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AR112300A2 - Purificación de polipéptidos pegilados - Google Patents

Purificación de polipéptidos pegilados

Info

Publication number
AR112300A2
AR112300A2 ARP180101676A AR112300A2 AR 112300 A2 AR112300 A2 AR 112300A2 AR P180101676 A ARP180101676 A AR P180101676A AR 112300 A2 AR112300 A2 AR 112300A2
Authority
AR
Argentina
Prior art keywords
cation exchange
mono
column
erythropoietin
exchange chromatography
Prior art date
Application number
Other languages
English (en)
Original Assignee
F Hofmann 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40120288&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR112300(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by F Hofmann La Roche Ag filed Critical F Hofmann La Roche Ag
Publication of AR112300A2 publication Critical patent/AR112300A2/es

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
    • C07K1/18—Ion-exchange chromatography
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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
    • A61K47/56—Medicinal 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
    • A61K47/59—Medicinal 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
    • A61K47/60—Medicinal 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
    • 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
    • C07K17/00—Carrier-bound or immobilised peptides; Preparation thereof
    • C07K17/02—Peptides being immobilised on, or in, an organic carrier
    • C07K17/08—Peptides being immobilised on, or in, an organic carrier the carrier being a synthetic polymer

Landscapes

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

Abstract

Reivindicación 1: Método para la producción de una eritropoyetina mono-PEGilada que comprende los siguientes pasos: a) PEGilar eritropoyetina, b) purificar eritropoyetina mono-PEGilada con dos pasos consecutivos de cromatografía de intercambio catiónico, en donde el primer y segundo paso de cromatografías de intercambio catiónico emplean el mismo tipo de material de intercambio catiónico, c) recuperar la eritropoyetina mono-PEGilada de la segunda columna de cromatografía de intercambio catiónico en forma sustancialmente homogénea, en donde los dos pasos consecutivos de cromatografía de intercambio catiónico se llevan a cabo utilizando diferentes métodos de elución, por lo que los dos pasos consecutivos de cromatografía de intercambio catiónico comprenden los siguientes pasos: (i) aplicar una solución acuosa tamponada, que comprende una mezcla de eritropoyetina mono-, poli-, no-PEGilada y formas de bajo peso molecular a una primera columna de cromatografía de intercambio catiónico en condiciones apropiadas para fijar dicha eritropoyetina. mono-PEGilada. al material de intercambio catiónico contenido en dicha primera columna, (ii) recuperar la eritropoyetina mono-PEGilada de la primera columna de cromatografía de intercambio catiónico por un método de elución por pasos con un aumento por pasos de la fuerza iónica del tampón que fluye a través de la misma, en donde la fracción de dicha eritropoyetina mono-PEGilada en la solución recuperada aumenta en comparación con la mezcla aplicada, (iii) aplicar la eritropoyetina mono-PEGilada recuperada del paso (ii) a una segunda columna de cromatografía de intercambio catiónico en condiciones apropiadas para fijar dicha eritropoyetina mono-PEGilada al material de intercambio catiónico contenido en dicha segunda columna, por lo que el material de intercambio catiónico contenido en dicha segunda columna es del mismo tipo que el material de intercambio catiónico en la primera columna, (iv) recuperar la eritropoyetina mono-PEGilada purificada en una forma sustancialmente homogénea de dicha segunda columna de cromatografía de intercambio catiónico por un método de elución continua con un aumento continuo de la fuerza iónica del tampón que fluye a través de la misma.
ARP180101676 2007-07-17 2018-06-14 Purificación de polipéptidos pegilados AR112300A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP07013959 2007-07-17

Publications (1)

Publication Number Publication Date
AR112300A2 true AR112300A2 (es) 2019-10-16

Family

ID=40120288

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP080103023A AR067537A1 (es) 2007-07-17 2008-07-14 Purificacion de polipeptidos pegilados
ARP180101676 AR112300A2 (es) 2007-07-17 2018-06-14 Purificación de polipéptidos pegilados

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP080103023A AR067537A1 (es) 2007-07-17 2008-07-14 Purificacion de polipeptidos pegilados

Country Status (21)

Country Link
US (2) US8138317B2 (es)
EP (1) EP2178900B1 (es)
JP (2) JP5307808B2 (es)
KR (1) KR101163297B1 (es)
CN (1) CN101889023B (es)
AR (2) AR067537A1 (es)
AT (1) ATE556086T1 (es)
AU (1) AU2008277887B2 (es)
BR (1) BRPI0813830A2 (es)
CA (1) CA2692612C (es)
CL (1) CL2008002053A1 (es)
DK (1) DK2178900T3 (es)
ES (1) ES2386323T3 (es)
IL (1) IL202940A (es)
PE (1) PE20090823A1 (es)
PL (1) PL2178900T3 (es)
PT (1) PT2178900E (es)
RU (1) RU2476439C2 (es)
TW (1) TWI363060B (es)
WO (1) WO2009010270A2 (es)
ZA (1) ZA201000283B (es)

Families Citing this family (13)

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Publication number Priority date Publication date Assignee Title
CL2008002054A1 (es) * 2007-07-17 2009-05-29 Hoffmann La Roche Metodo para la regeneracion de una columna de cromatografia de intercambio cationico despues de la elusion de eritropoyetina monopeguilada y metodo para obtener una eritropoyetina monopeguilada, incorporando el metodo de regeneracion de la columna de intercambio cationico.
CL2008002053A1 (es) * 2007-07-17 2009-05-22 Hoffmann La Roche Metodo para la purificacion de una eritropoyetina monopeguilada (epompeg) que consiste en proporcionar una solucion que contiene eritropoyetina mono, poli y no peguilada y hacerla pasar por dos pasos de cromatografia de intercambio cationico y metodo para producir epo mpeg que incluye metodo de purificacion.
CA2736141C (en) * 2008-09-23 2018-03-20 F. Hoffmann-La Roche Ag Purification of erythropoietin
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KR101578586B1 (ko) * 2010-09-14 2015-12-17 에프. 호프만-라 로슈 아게 Peg화된 에리트로포이에틴의 정제 방법
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
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WO2021072210A1 (en) * 2019-10-11 2021-04-15 Coherus Biosciences, Inc. Methods of purifying ranibizumab or a ranibizumab variant

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Also Published As

Publication number Publication date
EP2178900A2 (en) 2010-04-28
ES2386323T3 (es) 2012-08-17
BRPI0813830A2 (pt) 2015-01-06
PE20090823A1 (es) 2009-06-27
AU2008277887B2 (en) 2012-12-13
ATE556086T1 (de) 2012-05-15
JP5814978B2 (ja) 2015-11-17
CL2008002053A1 (es) 2009-05-22
IL202940A (en) 2015-07-30
CN101889023B (zh) 2013-03-20
WO2009010270A8 (en) 2010-04-29
DK2178900T3 (da) 2012-06-25
JP5307808B2 (ja) 2013-10-02
CA2692612A1 (en) 2009-01-22
RU2010105303A (ru) 2011-08-27
PL2178900T3 (pl) 2012-10-31
AU2008277887A1 (en) 2009-01-22
JP2010533664A (ja) 2010-10-28
KR20100072169A (ko) 2010-06-30
TW200914463A (en) 2009-04-01
KR101163297B1 (ko) 2012-07-05
CA2692612C (en) 2015-02-10
WO2009010270A3 (en) 2009-04-30
RU2476439C2 (ru) 2013-02-27
EP2178900B1 (en) 2012-05-02
AR067537A1 (es) 2009-10-14
US8138317B2 (en) 2012-03-20
ZA201000283B (en) 2011-06-29
JP2013189457A (ja) 2013-09-26
TWI363060B (en) 2012-05-01
US8889837B2 (en) 2014-11-18
WO2009010270A2 (en) 2009-01-22
US20110118448A1 (en) 2011-05-19
CN101889023A (zh) 2010-11-17
PT2178900E (pt) 2012-06-01
US20090118476A1 (en) 2009-05-07

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