JP7671697B2 - 安定な低粘度抗体製剤およびその使用 - Google Patents

安定な低粘度抗体製剤およびその使用 Download PDF

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Publication number
JP7671697B2
JP7671697B2 JP2021562990A JP2021562990A JP7671697B2 JP 7671697 B2 JP7671697 B2 JP 7671697B2 JP 2021562990 A JP2021562990 A JP 2021562990A JP 2021562990 A JP2021562990 A JP 2021562990A JP 7671697 B2 JP7671697 B2 JP 7671697B2
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days
antibody
months
antigen
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Japanese (ja)
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JP2022530050A5 (https=
JP2022530050A (ja
Inventor
アトゥール・サルージャ
マンジョリ・ガングリー
ケルビン・レンバート
ヤティン・ゴカルン
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Sanofi SA
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Sanofi SA
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71Decreased effector function due to an Fc-modification

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
JP2021562990A 2019-04-23 2020-04-23 安定な低粘度抗体製剤およびその使用 Active JP7671697B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025036010A JP2025087851A (ja) 2019-04-23 2025-03-07 安定な低粘度抗体製剤およびその使用

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962837518P 2019-04-23 2019-04-23
US62/837,518 2019-04-23
EP20305145 2020-02-17
EP20305145.3 2020-02-17
PCT/EP2020/061340 WO2020216847A1 (en) 2019-04-23 2020-04-23 Stable, low-viscosity antibody formulations and uses thereof

Related Child Applications (1)

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JP2025036010A Division JP2025087851A (ja) 2019-04-23 2025-03-07 安定な低粘度抗体製剤およびその使用

Publications (3)

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JP2022530050A JP2022530050A (ja) 2022-06-27
JP2022530050A5 JP2022530050A5 (https=) 2023-05-01
JP7671697B2 true JP7671697B2 (ja) 2025-05-02

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JP2021562990A Active JP7671697B2 (ja) 2019-04-23 2020-04-23 安定な低粘度抗体製剤およびその使用
JP2025036010A Pending JP2025087851A (ja) 2019-04-23 2025-03-07 安定な低粘度抗体製剤およびその使用

Family Applications After (1)

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JP2025036010A Pending JP2025087851A (ja) 2019-04-23 2025-03-07 安定な低粘度抗体製剤およびその使用

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Country Link
US (1) US20220218607A1 (https=)
EP (1) EP3958896A1 (https=)
JP (2) JP7671697B2 (https=)
KR (1) KR20220004104A (https=)
CN (1) CN114286690A (https=)
AU (1) AU2020262231A1 (https=)
BR (1) BR112021021099A2 (https=)
CA (1) CA3137464A1 (https=)
CO (1) CO2021015561A2 (https=)
IL (1) IL287435A (https=)
MA (1) MA55750A (https=)
MX (1) MX2021012968A (https=)
SG (1) SG11202111740PA (https=)
TW (1) TW202108171A (https=)
WO (1) WO2020216847A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11655302B2 (en) 2019-06-10 2023-05-23 Sanofi Anti-CD38 antibodies and formulations
IL293563A (en) * 2019-12-05 2022-08-01 Sanofi Aventis Us Llc Formulations of anti-cd38 antibodies for subcutaneous administration
JP2024546152A (ja) * 2021-12-16 2024-12-17 上海宝済薬業股▲ふん▼有限公司 免疫グロブリン分解酵素による切断に対抗するFc変異体
WO2024023843A1 (en) * 2022-07-26 2024-02-01 Dr. Reddy’S Laboratories Limited A pharmaceutical formulation of a therapeuticantibody and preparations thereof
WO2026006689A2 (en) 2024-06-28 2026-01-02 Firefly Bio, Inc. Bcl-xl degrader antibody conjugates and uses thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010513522A (ja) 2006-12-21 2010-04-30 アムジエン・インコーポレーテツド ポリペプチドを含有する安定な緩衝化された製剤
WO2011090088A1 (ja) 2010-01-20 2011-07-28 中外製薬株式会社 安定化抗体含有溶液製剤
US20160058863A1 (en) 2014-09-03 2016-03-03 Board Of Regents, The University Of Texas System Low viscosity concentrated protein dispersions
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5460944A (en) * 1991-10-28 1995-10-24 Boehringer Mannheim Gmbh Storable protein solution
US7612181B2 (en) 2005-08-19 2009-11-03 Abbott Laboratories Dual variable domain immunoglobulin and uses thereof
WO2009120684A1 (en) * 2008-03-25 2009-10-01 Medimmune, Llc Antibody formulation
CN102149825B (zh) 2008-07-08 2015-07-22 Abbvie公司 前列腺素e2双重可变结构域免疫球蛋白及其用途
WO2011028811A2 (en) 2009-09-01 2011-03-10 Abbott Laboratories Dual variable domain immunoglobulins and uses thereof
BR112012008833A2 (pt) 2009-10-15 2015-09-08 Abbott Lab imunoglobulinas de dominio variavel duplo e usos das mesmas
UY32979A (es) 2009-10-28 2011-02-28 Abbott Lab Inmunoglobulinas con dominio variable dual y usos de las mismas
EP3409289B1 (en) * 2010-02-26 2020-09-30 Novo Nordisk A/S Stable antibody containing compositions
NZ602685A (en) * 2010-03-01 2014-10-31 Cytodyn Inc Concentrated protein formulations and uses thereof
EP3252072A3 (en) 2010-08-03 2018-03-14 AbbVie Inc. Dual variable domain immunoglobulins and uses thereof
JP6345123B2 (ja) * 2012-02-16 2018-06-20 サンタラス, インコーポレイテッド 抗vla1(cd49a)抗体医薬組成物
DK3199552T3 (da) * 2012-11-20 2020-03-30 Sanofi Sa Anti-ceacam5-antistoffer og anvendelser heraf
TW201837053A (zh) * 2016-12-22 2018-10-16 法商賽諾菲公司 具有消耗活性的人源化cxcr3抗體及其使用方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010513522A (ja) 2006-12-21 2010-04-30 アムジエン・インコーポレーテツド ポリペプチドを含有する安定な緩衝化された製剤
WO2011090088A1 (ja) 2010-01-20 2011-07-28 中外製薬株式会社 安定化抗体含有溶液製剤
US20160058863A1 (en) 2014-09-03 2016-03-03 Board Of Regents, The University Of Texas System Low viscosity concentrated protein dispersions
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations

Also Published As

Publication number Publication date
CN114286690A (zh) 2022-04-05
CA3137464A1 (en) 2020-10-29
SG11202111740PA (en) 2021-11-29
CO2021015561A2 (es) 2021-12-10
TW202108171A (zh) 2021-03-01
JP2025087851A (ja) 2025-06-10
EP3958896A1 (en) 2022-03-02
KR20220004104A (ko) 2022-01-11
BR112021021099A2 (pt) 2021-12-14
US20220218607A1 (en) 2022-07-14
IL287435A (en) 2021-12-01
MA55750A (fr) 2022-03-02
WO2020216847A1 (en) 2020-10-29
AU2020262231A1 (en) 2021-12-16
MX2021012968A (es) 2022-01-18
JP2022530050A (ja) 2022-06-27

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