JP7880827B2 - 第ｘｉｉ因子抗原結合タンパク質の高濃度製剤 - Google Patents

第ｘｉｉ因子抗原結合タンパク質の高濃度製剤

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JP7880827B2
JP7880827B2 JP2022581380A JP2022581380A JP7880827B2 JP 7880827 B2 JP7880827 B2 JP 7880827B2 JP 2022581380 A JP2022581380 A JP 2022581380A JP 2022581380 A JP2022581380 A JP 2022581380A JP 7880827 B2 JP7880827 B2 JP 7880827B2
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approximately
seq
formulation
sequence shown
antibody
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JP2023531315A5 (enExample
JP2023531315A (ja
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マイケル・ジョンストン
ダイアナ・グレイス・グッドオール
ネイサン・アーロン・エドワーズ
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シーエスエル・イノベーション・プロプライエタリー・リミテッド
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Classifications

    • 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
    • C07K16/36—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61K9/0012—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
    • A61K9/08—Solutions
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2022581380A 2020-07-03 2021-07-05 第ｘｉｉ因子抗原結合タンパク質の高濃度製剤 Active JP7880827B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20184004.8 2020-07-03
EP20184004 2020-07-03
PCT/AU2021/050714 WO2022000046A1 (en) 2020-07-03 2021-07-05 High concentration formulation of factor xii antigen binding proteins

Publications (3)

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JP2023531315A JP2023531315A (ja) 2023-07-21
JP2023531315A5 JP2023531315A5 (enExample) 2024-07-12
JP7880827B2 true JP7880827B2 (ja) 2026-06-26

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JP2022581380A Active JP7880827B2 (ja) 2020-07-03 2021-07-05 第ｘｉｉ因子抗原結合タンパク質の高濃度製剤

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Country Link
US (1) US20240277839A1 (enExample)
EP (1) EP4175669A4 (enExample)
JP (1) JP7880827B2 (enExample)
KR (1) KR20230035355A (enExample)
CN (1) CN116322764A (enExample)
AU (1) AU2021302684A1 (enExample)
BR (1) BR112022026482A2 (enExample)
CA (1) CA3183508A1 (enExample)
CL (1) CL2023000004A1 (enExample)
IL (1) IL298989A (enExample)
MX (1) MX2022016365A (enExample)
WO (1) WO2022000046A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4337257A1 (en) * 2021-05-12 2024-03-20 AnaptysBio, Inc. Antibody composition
US20250042984A1 (en) * 2021-12-20 2025-02-06 CSL Innovation Pty Ltd Protein formulations and uses thereof

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014523253A (ja) 2011-07-22 2014-09-11 ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー 阻害性抗第ｘｉｉ／ｘｉｉａ因子モノクローナル抗体及びそれらの使用
JP2015528464A (ja) 2012-08-31 2015-09-28 バイエル・ヘルスケア・エルエルシーＢａｙｅｒ ＨｅａｌｔｈＣａｒｅＬＬＣ 抗体およびタンパク質製剤
JP2019513748A (ja) 2016-04-06 2019-05-30 シーエスエル、リミテッド アテローム性動脈硬化症の治療方法
JP2020501592A (ja) 2016-12-23 2020-01-23 セラム インスティテュート オブ インディア プライベート リミティド ダウンストリーム中の哺乳類細胞培養における抗体生産性の向上及び凝集の最小化のための改良された方法、製剤化方法及びそれにより得られる安定抗体製剤
WO2020113084A1 (en) 2018-11-28 2020-06-04 Oregon Health & Science University Therapeutic factor xii antibody
JP2020516608A (ja) 2017-04-06 2020-06-11 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． 安定な抗体製剤

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5859148B2 (ja) * 2012-03-08 2016-02-10 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ Ａβ抗体製剤
US8613919B1 (en) * 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
EP3325516B1 (en) * 2015-07-21 2021-12-15 Takeda Pharmaceutical Company Limited A monoclonal antibody inhibitor of factor xiia
EP3433274A1 (en) * 2016-03-25 2019-01-30 Visterra, Inc. Formulation of antibody molecules to dengue virus
JOP20170170B1 (ar) * 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق
EA202190056A1 (ru) * 2018-06-19 2021-05-28 Ридженерон Фармасьютикалз, Инк. АНТИТЕЛА ПРОТИВ ФАКТОРА XII/XIIa И ИХ ПРИМЕНЕНИЕ
US20230390418A1 (en) * 2020-10-29 2023-12-07 Regenxbio Inc. Vectorized factor xii antibodies and administration thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014523253A (ja) 2011-07-22 2014-09-11 ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー 阻害性抗第ｘｉｉ／ｘｉｉａ因子モノクローナル抗体及びそれらの使用
JP2015528464A (ja) 2012-08-31 2015-09-28 バイエル・ヘルスケア・エルエルシーＢａｙｅｒ ＨｅａｌｔｈＣａｒｅＬＬＣ 抗体およびタンパク質製剤
JP2019513748A (ja) 2016-04-06 2019-05-30 シーエスエル、リミテッド アテローム性動脈硬化症の治療方法
JP2020501592A (ja) 2016-12-23 2020-01-23 セラム インスティテュート オブ インディア プライベート リミティド ダウンストリーム中の哺乳類細胞培養における抗体生産性の向上及び凝集の最小化のための改良された方法、製剤化方法及びそれにより得られる安定抗体製剤
JP2020516608A (ja) 2017-04-06 2020-06-11 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． 安定な抗体製剤
WO2020113084A1 (en) 2018-11-28 2020-06-04 Oregon Health & Science University Therapeutic factor xii antibody

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Title
Ind Eng Chem Res，2016年，Vol. 55，pp. 11225-11234，doi: 10.1021/acs.iecr.6b02042
KANG, J. et al.，Rapid Formulation Development for Monoclonal Antibodies，BioProcess International，2016年04月13日，[検索日 2025.04.11], <URL: https://www.bioprocessintl.com/formulation/rapid-formulation-development-for-monoclonal-antibodies>
Pharm Res，2018年，Vol. 35, Article No. 133，pp. 1-14，doi: 10.1007/s11095-018-2398-1

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Publication number Publication date
WO2022000046A1 (en) 2022-01-06
CA3183508A1 (en) 2022-01-06
KR20230035355A (ko) 2023-03-13
CL2023000004A1 (es) 2023-08-25
AU2021302684A1 (en) 2023-02-23
EP4175669A1 (en) 2023-05-10
BR112022026482A2 (pt) 2023-01-31
MX2022016365A (es) 2023-01-30
US20240277839A1 (en) 2024-08-22
EP4175669A4 (en) 2025-11-12
JP2023531315A (ja) 2023-07-21
CN116322764A (zh) 2023-06-23
IL298989A (en) 2023-02-01

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