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PL3731872T3 - Sposób dostarczania kompozycji pegylowanego białka - Google Patents

Sposób dostarczania kompozycji pegylowanego białka

Info

Publication number
PL3731872T3
PL3731872T3 PL18830892T PL18830892T PL3731872T3 PL 3731872 T3 PL3731872 T3 PL 3731872T3 PL 18830892 T PL18830892 T PL 18830892T PL 18830892 T PL18830892 T PL 18830892T PL 3731872 T3 PL3731872 T3 PL 3731872T3
Authority
PL
Poland
Prior art keywords
protein composition
pegylated protein
providing
providing pegylated
composition
Prior art date
Application number
PL18830892T
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 PL3731872T3 publication Critical patent/PL3731872T3/pl

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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Toxicology (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Enzymes And Modification Thereof (AREA)
PL18830892T 2017-12-29 2018-12-28 Sposób dostarczania kompozycji pegylowanego białka PL3731872T3 (pl)

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
PL3731872T3 true PL3731872T3 (pl) 2022-03-21

Family

ID=60954808

Family Applications (1)

Application Number Title Priority Date Filing Date
PL18830892T PL3731872T3 (pl) 2017-12-29 2018-12-28 Sposób dostarczania kompozycji pegylowanego białka

Country Status (11)

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

Families Citing this family (6)

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KR102523239B1 (ko) 2017-12-29 2023-04-18 에프. 호프만-라 로슈 아게 페길화 단백질 조성물을 제공하기 위한 방법
CN111727063A (zh) * 2017-12-29 2020-09-29 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
EP3962924A1 (en) 2019-05-03 2022-03-09 Genentech, Inc. Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform
JP2023512991A (ja) * 2020-01-29 2023-03-30 メルク・シャープ・アンド・ドーム・エルエルシー 抗lag3抗体生成からの宿主細胞リパーゼの分離方法
KR20230098589A (ko) * 2020-10-30 2023-07-04 제넨테크, 인크. 감소된 가수분해 효소 활성률을 갖는 약제학적 조성물을 수득하기 위한 정제 플랫폼
TW202241922A (zh) * 2020-12-23 2022-11-01 愛爾蘭商爵士製藥愛爾蘭有限公司 純化電荷遮蔽的融合蛋白質之方法

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
WO1991006667A1 (en) 1989-11-06 1991-05-16 Cell Genesys, Inc. Production of proteins using homologous recombination
WO1991009955A1 (en) 1989-12-22 1991-07-11 Applied Research Systems Ars Holding N.V. 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
PT101031B (pt) 1991-11-05 2002-07-31 Transkaryotic Therapies Inc Processo para o fornecimento de proteinas por terapia genetica
US5968502A (en) 1991-11-05 1999-10-19 Transkaryotic Therapies, Inc. Protein production and protein delivery
US5641670A (en) 1991-11-05 1997-06-24 Transkaryotic Therapies, Inc. Protein production and protein delivery
AU673190B2 (en) 1992-07-13 1996-10-31 Bionebraska, Inc. Method for modification of recombinant polypeptides
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
AU2618500A (en) 1999-01-29 2000-08-18 Amgen, Inc. Gcsf conjugates
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
AU2003272585B2 (en) * 2002-09-20 2009-12-10 Pharmacia Corporation Process for decreasing aggregate levels of pegylated protein
US7267941B2 (en) 2002-12-19 2007-09-11 The Government of the United States of America as represented by The Secretary of The Department of Health and Human Services, The National Institutes of Health Cyanovirin variant-polymer conjugates
CN101010105A (zh) 2004-08-31 2007-08-01 法玛西雅厄普约翰有限责任公司 甘油支化的聚乙二醇人生长激素缀合物、其制备方法及其使用方法
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
AR067537A1 (es) 2007-07-17 2009-10-14 Hoffmann La Roche Purificacion de polipeptidos pegilados
WO2011018515A1 (en) * 2009-08-14 2011-02-17 Novo Nordisk Health Care Ag Method of purifying pegylated proteins
CN102639553A (zh) 2009-11-24 2012-08-15 诺沃—诺迪斯克保健股份有限公司 纯化聚乙二醇化蛋白质的方法
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
RU2566267C2 (ru) 2010-09-14 2015-10-20 Ф. Хоффманн-Ля Рош Аг Способ очистки пегилированного эритропоэтина
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
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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
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Also Published As

Publication number Publication date
JP2021508710A (ja) 2021-03-11
US11518781B2 (en) 2022-12-06
KR20200104381A (ko) 2020-09-03
KR102500631B1 (ko) 2023-02-15
US20210238223A1 (en) 2021-08-05
SI3731872T1 (sl) 2022-04-29
EP3731872A1 (en) 2020-11-04
CN111801120A (zh) 2020-10-20
ES2905105T3 (es) 2022-04-07
JP7410860B2 (ja) 2024-01-10
SG11202006140TA (en) 2020-07-29
JP2022160686A (ja) 2022-10-19
JP7464660B2 (ja) 2024-04-09
HRP20220041T1 (hr) 2022-04-15
WO2019129877A1 (en) 2019-07-04
EP3731872B1 (en) 2021-11-24

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