SI3731872T1 - Postopek za zagotavljanje sestavka PEGiliranih beljakovin - Google Patents

Postopek za zagotavljanje sestavka PEGiliranih beljakovin

Info

Publication number
SI3731872T1
SI3731872T1 SI201830545T SI201830545T SI3731872T1 SI 3731872 T1 SI3731872 T1 SI 3731872T1 SI 201830545 T SI201830545 T SI 201830545T SI 201830545 T SI201830545 T SI 201830545T SI 3731872 T1 SI3731872 T1 SI 3731872T1
Authority
SI
Slovenia
Prior art keywords
protein composition
pegylated protein
providing
providing pegylated
composition
Prior art date
Application number
SI201830545T
Other languages
English (en)
Inventor
Wolfgang Koehnlein
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 SI3731872T1 publication Critical patent/SI3731872T1/sl

Links

Classifications

    • 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
    • C07K1/20Partition-, reverse-phase or hydrophobic interaction chromatography
    • 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
    • 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
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/16Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166Fluid composition conditioning, e.g. gradient
    • 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
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1864Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
    • B01D15/1871Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in series
    • 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
    • B01D15/32Bonded phase chromatography
    • B01D15/325Reversed phase
    • B01D15/327Reversed phase with hydrophobic interaction
    • 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
    • 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]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates

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)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Toxicology (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
SI201830545T 2017-12-29 2018-12-28 Postopek za zagotavljanje sestavka PEGiliranih beljakovin SI3731872T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17211103 2017-12-29
EP18830892.8A EP3731872B1 (en) 2017-12-29 2018-12-28 Process for providing pegylated protein composition
PCT/EP2018/097124 WO2019129877A1 (en) 2017-12-29 2018-12-28 Process for providing pegylated protein composition

Publications (1)

Publication Number Publication Date
SI3731872T1 true SI3731872T1 (sl) 2022-04-29

Family

ID=60954808

Family Applications (1)

Application Number Title Priority Date Filing Date
SI201830545T SI3731872T1 (sl) 2017-12-29 2018-12-28 Postopek za zagotavljanje sestavka PEGiliranih beljakovin

Country Status (11)

Country Link
US (1) US11518781B2 (sl)
EP (1) EP3731872B1 (sl)
JP (2) JP7410860B2 (sl)
KR (1) KR102500631B1 (sl)
CN (1) CN111801120A (sl)
ES (1) ES2905105T3 (sl)
HR (1) HRP20220041T1 (sl)
PL (1) PL3731872T3 (sl)
SG (1) SG11202006140TA (sl)
SI (1) SI3731872T1 (sl)
WO (1) WO2019129877A1 (sl)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2909454T3 (es) * 2017-12-29 2022-05-06 Hoffmann La Roche Procedimiento para proporcionar una composición de proteína PEGilada
WO2021154908A1 (en) * 2020-01-29 2021-08-05 Merck Sharp & Dohme Corp. Methods of separating host cell lipases from an anti-lag3 antibody production

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990008822A1 (en) * 1989-02-03 1990-08-09 Genetics Institute, Inc. Erythropoietin receptor
FR2646438B1 (fr) 1989-03-20 2007-11-02 Pasteur Institut Procede de remplacement specifique d'une copie d'un gene present dans le genome receveur par l'integration d'un gene different de celui ou se fait l'integration
ES2127458T3 (es) 1989-11-06 1999-04-16 Cell Genesys Inc Produccion de proteinas utilizando recombinacion homologa.
CA2071989C (en) 1989-12-22 1999-07-27 Scott C. Chappel Endogenous gene expression modification with regulatory element
JP3051145B2 (ja) 1990-08-28 2000-06-12 住友製薬株式会社 新規なポリエチレングリコール誘導体修飾ペプチド
US5968502A (en) 1991-11-05 1999-10-19 Transkaryotic Therapies, Inc. Protein production and protein delivery
NZ245015A (en) 1991-11-05 1995-12-21 Transkaryotic Therapies Inc Delivery of human growth hormone through the administration of transfected cell lines encoding human growth hormone, which are physically protected from host immune response; the transfected cells and their production
US5641670A (en) 1991-11-05 1997-06-24 Transkaryotic Therapies, Inc. Protein production and protein delivery
ATE225801T1 (de) 1992-07-13 2002-10-15 Bionebraska Inc Verfahren zur modifizierung rekombinanter polypeptide
TW402639B (en) 1992-12-03 2000-08-21 Transkaryotic Therapies Inc Protein production and protein delivery
US5932462A (en) 1995-01-10 1999-08-03 Shearwater Polymers, Inc. Multiarmed, monofunctional, polymer for coupling to molecules and surfaces
US5886155A (en) * 1997-06-18 1999-03-23 Bioresources International Inc. Purification of miraculin glycoprotein using tandem hydrophobic interaction chromatography
EA200400067A1 (ru) 1999-01-29 2004-04-29 Эмджен Инк. Конъюгаты гксф
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
JP3108767B1 (ja) 1999-10-20 2000-11-13 農林水産省食品総合研究所長 chib2型キチナーゼの製造法
DE60330787D1 (de) * 2002-09-20 2010-02-11 Pharmacia Corp Verfahren zur verringerung der aggregatmengen des pegylierten proteins
ATE425767T1 (de) 2002-12-19 2009-04-15 Nektar Therapeutics Al Corp Konjugate von cyanovirin-varianten und einem polyalkylenoxid
WO2006024953A2 (en) 2004-08-31 2006-03-09 Pharmacia & Upjohn Company Llc Glycerol branched polyethylene glycol human growth hormone conjugates, process for their preparation, and methods of use thereof
WO2007010552A2 (en) 2005-03-17 2007-01-25 Serum Institute Of India Limited N- terminal peg conjugate of erythropoietin
US20100075375A1 (en) * 2006-10-03 2010-03-25 Novo Nordisk A/S Methods for the purification of polypeptide conjugates
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.
WO2011018515A1 (en) * 2009-08-14 2011-02-17 Novo Nordisk Health Care Ag Method of purifying pegylated proteins
WO2011064247A1 (en) 2009-11-24 2011-06-03 Novo Nordisk Health Care Ag Method of purifying pegylated proteins
CN102234310B (zh) * 2010-04-30 2017-02-08 杭州九源基因工程有限公司 一种聚乙二醇修饰蛋白的分离纯化方法
KR101578586B1 (ko) 2010-09-14 2015-12-17 에프. 호프만-라 로슈 아게 Peg화된 에리트로포이에틴의 정제 방법
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
US20140309175A1 (en) 2012-03-16 2014-10-16 Belrose Pharma, Inc. Polymeric conjugates of c1-inhibitors
CN104513306B (zh) 2014-12-15 2016-08-17 山西瑞亚力科技有限公司 载脂蛋白A1的纯化方法和ApoAI蛋白注射抗原
CN105037523B (zh) * 2015-06-25 2019-02-19 北京三元基因药业股份有限公司 干扰素突变体及其聚乙二醇衍生物
EP3337819B1 (en) * 2015-08-20 2024-02-21 F. Hoffmann-La Roche AG Method of purifying for producing recombinant polypeptides using fkpa

Also Published As

Publication number Publication date
CN111801120A (zh) 2020-10-20
JP7464660B2 (ja) 2024-04-09
KR20200104381A (ko) 2020-09-03
WO2019129877A1 (en) 2019-07-04
EP3731872B1 (en) 2021-11-24
US11518781B2 (en) 2022-12-06
ES2905105T3 (es) 2022-04-07
JP2021508710A (ja) 2021-03-11
JP7410860B2 (ja) 2024-01-10
KR102500631B1 (ko) 2023-02-15
EP3731872A1 (en) 2020-11-04
SG11202006140TA (en) 2020-07-29
JP2022160686A (ja) 2022-10-19
US20210238223A1 (en) 2021-08-05
HRP20220041T1 (hr) 2022-04-15
PL3731872T3 (pl) 2022-03-21

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