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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Publication number
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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JP2020555466A
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English (en)
Japanese (ja)
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JP2021521171A5 (https=
JPWO2019198101A5 (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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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
Publication of JPWO2019198101A5 publication Critical patent/JPWO2019198101A5/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 (3)

Publication Number Publication Date
JP2021521171A true JP2021521171A (ja) 2021-08-26
JP2021521171A5 JP2021521171A5 (https=) 2022-04-15
JPWO2019198101A5 JPWO2019198101A5 (https=) 2022-04-15

Family

ID=68164106

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

Country Status (10)

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

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2018007520A (es) 2015-12-18 2018-08-01 Astellas Pharma Inc Composicion farmaceutica que comprende un anticuerpo receptor de linfopoyetina estromal timica antihumano.
AU2019251452A1 (en) * 2018-04-10 2020-11-26 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
US20240101679A1 (en) * 2020-12-09 2024-03-28 Dr. Reddy’S Laboratories Limited Stable aqueous buffer free formulation of an integrin antibody
US20240254237A1 (en) * 2021-06-04 2024-08-01 Polpharma Biologics S.A. Vedolizumab formulation
EP4717712A2 (en) * 2021-12-27 2026-04-01 Polpharma Biologics S.A. Vedolizumab formulation
KR20250120995A (ko) 2022-11-07 2025-08-11 업스트림 바이오, 인크. 항-인간 tslp 수용체 항체를 포함하는 약제학적 조성물 및 이를 사용하는 방법
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
RU2358763C2 (ru) 2003-02-10 2009-06-20 Элан Фармасьютикалз, Инк. Композиции иммуноглобулина и способ их получения
EP2170390B1 (en) * 2007-06-14 2018-11-07 Biogen MA Inc. Natalizumab antibody formulations
KR101247418B1 (ko) * 2007-12-21 2013-03-25 에프. 호프만-라 로슈 아게 항체 제형
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
WO2017015198A1 (en) 2015-07-17 2017-01-26 Coherus Biosciences, Inc. Stable aqeous formulations of natalizumab
US20220267449A1 (en) 2019-06-10 2022-08-25 Takeda Pharmaceutical Company Limited METHODS OF PRODUCING AN ANTI-a4B7 ANTIBODY

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

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