MX342444B - Metodo para purificar eritropoyetina conjugada con polietilenglicol (peg). - Google Patents

Metodo para purificar eritropoyetina conjugada con polietilenglicol (peg).

Info

Publication number
MX342444B
MX342444B MX2013002554A MX2013002554A MX342444B MX 342444 B MX342444 B MX 342444B MX 2013002554 A MX2013002554 A MX 2013002554A MX 2013002554 A MX2013002554 A MX 2013002554A MX 342444 B MX342444 B MX 342444B
Authority
MX
Mexico
Prior art keywords
erythropoietin
residue
ethylene glycol
cation exchange
pegylated erythropoietin
Prior art date
Application number
MX2013002554A
Other languages
English (en)
Other versions
MX2013002554A (es
Inventor
Kuhne Wolfgang
Falkenstein Roberto
Koehnlein Wolfgang
Schurig Hartmut (Fallecido) Representado Por Su Heredera Legal Sibylle Schurig
Original Assignee
F Hoffmann-La Roche Ag *
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by F Hoffmann-La Roche Ag * filed Critical F Hoffmann-La Roche Ag *
Publication of MX2013002554A publication Critical patent/MX2013002554A/es
Publication of MX342444B publication Critical patent/MX342444B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475Growth factors; Growth regulators
    • C07K14/505Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J39/00Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
    • B01J39/26Cation exchangers for chromatographic processes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02PCLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P20/00Technologies relating to chemical industry
    • Y02P20/50Improvements relating to the production of bulk chemicals
    • Y02P20/582Recycling of unreacted starting or intermediate materials

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Toxicology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención se refiere a un método para la purificación de una proteína que comprende eritropoyetina y un residuo individual de poli(etilenglicol) de subproductos de reacción o un material de partida sin reaccionar por medio de un método de cromatografía de intercambio catiónico. Se ha descubierto que al emplear un material de cromatografía de intercambio catiónico SP Sephacryl S 500 HRMR acondicionado a una conductividad de 21 mS/cm y una elución de gradiente lineal, una proteína de fusión de eritropoyetina y un residuo individual de poli(etilenglicol) se pueden obtener en un paso individual con alta pureza y alto rendimiento. Figura 1.
MX2013002554A 2010-09-14 2011-09-13 Metodo para purificar eritropoyetina conjugada con polietilenglicol (peg). MX342444B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP10176616 2010-09-14
PCT/EP2011/065888 WO2012035037A1 (en) 2010-09-14 2011-09-13 Method for purifying pegylated erythropoietin

Publications (2)

Publication Number Publication Date
MX2013002554A MX2013002554A (es) 2013-05-28
MX342444B true MX342444B (es) 2016-09-29

Family

ID=43385653

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2013002554A MX342444B (es) 2010-09-14 2011-09-13 Metodo para purificar eritropoyetina conjugada con polietilenglicol (peg).

Country Status (15)

Country Link
US (4) US20120197007A1 (es)
EP (1) EP2616101B1 (es)
JP (1) JP5735650B2 (es)
KR (1) KR101578586B1 (es)
CN (1) CN103118708B (es)
BR (1) BR112013005890B1 (es)
CA (1) CA2808748C (es)
DK (1) DK2616101T3 (es)
ES (1) ES2500048T3 (es)
HK (1) HK1181661A1 (es)
MX (1) MX342444B (es)
PL (1) PL2616101T3 (es)
RU (1) RU2566267C2 (es)
SI (1) SI2616101T1 (es)
WO (1) WO2012035037A1 (es)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102816227A (zh) * 2012-08-30 2012-12-12 深圳赛保尔生物药业有限公司 回收促红细胞生成素的方法
DE102016210647B3 (de) 2016-06-15 2017-09-14 Schaeffler Technologies AG & Co. KG Keilkupplung-Synchronisation
EP3484911B1 (en) 2016-07-15 2020-11-04 H. Hoffnabb-La Roche Ag Method for purifying pegylated erythropoietin
US10695402B2 (en) 2017-03-16 2020-06-30 University Of Rochester Erythropoietin for gastrointestinal dysfunction
SG11202005990RA (en) * 2017-12-29 2020-07-29 Hoffmann La Roche Process for providing pegylated protein composition
CN111801120A (zh) 2017-12-29 2020-10-20 豪夫迈·罗氏有限公司 用于提供聚乙二醇化蛋白质组合物的方法
PL3731873T3 (pl) * 2017-12-29 2022-04-25 F. Hoffmann-La Roche Ag Sposób dostarczania kompozycji pegylowanego białka
WO2022159414A1 (en) 2021-01-22 2022-07-28 University Of Rochester Erythropoietin for gastroinfestinal dysfunction

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DE69032809T2 (de) 1989-11-06 1999-07-08 Cell Genesys, Inc., Foster City, Calif. Herstellung von Proteinen mittels homologer Rekombination
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PT101031B (pt) 1991-11-05 2002-07-31 Transkaryotic Therapies Inc Processo para o fornecimento de proteinas por terapia genetica
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
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JO2291B1 (en) 1999-07-02 2005-09-12 اف . هوفمان لاروش ايه جي Erythropoietin derivatives
CZ299516B6 (cs) 1999-07-02 2008-08-20 F. Hoffmann-La Roche Ag Konjugát erythropoetinového glykoproteinu, zpusobjeho výroby a použití a farmaceutická kompozice sjeho obsahem
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Also Published As

Publication number Publication date
HK1181661A1 (en) 2013-11-15
KR101578586B1 (ko) 2015-12-17
CN103118708A (zh) 2013-05-22
BR112013005890B1 (pt) 2022-02-08
WO2012035037A1 (en) 2012-03-22
RU2566267C2 (ru) 2015-10-20
US20120197007A1 (en) 2012-08-02
JP5735650B2 (ja) 2015-06-17
CA2808748C (en) 2018-09-11
BR112013005890A2 (pt) 2020-04-14
DK2616101T3 (da) 2014-08-04
KR20130073964A (ko) 2013-07-03
US20210094993A1 (en) 2021-04-01
ES2500048T3 (es) 2014-09-29
US20170008941A1 (en) 2017-01-12
JP2013537208A (ja) 2013-09-30
SI2616101T1 (sl) 2014-10-30
CA2808748A1 (en) 2012-03-22
MX2013002554A (es) 2013-05-28
CN103118708B (zh) 2015-08-26
US20140163207A1 (en) 2014-06-12
EP2616101B1 (en) 2014-07-09
PL2616101T3 (pl) 2015-01-30
EP2616101A1 (en) 2013-07-24
RU2013113724A (ru) 2014-10-20
US10273277B2 (en) 2019-04-30

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