JP6176849B2 - アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 - Google Patents

アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 Download PDF

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JP6176849B2
JP6176849B2 JP2013524738A JP2013524738A JP6176849B2 JP 6176849 B2 JP6176849 B2 JP 6176849B2 JP 2013524738 A JP2013524738 A JP 2013524738A JP 2013524738 A JP2013524738 A JP 2013524738A JP 6176849 B2 JP6176849 B2 JP 6176849B2
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antibody
preparation
protein
arginine
present
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JPWO2013012022A1 (ja
Inventor
大介 亀岡
大介 亀岡
誠也 安武
誠也 安武
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Chugai Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2013524738A 2011-07-19 2012-07-19 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 Active JP6176849B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2011157654 2011-07-19
JP2011157654 2011-07-19
PCT/JP2012/068276 WO2013012022A1 (ja) 2011-07-19 2012-07-19 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

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JPWO2013012022A1 JPWO2013012022A1 (ja) 2015-02-23
JP6176849B2 true JP6176849B2 (ja) 2017-08-09

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JP2017115935A Active JP6469765B2 (ja) 2011-07-19 2017-06-13 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

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US (2) US9574005B2 (enExample)
EP (1) EP2735315B1 (enExample)
JP (2) JP6176849B2 (enExample)
WO (1) WO2013012022A1 (enExample)

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WO2013012022A1 (ja) 2011-07-19 2013-01-24 中外製薬株式会社 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
WO2015063180A1 (en) * 2013-10-29 2015-05-07 Novozymes Biopharma Dk A/S Antibody composition
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JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
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RU2019138507A (ru) 2017-05-02 2021-06-02 Мерк Шарп И Доум Корп. Составы антител против lag3 и совместные составы антител против lag3 и антител против pd-1
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JP7235770B2 (ja) 2018-05-10 2023-03-08 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 高濃度vegf受容体融合タンパク質を含む製剤
CN113056482A (zh) 2018-10-18 2021-06-29 默沙东公司 抗rsv抗体的制剂及其使用方法
CN120842406A (zh) 2018-10-31 2025-10-28 默沙东有限责任公司 抗人pd-1抗体晶体及其使用方法
KR20210089215A (ko) 2018-11-07 2021-07-15 머크 샤프 앤드 돔 코포레이션 항-lag3 항체 및 항-pd-1 항체의 공동-제제
US12559551B2 (en) * 2019-05-24 2026-02-24 Regeneron Pharmaceuticals, Inc. Stabilized formulations containing anti-ANGPTL3 antibodies
EP3763356A1 (en) * 2019-07-12 2021-01-13 Ludwig-Maximilians-Universität München Excipient for biotherapeutics
JP6845973B1 (ja) * 2019-11-20 2021-03-24 中外製薬株式会社 抗体含有製剤
JP2025078889A (ja) * 2022-02-03 2025-05-21 天野エンザイム株式会社 酵素製剤
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WO2013012022A1 (ja) 2011-07-19 2013-01-24 中外製薬株式会社 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

Also Published As

Publication number Publication date
JPWO2013012022A1 (ja) 2015-02-23
JP2017222654A (ja) 2017-12-21
EP2735315B1 (en) 2019-10-02
EP2735315A4 (en) 2014-12-24
US9574005B2 (en) 2017-02-21
US20170112930A1 (en) 2017-04-27
JP6469765B2 (ja) 2019-02-13
US10898572B2 (en) 2021-01-26
WO2013012022A1 (ja) 2013-01-24
US20140206845A1 (en) 2014-07-24
EP2735315A1 (en) 2014-05-28

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