JP2023513312A - ヒト抗ｔｓｌｐ抗体の製剤及び炎症性疾患を治療する方法 - Google Patents

ヒト抗ｔｓｌｐ抗体の製剤及び炎症性疾患を治療する方法 Download PDF

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JP2023513312A
JP2023513312A JP2022548653A JP2022548653A JP2023513312A JP 2023513312 A JP2023513312 A JP 2023513312A JP 2022548653 A JP2022548653 A JP 2022548653A JP 2022548653 A JP2022548653 A JP 2022548653A JP 2023513312 A JP2023513312 A JP 2023513312A
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aqueous composition
calcium
amino acid
arginine
glutamate
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JP2023513312A5 (cg-RX-API-DMAC10.html
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アレクシス ルエラス，
クリストファー スローエイ，
クレア タリー，
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Amgen Inc
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Amgen Inc
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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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • 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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2022548653A 2020-02-13 2021-02-12 ヒト抗ｔｓｌｐ抗体の製剤及び炎症性疾患を治療する方法 Pending JP2023513312A (ja)

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JP2026015698A JP2026074118A (ja) 2020-02-13 2026-02-02 ヒト抗ｔｓｌｐ抗体の製剤及び炎症性疾患を治療する方法

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US202062976007P 2020-02-13 2020-02-13
US62/976,007 2020-02-13
US202163148105P 2021-02-10 2021-02-10
US63/148,105 2021-02-10
PCT/US2021/017880 WO2021163504A1 (en) 2020-02-13 2021-02-12 Formulations of human anti-tslp antibodies and methods of treating inflammatory disease

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JP2023513312A true JP2023513312A (ja) 2023-03-30
JP2023513312A5 JP2023513312A5 (cg-RX-API-DMAC10.html) 2024-02-20

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JP2026015698A Pending JP2026074118A (ja) 2020-02-13 2026-02-02 ヒト抗ｔｓｌｐ抗体の製剤及び炎症性疾患を治療する方法

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US (1) US20230078678A1 (cg-RX-API-DMAC10.html)
EP (1) EP4103235A1 (cg-RX-API-DMAC10.html)
JP (2) JP2023513312A (cg-RX-API-DMAC10.html)
KR (1) KR20220140772A (cg-RX-API-DMAC10.html)
CN (1) CN115279404A (cg-RX-API-DMAC10.html)
AU (1) AU2021219839A1 (cg-RX-API-DMAC10.html)
BR (1) BR112022016010A2 (cg-RX-API-DMAC10.html)
CA (1) CA3166964A1 (cg-RX-API-DMAC10.html)
CL (1) CL2022002193A1 (cg-RX-API-DMAC10.html)
CO (1) CO2022012868A2 (cg-RX-API-DMAC10.html)
CR (1) CR20220457A (cg-RX-API-DMAC10.html)
IL (1) IL295042A (cg-RX-API-DMAC10.html)
JO (1) JOP20220183A1 (cg-RX-API-DMAC10.html)
MX (1) MX2022010012A (cg-RX-API-DMAC10.html)
PE (1) PE20230112A1 (cg-RX-API-DMAC10.html)
PH (1) PH12022552050A1 (cg-RX-API-DMAC10.html)
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Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI917325B (zh) 2019-06-04 2026-03-11 大陸商江蘇恆瑞醫藥股份有限公司 能結合胸腺基質淋巴細胞生成素的抗體及其應用
MX2023006596A (es) * 2020-12-03 2023-06-19 Jiangsu Hengrui Pharmaceuticals Co Ltd Composicion farmaceutica de anticuerpo anti-tslp y uso de la misma.
US12110324B2 (en) 2022-07-22 2024-10-08 Flagship Pioneering Innovations Vi, Llc Antigen binding molecules targeting thymic stromal lymphopoietin (TSLP)
TW202529809A (zh) * 2023-10-17 2025-08-01 大陸商江蘇恆瑞醫藥股份有限公司 一種抗tslp抗體的醫藥組成物及其用途

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013527176A (ja) * 2010-05-14 2013-06-27 アムジエン・インコーポレーテツド 高濃度抗体製剤
JP2017531682A (ja) * 2014-10-23 2017-10-26 アムジエン・インコーポレーテツド 医薬製剤の粘度低下
WO2018191479A1 (en) * 2017-04-12 2018-10-18 Amgen Inc. Treatment of asthma with anti-tslp antibody
WO2019020069A1 (zh) * 2017-07-27 2019-01-31 江苏恒瑞医药股份有限公司 一种sost抗体药物组合物及其用途

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
ES2246502T3 (es) 1990-08-29 2006-02-16 Genpharm International, Inc. Animales no humanos transgenicos capaces de producir anticuerpos heterologos.
US7982016B2 (en) 2007-09-10 2011-07-19 Amgen Inc. Antigen binding proteins capable of binding thymic stromal lymphopoietin
US8359965B2 (en) 2007-09-17 2013-01-29 Oxford J Craig Apparatus and method for broad spectrum radiation attenuation
TW201018482A (en) 2008-08-08 2010-05-16 Glaxo Wellcome Mfg Pte Ltd Novel treatment
EP3594356A1 (en) 2009-11-04 2020-01-15 Merck Sharp & Dohme Corp. Engineered anti-tslp antibody
AR080428A1 (es) * 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
AR082163A1 (es) 2010-07-15 2012-11-14 Hoffmann La Roche Anticuerpos especificamente ligantes del tslpr humano y metodos de utilizacion de los mismos
AT510032B1 (de) 2010-11-30 2012-01-15 Steiner Erwin Ing Montageeinrichtung für fassadenelemente
US9100245B1 (en) 2012-02-08 2015-08-04 Amazon Technologies, Inc. Identifying protected media files
WO2014031718A1 (en) * 2012-08-23 2014-02-27 Merck Sharp & Dohme Corp. Stable formulations of antibodies to tslp
US9306926B2 (en) 2013-03-15 2016-04-05 Brian A. Truong User authentication using unique hidden identifiers
CN107428828A (zh) 2015-03-11 2017-12-01 葛兰素史密斯克莱知识产权发展有限公司 Tslp结合蛋白
EA038332B1 (ru) 2015-09-09 2021-08-10 Новартис Аг Молекулы, связывающиеся с тимусным стромальным лимфопоэтином (tslp), и способы применения таких молекул
US10994011B2 (en) * 2015-12-18 2021-05-04 Astellas Pharma Inc. Pharmaceutical composition comprising anti-human TSLP receptor antibody
MA48461A (fr) * 2017-04-28 2020-03-04 Amgen Inc Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
CA3066399A1 (en) 2017-06-08 2018-12-13 Amgen Inc. Torque driven drug delivery device
IL319987A (en) 2017-11-10 2025-06-01 Amgen Inc Plungers for drug delivery devices
WO2019178151A1 (en) 2018-03-13 2019-09-19 Amgen Inc. Methods for the preparation of trypsin-resistant polypeptides for mass spectrometric analysis
JP7719714B2 (ja) 2018-10-15 2025-08-06 アムジエン・インコーポレーテツド ダンピング機構を有する薬物送達装置
MA53913A (fr) 2018-10-15 2022-01-19 Amgen Inc Procédé d'assemblage de plate-forme pour dispositif d'administration de médicament
AU2020397170A1 (en) * 2019-12-05 2022-07-21 Sanofi-Aventis U.S. Llc Formulations of anti-CD38 antibodies for subcutaneous administration

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013527176A (ja) * 2010-05-14 2013-06-27 アムジエン・インコーポレーテツド 高濃度抗体製剤
JP2017531682A (ja) * 2014-10-23 2017-10-26 アムジエン・インコーポレーテツド 医薬製剤の粘度低下
WO2018191479A1 (en) * 2017-04-12 2018-10-18 Amgen Inc. Treatment of asthma with anti-tslp antibody
WO2019020069A1 (zh) * 2017-07-27 2019-01-31 江苏恒瑞医药股份有限公司 一种sost抗体药物组合物及其用途

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
KHEDDO, P. ET AL.: "The effect of arginine glutamate on the stability of monoclonal antibodies in solution", INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. Vol.473, No.1-2, JPN6025003444, 2014, pages 126 - 133, ISSN: 0005896701 *
SUDRIK, C. ET AL.: "Preferential interactions of trehalose, L-arginine.HCl and sodium chloride with therapeutically rele", MABS, vol. 9, no. 7, JPN6025003445, 2017, pages 1155 - 1168, ISSN: 0005896700 *
内山 進 ほか: "抗体医薬品の溶液物性", 薬剤学, vol. 第74巻, 第1号, JPN6025003447, 2014, pages 12 - 18, ISSN: 0005896698 *
荒川 力: "バイオ医薬品開発におけるアルギニンの貢献", 薬学雑誌, vol. 第130巻, 第6号, JPN6025003446, 2010, pages 793 - 800, ISSN: 0005896699 *

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CR20220457A (es) 2023-01-09
JP2026074118A (ja) 2026-05-01
WO2021163504A1 (en) 2021-08-19
IL295042A (en) 2022-09-01
AU2021219839A1 (en) 2022-08-25
EP4103235A1 (en) 2022-12-21
CN115279404A (zh) 2022-11-01
PH12022552050A1 (en) 2024-02-12
UY39083A (es) 2021-08-31
JOP20220183A1 (ar) 2023-01-30
CO2022012868A2 (es) 2022-12-09
US20230078678A1 (en) 2023-03-16
MX2022010012A (es) 2022-09-07
CA3166964A1 (en) 2021-08-19
KR20220140772A (ko) 2022-10-18
PE20230112A1 (es) 2023-01-27
BR112022016010A2 (pt) 2022-12-20
CL2022002193A1 (es) 2023-03-24

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