ES2507091T3 - Nanofiltración de soluciones del factor VII para eliminar virus - Google Patents
Nanofiltración de soluciones del factor VII para eliminar virus Download PDFInfo
- Publication number
- ES2507091T3 ES2507091T3 ES04804635.3T ES04804635T ES2507091T3 ES 2507091 T3 ES2507091 T3 ES 2507091T3 ES 04804635 T ES04804635 T ES 04804635T ES 2507091 T3 ES2507091 T3 ES 2507091T3
- Authority
- ES
- Spain
- Prior art keywords
- factor vii
- nanofiltration
- polypeptides
- eliminate viruses
- solutions
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
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
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- 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
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- 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
-
- 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
- C12N9/14—Hydrolases (3)
- C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
- C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
- C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
- C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
- C12N9/6424—Serine endopeptidases (3.4.21)
- C12N9/6437—Coagulation factor VIIa (3.4.21.21)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21021—Coagulation factor VIIa (3.4.21.21)
-
- 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
- C12N2740/00—Reverse transcribing RNA viruses
- C12N2740/00011—Details
- C12N2740/10011—Retroviridae
- C12N2740/13011—Gammaretrovirus, e.g. murine leukeamia virus
- C12N2740/13061—Methods of inactivation or attenuation
- C12N2740/13063—Methods of inactivation or attenuation by chemical treatment
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Medicinal Chemistry (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Virology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Toxicology (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Water Supply & Treatment (AREA)
- Analytical Chemistry (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
Abstract
Un método para retirar virus de una composición líquida del factor VII recombinante, donde dicha composición comprende uno o más polipéptidos del factor VII, donde la concentración de los polipéptidos del factor VII está comprendida en el intervalo de 0.01 a 5 mg/mL y donde la forma activada de los polipéptidos del factor VII representa un 50-100% de la masa del polipéptido o de los polipéptidos del factor FVII en la composición; donde dicho método comprende someter dicha solución a nanofiltración utilizando un nanofiltro que tiene un tamaño de poro de 80 nm como máximo.
Description
Claims (1)
-
imagen1
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DKPA200301775 | 2003-12-01 | ||
DK200301775 | 2003-12-01 | ||
PCT/EP2004/053206 WO2005054275A2 (en) | 2003-12-01 | 2004-12-01 | Nanofiltration of factor vii solutions to remove virus |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2507091T3 true ES2507091T3 (es) | 2014-10-14 |
Family
ID=34639198
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES19186952T Active ES2926359T3 (es) | 2003-12-01 | 2004-12-01 | Filtración de virus de composiciones líquidas del Factor VII |
ES04804635.3T Active ES2507091T3 (es) | 2003-12-01 | 2004-12-01 | Nanofiltración de soluciones del factor VII para eliminar virus |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES19186952T Active ES2926359T3 (es) | 2003-12-01 | 2004-12-01 | Filtración de virus de composiciones líquidas del Factor VII |
Country Status (14)
Country | Link |
---|---|
US (8) | US20070142625A1 (es) |
EP (3) | EP1711513B1 (es) |
JP (3) | JP4874806B2 (es) |
KR (1) | KR101234170B1 (es) |
CN (3) | CN1890257A (es) |
AU (1) | AU2004294403A1 (es) |
BR (1) | BRPI0416950B8 (es) |
CA (1) | CA2545474A1 (es) |
DK (1) | DK1711513T3 (es) |
ES (2) | ES2926359T3 (es) |
PL (1) | PL1711513T3 (es) |
PT (1) | PT1711513E (es) |
RU (1) | RU2472804C2 (es) |
WO (1) | WO2005054275A2 (es) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1890257A (zh) * | 2003-12-01 | 2007-01-03 | 诺和诺德医疗保健公司 | 液体因子ⅶ组合物的病毒过滤 |
DE102005037824A1 (de) * | 2005-08-08 | 2007-02-15 | Zlb Behring Gmbh | Neuartiges Virusreduktionsverfahren |
WO2012090067A1 (en) | 2010-12-30 | 2012-07-05 | Lfb Biotechnologies | Glycols as pathogen inactivating agents |
SG193564A1 (en) | 2011-03-25 | 2013-10-30 | Genentech Inc | Novel protein purification methods |
MY173835A (en) | 2012-06-21 | 2020-02-24 | Baxter Int | Virus filtration of cell culture media |
TWI641382B (zh) * | 2013-01-31 | 2018-11-21 | 韓美藥品股份有限公司 | 於包含因子vii之組成物中使病毒失活之方法 |
RU2526494C1 (ru) * | 2013-03-19 | 2014-08-20 | Государственное бюджетное образовательное учреждение высшего профессионального образования "Челябинская государственная медицинская академия" Министерства здравоохранения Российской Федерации" (ГБОУ ВПО ЧелГМА Минздрава России) | Способ удаления вируса иммунодефицита человека из спермы мужчины |
CN105722523B (zh) * | 2013-11-15 | 2022-06-14 | 豪夫迈·罗氏有限公司 | 使用环保洗涤剂的病毒灭活方法 |
CN105435644A (zh) * | 2014-09-29 | 2016-03-30 | 中国石油化工股份有限公司 | 一种纳滤膜及其制备方法 |
WO2021030787A1 (en) | 2019-08-15 | 2021-02-18 | Catalyst Biosciences, Inc. | Modified factor vii polypeptides for subcutaneous administration and on-demand treatment |
EP4189064A1 (en) * | 2020-07-30 | 2023-06-07 | Amgen Inc. | Cell culture media and methods of making and using the same |
Family Cites Families (58)
Publication number | Priority date | Publication date | Assignee | Title |
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US3100501A (en) | 1960-12-23 | 1963-08-13 | Crane Co | Removable head and seat ball valve construction |
JPS6033009B2 (ja) * | 1978-12-29 | 1985-07-31 | 三菱電機株式会社 | マイクロ波発振装置 |
US4456591A (en) | 1981-06-25 | 1984-06-26 | Baxter Travenol Laboratories, Inc. | Therapeutic method for activating factor VII |
US4540573A (en) * | 1983-07-14 | 1985-09-10 | New York Blood Center, Inc. | Undenatured virus-free biologically active protein derivatives |
GR860984B (en) | 1985-04-17 | 1986-08-18 | Zymogenetics Inc | Expression of factor vii and ix activities in mammalian cells |
US5580560A (en) | 1989-11-13 | 1996-12-03 | Novo Nordisk A/S | Modified factor VII/VIIa |
US5997864A (en) | 1995-06-07 | 1999-12-07 | Novo Nordisk A/S | Modified factor VII |
EP1479395A1 (en) | 1991-02-28 | 2004-11-24 | Novo Nordisk A/S | Modified factor VII |
DE4142908C2 (de) * | 1991-12-24 | 1994-02-10 | Octapharma Ag Glarus | Verfahren zur Herstellung eines virusinaktivierten Prothrombinkomplex-Konzentrats (PPSB) |
DK38293D0 (da) | 1993-03-31 | 1993-03-31 | Novo Nordisk As | Fremstilling af proteiner |
SE9500724D0 (sv) | 1994-06-23 | 1995-02-24 | Pharmacia Ab | Filtrering |
US5677162A (en) * | 1995-05-01 | 1997-10-14 | New York Blood Center, Inc. | Method for activating prothrombin to thrombin |
AT406019B (de) * | 1995-05-08 | 2000-01-25 | Immuno Ag | Verfahren zur herstellung eines arzneimittels enthaltend ein oder mehrere plasmaderivate |
EP0860444A1 (en) * | 1997-02-24 | 1998-08-26 | Stichting Centraal Laboratorium van de Bloedtransfusiedienst van het Nederlandse Rode Kruis (CLB) | Method for removing viruses from a protein solution |
AT405608B (de) * | 1997-04-08 | 1999-10-25 | Immuno Ag | Verfahren zur inaktivierung von pathogenen, insbesondere von viren, in einem biologischen material |
AT407159B (de) * | 1997-06-13 | 2001-01-25 | Immuno Ag | Verfahren zur abreicherung von viralen und molekularen pathogenen aus einem biologischen material |
AT407255B (de) * | 1997-06-20 | 2001-02-26 | Immuno Ag | Rekombinanter zellklon mit erhöhter stabilität in serum- und proteinfreiem medium und verfahren zur gewinnung des stabilen zellklons |
ATA159597A (de) * | 1997-09-19 | 2000-09-15 | Immuno Ag | Präparat zur behandlung von blutgerinnungsstörungen |
US6747003B1 (en) | 1997-10-23 | 2004-06-08 | Regents Of The University Of Minnesota | Modified vitamin K-dependent polypeptides |
US6017882A (en) | 1997-10-23 | 2000-01-25 | Regents Of The University Of Minnesota | Modified vitamin K-dependent polypeptides |
US7247708B2 (en) | 1997-10-23 | 2007-07-24 | Regents Of The University Of Minnesota | Modified vitamin K-dependent polypeptides |
US6693075B1 (en) | 1997-10-23 | 2004-02-17 | Regents Of The University Of Minnesota | Modified vitamin K-dependent polypeptides |
US5981254A (en) | 1997-10-30 | 1999-11-09 | Haemacure Corporation | Process for producing thrombin from plasma |
CN1284881A (zh) | 1997-11-05 | 2001-02-21 | 吉富制药株式会社 | 肝素辅助因子ⅱ制剂及其制备方法 |
FI106465B (fi) | 1998-06-10 | 2001-02-15 | Suomen Punainen Risti Veripalv | Menetelmä virusturvallisten farmaseuttisten koostumusten valmistamiseksi |
AT408613B (de) * | 1998-06-17 | 2002-01-25 | Immuno Ag | Pharmazeutisches faktor vii-präparat |
EP1198565A1 (en) | 1999-07-07 | 2002-04-24 | Maxygen Aps | A method for preparing modified polypeptides |
JP4451514B2 (ja) | 1999-08-24 | 2010-04-14 | 財団法人化学及血清療法研究所 | 血液凝固第vii因子改変体 |
WO2001058935A2 (en) | 2000-02-11 | 2001-08-16 | Maxygen Aps | FACTOR VII OR VIIa-LIKE MOLECULES |
AU2001254624A1 (en) | 2000-05-03 | 2001-11-12 | Novo-Nordisk A/S | Human coagulation factor vii variants |
DE10022092A1 (de) | 2000-05-08 | 2001-11-15 | Aventis Behring Gmbh | Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung |
US6423826B1 (en) | 2000-06-30 | 2002-07-23 | Regents Of The University Of Minnesota | High molecular weight derivatives of vitamin K-dependent polypeptides |
US20030211094A1 (en) | 2001-06-26 | 2003-11-13 | Nelsestuen Gary L. | High molecular weight derivatives of vitamin k-dependent polypeptides |
AU2001287550B2 (en) | 2000-09-13 | 2007-03-22 | Novo Nordisk Health Care Ag | Human coagulation factor VII variants |
WO2002029083A2 (en) | 2000-10-02 | 2002-04-11 | Novo Nordisk A/S | Industrial-scale serum-free production of recombinant proteins in mammalian cells |
AU2002218029A1 (en) | 2000-11-09 | 2002-05-21 | The Scripps Research Institute | Modified factor viia |
BR0208203A (pt) | 2001-03-22 | 2005-04-19 | Novo Nordisk Healthcare Ag | Polipeptìdeo do fator vii, derivado do fator vii, composição, composição farmacêutica, construção de polinucleotìdeo, célula hospedeira eucariótica, animal transgênico, planta transgênica, e, métodos para produzir o polipeptìdeo do fator vii e um derivado do fator vii, uso de um derivado do fator vii, métodos para o tratamento de episódios de hemorragia ou distúrbios de hemorragia em um paciente ou para a intensificação do sistema hemostático normal e para inibir a formação de trobo em um paciente |
WO2003027147A2 (en) | 2001-09-27 | 2003-04-03 | Novo Nordisk Health Care Ag | Human coagulation factor vii polypeptides |
US7125843B2 (en) | 2001-10-19 | 2006-10-24 | Neose Technologies, Inc. | Glycoconjugates including more than one peptide |
US7265085B2 (en) | 2001-10-10 | 2007-09-04 | Neose Technologies, Inc. | Glycoconjugation methods and proteins/peptides produced by the methods |
CN101724075B (zh) | 2001-10-10 | 2014-04-30 | 诺和诺德公司 | 肽的重构和糖缀合 |
US7265084B2 (en) | 2001-10-10 | 2007-09-04 | Neose Technologies, Inc. | Glycopegylation methods and proteins/peptides produced by the methods |
US7795210B2 (en) | 2001-10-10 | 2010-09-14 | Novo Nordisk A/S | Protein remodeling methods and proteins/peptides produced by the methods |
EP1451315B1 (en) | 2001-11-02 | 2014-05-21 | Novo Nordisk Health Care AG | Human coagulation factor vii polypeptides |
DE10211632A1 (de) | 2002-03-15 | 2003-10-09 | Aventis Behring Gmbh | Verfahren zur Abtrennung von Viren aus einer Proteinlösung durch Nanofiltration |
CA2484173A1 (en) | 2002-04-30 | 2003-11-13 | Merck & Co., Inc. | 4-azasteroid derivatives as androgen receptor modulators |
DK1499719T3 (da) | 2002-04-30 | 2011-02-28 | Bayer Healthcare Llc | Faktor VII- eller VIIa-polypeptidvarianter |
EP1523327A1 (de) | 2002-07-23 | 2005-04-20 | Bio-Products & Bio-Engineering Aktiengesellschaft | Thrombingenerierfahige und thrombinhaltige pharmazeutische wirkstoffzubereitungen und arzneimittel |
DK1528930T3 (da) | 2002-07-23 | 2009-08-03 | Bio & Bio Licensing Sa | Thrombindannelsesdygtige og thrombinholdige farmaceutiske præparater af virksomt stof samt lægemidler |
CA2502162C (en) | 2002-09-30 | 2014-04-15 | Maxygen Holdings Ltd. | Fvii or fviia variants having increased clotting activity |
ES2335994T3 (es) * | 2003-07-01 | 2010-04-07 | Novo Nordisk Health Care Ag | Composicion farmaceutica liquida, acuosa de polipeptidos factor vii. |
CN1890257A (zh) | 2003-12-01 | 2007-01-03 | 诺和诺德医疗保健公司 | 液体因子ⅶ组合物的病毒过滤 |
FR2901707B1 (fr) | 2006-05-31 | 2017-09-29 | Lab Francais Du Fractionnement | Composition de facteur vii recombinant ou transgenique, chaque molecule de facteur vii possedant deux sites de n-glycosylation a motifs glycanniques definis |
FR2901796A1 (fr) | 2006-05-31 | 2007-12-07 | Lab Francais Du Fractionnement | Procede d'extraction d'une ou de plusieurs proteines presentes dans du lait |
FR2904558B1 (fr) | 2006-08-01 | 2008-10-17 | Lab Francais Du Fractionnement | "composition de facteur vii recombinant ou transgenique, presentant majoritairement des formes glycanniques biantennees, bisialylees et non fucosylees" |
FR2910786B1 (fr) | 2006-12-29 | 2017-08-11 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies (Lfb) | "procede d'extraction d'une proteine presente dans du lait" |
FR2947181B1 (fr) | 2009-06-26 | 2012-05-04 | Lfb Biotechnologies | Composition de facteur vii |
EP2687595B1 (en) | 2012-07-19 | 2018-05-30 | Laboratoire Français du Fractionnement et des Biotechnologies | Method for purifying transgenic factor VII |
-
2004
- 2004-12-01 CN CNA2004800357085A patent/CN1890257A/zh active Pending
- 2004-12-01 CA CA002545474A patent/CA2545474A1/en not_active Abandoned
- 2004-12-01 CN CN201710263718.3A patent/CN106916802B/zh active Active
- 2004-12-01 CN CN201110303815.3A patent/CN102351953B/zh active Active
- 2004-12-01 EP EP20040804635 patent/EP1711513B1/en not_active Revoked
- 2004-12-01 RU RU2006118024/10A patent/RU2472804C2/ru active
- 2004-12-01 PT PT48046353T patent/PT1711513E/pt unknown
- 2004-12-01 WO PCT/EP2004/053206 patent/WO2005054275A2/en active Application Filing
- 2004-12-01 KR KR1020067010639A patent/KR101234170B1/ko active IP Right Grant
- 2004-12-01 EP EP19186952.8A patent/EP3594222B1/en active Active
- 2004-12-01 PL PL04804635T patent/PL1711513T3/pl unknown
- 2004-12-01 EP EP10181049A patent/EP2275432A1/en not_active Ceased
- 2004-12-01 ES ES19186952T patent/ES2926359T3/es active Active
- 2004-12-01 JP JP2006541943A patent/JP4874806B2/ja active Active
- 2004-12-01 DK DK04804635.3T patent/DK1711513T3/da active
- 2004-12-01 ES ES04804635.3T patent/ES2507091T3/es active Active
- 2004-12-01 AU AU2004294403A patent/AU2004294403A1/en not_active Abandoned
- 2004-12-01 BR BRPI0416950A patent/BRPI0416950B8/pt active IP Right Grant
-
2006
- 2006-05-23 US US11/439,828 patent/US20070142625A1/en not_active Abandoned
-
2008
- 2008-07-15 US US12/173,475 patent/US20080274534A1/en not_active Abandoned
-
2011
- 2011-03-28 JP JP2011069695A patent/JP5666359B2/ja active Active
- 2011-08-18 JP JP2011178873A patent/JP2012021007A/ja not_active Withdrawn
-
2012
- 2012-01-13 US US13/349,980 patent/US9102762B2/en active Active
-
2015
- 2015-06-29 US US14/753,551 patent/US20150299685A1/en not_active Abandoned
-
2016
- 2016-10-05 US US15/286,068 patent/US20170022482A1/en not_active Abandoned
-
2018
- 2018-09-28 US US16/145,565 patent/US20190032026A1/en not_active Abandoned
-
2020
- 2020-04-20 US US16/853,444 patent/US20200248150A1/en not_active Abandoned
-
2021
- 2021-11-09 US US17/522,216 patent/US20220064605A1/en not_active Abandoned
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