hr) |
| RU (2) | RU2636353C2 (hr) |
| SG (4) | SG10201912877SA (hr) |
| SI (1) | SI2831261T1 (hr) |
| WO (1) | WO2013148249A1 (hr) |
| ZA (1) | ZA201406434B (hr) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017212071A1 (en) | 2016-06-10 | 2017-12-14 | Lonza Ltd | Method for stabilizing proteins |
| AU2017354027C1 (en) * | 2016-11-07 | 2024-04-18 | Seagen Inc. | Distribution of engineered-cysteine caps |
| US20210024873A1 (en) * | 2018-03-27 | 2021-01-28 | Bristol-Myers Squibb Company | Real-time monitoring of protein concentration using ultraviolet signal |
| WO2020150491A1 (en) | 2019-01-16 | 2020-07-23 | Regeneron Pharmaceuticals, Inc. | Methods for characterizing disulfide bonds |
| CN109725088B (zh) * | 2019-03-16 | 2021-05-18 | 丁立平 | 一种测定豆芽中2-萘甲酸及其衍生物的气相色谱-质谱联用法 |
| CN110305903B (zh) * | 2019-07-31 | 2021-10-01 | 江苏璟泽生物医药有限公司 | 重组人促卵泡激素及其制备方法 |
| CN113155776A (zh) * | 2021-04-29 | 2021-07-23 | 华东交通大学 | 一种柑桔最佳采收期预测方法 |
| FR3146146A1 (fr) | 2023-02-24 | 2024-08-30 | Bgene Genetics | Production d’acide 1-4-dihydroxy-2-naphtoïque par Escherichia coli |
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2013
- 2013-03-14 MY MYPI2014002775A patent/MY171729A/en unknown
- 2013-03-14 CN CN201380027623.1A patent/CN104350156B/zh active Active
- 2013-03-14 PL PL13713295T patent/PL2831261T3/pl unknown
- 2013-03-14 JP JP2015503300A patent/JP6225162B2/ja active Active
- 2013-03-14 KR KR1020147026772A patent/KR102096678B1/ko active IP Right Grant
- 2013-03-14 CA CA3086730A patent/CA3086730A1/en not_active Abandoned
- 2013-03-14 AR ARP130100828A patent/AR090340A1/es active IP Right Grant
- 2013-03-14 SI SI201330894T patent/SI2831261T1/en unknown
- 2013-03-14 KR KR1020207008828A patent/KR20200037425A/ko not_active Application Discontinuation
- 2013-03-14 SG SG10201912877SA patent/SG10201912877SA/en unknown
- 2013-03-14 CN CN201910197577.9A patent/CN109880867A/zh active Pending
- 2013-03-14 WO PCT/US2013/031383 patent/WO2013148249A1/en active Application Filing
- 2013-03-14 AU AU2013240280A patent/AU2013240280A1/en not_active Abandoned
- 2013-03-14 BR BR112014023176-1A patent/BR112014023176B1/pt active IP Right Grant
- 2013-03-14 SG SG10201508420VA patent/SG10201508420VA/en unknown
- 2013-03-14 RU RU2014137554A patent/RU2636353C2/ru active
- 2013-03-14 SG SG10202007206WA patent/SG10202007206WA/en unknown
- 2013-03-14 US US13/826,166 patent/US20140080180A1/en not_active Abandoned
- 2013-03-14 CA CA2866753A patent/CA2866753C/en active Active
- 2013-03-14 SG SG11201406112TA patent/SG11201406112TA/en unknown
- 2013-03-14 EP EP13713295.7A patent/EP2831261B1/en active Active
- 2013-03-14 MX MX2014011558A patent/MX365947B/es active IP Right Grant
- 2013-03-14 ES ES13713295.7T patent/ES2654424T3/es active Active
- 2013-03-14 RU RU2017139267A patent/RU2017139267A/ru not_active Application Discontinuation
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2014
- 2014-08-31 IL IL234377A patent/IL234377B/en active IP Right Grant
- 2014-09-02 ZA ZA2014/06434A patent/ZA201406434B/en unknown
- 2014-09-25 MX MX2018007677A patent/MX2018007677A/es unknown
- 2014-09-25 MX MX2019007032A patent/MX2019007032A/es unknown
- 2014-09-26 US US14/497,964 patent/US9765379B2/en active Active
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2015
- 2015-06-09 US US14/734,848 patent/US20160130624A1/en not_active Abandoned
- 2015-08-10 HK HK15107689.4A patent/HK1207120A1/xx unknown
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2017
- 2017-04-13 AU AU2017202484A patent/AU2017202484B2/en active Active
- 2017-10-05 JP JP2017195016A patent/JP2018046825A/ja active Pending
- 2017-12-19 HR HRP20171966TT patent/HRP20171966T1/hr unknown
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2018
- 2018-02-28 US US15/908,526 patent/US20180291411A1/en not_active Abandoned
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2019
- 2019-02-07 US US16/270,494 patent/US20200199639A1/en not_active Abandoned
- 2019-03-18 JP JP2019049717A patent/JP2019141049A/ja not_active Withdrawn
- 2019-09-05 AU AU2019226192A patent/AU2019226192A1/en not_active Abandoned
- 2019-10-09 AR ARP190102873A patent/AR116615A2/es unknown
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2020
- 2020-08-14 JP JP2020137053A patent/JP2020202849A/ja not_active Withdrawn
- 2020-10-09 US US17/067,059 patent/US20210171997A1/en not_active Abandoned
-
2022
- 2022-07-13 US US17/864,255 patent/US20230069966A1/en not_active Abandoned
-
2024
- 2024-01-22 US US18/419,368 patent/US20240158825A1/en active Pending
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