RU2010131179A - Жидкая композиция, содержащая антитело высокой концентрации - Google Patents

Жидкая композиция, содержащая антитело высокой концентрации Download PDF

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RU2010131179A
RU2010131179A RU2010131179/15A RU2010131179A RU2010131179A RU 2010131179 A RU2010131179 A RU 2010131179A RU 2010131179/15 A RU2010131179/15 A RU 2010131179/15A RU 2010131179 A RU2010131179 A RU 2010131179A RU 2010131179 A RU2010131179 A RU 2010131179A
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composition according
antibody
composition
amount
liquid composition
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RU2010131179/15A
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RU2497544C2 (ru
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Тосиюки МОРИТИКА (JP)
Тосиюки МОРИТИКА
Дайсуке КАМЕОКА (JP)
Дайсуке КАМЕОКА
Йосими ИМАЕДА (JP)
Йосими ИМАЕДА
Терутоси МАЕДА (JP)
Терутоси МАЕДА
Оливер Борис ШТАУХ (DE)
Оливер Борис Штаух
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Чугаи Сейяку Кабусики Кайся (Jp)
Чугаи Сейяку Кабусики Кайся
Ф.Хоффманн-Ля Рош Аг (Ch)
Ф.Хоффманн-Ля Рош Аг
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    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
    • A61K47/26—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • 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
    • 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
    • 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
    • C07K2317/70—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

Abstract

1. Стабильная антителосодержащая жидкая композиция, характеризующаяся тем, что она содержит аргинин и метионин. ! 2. Композиция по п.1, дополнительно содержащая гистидиновый буферный агент. !3. Композиция по п.2, дополнительно содержащая поверхностно-активное вещество. ! 4. Композиция по любому из пп.1-3, содержащая антитело в количестве, по меньшей мере, 50 мг/мл. ! 5. Композиция по любому из пп.1-3, содержащая антитело в количестве, по меньшей мере, 100 мг/мл. ! 6. Композиция по любому из пп.1-3, содержащая антитело в количестве, по меньшей мере, 120 мг/мл. ! 7. Композиция по любому из пп.1-3, где антитело является антителом к рецептору IL-6. ! 8. Композиция по любому из пп.1-3, где антитело является гуманизированным антителом или антителом человека. ! 9. Композиция по любому из пп.1-3, дополнительно содержащая триптофан. ! 10. Композиция по любому из пп.1-3, имеющая рН в диапазоне от 4 до 8. ! 11. Композиция по любому из пп.1-3, где аргинин присутствует в количестве от 50 до 1500 мМ. ! 12. Композиция по любому из пп.1-3, имеющая вязкость от 2 до 15 мПа·с. ! 13. Композиция по любому из пп.1-3, которая стабильна при 22-28°С в течение, по меньшей мере, 6 месяцев. ! 14. Композиция по любому из пп.1-3, отличающаяся тем, что димеризация молекул антител ингибируется. ! 15. Композиция по любому из пп.1-3, отличающаяся тем, что деамидирование молекул антител ингибируется. ! 16. Композиция по любому из пп.1-3, которая предназначена для подкожного введения. ! 17. Композиция по любому из пп.1-3, которая не подвергалась лиофилизации во время приготовления этой композиции. ! 18. Способ ингибирования димеризации молекул антитела в жидкой композиции, содержащей антитело, предусматривающий добавление ар�

Claims (18)

1. Стабильная антителосодержащая жидкая композиция, характеризующаяся тем, что она содержит аргинин и метионин.
2. Композиция по п.1, дополнительно содержащая гистидиновый буферный агент.
3. Композиция по п.2, дополнительно содержащая поверхностно-активное вещество.
4. Композиция по любому из пп.1-3, содержащая антитело в количестве, по меньшей мере, 50 мг/мл.
5. Композиция по любому из пп.1-3, содержащая антитело в количестве, по меньшей мере, 100 мг/мл.
6. Композиция по любому из пп.1-3, содержащая антитело в количестве, по меньшей мере, 120 мг/мл.
7. Композиция по любому из пп.1-3, где антитело является антителом к рецептору IL-6.
8. Композиция по любому из пп.1-3, где антитело является гуманизированным антителом или антителом человека.
9. Композиция по любому из пп.1-3, дополнительно содержащая триптофан.
10. Композиция по любому из пп.1-3, имеющая рН в диапазоне от 4 до 8.
11. Композиция по любому из пп.1-3, где аргинин присутствует в количестве от 50 до 1500 мМ.
12. Композиция по любому из пп.1-3, имеющая вязкость от 2 до 15 мПа·с.
13. Композиция по любому из пп.1-3, которая стабильна при 22-28°С в течение, по меньшей мере, 6 месяцев.
14. Композиция по любому из пп.1-3, отличающаяся тем, что димеризация молекул антител ингибируется.
15. Композиция по любому из пп.1-3, отличающаяся тем, что деамидирование молекул антител ингибируется.
16. Композиция по любому из пп.1-3, которая предназначена для подкожного введения.
17. Композиция по любому из пп.1-3, которая не подвергалась лиофилизации во время приготовления этой композиции.
18. Способ ингибирования димеризации молекул антитела в жидкой композиции, содержащей антитело, предусматривающий добавление аргинина и метионина к этой жидкой композиции.
RU2010131179/15A 2007-12-27 2008-12-26 Жидкая композиция, содержащая антитело высокой концентрации RU2497544C2 (ru)

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JP2007336310 2007-12-27
JP2007-336310 2007-12-27
PCT/JP2008/073798 WO2009084659A1 (ja) 2007-12-27 2008-12-26 高濃度抗体含有溶液製剤

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US (8) US8568720B2 (ru)
EP (1) EP2238985B2 (ru)
JP (7) JP4937358B2 (ru)
KR (1) KR101083616B1 (ru)
CN (2) CN101883588B (ru)
AR (2) AR069969A1 (ru)
AU (1) AU2008344292B2 (ru)
BR (1) BRPI0818903B8 (ru)
CA (1) CA2708627C (ru)
CL (1) CL2008003910A1 (ru)
CO (1) CO6450630A2 (ru)
CR (1) CR11594A (ru)
CY (1) CY1113616T1 (ru)
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ES (1) ES2389881T5 (ru)
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IL (2) IL206548A (ru)
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NZ (1) NZ586378A (ru)
PE (1) PE20091174A1 (ru)
PL (1) PL2238985T5 (ru)
PT (1) PT2238985E (ru)
RU (2) RU2497544C2 (ru)
SG (1) SG2013049325A (ru)
SI (1) SI2238985T2 (ru)
TW (1) TWI375566B (ru)
UA (1) UA104134C2 (ru)
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