JP6483673B2 - 安定した水性抗体製剤 - Google Patents

安定した水性抗体製剤 Download PDF

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Publication number
JP6483673B2
JP6483673B2 JP2016525876A JP2016525876A JP6483673B2 JP 6483673 B2 JP6483673 B2 JP 6483673B2 JP 2016525876 A JP2016525876 A JP 2016525876A JP 2016525876 A JP2016525876 A JP 2016525876A JP 6483673 B2 JP6483673 B2 JP 6483673B2
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Prior art keywords
antibody
chain variable
variable region
formulation
seq
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Japanese (ja)
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JP2016535020A5 (enExample
JP2016535020A (ja
Inventor
リーチ，ウィリアム
レウス，レイチェル
マクギブニー，ジェイムズ
ニューエル，ケルシー
スチュアート，ケビン，ダグラス
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AstraZeneca AB
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AstraZeneca AB
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Priority to JP2019024364A priority Critical patent/JP6896781B2/ja
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    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • 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
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/06—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
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/14—Antitussive agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [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
    • 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
    • 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]

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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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
JP2016525876A 2013-10-24 2014-10-23 安定した水性抗体製剤 Active JP6483673B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2019024364A JP6896781B2 (ja) 2013-10-24 2019-02-14 安定した水性抗体製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361895143P 2013-10-24 2013-10-24
US61/895,143 2013-10-24
PCT/US2014/061997 WO2015061584A1 (en) 2013-10-24 2014-10-23 Stable, aqueous antibody formulations

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JP2016535020A JP2016535020A (ja) 2016-11-10
JP2016535020A5 JP2016535020A5 (enExample) 2017-11-24
JP6483673B2 true JP6483673B2 (ja) 2019-03-13

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JP2019024364A Active JP6896781B2 (ja) 2013-10-24 2019-02-14 安定した水性抗体製剤
JP2021096239A Pending JP2021152034A (ja) 2013-10-24 2021-06-09 安定した水性抗体製剤

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Country Status (23)

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US (4) US20150118249A1 (enExample)
EP (2) EP3060229B1 (enExample)
JP (3) JP6483673B2 (enExample)
KR (3) KR102238065B1 (enExample)
CN (4) CN112107538A (enExample)
AU (4) AU2014339984B2 (enExample)
BR (1) BR112016008576B1 (enExample)
CA (1) CA2926089C (enExample)
CY (1) CY1125697T1 (enExample)
DK (1) DK3060229T3 (enExample)
ES (1) ES2893861T3 (enExample)
HR (1) HRP20211371T1 (enExample)
HU (1) HUE055919T2 (enExample)
LT (1) LT3060229T (enExample)
MX (2) MX388893B (enExample)
PL (1) PL3060229T3 (enExample)
PT (1) PT3060229T (enExample)
RS (1) RS62419B1 (enExample)
RU (1) RU2763787C2 (enExample)
SG (2) SG11201603206UA (enExample)
SI (1) SI3060229T1 (enExample)
SM (1) SMT202100580T1 (enExample)
WO (1) WO2015061584A1 (enExample)

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Publication number Priority date Publication date Assignee Title
JP2019116480A (ja) * 2013-10-24 2019-07-18 アストラゼネカ アクチボラグ 安定した水性抗体製剤

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JP2019116480A (ja) 2019-07-18
DK3060229T3 (da) 2021-10-11
AU2022291595A1 (en) 2023-03-16
CN105611938B (zh) 2024-12-31
RU2016119755A (ru) 2017-11-27
MX2021015825A (es) 2022-02-03
SMT202100580T1 (it) 2021-11-12
WO2015061584A1 (en) 2015-04-30
RU2021137159A (ru) 2022-01-11
LT3060229T (lt) 2021-09-27
KR102238065B1 (ko) 2021-04-07
AU2014339984B2 (en) 2020-04-09
KR102109053B1 (ko) 2020-05-13
AU2020204608A1 (en) 2020-07-30
CA2926089C (en) 2022-08-30
CN119971024A (zh) 2025-05-13
RU2016119755A3 (enExample) 2018-04-28
US20150118249A1 (en) 2015-04-30
BR112016008576B1 (pt) 2023-03-07
US12582716B2 (en) 2026-03-24
SI3060229T1 (sl) 2021-11-30
ES2893861T3 (es) 2022-02-10
EP3060229A4 (en) 2017-08-16
MX388893B (es) 2025-03-20
EP3892288A1 (en) 2021-10-13
KR20160068946A (ko) 2016-06-15
AU2025230794A1 (en) 2025-10-02
SG10201803178UA (en) 2018-05-30
EP3060229B1 (en) 2021-08-25
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US20250170245A1 (en) 2025-05-29
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JP6896781B2 (ja) 2021-06-30
US20200297855A1 (en) 2020-09-24
CA2926089A1 (en) 2015-04-30
CN113350278A (zh) 2021-09-07
EP3060229A1 (en) 2016-08-31
RS62419B1 (sr) 2021-10-29
CN113350278B (zh) 2023-03-24
KR20200051844A (ko) 2020-05-13
MX2016004605A (es) 2016-11-14
PL3060229T3 (pl) 2021-12-27
BR112016008576A2 (pt) 2017-10-03
CN105611938A (zh) 2016-05-25
CN112107538A (zh) 2020-12-22
HK1221900A1 (zh) 2017-06-16
JP2021152034A (ja) 2021-09-30
HUE055919T2 (hu) 2022-01-28
PT3060229T (pt) 2021-10-07
SG11201603206UA (en) 2016-05-30
US20190201535A1 (en) 2019-07-04
CY1125697T1 (el) 2024-02-16
HRP20211371T1 (hr) 2021-11-26
RU2763787C2 (ru) 2022-01-11
AU2022291595B2 (en) 2025-06-12

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