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 PDFInfo
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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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- Prior art keywords
- aqueous composition
- calcium
- amino acid
- arginine
- glutamate
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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
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)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2026015698A Division 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 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023513312A true JP2023513312A (ja) | 2023-03-30 |
| JP2023513312A5 JP2023513312A5 (https=) | 2024-02-20 |
Family
ID=74858823
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022548653A Pending JP2023513312A (ja) | 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 |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US20230078678A1 (https=) |
| EP (1) | EP4103235A1 (https=) |
| JP (1) | JP2023513312A (https=) |
| KR (1) | KR20220140772A (https=) |
| CN (1) | CN115279404A (https=) |
| AU (1) | AU2021219839A1 (https=) |
| BR (1) | BR112022016010A2 (https=) |
| CA (1) | CA3166964A1 (https=) |
| CL (1) | CL2022002193A1 (https=) |
| CO (1) | CO2022012868A2 (https=) |
| CR (1) | CR20220457A (https=) |
| IL (1) | IL295042A (https=) |
| JO (1) | JOP20220183A1 (https=) |
| MX (1) | MX2022010012A (https=) |
| PE (1) | PE20230112A1 (https=) |
| PH (1) | PH12022552050A1 (https=) |
| UY (1) | UY39083A (https=) |
| WO (1) | WO2021163504A1 (https=) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7628966B2 (ja) | 2019-06-04 | 2025-02-12 | ジエンス ヘンルイ メデイシンカンパニー リミテッド | 胸線間質性リンパ球増殖因子に結合可能な抗体およびその使用 |
| CN116601295A (zh) * | 2020-12-03 | 2023-08-15 | 江苏恒瑞医药股份有限公司 | 一种抗tslp抗体药物组合物及其用途 |
| US12110324B2 (en) | 2022-07-22 | 2024-10-08 | Flagship Pioneering Innovations Vi, Llc | Antigen binding molecules targeting thymic stromal lymphopoietin (TSLP) |
| WO2025082377A1 (zh) * | 2023-10-17 | 2025-04-24 | 江苏恒瑞医药股份有限公司 | 一种抗tslp抗体的药物组合物及其用途 |
Citations (4)
| 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)
| 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 |
| ATE158021T1 (de) | 1990-08-29 | 1997-09-15 | Genpharm Int | Produktion und nützung nicht-menschliche transgentiere zur produktion heterologe antikörper |
| 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 |
| UY32038A (es) | 2008-08-08 | 2010-03-26 | Glaxo Wellcome Mfg Pte Ltd | Inmunoblobulinas anti-cd127 y sus usos |
| ES2784123T3 (es) | 2009-11-04 | 2020-09-22 | Merck Sharp & Dohme | Anticuerpo anti TSLP genomodificado |
| AR080428A1 (es) * | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
| WO2012007495A1 (en) | 2010-07-15 | 2012-01-19 | F. Hoffmann-La Roche Ag | Antibodies specifically binding to human tslpr and methods of use |
| 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 |
| KR20170123315A (ko) | 2015-03-11 | 2017-11-07 | 글락소스미스클라인 인털렉츄얼 프로퍼티 디벨로프먼트 리미티드 | Tslp 결합 단백질 |
| EA038332B1 (ru) | 2015-09-09 | 2021-08-10 | Новартис Аг | Молекулы, связывающиеся с тимусным стромальным лимфопоэтином (tslp), и способы применения таких молекул |
| SG10202012778YA (en) * | 2015-12-18 | 2021-01-28 | Astellas Pharma Inc | Pharmaceutical composition comprising anti-human tslp receptor antibody |
| EP3615065A1 (en) * | 2017-04-28 | 2020-03-04 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| JP7200134B2 (ja) | 2017-06-08 | 2023-01-06 | アムジエン・インコーポレーテツド | トルク駆動式薬物送達デバイス |
| MA50557A (fr) | 2017-11-10 | 2020-09-16 | Amgen Inc | Pistons pour dispositifs d'administration de médicament |
| EP4321870B1 (en) | 2018-03-13 | 2025-07-30 | Amgen Inc. | Methods for the preparation of trypsin-resistant polypeptides for mass spectrometric analysis |
| TW202541859A (zh) | 2018-10-15 | 2025-11-01 | 美商安進公司 | 具有阻尼機構之藥物遞送裝置及自動注射器 |
| WO2020081480A1 (en) | 2018-10-15 | 2020-04-23 | Amgen Inc. | Platform assembly process for drug delivery device |
| IL293563A (en) * | 2019-12-05 | 2022-08-01 | Sanofi Aventis Us Llc | Formulations of anti-cd38 antibodies for subcutaneous administration |
-
2021
- 2021-02-12 MX MX2022010012A patent/MX2022010012A/es unknown
- 2021-02-12 PH PH1/2022/552050A patent/PH12022552050A1/en unknown
- 2021-02-12 UY UY0001039083A patent/UY39083A/es unknown
- 2021-02-12 WO PCT/US2021/017880 patent/WO2021163504A1/en not_active Ceased
- 2021-02-12 CA CA3166964A patent/CA3166964A1/en active Pending
- 2021-02-12 CN CN202180017163.9A patent/CN115279404A/zh active Pending
- 2021-02-12 KR KR1020227030979A patent/KR20220140772A/ko active Pending
- 2021-02-12 BR BR112022016010A patent/BR112022016010A2/pt unknown
- 2021-02-12 EP EP21710162.5A patent/EP4103235A1/en active Pending
- 2021-02-12 CR CR20220457A patent/CR20220457A/es unknown
- 2021-02-12 JP JP2022548653A patent/JP2023513312A/ja active Pending
- 2021-02-12 US US17/760,427 patent/US20230078678A1/en active Pending
- 2021-02-12 PE PE2022001741A patent/PE20230112A1/es unknown
- 2021-02-12 IL IL295042A patent/IL295042A/en unknown
- 2021-02-12 AU AU2021219839A patent/AU2021219839A1/en active Pending
-
2022
- 2022-08-11 JO JOP/2022/0183A patent/JOP20220183A1/ar unknown
- 2022-08-12 CL CL2022002193A patent/CL2022002193A1/es unknown
- 2022-09-09 CO CONC2022/0012868A patent/CO2022012868A2/es unknown
Patent Citations (4)
| 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)
| 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: 0005699514 * |
| 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: 0005699513 * |
| 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: 0005699511 * |
| 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: 0005699512 * |
Also Published As
| Publication number | Publication date |
|---|---|
| PH12022552050A1 (en) | 2024-02-12 |
| CR20220457A (es) | 2023-01-09 |
| JOP20220183A1 (ar) | 2023-01-30 |
| US20230078678A1 (en) | 2023-03-16 |
| AU2021219839A1 (en) | 2022-08-25 |
| CO2022012868A2 (es) | 2022-12-09 |
| IL295042A (en) | 2022-09-01 |
| EP4103235A1 (en) | 2022-12-21 |
| CL2022002193A1 (es) | 2023-03-24 |
| WO2021163504A1 (en) | 2021-08-19 |
| PE20230112A1 (es) | 2023-01-27 |
| KR20220140772A (ko) | 2022-10-18 |
| CN115279404A (zh) | 2022-11-01 |
| CA3166964A1 (en) | 2021-08-19 |
| UY39083A (es) | 2021-08-31 |
| BR112022016010A2 (pt) | 2022-12-20 |
| MX2022010012A (es) | 2022-09-07 |
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