HUP0500061A2 - Rekombináns humán eritropoietin kromatográfiás tisztítása - Google Patents
Rekombináns humán eritropoietin kromatográfiás tisztításaInfo
- Publication number
- HUP0500061A2 HUP0500061A2 HU0500061A HUP0500061A HUP0500061A2 HU P0500061 A2 HUP0500061 A2 HU P0500061A2 HU 0500061 A HU0500061 A HU 0500061A HU P0500061 A HUP0500061 A HU P0500061A HU P0500061 A2 HUP0500061 A2 HU P0500061A2
- Authority
- HU
- Hungary
- Prior art keywords
- rhepo
- column
- eluted
- fractions
- supernatant
- Prior art date
Links
- 101000987586 Homo sapiens Eosinophil peroxidase Proteins 0.000 title abstract 2
- 101000920686 Homo sapiens Erythropoietin Proteins 0.000 title abstract 2
- 102000044890 human EPO Human genes 0.000 title abstract 2
- 238000011097 chromatography purification Methods 0.000 title 1
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 abstract 3
- 238000000034 method Methods 0.000 abstract 3
- 239000006228 supernatant Substances 0.000 abstract 3
- 238000005571 anion exchange chromatography Methods 0.000 abstract 2
- 239000006143 cell culture medium Substances 0.000 abstract 2
- 238000005119 centrifugation Methods 0.000 abstract 2
- 239000012501 chromatography medium Substances 0.000 abstract 2
- 238000001914 filtration Methods 0.000 abstract 2
- 230000001413 cellular effect Effects 0.000 abstract 1
- 239000000539 dimer Substances 0.000 abstract 1
- 238000000605 extraction Methods 0.000 abstract 1
- 238000002523 gelfiltration Methods 0.000 abstract 1
- 239000001963 growth medium Substances 0.000 abstract 1
- 239000002609 medium Substances 0.000 abstract 1
- 239000003960 organic solvent Substances 0.000 abstract 1
- 238000000746 purification Methods 0.000 abstract 1
- 239000011347 resin Substances 0.000 abstract 1
- 229920005989 resin Polymers 0.000 abstract 1
- 238000004366 reverse phase liquid chromatography Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 238000001542 size-exclusion chromatography Methods 0.000 abstract 1
- 238000005406 washing Methods 0.000 abstract 1
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
- C07K1/18—Ion-exchange chromatography
-
- 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
- C07K14/475—Growth factors; Growth regulators
- C07K14/505—Erythropoietin [EPO]
-
- 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
- C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Toxicology (AREA)
- Zoology (AREA)
- Analytical Chemistry (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Abstract
A találmány tárgya egy eljárás rekombináns humán eritropoietin (rhEpo)kinyerésére és tisztítására gazdasejteket tartalmazó sejttenyésztőtápközegből, amely abban áll, hogy (a) eltávolítják a gazdasejteket, asejtes alkotórészeket és a sejttörmeléket a sejttenyésztő tápközegbőla következő eljárások valamelyikével: (i) centrifugálással és eztkövető <depth' szűrési lépéssel, (ii) <depth' szűrési lépéssel vagy(iii) centrifugálással, hogy tisztított tenyésztőközeg-felülúszótkapjanak; (b) beállítják a felülúszó vezetőképességét 5 mS/cm vagyennél kisebb értékre és a pH-ját körülbelül 7,0 és 8,0 közöttiértékre; (c) a (b) lépésben kapott felülúszót felviszik egy oszlopra,amely anioncserélő kromatográfiás közeget tartalmaz, az oszlopotmossák, eluálják az rhEpo-t az oszlopról, és összegyűjtik az rhEpo-ttartalmazó csúcsfrakció(ka)t: (d) a (c) lépésből származó egyesítettcsúcsfrakciókat revertfázisú kromatográfiás lépésnek vetik alá olyangyanta alkalmazásával, amely közepes nyomáson (i bar) futtatható és aNaOH magas koncentrációira rezisztens, az rhEpa-t egy szerves oldószerlineáris gradiensével eluálják; (e) a (d) lépésben eluált egy vagytöbb, rhEpo-t tartalmazó frakciót felviszik egy oszlopra, amelyanioncserélő kromatográfiás közeget tartalmaz, az oszlopot mossák ésaz rhEpo-t egy lineáris sógradienssel segítségével eluálják; (f) az(e) lépésben eluált egy vagy több.; rhEpo-t tartalmazó frakciótszelektálják az rhEpo szalilácójának foka alapján; és (g) az (f)lépésben eluált egy vagy több, rhEpo-t tartalmazó frakciót alávetikegy vagy több méretkizárásos kromatográfiás lépésnek gélszűréses közegsegítségével, hogy eltávolítsák a potenciális dimereket és nagyobbaggregátumokat; és összegyűjtik az rhEpo-t tartalmazó eluátumot. Atalálmány szerinti eljárással meghatározott glikoforma összetételű,igen nagy tisztaságú rhEpo állítható elő. Ó
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US33383901P | 2001-11-28 | 2001-11-28 | |
| PCT/EP2002/013299 WO2003045996A1 (en) | 2001-11-28 | 2002-11-26 | Chromatographic purification of recombinant human erythropoietin |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HUP0500061A2 true HUP0500061A2 (hu) | 2005-04-28 |
Family
ID=23304479
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HU0500061A HUP0500061A2 (hu) | 2001-11-28 | 2002-11-26 | Rekombináns humán eritropoietin kromatográfiás tisztítása |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US20060099674A1 (hu) |
| EP (1) | EP1453857B1 (hu) |
| JP (1) | JP4293908B2 (hu) |
| KR (1) | KR20040065567A (hu) |
| CN (1) | CN1596268A (hu) |
| AU (1) | AU2002356733A1 (hu) |
| BR (1) | BR0214568A (hu) |
| CA (1) | CA2466627A1 (hu) |
| ES (1) | ES2525945T3 (hu) |
| HR (1) | HRP20040476A2 (hu) |
| HU (1) | HUP0500061A2 (hu) |
| IL (1) | IL161855A0 (hu) |
| MX (1) | MXPA04005189A (hu) |
| NO (1) | NO20042185L (hu) |
| NZ (1) | NZ533083A (hu) |
| PL (1) | PL368755A1 (hu) |
| RU (1) | RU2004119818A (hu) |
| SI (1) | SI1453857T1 (hu) |
| WO (1) | WO2003045996A1 (hu) |
| ZA (1) | ZA200403461B (hu) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2002247896A1 (en) * | 2002-03-26 | 2003-10-08 | Lek Pharmaceutical And Chemical Company D.D. | Process for the preparation of a desired erythropoietin glyco-isoform profile |
| SI1428878T1 (sl) * | 2002-12-13 | 2009-02-28 | Bioceuticals Arzneimittel Ag | Postopek za proizvodnjo in čiščenje eritropoietina |
| US7157276B2 (en) * | 2003-06-20 | 2007-01-02 | Biogen Idec Inc. | Use of depth filtration in series with continuous centrifugation to clarify mammalian cell cultures |
| KR100567448B1 (ko) * | 2003-11-05 | 2006-04-04 | 주식회사 인투젠 | 형질전환 동물의 유즙 전처리방법 및 이를 통한 인체단백질의 정제방법 |
| DE102004027816A1 (de) | 2004-06-08 | 2006-01-05 | Bioceuticals Arzneimittel Ag | Verfahren zur Reinigung von Erythropoietin |
| WO2006003926A1 (ja) * | 2004-06-30 | 2006-01-12 | Terumo Kabushiki Kaisha | ウィルス不活化ヘモグロビンおよびその製造方法 |
| US7531632B2 (en) * | 2006-02-16 | 2009-05-12 | Gtc Biotherapeutics, Inc. | Clarification of transgenic milk using depth filtration |
| KR100988706B1 (ko) * | 2007-03-07 | 2010-10-18 | 한미홀딩스 주식회사 | 재조합 에리트로포이에틴의 신규한 정제방법 |
| KR100900033B1 (ko) * | 2007-11-21 | 2009-06-01 | 한국생명공학연구원 | 인간 에리스로포이에틴의 정제방법 |
| DE102008002209A1 (de) | 2008-06-04 | 2009-12-10 | Evonik Degussa Gmbh | Verfahren zur Aufreinigung von Erythropoietin |
| US8779110B2 (en) | 2008-06-24 | 2014-07-15 | Dr. Reddy's Laboratories Limited | Purification of low isoelectric point isoforms of darbepoietin |
| CN102203113A (zh) * | 2008-10-17 | 2011-09-28 | 佩尔希维亚有限责任公司 | 澄清方法 |
| DE102008054716A1 (de) | 2008-12-16 | 2010-06-17 | Evonik Degussa Gmbh | Inprozesskontrolle in einem Verfahren zur Herstellung von EPO |
| US20120264688A1 (en) * | 2009-09-23 | 2012-10-18 | Walter Hinderer | Process for the purification of recombinant human erythropoietin (epo), epo thus purified and pharmaceutical compositions comprising same |
| WO2011063195A2 (en) * | 2009-11-20 | 2011-05-26 | Dr. Reddy's Laboratories Ltd. | Purification of modified cytokines |
| CN102453087B (zh) * | 2010-10-22 | 2013-12-25 | 广东赛保尔生物医药技术有限公司 | 一种单取代peg-epo的纯化及制备方法 |
| EP2640483A1 (en) * | 2010-11-15 | 2013-09-25 | Biogen Idec Inc. | Enrichment and concentration of select product isoforms by overloaded bind and elute chromatography |
| WO2012069474A2 (en) * | 2010-11-24 | 2012-05-31 | H. Lundbeck A/S | A method for reducing potential virus burden in a sample by cyanate treatment |
| KR101443257B1 (ko) | 2011-10-18 | 2014-09-19 | 주식회사 종근당 | 낮은 등전점을 갖는 에리스로포이에틴 유사체의 정제방법 |
| US10066001B2 (en) * | 2013-03-15 | 2018-09-04 | Apotex Inc. | Enhanced liquid formulation stability of erythropoietin alpha through purification processing |
| EP3016729B1 (fr) | 2013-07-05 | 2020-03-25 | Laboratoire Francais du Fractionnement et des Biotechnologies Societe Anonyme | Matrice de chromatographie d'affinité |
| KR101414897B1 (ko) | 2013-11-29 | 2014-07-04 | 씨제이헬스케어 주식회사 | 다베포에틴 알파의 정제 방법 |
| WO2015134640A1 (en) * | 2014-03-05 | 2015-09-11 | GlycoScientific LLC | Isotopically labeled glycans and methods for producing the same |
| CA2970732C (en) | 2014-12-15 | 2023-05-16 | Merck Patent Gmbh | Target molecule capture from crude solutions |
| EP3153522A1 (en) | 2015-10-09 | 2017-04-12 | Hetero Drugs Limited | Process for the purification of erythropoietin and darbepoetin alfa |
| CN106770597A (zh) * | 2017-03-01 | 2017-05-31 | 上海博威生物医药有限公司 | 用于检测组合物中促红细胞生成素电荷异质体的cze检测方法 |
| CN112940101A (zh) * | 2019-12-11 | 2021-06-11 | 深圳赛保尔生物药业有限公司 | 重组人促红细胞生成素的纯化方法 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4677195A (en) * | 1985-01-11 | 1987-06-30 | Genetics Institute, Inc. | Method for the purification of erythropoietin and erythropoietin compositions |
| US5856298A (en) * | 1989-10-13 | 1999-01-05 | Amgen Inc. | Erythropoietin isoforms |
| DE69130990T2 (de) * | 1990-02-20 | 1999-12-02 | Baxter Int | Gereinigtes, virusfreies menschliches Thrombin |
| DE19504211A1 (de) | 1995-02-09 | 1996-08-14 | Behringwerke Ag | Entfernen von Viren durch Ultrafiltration aus Proteinlösungen |
| TW442492B (en) * | 1995-07-26 | 2001-06-23 | Novartis Ag | Process for the enrichment of interferon |
| PT889949E (pt) * | 1996-03-13 | 2003-10-31 | Delta Biotechnology Ltd | Controlo de fermentacao |
| BR9917606A (pt) | 1998-11-06 | 2002-12-31 | Bio Sidus S A | Procedimento para a purificação de eritropoetina humana recombinante a partir de sobrenadantes de cultivo de células e eritropoetina humana recombinante obtida com tal procedimento |
-
2002
- 2002-11-26 ES ES02803796.8T patent/ES2525945T3/es not_active Expired - Lifetime
- 2002-11-26 CA CA002466627A patent/CA2466627A1/en not_active Abandoned
- 2002-11-26 MX MXPA04005189A patent/MXPA04005189A/es not_active Application Discontinuation
- 2002-11-26 JP JP2003547445A patent/JP4293908B2/ja not_active Expired - Lifetime
- 2002-11-26 EP EP02803796.8A patent/EP1453857B1/en not_active Expired - Lifetime
- 2002-11-26 NZ NZ533083A patent/NZ533083A/en unknown
- 2002-11-26 KR KR10-2004-7008088A patent/KR20040065567A/ko not_active Application Discontinuation
- 2002-11-26 PL PL02368755A patent/PL368755A1/xx unknown
- 2002-11-26 US US10/494,558 patent/US20060099674A1/en not_active Abandoned
- 2002-11-26 WO PCT/EP2002/013299 patent/WO2003045996A1/en active Application Filing
- 2002-11-26 BR BR0214568-5A patent/BR0214568A/pt not_active IP Right Cessation
- 2002-11-26 AU AU2002356733A patent/AU2002356733A1/en not_active Abandoned
- 2002-11-26 SI SI200231050T patent/SI1453857T1/sl unknown
- 2002-11-26 HU HU0500061A patent/HUP0500061A2/hu unknown
- 2002-11-26 RU RU2004119818/04A patent/RU2004119818A/ru not_active Application Discontinuation
- 2002-11-26 CN CNA028236017A patent/CN1596268A/zh active Pending
- 2002-11-26 IL IL16185502A patent/IL161855A0/xx unknown
-
2004
- 2004-05-06 ZA ZA200403461A patent/ZA200403461B/en unknown
- 2004-05-26 NO NO20042185A patent/NO20042185L/no not_active Application Discontinuation
- 2004-05-27 HR HR20040476A patent/HRP20040476A2/xx not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| KR20040065567A (ko) | 2004-07-22 |
| AU2002356733A1 (en) | 2003-06-10 |
| EP1453857A1 (en) | 2004-09-08 |
| US20060099674A1 (en) | 2006-05-11 |
| ES2525945T3 (es) | 2015-01-02 |
| WO2003045996A1 (en) | 2003-06-05 |
| RU2004119818A (ru) | 2006-01-10 |
| HRP20040476A2 (en) | 2005-10-31 |
| JP4293908B2 (ja) | 2009-07-08 |
| EP1453857B1 (en) | 2014-08-13 |
| CN1596268A (zh) | 2005-03-16 |
| NZ533083A (en) | 2006-09-29 |
| PL368755A1 (en) | 2005-04-04 |
| ZA200403461B (en) | 2006-05-31 |
| CA2466627A1 (en) | 2003-06-05 |
| JP2005518196A (ja) | 2005-06-23 |
| NO20042185L (no) | 2004-08-23 |
| IL161855A0 (en) | 2005-11-20 |
| SI1453857T1 (sl) | 2015-01-30 |
| MXPA04005189A (es) | 2005-02-17 |
| BR0214568A (pt) | 2004-11-03 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FD9A | Lapse of provisional protection due to non-payment of fees |