JP2021521171A - 治療用抗体の安定な製剤 - Google Patents

治療用抗体の安定な製剤 Download PDF

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JP2021521171A
JP2021521171A JP2020555466A JP2020555466A JP2021521171A JP 2021521171 A JP2021521171 A JP 2021521171A JP 2020555466 A JP2020555466 A JP 2020555466A JP 2020555466 A JP2020555466 A JP 2020555466A JP 2021521171 A JP2021521171 A JP 2021521171A
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Japan
Prior art keywords
antibody
preparation
sugar
vedolizumab
formulation
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Pending
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JP2020555466A
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English (en)
Japanese (ja)
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JP2021521171A5 (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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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 JP2021521171A publication Critical patent/JP2021521171A/ja
Publication of JP2021521171A5 publication Critical patent/JP2021521171A5/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
    • A61K47/06—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
    • 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
    • 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

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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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2020555466A 2018-04-10 2019-04-10 治療用抗体の安定な製剤 Pending JP2021521171A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201841013647 2018-04-10
IN201841013647 2018-04-10
PCT/IN2019/050293 WO2019198101A1 (en) 2018-04-10 2019-04-10 Stable formulations of therapeutic antibody

Publications (2)

Publication Number Publication Date
JP2021521171A true JP2021521171A (ja) 2021-08-26
JP2021521171A5 JP2021521171A5 (enExample) 2022-04-15

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
JP2020555466A Pending JP2021521171A (ja) 2018-04-10 2019-04-10 治療用抗体の安定な製剤

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Country Link
US (1) US12433947B2 (enExample)
EP (1) EP3773696A4 (enExample)
JP (1) JP2021521171A (enExample)
CN (1) CN112292146A (enExample)
AU (1) AU2019251453A1 (enExample)
BR (1) BR112020020703A2 (enExample)
CO (1) CO2020013571A2 (enExample)
SG (1) SG11202009876TA (enExample)
WO (1) WO2019198101A1 (enExample)
ZA (1) ZA202006264B (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10202012778YA (en) 2015-12-18 2021-01-28 Astellas Pharma Inc Pharmaceutical composition comprising anti-human tslp receptor antibody
WO2019198099A1 (en) * 2018-04-10 2019-10-17 Dr. Reddy's Laboratories Limited Stable antibody formulation
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
EP4259192A4 (en) * 2020-12-09 2024-11-20 Dr. Reddy's Laboratories Limited STABLE AQUEOUS BUFFER-FREE FORMULATION OF AN INTEGRIN ANTIBODY
EP4346899A1 (en) * 2021-06-04 2024-04-10 Polpharma Biologics S.A. Vedolizumab formulation
EP4717712A2 (en) * 2021-12-27 2026-04-01 Polpharma Biologics S.A. Vedolizumab formulation
TW202432601A (zh) 2022-11-07 2024-08-16 美商上游生物公司 包含抗人類ｔｓｌｐ受體抗體之醫藥組成物及其使用方法
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 (1)

* 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

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2236154T3 (en) 2003-02-10 2018-06-25 Biogen Ma Inc IMMUNOGLOBULIN INFORMATION AND METHOD OF PREPARING IT
NZ595526A (en) * 2007-06-14 2013-03-28 Biogen Idec Inc Pharmaceutical composition comprising a vla-4 binding antibody, a phosphate buffer and a surfactant
BRPI0820819B1 (pt) * 2007-12-21 2021-06-08 F. Hoffmann-La Roche Ag formulação de anticorpos humanizados b-ly 1 e seu uso
UA116189C2 (uk) 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
MX367097B (es) * 2011-05-02 2019-08-05 Millennium Pharm Inc FORMULACION PARA ANTICUERPO ANTI-A4ß7.
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
CN114375307B (zh) 2019-06-10 2025-12-05 武田药品工业株式会社 产生抗α4β7抗体的方法

Patent Citations (1)

* 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

Also Published As

Publication number Publication date
EP3773696A1 (en) 2021-02-17
CN112292146A (zh) 2021-01-29
US12433947B2 (en) 2025-10-07
US20210401982A1 (en) 2021-12-30
WO2019198101A1 (en) 2019-10-17
ZA202006264B (en) 2022-09-28
CO2020013571A2 (es) 2021-01-18
BR112020020703A2 (pt) 2021-01-12
EP3773696A4 (en) 2021-12-29
AU2019251453A2 (en) 2020-12-03
AU2019251453A1 (en) 2020-11-26
SG11202009876TA (en) 2020-11-27

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