DK2537862T3 - En fremgangsmåde til at oprense koagulationsfaktor VIII - Google Patents
En fremgangsmåde til at oprense koagulationsfaktor VIII Download PDFInfo
- Publication number
- DK2537862T3 DK2537862T3 DK12179389.7T DK12179389T DK2537862T3 DK 2537862 T3 DK2537862 T3 DK 2537862T3 DK 12179389 T DK12179389 T DK 12179389T DK 2537862 T3 DK2537862 T3 DK 2537862T3
- Authority
- DK
- Denmark
- Prior art keywords
- fviii
- resin
- composition
- material according
- buffer
- Prior art date
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 - B01D15/36
- 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)
Claims (16)
1. Sammensætning af materiale omfattende et oprenset rekombinant FVIII opnåeligt med en fremgangsmåde til at oprense eller berige koagulation FVIII ved anvendelse af kromatografi omfattende trinnene at - tilvejebringe en fraktion indeholdende FVIII i en vandig opløsning med en høj ionstyrke; - etablere kontakt mellem fraktionen indeholdende FVIII og en kationmultimodal resin; - vaske den kationmultimodale resin med FVIII adsorberet med en vandig vaskebuffer; - eluere FVIII-holdige fraktioner med en vandig elueringsbuffer omfattende mindst en aminosyre som er positivt ladet ved pH 6 til 8; og - hvor oprensningssekvensen endvidere omfatter de følgende trin: i. en kationbytterresin; ii. en anionisk membran; iii. et kemisk baseret inaktiveringstrin til lipidkappet vira; iv. et affinitetsresin baseret på en proteinligand bestående af et antistoffragment udtrykt i gær; v. et patogenfiltreringsfjernelsestrin med en gennemsnitlig porestørrelse på omkring 20 nm; vi. en anionbytterresin; vii. en størrelseseksklussionskromatografiresin, og kendetegnet ved at renheden efter det sidste oprensningstrin er > 4000 IU/mg og at DNA-indholdet er <1000pg/1000 IU FVIII.
2. Sammensætning af materiale ifølge krav 1, hvor den anioniske membran er Sartobind Q, i særdeleshed for DNA-reduktion.
3. Sammensætning af materiale ifølge krav 1, hvor den kationmultimodale resin er Capto MMC.
4. Sammensætning af materiale ifølge krav 1, hvor kationbytterresinen er SP Sepharose FF.
5. Sammensætning af materiale ifølge krav 1, hvor det kemiske baserede inaktiveringstrin for lipidkappet vira er en opløsningsmiddel-/detergent-inaktivering ved anvendelse af tri-n- butyl phosphat og Triton X-100.
6. Sammensætning af materiale ifølge krav 1, hvor affinitetsresinen baseret på en proteinligand er VHISelect, VHISelect-liganden bestående af et antistoffragment udtrykt i gær.
7. Sammensætning af materiale ifølge krav 1, hvor patogenfiltreringsfjernelsestrinnet udføres med et filter som har en nominal gennemsnitlig porestørrelse på omkring 20 nm i særdeleshed med Planova 20N.
8. Sammensætning af materiale ifølge krav 1, hvor anionbytterresinen er Q Sepharose FF.
9. Sammensætning af materiale ifølge krav 1, hvor størrelseseksklussionskromatografiresinen erSuperdex 200pg.
10. Sammensætning af materiale ifølge krav 1, kendetegnet ved at den rekombinante FVIII er udledt fra et derivat af human embryonisk nyrecelle 293.
11. Sammensætning af materiale ifølge krav 1, kendetegnet ved at den rekombinante FVIII er en B-domænedeleteret FVIII.
12. Sammensætning af materiale ifølge krav 1, kendetegnet ved at den vandige opløsning omfattende FVIII i en høj saltopløsning svarende til en ledningsevne fra omkring 25 til omkring 200 ms/cm ved 25°C.
13. Sammensætning af materiale ifølge krav 1, kendetegnet ved at aminosyren som er positivt ladet ved pH 6 til 8 er valgt fra gruppen af aminogrupper indeholdende aminosyrer såsom lysin; arginin, histidin og kombinationer deraf, i særdeleshed i koncentrationer på > 0,4M, i særdeleshed > 0,5M.
14. Sammensætning af materiale ifølge krav 1, hvor elueringsbufferen er yderligere omfattende mindst en hydroxylgruppe indeholdende organiske forbindelser såsom en alkohol, mindst en aminogruppe indeholdende organisk forbindelse såsom en aminosyre, mindst en kilde som tilvejebringer Ca2+-ioner, mindst en forbindelse til regulering af ionstyrken af bufferen såsom uorganiske salte, mindst en ikke-ionisk detergent og mindst et bufferstoftil at regulere pH'en fra omkring 6 til omkring 8 i særdeleshed til omkring en neutral værdi.
15. Sammensætning af materiale ifølge krav 1, kendetegnet ved at oprensningssekvensen endvidere omfatter patogen fjernelse-/inaktiveringstrin omfattende kromatografitrin, hvilke trin er baseret på forskellige fysiologiske egenskaber rettet mod patogenet som skal fjernes.
16. Sammensætning af materiale ifølge krav 1, kendetegnet ved at renheden efter det sidste rensningstrin er > 9000 IU/mg og fortrinsvis > 10 000 IU/mg protein og at DNA-indholdet er <100pg/ 1000 IU FVIII og fortrinsvis <10 pg/1000IU FVIII.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12940208P | 2008-06-24 | 2008-06-24 | |
| EP08158893 | 2008-06-24 | ||
| EP09769279A EP2300497B1 (en) | 2008-06-24 | 2009-06-24 | A process of purifying coagulation factor viii |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2537862T3 true DK2537862T3 (da) | 2015-06-15 |
Family
ID=40076764
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK09769279.2T DK2300497T3 (da) | 2008-06-24 | 2009-06-24 | Fremgangsmåde til oprensning af koagulationsfaktor VIII |
| DK12179389.7T DK2537862T3 (da) | 2008-06-24 | 2009-06-24 | En fremgangsmåde til at oprense koagulationsfaktor VIII |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK09769279.2T DK2300497T3 (da) | 2008-06-24 | 2009-06-24 | Fremgangsmåde til oprensning af koagulationsfaktor VIII |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US8329871B2 (da) |
| EP (2) | EP2537862B1 (da) |
| JP (1) | JP5619738B2 (da) |
| KR (3) | KR20160104740A (da) |
| CN (1) | CN102066417B (da) |
| AU (1) | AU2009264282B2 (da) |
| BR (1) | BRPI0914695B1 (da) |
| CA (1) | CA2728047C (da) |
| DK (2) | DK2300497T3 (da) |
| ES (2) | ES2391613T3 (da) |
| IL (3) | IL229583B (da) |
| MX (1) | MX2010013908A (da) |
| PL (1) | PL2300497T3 (da) |
| PT (1) | PT2300497E (da) |
| RU (2) | RU2567811C2 (da) |
| SI (1) | SI2300497T1 (da) |
| UA (1) | UA100901C2 (da) |
| WO (1) | WO2009156430A1 (da) |
| ZA (1) | ZA201009162B (da) |
Families Citing this family (40)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101293504B1 (ko) | 2007-07-11 | 2013-08-07 | 노보 노르디스크 에이/에스 | 혼합형 또는 다중형 수지를 사용하는 인자 ｖⅰⅰⅰ의 정제 |
| 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 |
| WO2010026186A1 (en) * | 2008-09-03 | 2010-03-11 | Octapharma Ag | New protecting compositions for recombinantly produced factor viii |
| US20110166332A1 (en) * | 2008-09-12 | 2011-07-07 | Ge Healthcare Bio-Sciences Ab | Enhanced antibody aggregate removal with capto adhere in the presence of protein-excluded zwitterions |
| TR201807352T4 (tr) * | 2010-03-30 | 2018-06-21 | Octapharma Ag | Granülosit koloni stimülatör faktörünün saflaştırılmasına yönelik proses, G-CSF. |
| DK3133157T3 (da) * | 2010-03-30 | 2019-08-12 | Octapharma Ag | Fremgangsmåde til oprensning af vitamin k-afhængige proteiner |
| WO2011131720A1 (en) | 2010-04-20 | 2011-10-27 | Octapharma Ag | New stabilizing agent for pharmaceutical proteins |
| WO2012049285A1 (en) | 2010-10-14 | 2012-04-19 | Octapharma Ag | A method for the quantitative glycosylation analysis of proteins |
| RU2591523C2 (ru) * | 2010-11-05 | 2016-07-20 | Ф. Хоффманн-Ля Рош Аг | Оптимизированный метод захвата антител хроматографией смешанного типа |
| EP3626737B1 (en) * | 2011-05-13 | 2023-11-29 | Octapharma AG | A method of increasing the productivity of eucaryotic cells in the production of recombinant fviii |
| CN103688177B (zh) | 2011-06-17 | 2017-07-04 | 学校法人东日本学园 | 狼疮抗凝物检测用血液凝固时间的测定方法 |
| CN103906762A (zh) * | 2011-10-26 | 2014-07-02 | 生物辐射实验室股份有限公司 | 在混合式层析中去除杀病毒剂 |
| CN104884147A (zh) | 2012-10-24 | 2015-09-02 | 建新公司 | 使用mes和mops作为流动相改性剂从多峰树脂洗脱生物分子 |
| US10188965B2 (en) | 2012-12-05 | 2019-01-29 | Csl Behring Gmbh | Hydrophobic charge induction chromatographic depletion of a protein from a solution |
| US20140154233A1 (en) * | 2012-12-05 | 2014-06-05 | Csl Limited | Method of purifying therapeutic proteins |
| 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 |
| AU2014226126B2 (en) * | 2013-03-08 | 2019-02-14 | Genzyme Corporation | Continuous purification of therapeutic proteins |
| US20160130361A1 (en) * | 2013-06-13 | 2016-05-12 | Biogen Ma Inc. | Anti-factor viii antibodies or uses thereof |
| WO2015005960A1 (en) | 2013-07-12 | 2015-01-15 | Emd Millipore Corporation | 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 |
| MX2016003871A (es) | 2013-09-24 | 2016-08-04 | Pfizer | Composiciones que comprenden poblaciones heterogeneas de proteinas recombinantes humanas de factor xa de coagulacion. |
| 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 |
| TWI709570B (zh) * | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析法及製法 |
| RU2695428C2 (ru) * | 2014-01-20 | 2019-07-23 | Октафарма Аг | СПОСОБ ПРОИЗВОДСТВА ФАКТОРА VIII, ИМЕЮЩЕГО УЛУЧШЕННОЕ СООТНОШЕНИЕ FVIII:C/FVIII:Ag |
| US10570380B2 (en) * | 2014-01-24 | 2020-02-25 | Am-Pharma B.V. | Downstream processing of an alkaline phosphatase |
| KR20230136616A (ko) * | 2014-02-04 | 2023-09-26 | 바이오젠 엠에이 인코포레이티드 | 번역 후 변형을 강화시키기 위한 통류 방식 양이온교환 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 |
| JP6599980B2 (ja) | 2014-05-29 | 2019-10-30 | エイジェンシー・フォー・サイエンス，テクノロジー・アンド・リサーチ | タンパク質抽出方法 |
| US10626164B2 (en) * | 2014-07-25 | 2020-04-21 | Csl Limited | Purification of VWF |
| GB201506113D0 (en) | 2015-04-10 | 2015-05-27 | Ge Healthcare Bio Sciences Ab | Method for chromatography |
| GB201506117D0 (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 |
| CA3068121A1 (en) | 2017-06-23 | 2018-12-27 | Baxalta Incorporated | Purification of factor viii subspecies |
| 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 |
| EP3676375A4 (en) | 2017-08-31 | 2021-04-07 | Green Cross Corporation | METHOD OF PURIFYING A SULFATASE PROTEIN |
| EP3843869A1 (en) | 2018-08-31 | 2021-07-07 | Genzyme Corporation | Sterile chromatography resin and use thereof in manufacturing processes |
| US20230092867A1 (en) * | 2020-01-20 | 2023-03-23 | WuXi Biologics Ireland Limited | A novel wash buffer solution for affinity chromatography |
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| SE9403915D0 (sv) | 1994-11-14 | 1994-11-14 | Annelie Almstedt | Process A |
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| AU2008209986B2 (en) * | 2007-02-01 | 2012-11-08 | Baxter Healthcare S.A. | FVIII-independent FIX-mutant proteins for hemophilia A treatment |
| EP2167117B1 (en) * | 2007-06-13 | 2012-08-15 | CSL Behring GmbH | Use of vwf stabilized fviii preparations for extravascular administration in the therapy and prophylactic treatment of bleeding disorders |
| KR101293504B1 (ko) | 2007-07-11 | 2013-08-07 | 노보 노르디스크 에이/에스 | 혼합형 또는 다중형 수지를 사용하는 인자 ｖⅰⅰⅰ의 정제 |
| 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 |
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2009
- 2009-06-24 DK DK09769279.2T patent/DK2300497T3/da active
- 2009-06-24 KR KR1020167023450A patent/KR20160104740A/ko active IP Right Grant
- 2009-06-24 RU RU2011102437/10A patent/RU2567811C2/ru active
- 2009-06-24 US US12/737,230 patent/US8329871B2/en active Active
- 2009-06-24 JP JP2011515372A patent/JP5619738B2/ja active Active
- 2009-06-24 PL PL09769279T patent/PL2300497T3/pl unknown
- 2009-06-24 WO PCT/EP2009/057883 patent/WO2009156430A1/en active Application Filing
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