JP2023504748A - 抗ｐｄ－ｌ１抗体製剤 - Google Patents

抗ｐｄ－ｌ１抗体製剤 Download PDF

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Publication number
JP2023504748A
JP2023504748A JP2022534224A JP2022534224A JP2023504748A JP 2023504748 A JP2023504748 A JP 2023504748A JP 2022534224 A JP2022534224 A JP 2022534224A JP 2022534224 A JP2022534224 A JP 2022534224A JP 2023504748 A JP2023504748 A JP 2023504748A
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JP
Japan
Prior art keywords
liquid pharmaceutical
pharmaceutical formulation
concentration
formulation
antibody
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JP2022534224A
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English (en)
Japanese (ja)
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JP2023504748A5 (https=
Inventor
アダ ヒュイ，
ジュディス チュー－シモニ，
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Genentech Inc
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Genentech Inc
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Application filed by Genentech Inc filed Critical Genentech Inc
Publication of JP2023504748A publication Critical patent/JP2023504748A/ja
Publication of JP2023504748A5 publication Critical patent/JP2023504748A5/ja
Priority to JP2025152037A priority Critical patent/JP2026009902A/ja
Withdrawn legal-status Critical Current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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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 [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
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2827—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against B7 molecules, e.g. CD80, CD86
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2022534224A 2019-12-09 2020-12-07 抗ｐｄ－ｌ１抗体製剤 Withdrawn JP2023504748A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025152037A JP2026009902A (ja) 2019-12-09 2025-09-12 抗ｐｄ－ｌ１抗体製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962945730P 2019-12-09 2019-12-09
US62/945,730 2019-12-09
PCT/US2020/063620 WO2021118930A2 (en) 2019-12-09 2020-12-07 Anti-pd-l1 antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025152037A Division JP2026009902A (ja) 2019-12-09 2025-09-12 抗ｐｄ－ｌ１抗体製剤

Publications (2)

Publication Number Publication Date
JP2023504748A true JP2023504748A (ja) 2023-02-06
JP2023504748A5 JP2023504748A5 (https=) 2023-12-14

Family

ID=74206149

Family Applications (2)

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JP2022534224A Withdrawn JP2023504748A (ja) 2019-12-09 2020-12-07 抗ｐｄ－ｌ１抗体製剤
JP2025152037A Pending JP2026009902A (ja) 2019-12-09 2025-09-12 抗ｐｄ－ｌ１抗体製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025152037A Pending JP2026009902A (ja) 2019-12-09 2025-09-12 抗ｐｄ－ｌ１抗体製剤

Country Status (15)

Country Link
US (1) US20230039268A1 (https=)
EP (1) EP4073120A2 (https=)
JP (2) JP2023504748A (https=)
KR (1) KR20220113414A (https=)
CN (1) CN114787191A (https=)
AU (1) AU2020399619A1 (https=)
BR (1) BR112022011228A2 (https=)
CA (1) CA3158987A1 (https=)
CL (2) CL2022001486A1 (https=)
CR (1) CR20220322A (https=)
IL (1) IL293580A (https=)
MX (1) MX2022006784A (https=)
PE (1) PE20221281A1 (https=)
TW (1) TWI886185B (https=)
WO (1) WO2021118930A2 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020081408A1 (en) 2018-10-18 2020-04-23 Merck Sharp & Dohme Corp. Formulations of anti-rsv antibodies and methods of use thereof
MX2021004928A (es) 2018-10-31 2021-06-08 Merck Sharp & Dohme Llc Cristales de anticuerpo anti-pd-1 humano y metodos de uso de los mismos.
AU2022417501A1 (en) 2021-12-22 2024-07-04 Genentech, Inc. Clinical formulations of anti-tigit antibodies
WO2024126750A1 (en) 2022-12-15 2024-06-20 F. Hoffmann-La Roche Ag Methods for treating cancer
EP4676963A1 (en) * 2023-03-08 2026-01-14 Immunovant Sciences GmbH High concentration protein formulations with polysorbate excipients and methods of making the same
WO2025085404A1 (en) 2023-10-16 2025-04-24 Genentech, Inc. Diagnostic and therapeutic methods for treating lung cancer

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013504540A (ja) * 2009-09-11 2013-02-07 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 高度に濃縮された薬学的製剤
JP2016533335A (ja) * 2013-09-27 2016-10-27 ジェネンテック， インコーポレイテッド 抗ｐｄｌ１抗体製剤
WO2018136412A2 (en) * 2017-01-17 2018-07-26 Genentech, Inc. Subcutaneous her2 antibody formulations

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US4675187A (en) 1983-05-16 1987-06-23 Bristol-Myers Company BBM-1675, a new antibiotic complex
US6548640B1 (en) 1986-03-27 2003-04-15 Btg International Limited Altered antibodies
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
DE3920358A1 (de) 1989-06-22 1991-01-17 Behringwerke Ag Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung
DE69120146T2 (de) 1990-01-12 1996-12-12 Cell Genesys Inc Erzeugung xenogener antikörper
WO1996033735A1 (en) 1995-04-27 1996-10-31 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6150584A (en) 1990-01-12 2000-11-21 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5661016A (en) 1990-08-29 1997-08-26 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
ATE158021T1 (de) 1990-08-29 1997-09-15 Genpharm Int Produktion und nützung nicht-menschliche transgentiere zur produktion heterologe antikörper
US5545806A (en) 1990-08-29 1996-08-13 Genpharm International, Inc. Ransgenic non-human animals for producing heterologous antibodies
US5625126A (en) 1990-08-29 1997-04-29 Genpharm International, Inc. Transgenic non-human animals for producing heterologous antibodies
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GB9114948D0 (en) 1991-07-11 1991-08-28 Pfizer Ltd Process for preparing sertraline intermediates
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US9345661B2 (en) * 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof

Patent Citations (3)

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JP2013504540A (ja) * 2009-09-11 2013-02-07 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 高度に濃縮された薬学的製剤
JP2016533335A (ja) * 2013-09-27 2016-10-27 ジェネンテック， インコーポレイテッド 抗ｐｄｌ１抗体製剤
WO2018136412A2 (en) * 2017-01-17 2018-07-26 Genentech, Inc. Subcutaneous her2 antibody formulations

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Also Published As

Publication number Publication date
CL2023001140A1 (es) 2023-10-06
WO2021118930A3 (en) 2021-08-19
TW202128223A (zh) 2021-08-01
TWI886185B (zh) 2025-06-11
WO2021118930A2 (en) 2021-06-17
AU2020399619A1 (en) 2022-06-09
JP2026009902A (ja) 2026-01-21
BR112022011228A2 (pt) 2022-10-11
EP4073120A2 (en) 2022-10-19
CA3158987A1 (en) 2021-06-17
CR20220322A (es) 2022-07-28
KR20220113414A (ko) 2022-08-12
PE20221281A1 (es) 2022-09-05
US20230039268A1 (en) 2023-02-09
MX2022006784A (es) 2022-07-11
IL293580A (en) 2022-08-01
CN114787191A (zh) 2022-07-22
CL2022001486A1 (es) 2023-01-20

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