DK2467399T3 - Oprensning af vWF til øget fjernelse af non-lipid-kappeklædte vira - Google Patents
Oprensning af vWF til øget fjernelse af non-lipid-kappeklædte vira Download PDFInfo
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- DK2467399T3 DK2467399T3 DK10747134.4T DK10747134T DK2467399T3 DK 2467399 T3 DK2467399 T3 DK 2467399T3 DK 10747134 T DK10747134 T DK 10747134T DK 2467399 T3 DK2467399 T3 DK 2467399T3
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- cation exchange
- exchange resin
- protein
- vwf
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Classifications
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- 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
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
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- Hematology (AREA)
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- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Analytical Chemistry (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (14)
1. Fremgangsmåde til fjernelse af et non-lipid-kappeklædt virus fra en protein-holdig opløsning omfattende at: påføre opløsningen til en kationbytningsharpiks ved en pH, der er højere end det isoelektriske punkt af proteinet; og vaske kationbytningsharpiksen med en vaskepuffer for at danne et eluat, hvor vaskepufferen har en pH, som er lig med eller lavere end opløsningen påført til kationbytningsharpiksen, hvor proteinet i opløsningen er et polypeptid, der har en molekylevægt på mindst 150 kilodalton, og hvorved det non-lipid-kappeklædte virus fjernes fra den proteinholdige opløsning.
2. Fremgangsmåde ifølge krav 1, hvor opløsningen påført til kationbytningsharpiksen er mindst 1 pH-enhed over det isoelektriske punkt af proteinet.
3. Fremgangsmåde til fjernelse af et non-lipid-kappeklædt virus fra en protein-holdig opløsning omfattende at: påføre opløsningen til en kationbytningsharpiks, vaske kationbytningsharpiksen med en første vaskepuffer ved en pH, der er højere end pH'en af opløsningen påført til kationbytningsharpiksen; og vaske kationbytningsharpiksen med en anden vaskepuffer for at danne et eluat, hvor det første elueringsmiddel har en pH, som er lig med eller lavere end den første vaskepuffer, hvor proteinet i opløsningen er et polypeptid, der har en molekylevægt på mindst 150 kilodalton, og hvorved det non-lipid-kappeklædte virus fjernes fra den proteinholdige opløsning.
4. Fremgangsmåde ifølge krav 3, hvor pH'en af den første vaskepuffer er mindst 1 pH-enhed over det isoelektriske punkt af proteinet påført til kationbytningsharpiksen.
5. Fremgangsmåde til fjernelse af et non-lipid-kappeklædt virus fra en protein-holdig opløsning omfattende at: påføre opløsningen til en kationbytningsharpiks ved en pH, der er højere end det isoelektriske punkt af proteinet; og vaske kationbytningsharpiksen med en første vaskepuffer ved en pH, der er højere end det isoelektriske punkt af proteinet påført til kationbytningsharpiksen; og vaske kationbytningsharpiksen med en anden vaskepuffer for at danne et eluat, hvor det første elueringsmiddel har en pH, som er lig med eller lavere end den første vaskepuffer, hvor proteinet i opløsningen er et polypeptid, der har en molekylevægt på mindst 150 kilodalton, og hvorved det non-lipid-kappeklædte virus fjernes fra den proteinholdige opløsning.
6. Fremgangsmåde ifølge krav 5, hvor opløsningen påført til kationbytningshar- piksen er mindst 1 pH-enhed over det isoelektriske punkt af proteinet.
7. Fremgangsmåde ifølge krav 5, hvor pH'en af den første vaskepuffer er mindst 1 pH-enhed over pH'en af opløsningen påført til kationbytningsharpiksen.
8. Fremgangsmåde ifølge kravene 2, 4, 6 eller 7, hvor pH'en er større end 7,0.
9. Fremgangsmåde ifølge et hvilket som helst af krav 1-8, hvor kationbytningsharpiksen har en negativ ladet gruppe valgt fra gruppen bestående af carboxymethyl (CM), sulfoalkyl (SP, SE), sulfaterede estere af cellulose, heparin og methylsulfonat (S).
10. Fremgangsmåde ifølge et hvilket som helst af krav 1-9, hvor proteinet er et blodkoagulationsprotein.
11. Fremgangsmåde ifølge krav 10, hvor blodkoagulationsproteinet er valgt fra gruppen bestående af faktor VIII og von Willebrand faktor.
12. Fremgangsmåde til fjernelse af et non-lipid-kappeklædt virus fra en von Willebrand faktor (VWF)-holdig opløsning omfattende at: påføre opløsningen til en kationbytningsharpiks ved en pH, der er højere end det isoelektriske punkt af VWF; og vaske kationbytningsharpiksen med en første vaskepuffer for at danne et eluat, hvor den første vaskepuffer har en pH, som er lig med eller lavere end opløsningen påført til kationbytningsharpiksen.
13. Fremgangsmåde til fjernelse af et non-lipid-kappeklædt virus fra en VWF-holdig opløsning omfattende at: påføre opløsningen til en kationbytningsharpiks, vaske kationbytningsharpiksen med en første vaskepuffer ved en pH, der er højere end pH'en af opløsningen påført til kationbytningsharpiksen; og vaske kationbytningsharpiksen med en anden vaskepuffer for at danne et eluat, hvor det første elueringsmiddel, der har en pH, der er lig med eller lavere end den første vaskepuffer.
14. Fremgangsmåde til fjernelse af et non-lipid-kappeklædt virus fra en VWF-holdig opløsning omfattende at: påføre opløsningen til en kationbytningsharpiks ved en pH, der er højere end det isoelektriske punkt af VWF; og vaske kationbytningsharpiksen med en første vaskepuffer ved en pH, der er højere end det isoelektriske punkt af VWF påført til kationbytningsharpiksen; og vaske kationbytningsharpiksen med en anden vaskepuffer for at danne et eluat, hvor det første elueringsmiddel, der har en pH, som er lig med eller lavere end den første vaskepuffer, og hvorved det non-lipid-kappeklædte virus fjernes fra den VWF-holdige opløsning.
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| US23557009P | 2009-08-20 | 2009-08-20 | |
| PCT/US2010/046180 WO2011022657A1 (en) | 2009-08-20 | 2010-08-20 | Purification of vwf for increased removal of non-lipid enveloped viruses |
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| ES (1) | ES2562256T5 (da) |
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| MX (1) | MX2012002129A (da) |
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| PL (1) | PL2467399T3 (da) |
| PT (1) | PT2467399E (da) |
| SG (2) | SG10201408106WA (da) |
| WO (1) | WO2011022657A1 (da) |
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| US11197916B2 (en) | 2007-12-28 | 2021-12-14 | Takeda Pharmaceutical Company Limited | Lyophilized recombinant VWF formulations |
| TWI508735B (zh) | 2008-10-21 | 2015-11-21 | 巴克斯特國際公司 | 凍乾的重組ｖｗｆ調配物 |
| PL3103861T3 (pl) * | 2012-06-21 | 2021-03-22 | Takeda Pharmaceutical Company Limited | Filtracja wirusowa pożywek do hodowli komórkowej |
| CN105026556A (zh) | 2013-02-22 | 2015-11-04 | 新加坡科技研究局 | 用带负电的颗粒对病毒制剂的色谱纯化 |
| JP6605593B2 (ja) * | 2014-06-06 | 2019-11-13 | オクタファルマ・アーゲー | 第ｖｉｉｉ因子およびフォン・ヴィルブランド因子ペプチドを含む製剤 |
| AU2015274238B2 (en) | 2014-06-13 | 2020-11-05 | Csl Limited | Improved production of recombinant von Willebrand factor in a bioreactor |
| US20200199176A1 (en) | 2017-08-23 | 2020-06-25 | Csl Behring Gmbh | Method for virus filtration of von willebrand factor |
| CN112533940A (zh) * | 2018-03-21 | 2021-03-19 | 百深公司 | 通过色谱方法分离vwf和vwf前肽 |
| WO2023170680A1 (en) | 2022-03-08 | 2023-09-14 | Equashield Medical Ltd | Fluid transfer station in a robotic pharmaceutical preparation system |
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| US3941763A (en) | 1975-03-28 | 1976-03-02 | American Home Products Corporation | PGlu-D-Met-Trp-Ser-Tyr-D-Ala-Leu-Arg-Pro-Gly-NH2 and intermediates |
| AU591671B2 (en) | 1985-04-11 | 1989-12-14 | Children's Medical Center Corporation | Von willebrand factor |
| US5728553A (en) * | 1992-09-23 | 1998-03-17 | Delta Biotechnology Limited | High purity albumin and method of producing |
| AT405403B (de) * | 1997-02-27 | 1999-08-25 | Immuno Ag | Reinigung von von willebrand-faktor durch kationenaustauscherchromatographie |
| AT406373B (de) | 1997-02-27 | 2000-04-25 | Immuno Ag | Verfahren zur reinigung von faktor viii/vwf-komplex mittels kationenaustauscherchromatographie |
| AT405485B (de) | 1997-05-28 | 1999-08-25 | Immuno Ag | Eine das vwf-propeptid enthaltende pharmazeutische präparation |
| US6531577B1 (en) | 1997-12-15 | 2003-03-11 | Hemasure Denmark A/S | von Willebrand factor (vWF)-containing preparation, process for preparing vWF-containing preparations, and use of such preparations |
| CN1260249C (zh) * | 1998-05-06 | 2006-06-21 | 基因技术股份有限公司 | 用离子交换层析纯化蛋白质 |
| DK1835938T3 (da) | 2004-12-27 | 2013-11-04 | Baxter Int | Polymer-von Willebrand-faktor-konjugater |
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- 2010-08-20 MX MX2012002129A patent/MX2012002129A/es active IP Right Grant
- 2010-08-20 AU AU2010284116A patent/AU2010284116B9/en active Active
- 2010-08-20 CN CN2010800395824A patent/CN102482341A/zh active Pending
- 2010-08-20 PT PT107471344T patent/PT2467399E/pt unknown
- 2010-08-20 CN CN201610190778.2A patent/CN106008697B/zh active Active
- 2010-08-20 NZ NZ598249A patent/NZ598249A/en unknown
- 2010-08-20 SG SG2012011177A patent/SG178478A1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CN102482341A (zh) | 2012-05-30 |
| US20110092681A1 (en) | 2011-04-21 |
| EP2467399A1 (en) | 2012-06-27 |
| ES2562256T3 (es) | 2016-03-03 |
| KR20120065342A (ko) | 2012-06-20 |
| BR112012003802A2 (pt) | 2016-11-22 |
| NZ598249A (en) | 2014-04-30 |
| EP2467399B1 (en) | 2015-11-11 |
| PT2467399E (pt) | 2016-03-18 |
| AU2010284116A1 (en) | 2012-03-08 |
| EP2467399B2 (en) | 2023-02-01 |
| ES2562256T5 (es) | 2023-07-20 |
| MX2012002129A (es) | 2012-06-08 |
| KR101894600B1 (ko) | 2018-09-03 |
| IN2012DN01849A (da) | 2015-08-21 |
| CA2771232A1 (en) | 2011-02-24 |
| AU2010284116B2 (en) | 2015-02-12 |
| SG10201408106WA (en) | 2015-01-29 |
| AU2010284116B9 (en) | 2015-03-26 |
| JP2013502434A (ja) | 2013-01-24 |
| WO2011022657A1 (en) | 2011-02-24 |
| PL2467399T3 (pl) | 2016-05-31 |
| JP5838159B2 (ja) | 2015-12-24 |
| HUE026907T2 (en) | 2016-07-28 |
| CN106008697A (zh) | 2016-10-12 |
| US9315560B2 (en) | 2016-04-19 |
| SG178478A1 (en) | 2012-04-27 |
| BR112012003802B1 (pt) | 2022-10-25 |
| CN106008697B (zh) | 2020-08-04 |
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