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)
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JP2021521159A5 (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
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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 JP2021521159A5 publication Critical patent/JP2021521159A5/ja
Priority to JP2023189255A priority Critical patent/JP7793581B2/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 [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
    • C07K16/2839—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 integrin superfamily
    • C07K16/2842—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 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 [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
    • C07K16/2839—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 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

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  • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (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 JP7793581B2 (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 JP7793581B2 (ja) 2018-04-10 2023-11-06 抗体製剤

Publications (2)

Publication Number Publication Date
JP2021521159A true JP2021521159A (ja) 2021-08-26
JP2021521159A5 JP2021521159A5 (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 Active JP7793581B2 (ja) 2018-04-10 2023-11-06 抗体製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023189255A Active JP7793581B2 (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 (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10994011B2 (en) 2015-12-18 2021-05-04 Astellas Pharma Inc. Pharmaceutical composition comprising anti-human TSLP receptor antibody
US12024561B2 (en) * 2018-04-10 2024-07-02 Dr. Reddy's Laboratories Limited Stable antibody formulation
WO2021228760A1 (en) * 2020-05-11 2021-11-18 Medimmune Limited Formulations of anti-il-33 antibodies
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
US20230340131A1 (en) * 2020-11-12 2023-10-26 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
JP2024516293A (ja) * 2021-05-07 2024-04-12 ドクター レディズ ラボラトリーズ リミテッド 抗体製剤の安定性を向上させる方法
WO2022253994A1 (en) * 2021-06-04 2022-12-08 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
EP4615502A1 (en) 2022-11-07 2025-09-17 Upstream Bio, Inc. Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same
EP4720125A1 (en) 2023-05-30 2026-04-08 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
EP4762093A1 (en) 2023-08-14 2026-06-24 Paragon Therapeutics, Inc. Alpha 4 beta 7 integrin binding proteins 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
CN103040732B (zh) * 2003-02-10 2015-04-01 伊兰药品公司 免疫球蛋白制剂及其制备方法
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
US20210322549A1 (en) * 2015-07-17 2021-10-21 Coherus Biosciences, Inc. Stable Aqueous Formulations of Natalizumab
WO2019147824A1 (en) * 2018-01-26 2019-08-01 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a pde4 inhibitor
EP3884276A2 (en) * 2018-11-23 2021-09-29 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
JP2024001364A (ja) 2024-01-09
WO2019198100A1 (en) 2019-10-17
EP3773694A4 (en) 2021-12-29
ZA202006263B (en) 2022-01-26
EP3773694A1 (en) 2021-02-17
SG11202009874QA (en) 2020-11-27
AU2019253070A2 (en) 2020-12-03
JP7793581B2 (ja) 2026-01-05
CN112218654A (zh) 2021-01-12
BR112020020707A2 (pt) 2021-01-12
CO2020013552A2 (es) 2021-01-18
US20210147555A1 (en) 2021-05-20
US12030948B2 (en) 2024-07-09
AU2019253070A1 (en) 2020-11-26

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