ES2538706T3 - Procedimiento de purificación del factor de coagulación VIII - Google Patents
Procedimiento de purificación del factor de coagulación VIII Download PDFInfo
- Publication number
- ES2538706T3 ES2538706T3 ES12179389.7T ES12179389T ES2538706T3 ES 2538706 T3 ES2538706 T3 ES 2538706T3 ES 12179389 T ES12179389 T ES 12179389T ES 2538706 T3 ES2538706 T3 ES 2538706T3
- Authority
- ES
- Spain
- Prior art keywords
- fviii
- resin
- purification
- stage
- buffer
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/55—Protease inhibitors
- A61K38/57—Protease inhibitors from animals; from humans
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
- B01D15/3847—Multimodal interactions
-
- 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
- C07K14/745—Blood coagulation or fibrinolysis factors
-
- 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)
-
- 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)
- C12N9/647—Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Genetics & Genomics (AREA)
- Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Hematology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Immunology (AREA)
- Toxicology (AREA)
- Analytical Chemistry (AREA)
- Biomedical Technology (AREA)
- Wood Science & Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12940208P | 2008-06-24 | 2008-06-24 | |
| US129402P | 2008-06-24 | ||
| EP08158893 | 2008-06-24 | ||
| EP08158893 | 2008-06-24 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2538706T3 true ES2538706T3 (es) | 2015-06-23 |
Family
ID=40076764
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES09769279T Active ES2391613T3 (es) | 2008-06-24 | 2009-06-24 | Un procedimiento para purificar el factor de coagulación VIII |
| ES12179389.7T Active ES2538706T3 (es) | 2008-06-24 | 2009-06-24 | Procedimiento de purificación del factor de coagulación VIII |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES09769279T Active ES2391613T3 (es) | 2008-06-24 | 2009-06-24 | Un procedimiento para purificar el factor de coagulación VIII |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US8329871B2 (enExample) |
| EP (2) | EP2537862B1 (enExample) |
| JP (1) | JP5619738B2 (enExample) |
| KR (3) | KR101804136B1 (enExample) |
| CN (1) | CN102066417B (enExample) |
| AU (1) | AU2009264282B2 (enExample) |
| BR (1) | BRPI0914695B1 (enExample) |
| CA (1) | CA2728047C (enExample) |
| DK (2) | DK2537862T3 (enExample) |
| ES (2) | ES2391613T3 (enExample) |
| IL (3) | IL209758A (enExample) |
| MX (1) | MX2010013908A (enExample) |
| PL (1) | PL2300497T3 (enExample) |
| PT (1) | PT2300497E (enExample) |
| RU (2) | RU2698392C2 (enExample) |
| SI (1) | SI2300497T1 (enExample) |
| UA (1) | UA100901C2 (enExample) |
| WO (1) | WO2009156430A1 (enExample) |
| ZA (1) | ZA201009162B (enExample) |
Families Citing this family (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2167526B1 (en) | 2007-07-11 | 2011-03-30 | Novo Nordisk A/S | Purification of factor viii using a mixed-mode or multimodal resin |
| EP2027875A1 (en) * | 2007-08-23 | 2009-02-25 | Octapharma AG | A Process for Isolation and Purification of a Target Protein free of Prion Protein (PrPSC) |
| AU2009284113B2 (en) | 2008-08-21 | 2015-05-14 | Octapharma Ag | Recombinantly produced human factor VIII and IX |
| KR101691443B1 (ko) * | 2008-09-03 | 2016-12-30 | 옥타파마 아게 | 재조합에 의해 제조된 인자 ⅷ을 위한 신규한 보호 조성물 |
| EP2326658A4 (en) * | 2008-09-12 | 2013-04-10 | Ge Healthcare Bio Sciences Ab | REMOVAL OF REINFORCED PROTEIN AGGREGATES WITH MULTIMODAL ANION DERIVATIVES IN THE PRESENCE OF TWITTERS WITHOUT PROTEINS |
| CN102858797B (zh) * | 2010-03-30 | 2016-05-11 | 奥克塔法马股份有限公司 | 纯化生长因子蛋白的方法 |
| TR201911082T4 (tr) * | 2010-03-30 | 2019-08-21 | Octapharma Ag | K vitaminine bağımlı proteinlerin saflaştırılması için bir işlem. |
| ES2639641T3 (es) | 2010-04-20 | 2017-10-27 | Octapharma Ag | Nuevo agente estabilizante para proteínas farmacéuticas |
| WO2012049285A1 (en) | 2010-10-14 | 2012-04-19 | Octapharma Ag | A method for the quantitative glycosylation analysis of proteins |
| JP5947802B2 (ja) * | 2010-11-05 | 2016-07-06 | エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト | ミックスモードクロマトグラフィーによる抗体捕捉の最適化方法 |
| KR101980164B1 (ko) * | 2011-05-13 | 2019-05-20 | 옥타파마 아게 | 재조합 fviii의 생산에서 진핵 세포의 생산성을 증가시키는 방법 |
| ES2613723T3 (es) | 2011-06-17 | 2017-05-25 | School Juridical Person Higashi-Nippon-Gakuen | Método de medición del tiempo de coagulación sanguínea para detectar anticoagulantes de Lupus |
| EP2771358A4 (en) * | 2011-10-26 | 2015-08-26 | Bio Rad Laboratories | ELIMINATION OF VIRAL AGENTS IN MIXED MODE CHROMATOGRAPHY |
| AU2013334644B2 (en) * | 2012-10-24 | 2018-07-12 | Genzyme Corporation | Elution of biomolecules from multi-modal resins using mes and mops as mobile phase modifiers |
| US20140154233A1 (en) * | 2012-12-05 | 2014-06-05 | Csl Limited | Method of purifying therapeutic proteins |
| US10188965B2 (en) | 2012-12-05 | 2019-01-29 | Csl Behring Gmbh | Hydrophobic charge induction chromatographic depletion of a protein from a solution |
| CN103880947B (zh) * | 2012-12-21 | 2016-01-13 | 武汉禾元生物科技股份有限公司 | 一种分离纯化高纯度重组人血清白蛋白的层析方法 |
| HK1219964A1 (zh) | 2013-03-08 | 2017-04-21 | Genzyme Corporation | 治疗性蛋白药物物质的整合连续制造 |
| US20160130361A1 (en) * | 2013-06-13 | 2016-05-12 | Biogen Ma Inc. | Anti-factor viii antibodies or uses thereof |
| CA2910770C (en) | 2013-07-12 | 2018-02-27 | Merck Patent Gmbh | Removal of fragments from a sample containing a target protein using activated carbon |
| EP3043813B1 (en) * | 2013-08-08 | 2021-01-13 | Bioverativ Therapeutics Inc. | Purification of chimeric fviii molecules |
| KR101988705B1 (ko) | 2013-09-24 | 2019-06-12 | 화이자 인코포레이티드 | 재조합 인간 응고 인자 Xa 단백질의 이질적 집단을 포함하는 조성물 |
| TWI709569B (zh) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析樹脂及其用於製造方法的用途 |
| TWI671312B (zh) * | 2014-01-17 | 2019-09-11 | 美商健臻公司 | 無菌層析法及製法 |
| EP3097118B1 (en) * | 2014-01-20 | 2018-07-18 | Octapharma AG | A process for manufacturing factor viii having an improved ratio of fviii:c/fviii:ag |
| CA2936829C (en) * | 2014-01-24 | 2024-05-28 | Am-Pharma B.V. | Downstream processing of an alkaline phosphatase |
| KR102382402B1 (ko) | 2014-02-04 | 2022-04-01 | 바이오젠 엠에이 인코포레이티드 | 번역 후 변형을 강화시키기 위한 통류 방식 양이온 교환 크로마토그래피의 용도 |
| CN104861060A (zh) * | 2014-02-21 | 2015-08-26 | 神州细胞工程有限公司 | 一种纯化凝血因子viii的方法 |
| CN106232614A (zh) | 2014-05-29 | 2016-12-14 | 新加坡科技研究局 | 蛋白质提取方法 |
| US10626164B2 (en) * | 2014-07-25 | 2020-04-21 | Csl Limited | Purification of VWF |
| GB201506117D0 (en) | 2015-04-10 | 2015-05-27 | Ge Healthcare Bio Sciences Ab | Method for chromatography |
| GB201506113D0 (en) | 2015-04-10 | 2015-05-27 | Ge Healthcare Bio Sciences Ab | Method for chromatography |
| WO2016207328A1 (en) * | 2015-06-24 | 2016-12-29 | Glycotope Gmbh | PROCESS FOR THE PURIFICATION OF γ-CARBOXYLATED POLYPEPTIDES |
| EP3205665A1 (en) | 2016-02-11 | 2017-08-16 | Octapharma AG | Method of separating factor viii from blood products |
| GB201617240D0 (en) * | 2016-10-11 | 2016-11-23 | Profactor Pharma Ltd | Purification process |
| CN111183151B (zh) * | 2017-06-23 | 2024-06-07 | 武田药品工业株式会社 | 因子viii亚种的纯化 |
| CN107226859B (zh) * | 2017-08-10 | 2020-11-24 | 博雅生物制药集团股份有限公司 | 一种人凝血因子ⅷ的制备方法 |
| US11584777B2 (en) | 2017-08-31 | 2023-02-21 | Green Cross Corporation | Method for purifying a sulfatase protein |
| CA3080656A1 (en) | 2017-10-30 | 2019-05-09 | Baxalta GmbH | Environmentally compatible detergents for inactivation of lipid-enveloped viruses |
| AU2019332764B2 (en) | 2018-08-31 | 2025-05-29 | Genzyme Corporation | Sterile chromatography resin and use thereof in manufacturing processes |
| EP4093745A4 (en) * | 2020-01-20 | 2024-03-06 | Wuxi Biologics Ireland Limited | NEW WASH BUFFER SOLUTION FOR AFFINITY CHROMATOGRAPHY |
| CN118217951B (zh) * | 2024-04-01 | 2025-05-23 | 山东建筑大学 | 一种水中的高纯度磷回收装置和方法 |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4540573A (en) | 1983-07-14 | 1985-09-10 | New York Blood Center, Inc. | Undenatured virus-free biologically active protein derivatives |
| US5605884A (en) * | 1987-10-29 | 1997-02-25 | Rhone-Poulenc Rorer Pharmaceuticals Inc. | Factor VIII formulations in high ionic strength media |
| US5316680A (en) * | 1992-10-21 | 1994-05-31 | Cornell Research Foundation, Inc. | Multimodal chromatographic separation media and process for using same |
| JPH08506710A (ja) | 1993-06-11 | 1996-07-16 | ノーザン・テレコム・リミテッド | ユーザ制御呼管理サービス方法および装置 |
| DE4337573C1 (de) * | 1993-11-04 | 1995-05-18 | Octapharma Ag | Verfahren zur Herstellung einer virusinaktivierten Faktor VIII enthaltenden Fraktion mittels chromatographischer Methoden |
| SE9403915D0 (sv) | 1994-11-14 | 1994-11-14 | Annelie Almstedt | Process A |
| AUPR638801A0 (en) * | 2001-07-13 | 2001-08-09 | Life Therapeutics Limited | Factor viii separation |
| WO2005082483A1 (en) * | 2004-02-27 | 2005-09-09 | Ge Healthcare Bio-Sciences Ab | A process for the purification of antibodies |
| PL1765866T3 (pl) * | 2004-06-07 | 2014-06-30 | Therapure Biopharma Inc | Wydzielanie białek osocza lub surowicy |
| EP1707634A1 (en) * | 2005-03-29 | 2006-10-04 | Octapharma AG | Method for isolation of recombinantly produced proteins |
| FR2887883B1 (fr) * | 2005-06-29 | 2007-08-31 | Lab Francais Du Fractionnement | Procede de separation des proteines fibrinogene, facteur xiii et colle biologique d'une fraction plasmatique solubilisee et de preparation de concentres lyophilises desdites proteines |
| EP1739179A1 (en) | 2005-06-30 | 2007-01-03 | Octapharma AG | Serum-free stable transfection and production of recombinant human proteins in human cell lines |
| WO2008008975A2 (en) * | 2006-07-14 | 2008-01-17 | Genentech, Inc. | Refolding of recombinant proteins |
| RU2324495C1 (ru) * | 2006-08-31 | 2008-05-20 | Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации | Способ получения препарата фактора свертывания viii крови человека |
| CA2674881A1 (en) * | 2007-02-01 | 2008-08-07 | Baxter International Inc. | Fviii-independent fix-mutant proteins for hemophilia a treatment |
| JP2010529155A (ja) * | 2007-06-13 | 2010-08-26 | ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー | 出血性疾患の治療及び予防的処置における血管外投与のためのvwf安定化fviii製剤及びfviiiなしのvwf製剤の使用 |
| EP2167526B1 (en) * | 2007-07-11 | 2011-03-30 | Novo Nordisk A/S | Purification of factor viii using a mixed-mode or multimodal resin |
| GB0723712D0 (en) * | 2007-12-04 | 2008-01-16 | Apitope Technology Bristol Ltd | Peptides |
| DE102008032361A1 (de) * | 2008-07-10 | 2010-01-21 | Csl Behring Gmbh | Der Einsatz von Faktor VIII und vWF bzw. vWF-enthaltenden Konzentraten zur Therapie der durch Thrombocyten-Inhibitoren induzierte Koagulopathie |
-
2009
- 2009-06-24 SI SI200930362T patent/SI2300497T1/sl unknown
- 2009-06-24 CN CN200980123974.6A patent/CN102066417B/zh active Active
- 2009-06-24 US US12/737,230 patent/US8329871B2/en active Active
- 2009-06-24 RU RU2015141849A patent/RU2698392C2/ru active
- 2009-06-24 PL PL09769279T patent/PL2300497T3/pl unknown
- 2009-06-24 EP EP12179389.7A patent/EP2537862B1/en not_active Revoked
- 2009-06-24 KR KR1020177024076A patent/KR101804136B1/ko active Active
- 2009-06-24 DK DK12179389.7T patent/DK2537862T3/en active
- 2009-06-24 EP EP09769279A patent/EP2300497B1/en active Active
- 2009-06-24 MX MX2010013908A patent/MX2010013908A/es active IP Right Grant
- 2009-06-24 ES ES09769279T patent/ES2391613T3/es active Active
- 2009-06-24 AU AU2009264282A patent/AU2009264282B2/en active Active
- 2009-06-24 RU RU2011102437/10A patent/RU2567811C2/ru active
- 2009-06-24 WO PCT/EP2009/057883 patent/WO2009156430A1/en not_active Ceased
- 2009-06-24 KR KR1020167023450A patent/KR20160104740A/ko not_active Abandoned
- 2009-06-24 PT PT09769279T patent/PT2300497E/pt unknown
- 2009-06-24 CA CA2728047A patent/CA2728047C/en active Active
- 2009-06-24 JP JP2011515372A patent/JP5619738B2/ja active Active
- 2009-06-24 DK DK09769279.2T patent/DK2300497T3/da active
- 2009-06-24 ES ES12179389.7T patent/ES2538706T3/es active Active
- 2009-06-24 UA UAA201100699A patent/UA100901C2/ru unknown
- 2009-06-24 KR KR1020107028866A patent/KR101700722B1/ko active Active
- 2009-06-24 BR BRPI0914695-4A patent/BRPI0914695B1/pt active IP Right Grant
-
2010
- 2010-12-05 IL IL209758A patent/IL209758A/en active IP Right Grant
- 2010-12-05 IL IL229583A patent/IL229583B/en active IP Right Grant
- 2010-12-21 ZA ZA2010/09162A patent/ZA201009162B/en unknown
-
2013
- 2013-11-24 IL IL229583A patent/IL229583A0/en unknown
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