JP2023514721A - 抗内皮リパーゼ抗体の製剤 - Google Patents

抗内皮リパーゼ抗体の製剤 Download PDF

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Publication number
JP2023514721A
JP2023514721A JP2022550151A JP2022550151A JP2023514721A JP 2023514721 A JP2023514721 A JP 2023514721A JP 2022550151 A JP2022550151 A JP 2022550151A JP 2022550151 A JP2022550151 A JP 2022550151A JP 2023514721 A JP2023514721 A JP 2023514721A
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JP
Japan
Prior art keywords
pharmaceutical formulation
antibody
specifically binds
endothelial lipase
seq
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Pending
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JP2022550151A
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English (en)
Japanese (ja)
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JP2023514721A5 (https=
Inventor
サハール マヌバイ パテール
スワプニル クシャル パンサーレ
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メディミューン，エルエルシー
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Publication of JP2023514721A publication Critical patent/JP2023514721A/ja
Publication of JP2023514721A5 publication Critical patent/JP2023514721A5/ja
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Cardiology (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2022550151A 2020-02-24 2021-02-23 抗内皮リパーゼ抗体の製剤 Pending JP2023514721A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062980658P 2020-02-24 2020-02-24
US62/980,658 2020-02-24
PCT/US2021/019213 WO2021173537A1 (en) 2020-02-24 2021-02-23 Formulations of anti-endothelial lipase antibodies

Publications (2)

Publication Number Publication Date
JP2023514721A true JP2023514721A (ja) 2023-04-07
JP2023514721A5 JP2023514721A5 (https=) 2024-03-06

Family

ID=77492003

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2022550151A Pending JP2023514721A (ja) 2020-02-24 2021-02-23 抗内皮リパーゼ抗体の製剤

Country Status (8)

Country Link
US (1) US20230131324A1 (https=)
EP (1) EP4110290A4 (https=)
JP (1) JP2023514721A (https=)
CN (1) CN115297838A (https=)
AU (1) AU2021227871A1 (https=)
CA (1) CA3211692A1 (https=)
TW (1) TWI887362B (https=)
WO (1) WO2021173537A1 (https=)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007524602A (ja) * 2003-04-04 2007-08-30 ジェネンテック・インコーポレーテッド 高濃度抗体及びタンパク質製剤
JP2012072170A (ja) * 2007-12-27 2012-04-12 Chugai Pharmaceut Co Ltd 高濃度抗体含有溶液製剤
JP2012519706A (ja) * 2009-03-06 2012-08-30 ジェネンテック， インコーポレイテッド 抗体製剤
WO2016039402A1 (ja) * 2014-09-11 2016-03-17 塩野義製薬株式会社 血管内皮リパーゼの酵素活性を阻害するヒト化モノクローナル抗体

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7507808B2 (en) * 2002-12-12 2009-03-24 Isis Pharmaceuticals, Inc. Modulation of endothelial lipase expression
AR060487A1 (es) * 2006-04-21 2008-06-18 Xoma Technology Ltd Composiciones farmaceuticas de antagonistas del anticuerpo anti- cd40
WO2012076670A2 (en) * 2010-12-10 2012-06-14 Novartis Ag Antibody formulation
JP6635655B2 (ja) * 2011-12-08 2020-01-29 アムジエン・インコーポレーテツド ヒトｌｃａｔ抗原結合タンパク質および治療法におけるそれらの使用
CN104768578A (zh) * 2012-10-25 2015-07-08 米迪缪尼有限公司 稳定的低粘度抗体配制品
WO2015095568A1 (en) * 2013-12-18 2015-06-25 Kelvin Lee Reduction of lipase activity in product formulations
CA2959571A1 (en) * 2014-09-03 2016-03-10 Medimmune Limited Stable anti-il-4r-alpha antibody formulation
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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007524602A (ja) * 2003-04-04 2007-08-30 ジェネンテック・インコーポレーテッド 高濃度抗体及びタンパク質製剤
JP2012072170A (ja) * 2007-12-27 2012-04-12 Chugai Pharmaceut Co Ltd 高濃度抗体含有溶液製剤
JP2012519706A (ja) * 2009-03-06 2012-08-30 ジェネンテック， インコーポレイテッド 抗体製剤
WO2016039402A1 (ja) * 2014-09-11 2016-03-17 塩野義製薬株式会社 血管内皮リパーゼの酵素活性を阻害するヒト化モノクローナル抗体

Also Published As

Publication number Publication date
CA3211692A1 (en) 2023-09-02
CN115297838A (zh) 2022-11-04
EP4110290A1 (en) 2023-01-04
EP4110290A4 (en) 2024-06-05
US20230131324A1 (en) 2023-04-27
TW202146046A (zh) 2021-12-16
WO2021173537A1 (en) 2021-09-02
AU2021227871A1 (en) 2022-09-15
TWI887362B (zh) 2025-06-21

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