JP2023533963A - 抗ｃｔｌａ－４抗体を含む安定化製剤 - Google Patents

抗ｃｔｌａ－４抗体を含む安定化製剤 Download PDF

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Publication number
JP2023533963A
JP2023533963A JP2023501015A JP2023501015A JP2023533963A JP 2023533963 A JP2023533963 A JP 2023533963A JP 2023501015 A JP2023501015 A JP 2023501015A JP 2023501015 A JP2023501015 A JP 2023501015A JP 2023533963 A JP2023533963 A JP 2023533963A
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Prior art keywords
pharmaceutical formulation
antibody
stable
stable pharmaceutical
seq
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JP2023501015A
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Japanese (ja)
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JPWO2022010988A5 (enExample
Inventor
ユアン・チェン
デーヴィッド・ビー・ルドウィッグ
シャオリン・タン
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Publication of JP2023533963A publication Critical patent/JP2023533963A/ja
Publication of JPWO2022010988A5 publication Critical patent/JPWO2022010988A5/ja
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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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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
    • C07K16/2818—Immunoglobulins [IGs], 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 against CD28 or CD152
    • 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
    • A61K47/22—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
    • A61K9/08—Solutions
    • 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
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
JP2023501015A 2020-07-08 2021-07-07 抗ｃｔｌａ－４抗体を含む安定化製剤 Pending JP2023533963A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063049540P 2020-07-08 2020-07-08
US63/049,540 2020-07-08
PCT/US2021/040648 WO2022010988A1 (en) 2020-07-08 2021-07-07 Stabilized formulations containing anti-ctla-4 antibodies

Publications (2)

Publication Number Publication Date
JP2023533963A true JP2023533963A (ja) 2023-08-07
JPWO2022010988A5 JPWO2022010988A5 (enExample) 2024-07-16

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JP2023501015A Pending JP2023533963A (ja) 2020-07-08 2021-07-07 抗ｃｔｌａ－４抗体を含む安定化製剤

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Country Link
US (1) US20220031843A1 (enExample)
EP (1) EP4178983A1 (enExample)
JP (1) JP2023533963A (enExample)
KR (1) KR20230035595A (enExample)
CN (1) CN115812080A (enExample)
AU (1) AU2021305093A1 (enExample)
CA (1) CA3185091A1 (enExample)
IL (1) IL299152A (enExample)
MX (1) MX2022016218A (enExample)
WO (1) WO2022010988A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11525629B2 (en) 2020-02-04 2022-12-13 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013516481A (ja) * 2010-01-08 2013-05-13 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン６受容体（ｉｌ−６ｒ）抗体を含有する安定化製剤
JP2014525915A (ja) * 2011-07-28 2014-10-02 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗ｐｃｓｋ９抗体を含む安定化製剤
JP2015505539A (ja) * 2012-01-23 2015-02-23 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 抗ａｎｇ２抗体を含有する安定化製剤
JP2015511847A (ja) * 2012-03-02 2015-04-23 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 固定用量薬剤送達デバイス
WO2019023482A1 (en) * 2017-07-27 2019-01-31 Regeneron Pharmaceuticals, Inc. ANTI-CTLA-4 ANTIBODIES AND USES THEREOF
US20230203164A1 (en) * 2019-12-25 2023-06-29 Bio-Thera Solutions, Ltd. Anti-ctla-4 monoclonal antibody, preparation method therefor, and application thereof

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
KR101867279B1 (ko) * 2010-10-06 2018-06-15 리제너론 파아마슈티컬스, 인크. 항―인터류킨―４ 수용체（ｉｌ－４ｒ） 항체를 함유하는 안정화된 제형
AR092325A1 (es) * 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
NZ735820A (en) * 2015-04-17 2025-02-28 Bristol Myers Squibb Co Compositions comprising a combination of an anti-pd-1 antibody and another antibody
MA50501A (fr) * 2017-05-02 2020-09-09 Merck Sharp & Dohme Formulations stables d'anticorps anti-ctla4 seuls et en combinaison avec des anticorps anti-récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation
US20210317220A1 (en) * 2018-09-24 2021-10-14 Janssen Biotech, Inc. Method of providing safe administration of an anti-cd154 antibody

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013516481A (ja) * 2010-01-08 2013-05-13 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン６受容体（ｉｌ−６ｒ）抗体を含有する安定化製剤
JP2014525915A (ja) * 2011-07-28 2014-10-02 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗ｐｃｓｋ９抗体を含む安定化製剤
JP2015505539A (ja) * 2012-01-23 2015-02-23 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 抗ａｎｇ２抗体を含有する安定化製剤
JP2015511847A (ja) * 2012-03-02 2015-04-23 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 固定用量薬剤送達デバイス
WO2019023482A1 (en) * 2017-07-27 2019-01-31 Regeneron Pharmaceuticals, Inc. ANTI-CTLA-4 ANTIBODIES AND USES THEREOF
US20230203164A1 (en) * 2019-12-25 2023-06-29 Bio-Thera Solutions, Ltd. Anti-ctla-4 monoclonal antibody, preparation method therefor, and application thereof

Also Published As

Publication number Publication date
CN115812080A (zh) 2023-03-17
CA3185091A1 (en) 2022-01-13
WO2022010988A1 (en) 2022-01-13
IL299152A (en) 2023-02-01
EP4178983A1 (en) 2023-05-17
MX2022016218A (es) 2023-03-31
AU2021305093A1 (en) 2023-03-09
KR20230035595A (ko) 2023-03-14
US20220031843A1 (en) 2022-02-03

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