RU2008142359A - COMPOSITION OF HUMAN MONOCLONAL ANTIBODY TO IGF-1R - Google Patents

COMPOSITION OF HUMAN MONOCLONAL ANTIBODY TO IGF-1R Download PDF

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RU2008142359A
RU2008142359A RU2008142359/15A RU2008142359A RU2008142359A RU 2008142359 A RU2008142359 A RU 2008142359A RU 2008142359/15 A RU2008142359/15 A RU 2008142359/15A RU 2008142359 A RU2008142359 A RU 2008142359A RU 2008142359 A RU2008142359 A RU 2008142359A
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concentration
igf
humat
histidine
polysorbate
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Адельберт ГРОССМАНН (DE)
Адельберт ГРОССМАНН
Ханс-Кристиан МАЛЕР (CH)
Ханс-Кристиан МАЛЕР
Астрид ПАППЕНБЕРГЕР (CH)
Астрид ПАППЕНБЕРГЕР
Оливер Борис ШТАУХ (DE)
Оливер Борис Штаух
Ян Олаф ШТРАКЕ (DE)
Ян Олаф ШТРАКЕ
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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
    • 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
    • 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
    • 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
    • A61K47/16—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
    • 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
    • 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
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/2863—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 growth factors, growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

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  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Abstract

1. Композиция, выбранная из группы, которая включает композиции, имеющие следующие составы: ! huМАт к IGF-1R в концентрации от примерно 1 до примерно 150 мг/мл, ! Твин 20 в концентрации 0,01% (мас./об.), ! L-гистидин в концентрации 20 мМ, ! NaCl в концентрации 140 мМ, ! рН 6,0, ! или ! huМАт к IGF-1R в концентрации 25 мг/мл, ! полисорбат 20 в концентрации 0,01%, ! L-гистидин в концентрации 20 мМ, ! NaCl в концентрации 140 мМ, ! рН 6,0, ! или ! huМАт к IGF-1R в концентрации 25 мг/мл, ! полисорбат 20 в концентрации 0,03%, ! L-гистидин в концентрации 20 мМ, ! NaCl в концентрации 140 мМ, ! рН 6,0, ! или ! huМАт к IGF-1R в концентрации 25 мг/мл, ! полисорбат 20 в концентрации 0,05%, ! L-гистидин в концентрации 20 мМ, ! NaCl в концентрации 140 мМ, ! рН 6,0, ! или ! huМАт к IGF-1R в концентрации 10 мг/мл, ! полисорбат 20 в концентрации 0,01%, ! L-гистидин в концентрации 20 мМ, ! NaCl в концентрации 140 мМ, ! рН 6,0, ! или ! huМАт к IGF-1R в концентрации 10 мг/мл, ! полисорбат 20 в концентрации 0,03%, ! L-гистидин в концентрации 20 мМ, ! NaCl в концентрации 140 мМ, ! Н 6,0, ! или ! huМАт к IGF-1R в концентрации 10 мг/мл, ! полисорбат 20 в концентрации 0,05%, ! L-гистидин в концентрации 20 мМ, ! NaCl в концентрации 140 мМ, ! рН 6,0, ! или ! huМАт к IGF-1R в концентрации 25 мг/мл, ! L-гистидин в концентрации 20 мМ, ! NaCl в концентрации 140 мМ, ! рН 5,5, ! или ! huМАт к IGF-1R в концентрации 25 мг/мл, ! полисорбат 20 в концентрации 0,01%, ! L-гистидин в концентрации 20 мМ, ! дигидрат трегалозы в концентрации 250 мМ, ! рН5,5, ! или ! huМАт к IGF-1R в концентрации 25 мг/мл, ! L-гистидин в концентрации 20 мМ, ! дигидрат трегалозы в концентрации 250 мМ, ! рН 6,0, ! или ! huМАт к IGF-1R в концентрации 25 мг/мл, ! полисорбат 20 в концентрации 0,01%, ! L-гистидин в концентрации 20 мМ, ! дигидрат трегалозы в концентрации 250 мМ, ! рН 6,0, ! или ! huМАт к IGF-1R 1. A composition selected from the group that includes compositions having the following compositions:! hUMAT to IGF-1R at a concentration of from about 1 to about 150 mg / ml,! Tween 20 at a concentration of 0.01% (w / v),! L-histidine at a concentration of 20 mm,! NaCl at a concentration of 140 mm,! pH 6.0! or ! hUMAT to IGF-1R at a concentration of 25 mg / ml,! polysorbate 20 at a concentration of 0.01%,! L-histidine at a concentration of 20 mm,! NaCl at a concentration of 140 mm,! pH 6.0! or ! hUMAT to IGF-1R at a concentration of 25 mg / ml,! polysorbate 20 at a concentration of 0.03%,! L-histidine at a concentration of 20 mm,! NaCl at a concentration of 140 mm,! pH 6.0! or ! hUMAT to IGF-1R at a concentration of 25 mg / ml,! polysorbate 20 at a concentration of 0.05%,! L-histidine at a concentration of 20 mm,! NaCl at a concentration of 140 mm,! pH 6.0! or ! huMat to IGF-1R at a concentration of 10 mg / ml,! polysorbate 20 at a concentration of 0.01%,! L-histidine at a concentration of 20 mm,! NaCl at a concentration of 140 mm,! pH 6.0! or ! huMat to IGF-1R at a concentration of 10 mg / ml,! polysorbate 20 at a concentration of 0.03%,! L-histidine at a concentration of 20 mm,! NaCl at a concentration of 140 mm,! H 6.0,! or ! huMat to IGF-1R at a concentration of 10 mg / ml,! polysorbate 20 at a concentration of 0.05%,! L-histidine at a concentration of 20 mm,! NaCl at a concentration of 140 mm,! pH 6.0! or ! hUMAT to IGF-1R at a concentration of 25 mg / ml,! L-histidine at a concentration of 20 mm,! NaCl at a concentration of 140 mm,! pH 5.5! or ! hUMAT to IGF-1R at a concentration of 25 mg / ml,! polysorbate 20 at a concentration of 0.01%,! L-histidine at a concentration of 20 mm,! trehalose dihydrate at a concentration of 250 mM,! pH5.5! or ! hUMAT to IGF-1R at a concentration of 25 mg / ml,! L-histidine at a concentration of 20 mm,! trehalose dihydrate at a concentration of 250 mM,! pH 6.0! or ! hUMAT to IGF-1R at a concentration of 25 mg / ml,! polysorbate 20 at a concentration of 0.01%,! L-histidine at a concentration of 20 mm,! trehalose dihydrate at a concentration of 250 mM,! pH 6.0! or ! hUMAT to IGF-1R

Claims (10)

1. Композиция, выбранная из группы, которая включает композиции, имеющие следующие составы:1. A composition selected from the group which includes compositions having the following compositions: huМАт к IGF-1R в концентрации от примерно 1 до примерно 150 мг/мл,hUMAT to IGF-1R at a concentration of from about 1 to about 150 mg / ml, Твин 20 в концентрации 0,01% (мас./об.),Tween 20 at a concentration of 0.01% (w / v), L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, NaCl в концентрации 140 мМ,NaCl at a concentration of 140 mm, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, полисорбат 20 в концентрации 0,01%,polysorbate 20 at a concentration of 0.01%, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, NaCl в концентрации 140 мМ,NaCl at a concentration of 140 mm, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, полисорбат 20 в концентрации 0,03%,polysorbate 20 at a concentration of 0.03%, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, NaCl в концентрации 140 мМ,NaCl at a concentration of 140 mm, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, полисорбат 20 в концентрации 0,05%,polysorbate 20 at a concentration of 0.05%, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, NaCl в концентрации 140 мМ,NaCl at a concentration of 140 mm, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 10 мг/мл,huMat to IGF-1R at a concentration of 10 mg / ml, полисорбат 20 в концентрации 0,01%,polysorbate 20 at a concentration of 0.01%, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, NaCl в концентрации 140 мМ,NaCl at a concentration of 140 mm, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 10 мг/мл,huMat to IGF-1R at a concentration of 10 mg / ml, полисорбат 20 в концентрации 0,03%,polysorbate 20 at a concentration of 0.03%, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, NaCl в концентрации 140 мМ,NaCl at a concentration of 140 mm, Н 6,0,H 6.0, илиor huМАт к IGF-1R в концентрации 10 мг/мл,huMat to IGF-1R at a concentration of 10 mg / ml, полисорбат 20 в концентрации 0,05%,polysorbate 20 at a concentration of 0.05%, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, NaCl в концентрации 140 мМ,NaCl at a concentration of 140 mm, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, NaCl в концентрации 140 мМ,NaCl at a concentration of 140 mm, рН 5,5,pH 5.5 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, полисорбат 20 в концентрации 0,01%,polysorbate 20 at a concentration of 0.01%, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, дигидрат трегалозы в концентрации 250 мМ,trehalose dihydrate at a concentration of 250 mM, рН5,5,pH 5.5 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, дигидрат трегалозы в концентрации 250 мМ,trehalose dihydrate at a concentration of 250 mM, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, полисорбат 20 в концентрации 0,01%,polysorbate 20 at a concentration of 0.01%, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, дигидрат трегалозы в концентрации 250 мМ,trehalose dihydrate at a concentration of 250 mM, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, дигидрат трегалозы в концентрации 250 мМ,trehalose dihydrate at a concentration of 250 mM, полисорбат 20 в концентрации 0,05%,polysorbate 20 at a concentration of 0.05%, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, дигидрат трегалозы в концентрации 60 мМ,trehalose dihydrate at a concentration of 60 mm, полисорбат 20 в концентрации 0,01%,polysorbate 20 at a concentration of 0.01%, рН 6,0,pH 6.0 илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, сукцинат в концентрации 20 мМ,succinate at a concentration of 20 mm, дигидрат трегалозы в концентрации 250 мМ,trehalose dihydrate at a concentration of 250 mM, полисорбат 20 в концентрации 0,01%,polysorbate 20 at a concentration of 0.01%, РН 5,5,PH 5.5, илиor huМАт к IGF-1R в концентрации 25 мг/мл,huMat to IGF-1R at a concentration of 25 mg / ml, L-гистидин в концентрации 20 мМ,L-histidine at a concentration of 20 mm, дигидрат трегалозы в концентрации 60 мМ,trehalose dihydrate at a concentration of 60 mm, полисорбат 20 в концентрации 0,01%,polysorbate 20 at a concentration of 0.01%, при рН 6,0.at pH 6.0. 2. Композиция по п.1, которая находится в жидкой форме, лиофилизированной форме или в жидкой форме, восстановленной из лиофилизированной формы.2. The composition according to claim 1, which is in liquid form, lyophilized form or in liquid form, recovered from the lyophilized form. 3. Композиция по одному из п.1 или 2, которую можно вводить внутривенно (i.v.) или подкожно (s.c.) или любым другим парентеральным путем.3. The composition according to one of claim 1 or 2, which can be administered intravenously (i.v.) or subcutaneously (s.c.) or by any other parenteral route. 4. Композиция по п.1 или 2, которая дополнительно содержит один или несколько придающих изотоничность агентов в количестве от примерно 5 до примерно 350 мМ.4. The composition according to claim 1 or 2, which further comprises one or more isotonicizing agents in an amount of from about 5 to about 350 mM. 5. Композиция по п.4, в которой придающий изотоничность агент выбран из группы, включающей хлорид натрия (NaCl), хлорид калия, сахара, такие как глюкоза, глицерин, аминокислоты и их комбинации.5. The composition of claim 4, wherein the isotonicity agent is selected from the group consisting of sodium chloride (NaCl), potassium chloride, sugars such as glucose, glycerin, amino acids, and combinations thereof. 6. Композиция по п.1 или 2, которая дополнительно содержит сахар к количестве от примерно 25 до примерно 500 мМ.6. The composition according to claim 1 or 2, which further comprises sugar to an amount of from about 25 to about 500 mm. 7. Композиция по п.6, в которой сахара выбраны из группы, включающей трегалозу, сахарозу, лактозу, глюкозу, маннозу, мальтозу, галактозу, фруктозу, сорбозу, раффинозу, глюкозамин, N-метилглюкозамин («меглумин»), галактозамин и нейраминовую кислоту.7. The composition according to claim 6, in which the sugars are selected from the group comprising trehalose, sucrose, lactose, glucose, mannose, maltose, galactose, fructose, sorbose, raffinose, glucosamine, N-methylglucosamine ("meglumine"), galactosamine and neuraminic acid. 8. Композиция по п.1 или 2, которая содержит дополнительно один или несколько фармацевтически приемлемых ингредиентов, выбранных из группы, включающей антиоксиданты, аскорбиновую кислоту, глутатион, консерванты, например, м-крезол, фенол, бензиловый спирт, метилпарабен, пропилпарабен, хлорбутанол, тиомерсал, бензалконийхлорид, циклодекстрин, например, гидроксипропил-β-циклодекстрин, сульфобутилэтил-β-циклодекстрин, β-циклодекстрин, полиэтиленгликоль, например, ПЭГ 3000, 3350, 4000, 6000, альбумин, человеческий сывороточный альбумин (ЧСА), бычий сывороточный альбумин (БСА), многоатомный спирт, глицерин, этанол, маннит, соли, ацетатные соли (например, ацетат натрия), хлорид магния, хлорид кальция, трометамин, ЭДТК (например, Na-ЭДТК).8. The composition according to claim 1 or 2, which additionally contains one or more pharmaceutically acceptable ingredients selected from the group consisting of antioxidants, ascorbic acid, glutathione, preservatives, for example, m-cresol, phenol, benzyl alcohol, methylparaben, propylparaben, chlorobutanol , thiomersal, benzalkonium chloride, cyclodextrin, for example, hydroxypropyl-β-cyclodextrin, sulfobutylethyl-β-cyclodextrin, β-cyclodextrin, polyethylene glycol, for example, PEG 3000, 3350, 4000, 6000, albumin, human serum albumin (HSA), bovine serum rotary albumin (BSA), polyhydric alcohol, glycerin, ethanol, mannitol, salts, acetate salts (e.g. sodium acetate), magnesium chloride, calcium chloride, tromethamine, EDTA (e.g. Na-EDTA). 9. Применение композиции по одному из пп.1-8 для приготовления лекарственного средства, которое можно применять для лечения заболеваний, модулируемых рецептором IGF-IR.9. The use of the composition according to one of claims 1 to 8 for the preparation of a medicinal product that can be used to treat diseases modulated by the IGF-IR receptor. 10. Применение по п.9, в котором болезнь выбрана из группы, включающей рак молочной железы, колоректальный рак, немелкоклеточный рак легкого (NSCLC) и рак предстательной железы. 10. The use according to claim 9, in which the disease is selected from the group comprising breast cancer, colorectal cancer, non-small cell lung cancer (NSCLC) and prostate cancer.
RU2008142359/15A 2006-03-28 2007-03-19 COMPOSITION OF HUMAN MONOCLONAL ANTIBODY TO IGF-1R RU2008142359A (en)

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