EA026226B1 - Не содержащие аргинина композиции слитого fc-полипептида и способы их применения - Google Patents

Не содержащие аргинина композиции слитого fc-полипептида и способы их применения Download PDF

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Publication number
EA026226B1
EA026226B1 EA201490195A EA201490195A EA026226B1 EA 026226 B1 EA026226 B1 EA 026226B1 EA 201490195 A EA201490195 A EA 201490195A EA 201490195 A EA201490195 A EA 201490195A EA 026226 B1 EA026226 B1 EA 026226B1
Authority
EA
Eurasian Patent Office
Prior art keywords
composition
concentration
arginine
polypeptide
composition according
Prior art date
Application number
EA201490195A
Other languages
English (en)
Russian (ru)
Other versions
EA201490195A1 (ru
Inventor
Кевин Мэлоуни
Кэ Гун
Рой Алстон
Original Assignee
Байоджен Айдек Ма Инк.
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 Байоджен Айдек Ма Инк. filed Critical Байоджен Айдек Ма Инк.
Publication of EA201490195A1 publication Critical patent/EA201490195A1/ru
Publication of EA026226B1 publication Critical patent/EA026226B1/ru

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    • 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
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • 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
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/68Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K19/00Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • 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
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/525Tumour necrosis factor [TNF]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
EA201490195A 2011-07-01 2012-06-29 Не содержащие аргинина композиции слитого fc-полипептида и способы их применения EA026226B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161504110P 2011-07-01 2011-07-01
PCT/US2012/044988 WO2013006454A1 (en) 2011-07-01 2012-06-29 Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use

Publications (2)

Publication Number Publication Date
EA201490195A1 EA201490195A1 (ru) 2014-04-30
EA026226B1 true EA026226B1 (ru) 2017-03-31

Family

ID=46579322

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201490195A EA026226B1 (ru) 2011-07-01 2012-06-29 Не содержащие аргинина композиции слитого fc-полипептида и способы их применения

Country Status (13)

Country Link
US (2) US10995130B2 (enExample)
EP (1) EP2726090B1 (enExample)
JP (2) JP6463968B2 (enExample)
KR (1) KR102061355B1 (enExample)
CN (2) CN103930124B (enExample)
AU (2) AU2012279205B2 (enExample)
BR (1) BR112013033671B1 (enExample)
CA (1) CA2840711C (enExample)
DK (1) DK2726090T3 (enExample)
EA (1) EA026226B1 (enExample)
MX (2) MX358137B (enExample)
WO (1) WO2013006454A1 (enExample)
ZA (1) ZA201400490B (enExample)

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EP1909831A4 (en) 2005-06-14 2013-02-20 Amgen Inc SELF-BUFFING PROTEIN FORMULATIONS
UA124083C2 (uk) 2011-06-28 2021-07-21 ІНГІБРЕКС, Інк. Злитий серпіновий поліпептид і спосіб його застосування
WO2013006454A1 (en) 2011-07-01 2013-01-10 Biogen Idec Ma Inc. Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use
BR112014009031A2 (pt) * 2011-10-18 2017-05-09 Coherus Biosciences Inc formulações de etanercept estabilizadas com íons de metais
US10485869B2 (en) 2011-10-18 2019-11-26 Coherus Biosciences, Inc. Etanercept formulations stabilized with meglumine
MX2015000337A (es) * 2012-07-09 2015-09-25 Coherus Biosciences Inc Formulaciones de etanercept que exhiben reduccion notable en particulas subvisibles.
MX2015003007A (es) 2012-09-07 2015-06-05 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab.
LT2895188T (lt) 2012-09-11 2018-04-10 Coherus Biosciences, Inc. Aukšto grynumo ir geros išeigos teisingos struktūros etanerceptas
JP6026002B2 (ja) * 2012-11-27 2016-11-16 アルテオジェン インコーポレイテッド タンパク質とFcドメインを融合した融合タンパク質の安定化用組成物
JP2016518386A (ja) * 2013-05-02 2016-06-23 マブキシェンス エス.アー. TNFR:Fc融合ポリペプチドの代替配合物
WO2015056613A1 (ja) * 2013-10-15 2015-04-23 Meiji Seikaファルマ株式会社 安定化されたポリペプチド水性製剤
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
ES2600488T3 (es) 2014-05-23 2017-02-09 Ares Trading S.A. Composición farmacéutica líquida
ES2607489T3 (es) 2014-05-23 2017-03-31 Ares Trading S.A. Composición farmacéutica líquida
US9821059B2 (en) * 2014-10-17 2017-11-21 Alteogen Inc. Composition for stabilizing protein and pharmaceutical formulation comprising the same
AU2015371381A1 (en) * 2014-12-22 2017-07-20 Ares Trading S.A. Liquid pharmaceutical composition
WO2016149139A1 (en) * 2015-03-13 2016-09-22 Samsung Bioepis Co., Ltd. Anti-tnf-alpha polypeptide composition and use thereof
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
WO2017184880A1 (en) 2016-04-20 2017-10-26 Coherus Biosciences, Inc. A method of filling a container with no headspace
AU2017345490B2 (en) 2016-10-21 2022-07-07 Amgen Inc. Pharmaceutical formulations and methods of making the same
WO2018080196A2 (ko) * 2016-10-28 2018-05-03 (주)셀트리온 안정한 약제학적 제제
US11253569B2 (en) 2018-05-03 2022-02-22 Seattle Children's Hospital Methods of treating Kawasaki Disease
CN111228225B (zh) * 2018-11-28 2022-08-26 鲁南制药集团股份有限公司 一种重组人肿瘤坏死因子受体-Fc融合蛋白冻干制剂
GB201901547D0 (en) 2019-02-05 2019-03-27 Arecor Ltd Stabilized Fc Fusion protein solutions
CN118510549A (zh) * 2021-09-22 2024-08-16 圣诺制药公司 具有减小的纳米颗粒尺寸和改善的多分散性指数的纳米颗粒药物组合物

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WO2005012353A1 (en) * 2003-08-01 2005-02-10 Amgen Inc. Crystalline tumor necrosis factor receptor 2 polypeptides
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Also Published As

Publication number Publication date
CA2840711C (en) 2023-10-17
CA2840711A1 (en) 2013-01-10
KR102061355B1 (ko) 2019-12-31
BR112013033671B1 (pt) 2022-10-18
AU2017265026A1 (en) 2017-12-07
BR112013033671A2 (pt) 2017-01-24
WO2013006454A1 (en) 2013-01-10
JP6463968B2 (ja) 2019-02-06
AU2012279205A1 (en) 2014-02-06
MX2014000093A (es) 2014-11-12
US20210309719A1 (en) 2021-10-07
ZA201400490B (en) 2017-09-27
CN103930124B (zh) 2021-05-11
CN113244374A (zh) 2021-08-13
MX358137B (es) 2018-08-06
MX2018009524A (es) 2021-11-16
CN103930124A (zh) 2014-07-16
US10995130B2 (en) 2021-05-04
KR20140056218A (ko) 2014-05-09
AU2017265026B2 (en) 2019-10-24
NZ620160A (en) 2016-07-29
EP2726090A1 (en) 2014-05-07
EP2726090B1 (en) 2020-01-01
AU2012279205B2 (en) 2017-08-31
DK2726090T3 (da) 2020-01-20
US20140255400A1 (en) 2014-09-11
JP2014518276A (ja) 2014-07-28
JP2017186349A (ja) 2017-10-12
US11834491B2 (en) 2023-12-05
EA201490195A1 (ru) 2014-04-30

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