UA94264C2 - Стабильная жидкая фармацевтическая композиция, которая содержит антагонистическое моноклональное антитело к cd40 - Google Patents

Стабильная жидкая фармацевтическая композиция, которая содержит антагонистическое моноклональное антитело к cd40

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Publication number
UA94264C2
UA94264C2 UAA200813220A UAA200813220A UA94264C2 UA 94264 C2 UA94264 C2 UA 94264C2 UA A200813220 A UAA200813220 A UA A200813220A UA A200813220 A UAA200813220 A UA A200813220A UA 94264 C2 UA94264 C2 UA 94264C2
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Ukraine
Prior art keywords
antibody
antagonist anti
stable liquid
pharmaceutical composition
containing pharmaceutical
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UAA200813220A
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English (en)
Ukrainian (uk)
Inventor
Сяофен Лу
Бао-Лу Чень
Кидисти Арайа
Аугустус ОКХАМАФЕ
Original Assignee
Новартис Аг
Ксома Текнолоджи Лтд.
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Application filed by Новартис Аг, Ксома Текнолоджи Лтд. filed Critical Новартис Аг
Publication of UA94264C2 publication Critical patent/UA94264C2/ru

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
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    • 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
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    • A61P7/06Antianaemics
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    • C07ORGANIC CHEMISTRY
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    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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    • C07K2317/00Immunoglobulins specific features
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    • 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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Abstract

Изобретение относится к стабильной жидкой фармацевтической композиции, которая содержит антагонистическое моноклональное антитело к CD40, аргинин в его кислотной форме (аргинин-HCl) в количестве, достаточном для того, чтобы сделать композицию практически изотонической; и буферный агент для поддержания значения рН композиции на уровне от приблизительно 5,0 до приблизительно 7,0, где буферный агент представляет собой буфер на основе цитрата/лимонной кислоты. Изобретение также относится к способу повышения стабильности моноклонального антитела к CD40 в жидкой фармацевтической композиции, способа лечения индивидуума, который имеет раковое или предраковое состояние, которое ассоциировано с клетками, экспресирующими CD40, а также способу лечения индивидуума, который имеет воспалительное заболевание или аутоимунное заболевание.
UAA200813220A 2006-04-21 2007-04-17 Стабильная жидкая фармацевтическая композиция, которая содержит антагонистическое моноклональное антитело к cd40 UA94264C2 (ru)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US79401106P 2006-04-21 2006-04-21

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UA94264C2 true UA94264C2 (ru) 2011-04-26

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Country Status (30)

Country Link
US (2) US8945564B2 (ru)
EP (1) EP2019841A2 (ru)
JP (2) JP5290152B2 (ru)
KR (1) KR101317235B1 (ru)
CN (1) CN101426817B (ru)
AR (1) AR060487A1 (ru)
AU (1) AU2007240507B2 (ru)
BR (1) BRPI0710826A2 (ru)
CA (1) CA2649907A1 (ru)
CR (1) CR10379A (ru)
CU (1) CU23856A3 (ru)
EA (1) EA018301B1 (ru)
EC (1) ECSP088903A (ru)
GE (1) GEP20125628B (ru)
GT (1) GT200700034A (ru)
HN (1) HN2008001572A (ru)
IL (1) IL194642A0 (ru)
MA (1) MA30470B1 (ru)
ME (1) MEP39508A (ru)
MX (1) MX2008013508A (ru)
NI (1) NI200800284A (ru)
NO (1) NO20084796L (ru)
NZ (1) NZ571757A (ru)
SA (1) SA07280191B1 (ru)
SM (1) SMP200800064B (ru)
SV (1) SV2008003071A (ru)
TN (1) TNSN08412A1 (ru)
TW (1) TW200808349A (ru)
UA (1) UA94264C2 (ru)
WO (1) WO2007124299A2 (ru)

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