JP2020508331A - 安定化された抗体溶液 - Google Patents

安定化された抗体溶液 Download PDF

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Publication number
JP2020508331A
JP2020508331A JP2019546176A JP2019546176A JP2020508331A JP 2020508331 A JP2020508331 A JP 2020508331A JP 2019546176 A JP2019546176 A JP 2019546176A JP 2019546176 A JP2019546176 A JP 2019546176A JP 2020508331 A JP2020508331 A JP 2020508331A
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JP
Japan
Prior art keywords
aqueous solution
antibody
antibody protein
use according
protein
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2019546176A
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English (en)
Japanese (ja)
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JP2020508331A5 (cg-RX-API-DMAC10.html
Inventor
ジェゼク ジャン
ジェゼク ジャン
ジェリング デビッド
ジェリング デビッド
Original Assignee
アレコル リミテッド
アレコル リミテッド
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Publication date
Application filed by アレコル リミテッド, アレコル リミテッド filed Critical アレコル リミテッド
Publication of JP2020508331A publication Critical patent/JP2020508331A/ja
Publication of JP2020508331A5 publication Critical patent/JP2020508331A5/ja
Priority to JP2023022283A priority Critical patent/JP2023071755A/ja
Priority to JP2025018097A priority patent/JP2025087696A/ja
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/26—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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 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
    • A61K47/59—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 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
    • A61K47/60—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 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
    • 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
    • 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
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/32—Fusion polypeptide fusions with soluble part of a cell surface receptor, "decoy receptors"

Landscapes

  • 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)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2019546176A 2017-02-24 2018-02-23 安定化された抗体溶液 Pending JP2020508331A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2023022283A JP2023071755A (ja) 2017-02-24 2023-02-16 安定化された抗体溶液
JP2025018097A JP2025087696A (ja) 2017-02-24 2025-02-06 安定化された抗体溶液

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1703062.8A GB201703062D0 (en) 2017-02-24 2017-02-24 Stabilized antibody protein solutions
GB1703062.8 2017-02-24
PCT/GB2018/050481 WO2018154320A1 (en) 2017-02-24 2018-02-23 Stabilized antibody solutions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023022283A Division JP2023071755A (ja) 2017-02-24 2023-02-16 安定化された抗体溶液

Publications (2)

Publication Number Publication Date
JP2020508331A true JP2020508331A (ja) 2020-03-19
JP2020508331A5 JP2020508331A5 (cg-RX-API-DMAC10.html) 2021-04-08

Family

ID=58544129

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2019546176A Pending JP2020508331A (ja) 2017-02-24 2018-02-23 安定化された抗体溶液
JP2023022283A Pending JP2023071755A (ja) 2017-02-24 2023-02-16 安定化された抗体溶液
JP2025018097A Pending JP2025087696A (ja) 2017-02-24 2025-02-06 安定化された抗体溶液

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2023022283A Pending JP2023071755A (ja) 2017-02-24 2023-02-16 安定化された抗体溶液
JP2025018097A Pending JP2025087696A (ja) 2017-02-24 2025-02-06 安定化された抗体溶液

Country Status (6)

Country Link
US (1) US20200023061A1 (cg-RX-API-DMAC10.html)
EP (1) EP3585360B1 (cg-RX-API-DMAC10.html)
JP (3) JP2020508331A (cg-RX-API-DMAC10.html)
ES (1) ES3017936T3 (cg-RX-API-DMAC10.html)
GB (1) GB201703062D0 (cg-RX-API-DMAC10.html)
WO (1) WO2018154320A1 (cg-RX-API-DMAC10.html)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023528305A (ja) * 2020-05-29 2023-07-04 アムジエン・インコーポレーテツド 抗体製剤及びその使用
JP2024507347A (ja) * 2021-02-17 2024-02-19 アレコル リミテッド Ｆｃドメインを含む操作されたタンパク質コンストラクトの水性組成物

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
EP3372241A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372242A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
CN112618482A (zh) * 2019-09-24 2021-04-09 江苏恒瑞医药股份有限公司 新型蛋白制剂
EP4072600A1 (en) * 2019-12-12 2022-10-19 Eli Lilly and Company Methods for viral inactivation by environmentally compatible detergents
CN111665352B (zh) * 2020-06-23 2024-05-17 广州市丹蓝生物科技有限公司 一种储存剂及由其制备的抗体溶液制剂及其应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006502116A (ja) * 2002-07-12 2006-01-19 メダレックス， インク． タンパク質の酸化分解を防ぐ方法及び組成物
US20130209465A1 (en) * 2010-07-30 2013-08-15 Arecor Ltd. Stabilized Aqueous Antibody Compositions

Family Cites Families (11)

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US20030138417A1 (en) * 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
EP1865986B1 (en) 2005-03-08 2016-02-17 Pfizer Products Inc. Anti-ctla-4 antibody compositions
CA2665567C (en) * 2006-10-06 2012-07-03 Amgen Inc. Stable formulations
US7705132B2 (en) * 2006-10-20 2010-04-27 Amgen Inc. Stable polypeptide formulations
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
CA2690382A1 (en) * 2007-06-14 2008-12-24 Biogen Idec Ma Inc. Antibody formulations
MX2011005672A (es) 2008-11-28 2011-06-20 Abbott Lab Composiciones de anticuerpo estables y metodos para estabilizar a las mismas.
GB2499015A (en) 2012-02-03 2013-08-07 Reckitt Benckiser Nv Detergent dispensing device.
US20170360929A1 (en) * 2014-12-23 2017-12-21 Pfizer Inc. Stable aqueous antibody formulation for anti tnf alpha antibodies
WO2016120753A1 (en) * 2015-01-28 2016-08-04 Pfizer Inc. Stable aqueous anti- vascular endothelial growth factor (vegf) antibody formulation
GB201612317D0 (en) * 2016-07-15 2016-08-31 Philogen Spa Antibody compositions

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006502116A (ja) * 2002-07-12 2006-01-19 メダレックス， インク． タンパク質の酸化分解を防ぐ方法及び組成物
US20130209465A1 (en) * 2010-07-30 2013-08-15 Arecor Ltd. Stabilized Aqueous Antibody Compositions

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023528305A (ja) * 2020-05-29 2023-07-04 アムジエン・インコーポレーテツド 抗体製剤及びその使用
JP2024507347A (ja) * 2021-02-17 2024-02-19 アレコル リミテッド Ｆｃドメインを含む操作されたタンパク質コンストラクトの水性組成物

Also Published As

Publication number Publication date
ES3017936T3 (en) 2025-05-14
US20200023061A1 (en) 2020-01-23
WO2018154320A1 (en) 2018-08-30
EP3585360C0 (en) 2025-01-22
JP2025087696A (ja) 2025-06-10
JP2023071755A (ja) 2023-05-23
GB201703062D0 (en) 2017-04-12
EP3585360A1 (en) 2020-01-01
EP3585360B1 (en) 2025-01-22

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