JP7008023B2 - 低減されたポリソルベート分解を有する製剤 - Google Patents

低減されたポリソルベート分解を有する製剤 Download PDF

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Publication number
JP7008023B2
JP7008023B2 JP2018534668A JP2018534668A JP7008023B2 JP 7008023 B2 JP7008023 B2 JP 7008023B2 JP 2018534668 A JP2018534668 A JP 2018534668A JP 2018534668 A JP2018534668 A JP 2018534668A JP 7008023 B2 JP7008023 B2 JP 7008023B2
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polysorbate
antibody
months
preparation
cyclodextrin
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JP2019504056A5 (https=
JP2019504056A (ja
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ブライアン コノリー，
リディア ハンバーグ，
エミリー ホルツ，
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Genentech Inc
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Genentech Inc
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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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K47/26—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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/10—Dispersions; Emulsions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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'

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2018534668A 2015-12-30 2016-12-28 低減されたポリソルベート分解を有する製剤 Active JP7008023B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021188331A JP2022036977A (ja) 2015-12-30 2021-11-19 低減されたポリソルベート分解を有する製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562272965P 2015-12-30 2015-12-30
US62/272,965 2015-12-30
PCT/US2016/069046 WO2017117311A1 (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate

Related Child Applications (1)

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JP2021188331A Division JP2022036977A (ja) 2015-12-30 2021-11-19 低減されたポリソルベート分解を有する製剤

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JP2019504056A JP2019504056A (ja) 2019-02-14
JP2019504056A5 JP2019504056A5 (https=) 2020-02-13
JP7008023B2 true JP7008023B2 (ja) 2022-01-25

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JP2018534668A Active JP7008023B2 (ja) 2015-12-30 2016-12-28 低減されたポリソルベート分解を有する製剤
JP2021188331A Withdrawn JP2022036977A (ja) 2015-12-30 2021-11-19 低減されたポリソルベート分解を有する製剤

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US (4) US10525137B2 (https=)
EP (1) EP3397287B8 (https=)
JP (2) JP7008023B2 (https=)
KR (2) KR102796135B1 (https=)
CN (2) CN115400220A (https=)
AU (2) AU2016380988B2 (https=)
BR (1) BR112018010945A2 (https=)
CA (1) CA3007419A1 (https=)
ES (1) ES3038408T3 (https=)
HR (1) HRP20250951T1 (https=)
HU (1) HUE072357T2 (https=)
IL (2) IL299759A (https=)
PL (1) PL3397287T3 (https=)
SG (1) SG11201804961UA (https=)
WO (1) WO2017117311A1 (https=)

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EP3560945A1 (en) 2018-04-27 2019-10-30 F. Hoffmann-La Roche AG Methods for purification of polypeptides using polysorbates
EA202192422A1 (ru) * 2019-03-05 2021-12-09 Ридженерон Фармасьютикалз, Инк. Человеческий сывороточный альбумин в составах
CN114981286B (zh) * 2019-05-03 2026-02-13 豪夫迈·罗氏有限公司 降低从纯化平台获得的组合物中酶水解活性速率的方法
BR112021025558A2 (pt) 2019-06-17 2022-03-03 Intas Pharmaceuticals Ltd Formulação estável de cetrorelix e processo para a preparação de uma formulação estável
EP3989937A1 (en) 2019-06-28 2022-05-04 Genentech, Inc. Composition and methods for stabilizing liquid protein formulations
AU2021208515A1 (en) 2020-01-15 2022-08-04 F. Hoffmann-La Roche Ag Methods to decrease impurities from recombinant protein manufacturing processes
IL296330A (en) * 2020-03-20 2022-11-01 Glaxosmithkline Ip Dev Ltd Method for detecting polysorbates
WO2022094116A1 (en) * 2020-10-30 2022-05-05 Genentech, Inc. Purification platforms for obtaining pharmaceutical compositions having a reduced hydrolytic enzyme activity rate
CA3236891A1 (en) 2021-12-20 2023-06-29 Boehringer Ingelheim International Gmbh Method for determining the degree of oxidative degradation of polysorbate 20 in aqueous formulations

Citations (3)

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JP2006008684A (ja) 2004-06-22 2006-01-12 Ibsa Inst Biochimique Sa ジクロフェナクナトリウムとβ−シクロデキストリンとを有する注入可能薬学組成物
JP2009526858A (ja) 2006-02-15 2009-07-23 ティカ レーケメデル アーベー コルチコステロイド溶液を製造する方法
JP2015509526A (ja) 2012-03-07 2015-03-30 カディラ ヘルスケア リミティド 医薬製剤

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