JP2020509025A - モノクローナル抗体製剤 - Google Patents

モノクローナル抗体製剤 Download PDF

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Publication number
JP2020509025A
JP2020509025A JP2019547137A JP2019547137A JP2020509025A JP 2020509025 A JP2020509025 A JP 2020509025A JP 2019547137 A JP2019547137 A JP 2019547137A JP 2019547137 A JP2019547137 A JP 2019547137A JP 2020509025 A JP2020509025 A JP 2020509025A
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Japan
Prior art keywords
formulation
concentration
present
monoclonal antibody
antibody
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Pending
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JP2019547137A
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English (en)
Japanese (ja)
Inventor
ブライアン・アンドリュー・ロボ
アンバリッシュ・ウマカント・シャー
モニカ・スード・シャルマ
デボラ・スウィート・ゴールドバーグ
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MedImmune Ltd
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MedImmune Ltd
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Publication of JP2020509025A publication Critical patent/JP2020509025A/ja
Priority to JP2020100961A priority Critical patent/JP7590125B2/ja
Priority to JP2023034558A priority patent/JP2023071916A/ja
Priority to JP2025014959A priority patent/JP2025072446A/ja
Pending legal-status Critical Current

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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
    • 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
    • A61K47/08—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
    • A61K47/16—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
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    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • C07K16/11—Paramyxoviridae (F); Pneumoviridae (F), e.g. respiratory syncytial virus [RSV]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Virology (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Communicable Diseases (AREA)
  • Obesity (AREA)
  • Orthopedic Medicine & Surgery (AREA)
JP2019547137A 2017-03-01 2018-02-28 モノクローナル抗体製剤 Pending JP2020509025A (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2020100961A JP7590125B2 (ja) 2017-03-01 2020-06-10 モノクローナル抗体製剤
JP2023034558A JP2023071916A (ja) 2017-03-01 2023-03-07 モノクローナル抗体製剤
JP2025014959A JP2025072446A (ja) 2017-03-01 2025-01-31 モノクローナル抗体製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762465269P 2017-03-01 2017-03-01
US62/465,269 2017-03-01
PCT/EP2018/054960 WO2018158332A1 (en) 2017-03-01 2018-02-28 Formulations of monoclonal antibodies

Related Child Applications (2)

Application Number Title Priority Date Filing Date
JP2020100961A Division JP7590125B2 (ja) 2017-03-01 2020-06-10 モノクローナル抗体製剤
JP2023034558A Division JP2023071916A (ja) 2017-03-01 2023-03-07 モノクローナル抗体製剤

Publications (1)

Publication Number Publication Date
JP2020509025A true JP2020509025A (ja) 2020-03-26

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ID=61868490

Family Applications (5)

Application Number Title Priority Date Filing Date
JP2019547137A Pending JP2020509025A (ja) 2017-03-01 2018-02-28 モノクローナル抗体製剤
JP2020100961A Active JP7590125B2 (ja) 2017-03-01 2020-06-10 モノクローナル抗体製剤
JP2023030012A Pending JP2023060016A (ja) 2017-03-01 2023-02-28 モノクローナル抗体製剤
JP2023034558A Pending JP2023071916A (ja) 2017-03-01 2023-03-07 モノクローナル抗体製剤
JP2025014959A Pending JP2025072446A (ja) 2017-03-01 2025-01-31 モノクローナル抗体製剤

Family Applications After (4)

Application Number Title Priority Date Filing Date
JP2020100961A Active JP7590125B2 (ja) 2017-03-01 2020-06-10 モノクローナル抗体製剤
JP2023030012A Pending JP2023060016A (ja) 2017-03-01 2023-02-28 モノクローナル抗体製剤
JP2023034558A Pending JP2023071916A (ja) 2017-03-01 2023-03-07 モノクローナル抗体製剤
JP2025014959A Pending JP2025072446A (ja) 2017-03-01 2025-01-31 モノクローナル抗体製剤

Country Status (10)

Country Link
US (5) US20200283516A1 (enExample)
EP (2) EP3797792A1 (enExample)
JP (5) JP2020509025A (enExample)
KR (1) KR102589598B1 (enExample)
CN (2) CN112057419B (enExample)
AU (2) AU2018227036B2 (enExample)
BR (1) BR112019018022A2 (enExample)
CA (2) CA3054386A1 (enExample)
MX (1) MX2019010282A (enExample)
WO (1) WO2018158332A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023520597A (ja) * 2020-04-06 2023-05-17 ザ ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティー 抗体製剤
WO2024190892A1 (ja) 2023-03-16 2024-09-19 小野薬品工業株式会社 抗体製剤

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UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
HUE056580T2 (hu) 2013-05-30 2022-02-28 Kiniksa Pharmaceuticals Ltd Onkosztatin-M-receptor antigénjét kötõ fehérjék
HUE064292T2 (hu) 2013-12-26 2024-03-28 Mitsubishi Tanabe Pharma Corp Humán anti-IL-33 semlegesítõ monoklonális antitest
RS60387B1 (sr) 2014-01-15 2020-07-31 Medimmune Llc Rsv-specifična antitela i njihovi funkcionalni delovi
RU2021125449A (ru) 2014-10-01 2021-09-16 Медиммьюн Лимитед Антитела к тикагрелору и способы применения
WO2017189805A1 (en) 2016-04-27 2017-11-02 Abbvie Inc. Methods of treatment of diseases in which il-13 activity is detrimental using anti-il-13 antibodies
TWI911431B (zh) 2017-03-01 2026-01-11 英商梅迪繆思有限公司 抗rsv單株抗體配製物
US10493149B2 (en) 2017-04-11 2019-12-03 Kiniksa Pharmaceuticals, Ltd. Stable anti-OSMR antibody formulation
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
WO2019045075A1 (ja) 2017-08-31 2019-03-07 田辺三菱製薬株式会社 Ｉｌ－３３アンタゴニストを含む子宮内膜症治療剤
CN120267816A (zh) * 2018-09-14 2025-07-08 田边三菱制药株式会社 含有人抗il-33单克隆抗体的医药用组合物
EP3852617B1 (en) * 2018-09-20 2025-09-10 SFJ Pharma X, Inc. Use of antibody fragments for reversing ticagrelor activity
MX2021004356A (es) 2018-10-18 2021-05-31 Merck Sharp & Dohme Llc Formulaciones de anticuerpos anti-rsv y metodos de uso de las mismas.
MA54089A (fr) 2018-10-31 2022-02-09 Merck Sharp & Dohme Anticorps anti-pd-1 humain et procédés d'utilisation associés
JP7503056B6 (ja) 2018-11-07 2024-07-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体および抗ｐｄ－１抗体の共－製剤
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
US12024553B2 (en) * 2019-04-30 2024-07-02 Medimmune Limited Dosage regimens for and compositions including anti-RSV antibodies
EP4121543A4 (en) 2020-03-17 2024-04-24 Xbrane Biopharma AB NOVEL COMBINATION OF TIS SEQUENCE AND SIGNAL PEPTIDE SEQUENCE TO EXPRESS RECOMBINANT PROTEIN
EP4126943B1 (en) 2020-03-23 2026-04-22 MedImmune Limited Methods for treating atopic dermatitis and related disorders
CA3097453A1 (en) 2020-03-23 2021-09-23 Medimmune Limited Methods for treating atopic dermatitis and related disorders
WO2021228760A1 (en) * 2020-05-11 2021-11-18 Medimmune Limited Formulations of anti-il-33 antibodies
CN116997352A (zh) * 2021-03-24 2023-11-03 Jcr制药股份有限公司 稳定的水性药物组合物或冷冻干燥药物组合物
GB202108379D0 (en) 2021-06-11 2021-07-28 Medlmmune Ltd Methods for treating a topic dermatitis and related disorders
KR20240046243A (ko) 2021-08-16 2024-04-08 메디뮨 엘엘씨 항-il-13 항체 제제
EP4408885A1 (en) 2021-09-28 2024-08-07 MedImmune Limited Methods for treating atopic dermatitis and related disorders
CN119095584A (zh) * 2022-12-01 2024-12-06 天境生物科技(杭州)有限公司 抗gm-csf抗体的液体药物配制品及其用途
CN121846262A (zh) * 2026-01-05 2026-04-14 上海生物制品研究所有限责任公司 抗呼吸道合胞病毒单克隆抗体制剂

Citations (6)

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