DK1538202T3 - Fremstilling af humant alpha-galactosidase a - Google Patents
Fremstilling af humant alpha-galactosidase a Download PDFInfo
- Publication number
- DK1538202T3 DK1538202T3 DK04030107.9T DK04030107T DK1538202T3 DK 1538202 T3 DK1538202 T3 DK 1538202T3 DK 04030107 T DK04030107 T DK 04030107T DK 1538202 T3 DK1538202 T3 DK 1538202T3
- Authority
- DK
- Denmark
- Prior art keywords
- gal
- human
- cells
- cell
- seq
- Prior art date
Links
Classifications
-
- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- 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
- C07K14/575—Hormones
- C07K14/61—Growth hormones [GH] (Somatotropin)
-
- 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)
- C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
- C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
- C12N9/2465—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1) acting on alpha-galactose-glycoside bonds, e.g. alpha-galactosidase (3.2.1.22)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
Claims (21)
1. Fremgangsmåde til fremstilling af oprenset humant α-Gal A, omfattende (a) dyrkning af en genetisk manipuleret human celle, der er modificeret til overekspression of secernering af humant α-Gal A i et medium, (b) opsamling af mediet, der omfatter den humane α-Gal A fra de dyrkede celler, og (c) oprensning af humant α-Gal A fra mediet ved (i) at passere mediet over en harpiks for hydrofob interaktions og eluere humant α-Gal A fra harpiksen og (ii) passere den eluerede humane α-Gal A over søjler, der indeholder en immobiliseret heparin-harpiks, hydroxyapatit, en anionbytter-harpiks og en størrelseseksklusions-harpiks og eluere oprenset humant a-Gal A fra den sidste søjle, hvor den oprensede humane α-Gal A er fri for proteinholdige stoffer med lectin-affinitet og α-Gal A-substratanaloger.
2. Fremgangsmåde ifølge krav 1, hvorved cellen er blevet transficeret med et DNA-molekyle, der koder for humant α-Gal A.
3. Fremgangsmåde ifølge krav 1, hvorved cellen er blevet transficeret med et DNA-molekyle, der omfatter et reguleringselement, som kontrollerer ekspression af kodningssekvensen for α-Gal A.
4. Fremgangsmåde ifølge krav 1, hvorved cellen er modificeret ved genaktivering til eksprimering af humant α-Gal A.
5. Fremgangsmåde ifølge et hvilket som helst af kravene 1-4, hvorved cellen er en fibroblast.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1-4, hvorved cellen er en primær celle.
7. Fremgangsmåde ifølge et hvilket som helst af kravene 1-4, hvorved cellen er en sekundær celle.
8. Fremgangsmåde ifølge krav 5, hvorved den oprensede humane α-Gal A har en specifik aktivitet på 2,2-2,9 χ 106enheder/mg protein.
9. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvorved passage af mediet over en harpiks for hydrofob interaktion udgør det første kromatografitrin under oprensning.
10. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvorved den funktionelle enhed af harpiksen for hydrofob interaktion omfatter en butylgruppe.
11. Farmaceutisk sammensætning omfattende et oprenset humant a-Gal A-enzym, der er glycosyleret til anvendelse i en a-Gal A-deficiens enzymbytningsterapi, hvor sammensætningen er fri for (i) proteinholdige stoffer med lectin-affinitet og (ii) a-Gal A-substratanaloger.
12. Farmaceutisk sammensætning til anvendelse ifølge krav 11, hvor enzymet er modificeret ved sialylering.
13. Farmaceutisk sammensætning til anvendelse ifølge krav 11 eller 12, hvor enzymet indeholder mannose-6-phosphat i dets N-koblede oligosaccharider.
14. Farmaceutisk sammensætning til anvendelse ifølge krav 11, hvor den humane a-Gal A internaliseres af celler via mannose- eller mannose-6-phosphat-receptoren.
15. Farmaceutisk sammensætning til anvendelse ifølge et hvilket som helst af kravene 11-14, yderligere omfattende en farmaceutisk acceptabel bærer, hvor sammensætningen har en pH-værdi under 6,5.
16. Farmaceutisk sammensætning til anvendelse ifølge et hvilket som helst af kravene 11-15, yderligere omfattende en farmaceutisk acceptabel excipiens.
17. Farmaceutisk sammensætning til anvendelse ifølge krav 16, hvor excipiensen er udvalgt fra en buffer, en aminosyre, et urinstof, en alkohol, ascorbinsyre, et phospholipid, et protein, EDTA, natriumchlorid, liposomer, polyvinylpyrrolidon, mannitol, sorbitol, glycerol, propylenglycol og polyethylenglycol (PEG).
18. Farmaceutisk sammensætning til anvendelse ifølge krav 17, hvor bufferen er udvalgt fra citrat, phosphatbuffer, acetatbuffer og bicarbonatbuffer.
19. Farmaceutisk sammensætning til anvendelse ifølge krav 17, hvor proteinet er udvalgt fra serumalbumin og gelatine.
20. Farmaceutisk sammensætning til anvendelse ifølge krav 17, hvor PEG er udvalgt fra PEG-4000 og PEG-6000.
21. Farmaceutisk sammensætning til anvendelse ifølge et hvilket som helst af kravene 11-20, hvor det humane α-Gal A-enzym indgives i en dosis på 0,01-100 mg/kg legemsvægt.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US71261496A | 1996-09-13 | 1996-09-13 | |
| EP97942567A EP0935651B1 (en) | 1996-09-13 | 1997-09-12 | THERAPY FOR alpha-GALACTOSIDASE A DEFICIENCY |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1538202T3 true DK1538202T3 (da) | 2014-03-24 |
Family
ID=24862863
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK04030107.9T DK1538202T3 (da) | 1996-09-13 | 1997-09-12 | Fremstilling af humant alpha-galactosidase a |
| DK10181859.9T DK2374876T3 (da) | 1996-09-13 | 1997-09-12 | Fremgangsmåde til oprensning af alfa-galactosidase A |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10181859.9T DK2374876T3 (da) | 1996-09-13 | 1997-09-12 | Fremgangsmåde til oprensning af alfa-galactosidase A |
Country Status (21)
| Country | Link |
|---|---|
| EP (4) | EP1538202B1 (da) |
| JP (7) | JP4001925B2 (da) |
| KR (2) | KR20050084473A (da) |
| CN (1) | CN1268741C (da) |
| AT (1) | ATE286120T1 (da) |
| AU (1) | AU4424497A (da) |
| CA (1) | CA2265464C (da) |
| DE (1) | DE69732129T2 (da) |
| DK (2) | DK1538202T3 (da) |
| ES (3) | ES2458292T3 (da) |
| HK (3) | HK1022173A1 (da) |
| HU (2) | HU227189B1 (da) |
| IL (2) | IL128960A (da) |
| MX (1) | MX340738B (da) |
| NO (4) | NO328443B1 (da) |
| NZ (2) | NZ506214A (da) |
| PL (1) | PL190041B1 (da) |
| PT (1) | PT1538202E (da) |
| RU (1) | RU2179034C2 (da) |
| TW (1) | TW585919B (da) |
| WO (1) | WO1998011206A2 (da) |
Families Citing this family (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6458574B1 (en) * | 1996-09-12 | 2002-10-01 | Transkaryotic Therapies, Inc. | Treatment of a α-galactosidase a deficiency |
| US6083725A (en) | 1996-09-13 | 2000-07-04 | Transkaryotic Therapies, Inc. | Tranfected human cells expressing human α-galactosidase A protein |
| JP2002522509A (ja) * | 1997-10-29 | 2002-07-23 | ジェンザイム・コーポレイション | リソソーム貯蔵疾患治療組成物および方法 |
| EP1658857A1 (en) * | 1997-10-29 | 2006-05-24 | Genzyme Corporation | Compositions and methods for treating lysosomal storage disease |
| US6274597B1 (en) | 1998-06-01 | 2001-08-14 | Mount Sinai School Of Medicine Of New York University | Method of enhancing lysosomal α-Galactosidase A |
| AU2012241170B2 (en) * | 1999-03-11 | 2016-07-28 | Shire Human Genetic Therapies, Inc. | Treatment of alpha-Galactosidase A deficiency |
| AU2016250357B2 (en) * | 1999-03-11 | 2018-11-01 | Shire Human Genetic Therapies, Inc. | Treatment of alpha-Galactosidase A deficiency |
| AU2004242550B2 (en) * | 1999-03-11 | 2008-04-03 | Shire Human Genetic Therapies, Inc. | Treatment of alpha-Galactosidase A deficiency |
| EP2275559A3 (en) * | 1999-09-28 | 2011-03-23 | Shire Human Genetic Therapies, Inc. | Optimized messenger RNA |
| WO2002064799A2 (en) | 1999-09-28 | 2002-08-22 | Transkaryotic Therapies, Inc. | Optimized messenger rna |
| WO2001042442A2 (en) | 1999-12-10 | 2001-06-14 | Cytos Biotechnology Ag | Activation of endogenous genes by genomic introduction of a replicon |
| JP2003523330A (ja) | 2000-02-04 | 2003-08-05 | チルドレンズ・ホスピタル・リサーチ・ファウンデイション | アテローム性動脈硬化症および関連疾患のための脂質加水分解治療 |
| AU2001269923A1 (en) | 2000-06-19 | 2002-01-02 | Genzyme Corporation | Combination enzyme replacement, gene therapy and small molecule therapy for lysosomal storage diseases |
| US7138262B1 (en) * | 2000-08-18 | 2006-11-21 | Shire Human Genetic Therapies, Inc. | High mannose proteins and methods of making high mannose proteins |
| IL140110A0 (en) | 2000-12-05 | 2002-02-10 | Applied Research Systems | Improvement of homogeneity and secretion of recombinant proteins in mammalian systems |
| EP1503788B1 (en) | 2002-04-25 | 2011-06-29 | Shire Human Genetic Therapies, Inc. | Treatment of alpha-galactosidase a deficiency |
| EP1587923B1 (en) * | 2003-01-22 | 2011-08-24 | Duke University | Improved constructs for expressing lysosomal polypeptides |
| TWI500765B (zh) | 2005-11-18 | 2015-09-21 | Tokyo Metropolitan Inst Medical Science | 轉換基質特異性之新穎高機能酵素 |
| AR059089A1 (es) | 2006-01-20 | 2008-03-12 | Genzyme Corp | Administracion intraventricular de una enzima para enfermedades de almacenamiento lisosomal |
| RS52459B (en) | 2006-02-07 | 2013-02-28 | Shire Human Genetic Therapies Inc. | STABILIZED GLUCOCEREBROSIDASE COMPOSITIONS |
| EP1988823B1 (en) | 2006-02-09 | 2018-08-15 | Genzyme Corporation | Slow intraventricular delivery |
| US8569032B2 (en) | 2007-05-18 | 2013-10-29 | Tokyo Metropolitan Institute Of Medical Science | Proteins having acquired A-galactosidase activity |
| EP2889043B1 (en) | 2008-12-16 | 2019-04-10 | Genzyme Corporation | Synthetic intermediates for preparing oligosaccharide-protein conjugates |
| ES2668079T3 (es) | 2009-07-28 | 2018-05-16 | Shire Human Genetic Therapies | Composiciones y métodos para tratar la enfermedad de Gaucher |
| LT3205351T (lt) | 2010-04-23 | 2023-07-25 | Alexion Pharmaceuticals, Inc. | Lizosomų kaupimosi ligos fermentas |
| US9453847B2 (en) | 2010-07-19 | 2016-09-27 | Shire Human Genetic Therapies, Inc. | Mannose receptor C type 1 (MRC1) codon optimized cell line and uses thereof |
| PL2977057T3 (pl) | 2010-09-09 | 2020-06-01 | Alexion Pharmaceuticals, Inc. | Izolowana rekombinowana ludzka lizosomalna N-glikozylowana kwaśna lipaza |
| EP2675472A4 (en) | 2011-02-15 | 2014-09-17 | Synageva Biopharma Corp | METHOD FOR THE TREATMENT OF LACK OF LYSOSOMAL SAURER LIPASE |
| US20140301977A1 (en) * | 2011-11-02 | 2014-10-09 | Genentech, Inc. | Overload and elute chromatography |
| CA2865614A1 (en) | 2012-03-02 | 2013-09-06 | Shire Human Genetic Therapies, Inc. | Compositions and methods for treating type iii gaucher disease |
| CN104507503A (zh) * | 2012-06-29 | 2015-04-08 | 康斯乔最高科学研究公司(Csic) | 用于递送生物活性化合物的功能化脂质体 |
| JP6226435B2 (ja) * | 2012-07-26 | 2017-11-08 | Ｊｃｒファーマ株式会社 | 組換えヒトα−ガラクトシダーゼＡの製造方法 |
| WO2014016873A1 (en) | 2012-07-26 | 2014-01-30 | Jcr Pharmaceuticals Co., Ltd. | Method for production of recombinant human alpha-galactosidase a |
| 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 |
| TW202332774A (zh) | 2013-10-23 | 2023-08-16 | 美商健臻公司 | 重組醣蛋白及其用途 |
| KR102438885B1 (ko) * | 2014-12-22 | 2022-09-01 | 코덱시스, 인코포레이티드 | 인간 알파-갈락토시다제 변이체 |
| WO2016116966A1 (en) | 2015-01-22 | 2016-07-28 | Jcr Pharmaceuticals Co., Ltd. | Method for purification of recombinant human alpha-galactosidase a from material containing contaminant host cell proteins |
| GB201508025D0 (en) * | 2015-05-11 | 2015-06-24 | Ucl Business Plc | Fabry disease gene therapy |
| TW201906618A (zh) | 2017-06-30 | 2019-02-16 | 日商富士軟片股份有限公司 | 溶酶體病處置劑 |
| ES2716305B2 (es) | 2017-12-11 | 2019-11-27 | Fund Biomedica Galicia Sur | Uso de chaperonas farmacologicas para el tratamiento de enfermedades de deposito lisosomal |
| KR20210106537A (ko) | 2018-12-20 | 2021-08-30 | 코덱시스, 인코포레이티드 | 인간 알파 갈락토시다제 변이체 |
| CN111308095A (zh) * | 2020-03-04 | 2020-06-19 | 北京师范大学 | 用于诊断前列腺癌的尿液蛋白标记物 |
| WO2024044697A2 (en) * | 2022-08-24 | 2024-02-29 | Walking Fish Therapeutics, Inc. | Compositions and methods for treatment of fabry disease |
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-
1997
- 1997-09-12 EP EP04030107.9A patent/EP1538202B1/en not_active Expired - Lifetime
- 1997-09-12 HU HU9904666A patent/HU227189B1/hu unknown
- 1997-09-12 DK DK04030107.9T patent/DK1538202T3/da active
- 1997-09-12 PT PT40301079T patent/PT1538202E/pt unknown
- 1997-09-12 KR KR1020057011793A patent/KR20050084473A/ko not_active Application Discontinuation
- 1997-09-12 EP EP10181991A patent/EP2327775A3/en not_active Withdrawn
- 1997-09-12 PL PL97332188A patent/PL190041B1/pl unknown
- 1997-09-12 JP JP51400498A patent/JP4001925B2/ja not_active Expired - Lifetime
- 1997-09-12 CN CNB97197909XA patent/CN1268741C/zh not_active Expired - Lifetime
- 1997-09-12 EP EP97942567A patent/EP0935651B1/en not_active Expired - Lifetime
- 1997-09-12 AT AT97942567T patent/ATE286120T1/de active
- 1997-09-12 EP EP10181859.9A patent/EP2374876B1/en not_active Expired - Lifetime
- 1997-09-12 KR KR1019997002088A patent/KR100547402B1/ko not_active IP Right Cessation
- 1997-09-12 ES ES04030107.9T patent/ES2458292T3/es not_active Expired - Lifetime
- 1997-09-12 DE DE69732129T patent/DE69732129T2/de not_active Expired - Lifetime
- 1997-09-12 AU AU44244/97A patent/AU4424497A/en not_active Abandoned
- 1997-09-12 DK DK10181859.9T patent/DK2374876T3/da active
- 1997-09-12 HU HU1000445A patent/HU230275B1/hu unknown
- 1997-09-12 MX MX2014010892A patent/MX340738B/es unknown
- 1997-09-12 CA CA002265464A patent/CA2265464C/en not_active Expired - Lifetime
- 1997-09-12 NZ NZ506214A patent/NZ506214A/xx not_active IP Right Cessation
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- 1997-09-12 RU RU99107287/14A patent/RU2179034C2/ru active
- 1997-09-12 NZ NZ334721A patent/NZ334721A/xx not_active IP Right Cessation
- 1997-09-12 WO PCT/US1997/016603 patent/WO1998011206A2/en active Application Filing
- 1997-09-13 TW TW086113342A patent/TW585919B/zh not_active IP Right Cessation
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1999
- 1999-03-12 NO NO19991225A patent/NO328443B1/no not_active IP Right Cessation
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2000
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2005
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2006
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2007
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2008
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2009
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2011
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2014
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