KR102218495B1 - 단백질-함유 제제의 안정화에 유용한 조성물 및 방법 - Google Patents

단백질-함유 제제의 안정화에 유용한 조성물 및 방법 Download PDF

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KR102218495B1
KR102218495B1 KR1020197025585A KR20197025585A KR102218495B1 KR 102218495 B1 KR102218495 B1 KR 102218495B1 KR 1020197025585 A KR1020197025585 A KR 1020197025585A KR 20197025585 A KR20197025585 A KR 20197025585A KR 102218495 B1 KR102218495 B1 KR 102218495B1
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antibody
protein
acid
antibodies
ppm
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KR20190104254A (ko
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준얀 지
준 리우
유창 존 왕
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제넨테크, 인크.
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    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • A61K39/39591—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
    • A61K47/08—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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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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)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
KR1020197025585A 2010-03-22 2011-03-21 단백질-함유 제제의 안정화에 유용한 조성물 및 방법 Active KR102218495B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US31632610P 2010-03-22 2010-03-22
US61/316,326 2010-03-22
PCT/US2011/029206 WO2011119487A2 (en) 2010-03-22 2011-03-21 Compositions and methods useful for stabilizing protein-containing formulations

Related Parent Applications (1)

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KR1020177036456A Division KR20180000342A (ko) 2010-03-22 2011-03-21 단백질-함유 제제의 안정화에 유용한 조성물 및 방법

Publications (2)

Publication Number Publication Date
KR20190104254A KR20190104254A (ko) 2019-09-06
KR102218495B1 true KR102218495B1 (ko) 2021-02-19

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KR1020197025585A Active KR102218495B1 (ko) 2010-03-22 2011-03-21 단백질-함유 제제의 안정화에 유용한 조성물 및 방법
KR1020177036456A Ceased KR20180000342A (ko) 2010-03-22 2011-03-21 단백질-함유 제제의 안정화에 유용한 조성물 및 방법
KR1020127024667A Active KR101878369B1 (ko) 2010-03-22 2011-03-21 단백질-함유 제제의 안정화에 유용한 조성물 및 방법

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KR1020127024667A Active KR101878369B1 (ko) 2010-03-22 2011-03-21 단백질-함유 제제의 안정화에 유용한 조성물 및 방법

Country Status (15)

Country Link
US (3) US9662395B2 (enExample)
EP (2) EP3513810A1 (enExample)
JP (3) JP5937059B2 (enExample)
KR (3) KR102218495B1 (enExample)
CN (3) CN106983862A (enExample)
BR (1) BR112012021873B8 (enExample)
CA (2) CA2792125C (enExample)
ES (1) ES2722201T3 (enExample)
HR (1) HRP20190751T1 (enExample)
MX (1) MX354867B (enExample)
PL (1) PL2550018T3 (enExample)
RU (1) RU2584232C2 (enExample)
SI (1) SI2550018T1 (enExample)
TR (1) TR201905081T4 (enExample)
WO (1) WO2011119487A2 (enExample)

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KR102218495B1 (ko) 2010-03-22 2021-02-19 제넨테크, 인크. 단백질-함유 제제의 안정화에 유용한 조성물 및 방법
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CN106771244B (zh) * 2016-12-28 2018-02-02 广州华弘生物科技有限公司 一种纤维蛋白原定量检测试剂盒及检测方法
TWI841554B (zh) 2018-03-21 2024-05-11 丹麥商珍美寶股份有限公司 以鉑為主之劑與抗組織因子抗體－藥物共軛物的組合治療癌症之方法
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TWI844571B (zh) 2018-10-30 2024-06-11 丹麥商珍美寶股份有限公司 使用抗血管內皮生長因子（ｖｅｇｆ）抗體與抗組織因子（ｔｆ）抗體－藥物共軛體之組合以治療癌症之方法
KR20210145152A (ko) * 2019-04-01 2021-12-01 제넨테크, 인크. 단백질-함유 제제들의 안정화를 위한 조성물들 및 방법들
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CN111964942A (zh) * 2020-08-28 2020-11-20 湖南海尚仪器设备有限公司 基于工业环境污染物检测的采样方法
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CN112816684B (zh) * 2021-01-07 2024-08-30 武汉华美生物工程有限公司 血清淀粉样蛋白a的校准品稀释液、其制备方法及其应用
KR20240125027A (ko) * 2021-12-20 2024-08-19 베링거 인겔하임 인터내셔날 게엠베하 수성 제형 중 폴리소르베이트 20의 산화 분해도를 측정하는 방법
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