JP2021521159A - 抗体製剤 - Google Patents

抗体製剤 Download PDF

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Publication number
JP2021521159A
JP2021521159A JP2020555387A JP2020555387A JP2021521159A JP 2021521159 A JP2021521159 A JP 2021521159A JP 2020555387 A JP2020555387 A JP 2020555387A JP 2020555387 A JP2020555387 A JP 2020555387A JP 2021521159 A JP2021521159 A JP 2021521159A
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JP
Japan
Prior art keywords
antibody
preparation
sugar
vedolizumab
weeks
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2020555387A
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English (en)
Japanese (ja)
Other versions
JPWO2019198100A5 (enExample
Inventor
ムラリ ジャヤラマン，
ムラリ ジャヤラマン，
アヌジャ チャンドラセカール，
アヌジャ チャンドラセカール，
Original Assignee
ドクター レディズ ラボラトリーズ リミテッド
ドクター レディズ ラボラトリーズ リミテッド
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ドクター レディズ ラボラトリーズ リミテッド, ドクター レディズ ラボラトリーズ リミテッド filed Critical ドクター レディズ ラボラトリーズ リミテッド
Publication of JP2021521159A publication Critical patent/JP2021521159A/ja
Publication of JPWO2019198100A5 publication Critical patent/JPWO2019198100A5/ja
Priority to JP2023189255A priority Critical patent/JP2024001364A/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
    • 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
    • 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
    • A61K9/14—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
    • 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
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2842—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta1-subunit-containing molecules, e.g. CD29, CD49
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2020555387A 2018-04-10 2019-04-10 抗体製剤 Pending JP2021521159A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023189255A JP2024001364A (ja) 2018-04-10 2023-11-06 抗体製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201841013646 2018-04-10
IN201841013646 2018-04-10
PCT/IN2019/050292 WO2019198100A1 (en) 2018-04-10 2019-04-10 Antibody formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023189255A Division JP2024001364A (ja) 2018-04-10 2023-11-06 抗体製剤

Publications (2)

Publication Number Publication Date
JP2021521159A true JP2021521159A (ja) 2021-08-26
JPWO2019198100A5 JPWO2019198100A5 (enExample) 2022-04-15

Family

ID=68163986

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2020555387A Pending JP2021521159A (ja) 2018-04-10 2019-04-10 抗体製剤
JP2023189255A Pending JP2024001364A (ja) 2018-04-10 2023-11-06 抗体製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023189255A Pending JP2024001364A (ja) 2018-04-10 2023-11-06 抗体製剤

Country Status (10)

Country Link
US (1) US12030948B2 (enExample)
EP (1) EP3773694A4 (enExample)
JP (2) JP2021521159A (enExample)
CN (1) CN112218654A (enExample)
AU (1) AU2019253070A1 (enExample)
BR (1) BR112020020707A2 (enExample)
CO (1) CO2020013552A2 (enExample)
SG (1) SG11202009874QA (enExample)
WO (1) WO2019198100A1 (enExample)
ZA (1) ZA202006263B (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3391904B1 (en) 2015-12-18 2024-12-04 Upstream Bio, Inc. Pharmaceutical composition containing anti-human tslp receptor antibody
US12024561B2 (en) * 2018-04-10 2024-07-02 Dr. Reddy's Laboratories Limited Stable antibody formulation
CN115551542A (zh) * 2020-05-11 2022-12-30 免疫医疗有限公司 抗il-33抗体的配制品
WO2024098180A1 (en) * 2022-11-07 2024-05-16 Wuxi Biologics (Hong Kong) Limited Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same
WO2022101935A1 (en) * 2020-11-12 2022-05-19 Dr. Reddy’S Laboratories Limited Stable aqueous high concentration formulation of integrin antibody
US20240100158A1 (en) * 2021-01-20 2024-03-28 Dr. Reddy’S Laboratories Limited Freeze dried antibody formulations and methods thereof
BR112023022811A2 (pt) * 2021-05-07 2024-01-16 Dr Reddys Laboratories Ltd Formulações farmacêuticas de um anticorpo alfa-4-beta-7 de alta concentração e de vedolizumabe de alta concentração, e, métodos para controlar a formação de partículas subvisíveis em um anticorpo alfa-4-beta-7 e de variantes de carga ou agregados ou fragmentação do anticorpo em uma composição de anticorpo alfa-4-beta-7 de alta concentração, para controlar a opalescência em uma composição de anticorpo alfa-4-beta-7 de alta concentração e para preparar uma composição de anticorpo alfa-4-beta-7
US20240254237A1 (en) * 2021-06-04 2024-08-01 Polpharma Biologics S.A. Vedolizumab formulation
CN113813377A (zh) * 2021-09-07 2021-12-21 杭州远大生物制药有限公司 抗α4β7抗体制剂及其应用
CN120548195A (zh) 2022-11-07 2025-08-26 上游生物公司 包含抗人类tslp受体抗体的药物组合物和其使用方法
AU2024282654A1 (en) 2023-05-30 2025-12-04 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
WO2025041000A1 (en) * 2023-08-21 2025-02-27 Intas Pharmaceuticals Ltd. STABLE LIQUID CITRATE FREE FORMULATION OF AN ANTI-α4β7 ANTIBODY

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010530003A (ja) * 2007-06-14 2010-09-02 エラン ファーマシューティカルズ，インコーポレイテッド 凍結乾燥免疫グロブリン製剤および調製方法
JP2014514346A (ja) * 2011-05-02 2014-06-19 ミレニアム ファーマシューティカルズ， インコーポレイテッド 抗α４β７抗体のための製剤
JP2014515763A (ja) * 2011-05-02 2014-07-03 ミレニアム ファーマシューティカルズ， インコーポレイテッド 抗α４β７抗体のための製剤

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2358763C2 (ru) * 2003-02-10 2009-06-20 Элан Фармасьютикалз, Инк. Композиции иммуноглобулина и способ их получения
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
WO2012076670A2 (en) * 2010-12-10 2012-06-14 Novartis Ag Antibody formulation
TWI752912B (zh) * 2015-07-17 2022-01-21 美商寇西勒斯生物科技股份有限公司 那他珠單抗的穩定水性調配物
WO2019147824A1 (en) * 2018-01-26 2019-08-01 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a pde4 inhibitor
US20220364171A1 (en) * 2018-11-23 2022-11-17 Katholieke Universiteit Leuven Predicting a treatment response in inflammatory bowel disease

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010530003A (ja) * 2007-06-14 2010-09-02 エラン ファーマシューティカルズ，インコーポレイテッド 凍結乾燥免疫グロブリン製剤および調製方法
JP2014514346A (ja) * 2011-05-02 2014-06-19 ミレニアム ファーマシューティカルズ， インコーポレイテッド 抗α４β７抗体のための製剤
JP2014515763A (ja) * 2011-05-02 2014-07-03 ミレニアム ファーマシューティカルズ， インコーポレイテッド 抗α４β７抗体のための製剤

Also Published As

Publication number Publication date
ZA202006263B (en) 2022-01-26
CN112218654A (zh) 2021-01-12
SG11202009874QA (en) 2020-11-27
US20210147555A1 (en) 2021-05-20
JP2024001364A (ja) 2024-01-09
WO2019198100A1 (en) 2019-10-17
AU2019253070A2 (en) 2020-12-03
EP3773694A1 (en) 2021-02-17
AU2019253070A1 (en) 2020-11-26
CO2020013552A2 (es) 2021-01-18
BR112020020707A2 (pt) 2021-01-12
US12030948B2 (en) 2024-07-09
EP3773694A4 (en) 2021-12-29

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