ES2688144T3 - Procedimiento de fabricación de Factor VIII que tiene una relación mejorada de FVIII:C/FVIII:AG - Google Patents
Procedimiento de fabricación de Factor VIII que tiene una relación mejorada de FVIII:C/FVIII:AG Download PDFInfo
- Publication number
- ES2688144T3 ES2688144T3 ES15700725T ES15700725T ES2688144T3 ES 2688144 T3 ES2688144 T3 ES 2688144T3 ES 15700725 T ES15700725 T ES 15700725T ES 15700725 T ES15700725 T ES 15700725T ES 2688144 T3 ES2688144 T3 ES 2688144T3
- Authority
- ES
- Spain
- Prior art keywords
- factor viii
- fviii
- affinity
- affinity chromatography
- chromatography resin
- 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
- 108010054218 Factor VIII Proteins 0.000 title abstract 7
- 102000001690 Factor VIII Human genes 0.000 title abstract 7
- 229960000301 factor viii Drugs 0.000 title abstract 7
- 102100026735 Coagulation factor VIII Human genes 0.000 title abstract 4
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 title abstract 4
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 7
- 238000001042 affinity chromatography Methods 0.000 abstract 5
- 239000012539 chromatography resin Substances 0.000 abstract 5
- 239000011780 sodium chloride Substances 0.000 abstract 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 abstract 3
- 239000003446 ligand Substances 0.000 abstract 2
- 240000004808 Saccharomyces cerevisiae Species 0.000 abstract 1
- 230000027455 binding Effects 0.000 abstract 1
- 238000011210 chromatographic step Methods 0.000 abstract 1
- 238000004587 chromatography analysis Methods 0.000 abstract 1
- 238000010828 elution Methods 0.000 abstract 1
- 239000012634 fragment Substances 0.000 abstract 1
- 239000011347 resin Substances 0.000 abstract 1
- 229920005989 resin Polymers 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 230000009870 specific binding Effects 0.000 abstract 1
- 238000005406 washing Methods 0.000 abstract 1
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
- 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
- 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
-
- 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
- B01D15/34—Size selective separation, e.g. size exclusion chromatography, gel filtration, permeation
-
- 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
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
- B01D15/361—Ion-exchange
- B01D15/363—Anion-exchange
-
- 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 - B01D15/36
- B01D15/3804—Affinity chromatography
- B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G, L chromatography
-
- 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
-
- 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
-
- 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
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Analytical Chemistry (AREA)
- Hematology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Toxicology (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Un procedimiento de fabricación de un producto de Factor VIII que tiene una relación de FVIII:C/FVIII:Ag de al menos 0,7 en el producto de Factor VIII usando cromatografía, en el que se realiza al menos una etapa cromatográfica por medio del uso de una resina de cromatografía de afinidad que tiene una afinidad por la unión específica con el Factor VIII que se efectúa por un ligando de afinidad que se inmoviliza en la resina de cromatografía de afinidad, siendo dicho ligando de afinidad un fragmento de anticuerpo Fab obtenido de levadura de 13 kD dirigido a la molécula de Factor VIII, en el que - se produce unión de Factor VIII con la resina de cromatografía de afinidad en condiciones de baja salinidad equivalentes a una concentración de cloruro sódico de 0,1 - 0,5 mol/kg, - lavado de la resina de cromatografía de afinidad en concentración salina aumentada en el intervalo de 0,3 - 4 mol/kg de cloruro sódico para la retirada de la cadena ligera, y - elución y recogida de Factor VIII en una fracción separada empleando una concentración salina en el intervalo de 0,5 - 4 mol/kg de cloruro sódico en combinación con etilenglicol 40-60 %, y en el que la carga de la resina de cromatografía de afinidad con Factor VIII biológicamente activo es de al menos 10.000 UI/ml de resina.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14151769 | 2014-01-20 | ||
| PCT/EP2015/051028 WO2015107222A1 (en) | 2014-01-20 | 2015-01-20 | A process for manufacturing factor viii having an improved ratio of fviii:c/fviii:ag |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2688144T3 true ES2688144T3 (es) | 2018-10-31 |
Family
ID=49949592
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES15700725T Active ES2688144T3 (es) | 2014-01-20 | 2015-01-20 | Procedimiento de fabricación de Factor VIII que tiene una relación mejorada de FVIII:C/FVIII:AG |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US10822393B2 (es) |
| EP (1) | EP3097118B1 (es) |
| JP (1) | JP6778111B2 (es) |
| KR (1) | KR101908074B1 (es) |
| CN (1) | CN106414491B (es) |
| AU (1) | AU2015207472B2 (es) |
| CA (1) | CA2934705C (es) |
| DK (1) | DK3097118T3 (es) |
| ES (1) | ES2688144T3 (es) |
| IL (1) | IL246671B (es) |
| RU (1) | RU2695428C2 (es) |
| WO (1) | WO2015107222A1 (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101908074B1 (ko) | 2014-01-20 | 2018-10-15 | 옥타파마 아게 | 개선된 FVIII:C/FVIII:Ag의 비를 갖는 인자 VIII의 제조방법 |
| EP3205665A1 (en) * | 2016-02-11 | 2017-08-16 | Octapharma AG | Method of separating factor viii from blood products |
| US11299533B2 (en) * | 2017-06-23 | 2022-04-12 | Takeda Pharmaceutical Company Limited | Purification of factor VIII subspecies |
| RU2761024C2 (ru) | 2017-08-04 | 2021-12-02 | Шайр Хьюман Дженетик Терапиз, Инк. | Устройство связывания антитело-смола и способы |
| JP2021519280A (ja) * | 2018-03-21 | 2021-08-10 | バクスアルタ インコーポレイテッド | クロマトグラフィー法によるｖｗｆとｖｗｆプロペプチドの分離 |
| BE1027107B1 (fr) | 2019-03-25 | 2021-02-15 | Sumitomo Chemical Co | Compose, resine, composition de photoresist et procede de production de motif de photoresist |
| KR20220029733A (ko) * | 2019-07-04 | 2022-03-08 | 체에스엘 베링 렝나우 아게 | 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf) |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4675385A (en) * | 1985-03-27 | 1987-06-23 | Alpha Therapeutic Corporation | Isolation of human plasma procoagulant protein factor VIII from biological factors |
| FR2619314B1 (fr) | 1987-08-11 | 1990-06-15 | Transgene Sa | Analogue du facteur viii, procede de preparation et composition pharmaceutique le contenant |
| FR2650393A1 (fr) | 1989-07-28 | 1991-02-01 | Herault Ctre Rgl Transfusion S | Methode de purification du facteur vii (f viii) par chromatographie echangeuse d'ions |
| DE3926034C3 (de) | 1989-08-07 | 1996-11-21 | Behringwerke Ag | Verfahren zur Herstellung eines stabilen Faktors VIII |
| WO1997033178A1 (de) | 1996-03-08 | 1997-09-12 | Octapharma Ag | Verfahren zur eignungsprüfung von faktor viii-haltigen proteinfraktionen |
| EP1136553A1 (en) | 2000-03-22 | 2001-09-26 | Octagene GmbH | Production of recombinant blood clotting factors in human cell lines |
| US8192959B2 (en) * | 2002-04-22 | 2012-06-05 | Genencor International Inc | Promoter and plasmid system for genetic engineering |
| US7041635B2 (en) * | 2003-01-28 | 2006-05-09 | In2Gen Co., Ltd. | Factor VIII polypeptide |
| LT2363414T (lt) | 2004-11-12 | 2022-10-25 | Bayer Healthcare Llc | Fviii modifikacija, nukreipta į tam tikrą vietą |
| GB0509443D0 (en) * | 2005-05-09 | 2005-06-15 | Prometic Biosciences Ltd | Affinity adsorbents for factor VIII and von willebrand's factor |
| EP1739179A1 (en) | 2005-06-30 | 2007-01-03 | Octapharma AG | Serum-free stable transfection and production of recombinant human proteins in human cell lines |
| CA2673459C (en) | 2006-12-22 | 2016-09-13 | Stefan Schulte | Modified coagulation factors with prolonged in vivo half-life |
| EP2150264A4 (en) | 2007-04-26 | 2014-09-24 | Bayer Healthcare Llc | STABILIZATION OF LIQUID SOLUTIONS OF A RECOMBINANT PROTEIN FOR FROZEN STORAGE |
| FR2920429B1 (fr) * | 2007-08-30 | 2012-10-05 | Lfb Biotechnologies | Procede de purification du facteur viii et du facteur von willebrand |
| RU2698392C2 (ru) * | 2008-06-24 | 2019-08-26 | Октафарма Аг | Способ очистки фактора свертывания крови viii |
| CN107050437A (zh) | 2008-09-03 | 2017-08-18 | 奥克塔法马股份有限公司 | 重组制备的因子viii的新型保护组合物 |
| US20120093840A1 (en) | 2009-04-06 | 2012-04-19 | Novo Nordisk A/S | Targeted delivery of factor viii proteins to platelets |
| KR101908074B1 (ko) | 2014-01-20 | 2018-10-15 | 옥타파마 아게 | 개선된 FVIII:C/FVIII:Ag의 비를 갖는 인자 VIII의 제조방법 |
-
2015
- 2015-01-20 KR KR1020167022707A patent/KR101908074B1/ko active IP Right Grant
- 2015-01-20 JP JP2016547543A patent/JP6778111B2/ja active Active
- 2015-01-20 RU RU2016134000A patent/RU2695428C2/ru active
- 2015-01-20 CA CA2934705A patent/CA2934705C/en active Active
- 2015-01-20 DK DK15700725.3T patent/DK3097118T3/en active
- 2015-01-20 AU AU2015207472A patent/AU2015207472B2/en active Active
- 2015-01-20 EP EP15700725.3A patent/EP3097118B1/en active Active
- 2015-01-20 ES ES15700725T patent/ES2688144T3/es active Active
- 2015-01-20 WO PCT/EP2015/051028 patent/WO2015107222A1/en active Application Filing
- 2015-01-20 US US15/112,936 patent/US10822393B2/en active Active
- 2015-01-20 CN CN201580005204.7A patent/CN106414491B/zh active Active
-
2016
- 2016-07-10 IL IL246671A patent/IL246671B/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| RU2016134000A3 (es) | 2018-09-04 |
| AU2015207472A8 (en) | 2016-07-14 |
| AU2015207472A1 (en) | 2016-06-30 |
| AU2015207472B2 (en) | 2018-11-22 |
| KR20160108553A (ko) | 2016-09-19 |
| WO2015107222A1 (en) | 2015-07-23 |
| RU2016134000A (ru) | 2018-02-26 |
| EP3097118B1 (en) | 2018-07-18 |
| JP6778111B2 (ja) | 2020-10-28 |
| CN106414491A (zh) | 2017-02-15 |
| KR101908074B1 (ko) | 2018-10-15 |
| EP3097118A1 (en) | 2016-11-30 |
| CA2934705A1 (en) | 2015-07-23 |
| DK3097118T3 (en) | 2018-11-05 |
| CA2934705C (en) | 2020-03-31 |
| RU2695428C2 (ru) | 2019-07-23 |
| US10822393B2 (en) | 2020-11-03 |
| IL246671B (en) | 2018-11-29 |
| US20160340410A1 (en) | 2016-11-24 |
| JP2017509593A (ja) | 2017-04-06 |
| CN106414491B (zh) | 2021-06-18 |
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