JP2021521168A - 安定な抗体製剤 - Google Patents

安定な抗体製剤 Download PDF

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Publication number
JP2021521168A
JP2021521168A JP2020555449A JP2020555449A JP2021521168A JP 2021521168 A JP2021521168 A JP 2021521168A JP 2020555449 A JP2020555449 A JP 2020555449A JP 2020555449 A JP2020555449 A JP 2020555449A JP 2021521168 A JP2021521168 A JP 2021521168A
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JP
Japan
Prior art keywords
antibody
preparation
stable
salt
formulation
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Pending
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JP2020555449A
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English (en)
Japanese (ja)
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JP2021521168A5 (https=
JPWO2019198099A5 (https=
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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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=68164052&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP2021521168(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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 JP2021521168A publication Critical patent/JP2021521168A/ja
Publication of JP2021521168A5 publication Critical patent/JP2021521168A5/ja
Publication of JPWO2019198099A5 publication Critical patent/JPWO2019198099A5/ja
Pending legal-status Critical Current

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    • 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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • 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
    • 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
    • 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)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2020555449A 2018-04-10 2019-04-10 安定な抗体製剤 Pending JP2021521168A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201841013645 2018-04-10
IN201841013645 2018-04-10
PCT/IN2019/050291 WO2019198099A1 (en) 2018-04-10 2019-04-10 Stable antibody formulation

Publications (3)

Publication Number Publication Date
JP2021521168A true JP2021521168A (ja) 2021-08-26
JP2021521168A5 JP2021521168A5 (https=) 2022-04-15
JPWO2019198099A5 JPWO2019198099A5 (https=) 2022-04-15

Family

ID=68164052

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2020555449A Pending JP2021521168A (ja) 2018-04-10 2019-04-10 安定な抗体製剤

Country Status (10)

Country Link
US (1) US12024561B2 (https=)
EP (1) EP3773695A4 (https=)
JP (1) JP2021521168A (https=)
CN (1) CN112243379A (https=)
AU (1) AU2019251452A1 (https=)
BR (1) BR112020020741A2 (https=)
CO (1) CO2020013545A2 (https=)
SG (1) SG11202009872YA (https=)
WO (1) WO2019198099A1 (https=)
ZA (1) ZA202006262B (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024249568A1 (en) 2023-05-30 2024-12-05 Paragon Therapeutics, Inc. Alpha4beta7 integrin antibody compositions and methods of use
CN121889424A (zh) 2023-08-14 2026-04-17 派拉冈医疗公司 α4β7整联蛋白结合蛋白及使用方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006517233A (ja) * 2003-02-10 2006-07-20 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 免疫グロブリン製剤およびその調製の方法
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
JP2012519706A (ja) * 2009-03-06 2012-08-30 ジェネンテック， インコーポレイテッド 抗体製剤

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009141239A1 (en) * 2008-05-20 2009-11-26 F. Hoffmann-La Roche Ag A pharmaceutical formulation comprising an antibody against ox40l, uses thereof
UA116189C2 (uk) * 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
DK3311834T3 (da) * 2011-05-02 2026-04-20 Millennium Pharmaceuticals Inc Formulering til anti-alfa4beta7-antistof
AU2019251453A1 (en) * 2018-04-10 2020-11-26 Dr. Reddy’S Laboratories Limited Stable formulations of therapeutic antibody
US12030948B2 (en) * 2018-04-10 2024-07-09 Dr. Reddy's Laboratories Limited Antibody formulation
US20220267449A1 (en) * 2019-06-10 2022-08-25 Takeda Pharmaceutical Company Limited METHODS OF PRODUCING AN ANTI-a4B7 ANTIBODY
AU2020290999A1 (en) * 2019-06-10 2022-02-03 Takeda Pharmaceutical Company Limited Antibody purification methods and compositions thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006517233A (ja) * 2003-02-10 2006-07-20 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 免疫グロブリン製剤およびその調製の方法
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
JP2012519706A (ja) * 2009-03-06 2012-08-30 ジェネンテック， インコーポレイテッド 抗体製剤

Also Published As

Publication number Publication date
SG11202009872YA (en) 2020-11-27
EP3773695A4 (en) 2021-12-22
CO2020013545A2 (es) 2021-01-18
EP3773695A1 (en) 2021-02-17
AU2019251452A1 (en) 2020-11-26
ZA202006262B (en) 2023-01-25
BR112020020741A2 (pt) 2021-01-19
US12024561B2 (en) 2024-07-02
AU2019251452A2 (en) 2020-12-03
WO2019198099A1 (en) 2019-10-17
CN112243379A (zh) 2021-01-19
US20210253714A1 (en) 2021-08-19

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