CN115243718A - 稳定的抗体制剂 - Google Patents

稳定的抗体制剂 Download PDF

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Publication number
CN115243718A
CN115243718A CN202180010566.0A CN202180010566A CN115243718A CN 115243718 A CN115243718 A CN 115243718A CN 202180010566 A CN202180010566 A CN 202180010566A CN 115243718 A CN115243718 A CN 115243718A
Authority
CN
China
Prior art keywords
antibody
seq
pharmaceutical formulation
formulation
amino acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202180010566.0A
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English (en)
Chinese (zh)
Inventor
Y·曹
D·刘
L·徐
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Regeneron Pharmaceuticals Inc
Original Assignee
Regeneron Pharmaceuticals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of CN115243718A publication Critical patent/CN115243718A/zh
Pending legal-status Critical Current

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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
    • 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
    • A61K39/42—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN202180010566.0A 2020-01-24 2021-01-22 稳定的抗体制剂 Pending CN115243718A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062965786P 2020-01-24 2020-01-24
US62/965,786 2020-01-24
PCT/US2021/014524 WO2021150829A1 (en) 2020-01-24 2021-01-22 Stable antibody formulation

Publications (1)

Publication Number Publication Date
CN115243718A true CN115243718A (zh) 2022-10-25

Family

ID=74858743

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180010566.0A Pending CN115243718A (zh) 2020-01-24 2021-01-22 稳定的抗体制剂

Country Status (13)

Country Link
US (2) US12337199B2 (https=)
EP (1) EP4093435A1 (https=)
JP (2) JP7674369B2 (https=)
KR (1) KR20220131923A (https=)
CN (1) CN115243718A (https=)
AU (1) AU2021210942A1 (https=)
BR (1) BR112022014240A2 (https=)
CA (1) CA3162569A1 (https=)
CL (2) CL2022001989A1 (https=)
CO (1) CO2022010254A2 (https=)
IL (1) IL294375B1 (https=)
MX (1) MX2022008949A (https=)
WO (1) WO2021150829A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107635527B (zh) 2015-03-10 2021-04-23 里珍纳龙药品有限公司 无菌刺穿系统和方法
EP3487521A4 (en) 2016-07-21 2020-07-01 Emory University ANTIBODIES AGAINST EBOLA VIRUS AND LIAISON AGENTS DERIVED THEREFROM
KR102540409B1 (ko) 2017-05-05 2023-06-09 리제너론 파아마슈티컬스, 인크. 자동 주사기
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector
TW202529831A (zh) 2023-10-02 2025-08-01 美商再生元醫藥公司 藥物遞輸裝置安全系統
US12514939B2 (en) 2024-02-14 2026-01-06 Alpha-9 Oncology, Inc. Stable radiopharmaceutical compositions and uses thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103429264A (zh) * 2011-03-31 2013-12-04 默沙东公司 针对人程序性死亡受体pd-1的抗体的稳定制剂和有关的治疗
CN107667115A (zh) * 2015-01-26 2018-02-06 瑞泽恩制药公司 针对埃博拉病毒糖蛋白的人抗体
WO2019206987A1 (en) * 2018-04-25 2019-10-31 Medimmune Limited Formulations of human anti-pd-l1 antibodies

Family Cites Families (16)

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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
US6630144B1 (en) 1999-08-30 2003-10-07 The United States Of America As Represented By The Secretary Of The Army Monoclonal antibodies to Ebola glycoprotein
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
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
US6875433B2 (en) 2002-08-23 2005-04-05 The United States Of America As Represented By The Secretary Of The Army Monoclonal antibodies and complementarity-determining regions binding to Ebola glycoprotein
WO2009094755A1 (en) 2008-02-01 2009-08-06 Her Majesty The Queen In Right Of Canada As Represented By The Minister Of Health Monoclonal antibodies for ebola and marburg viruses
AR070315A1 (es) * 2008-02-07 2010-03-31 Merck & Co Inc Anticuerpos 1b20 antagonistas de pcsk9
CA2741523C (en) 2008-10-24 2022-06-21 Jonathan S. Towner Human ebola virus species and compositions and methods thereof
WO2014031718A1 (en) * 2012-08-23 2014-02-27 Merck Sharp & Dohme Corp. Stable formulations of antibodies to tslp
JP6041580B2 (ja) * 2012-08-28 2016-12-14 京セラ株式会社 電子機器、制御方法、及び制御プログラム
TN2017000440A1 (en) 2015-04-17 2019-04-12 Bristol Myers Squibb Co Compositions comprising a combination of an anti-pd-1 antibody and another antibody
JP7402693B2 (ja) * 2017-05-02 2023-12-21 メルク・シャープ・アンド・ドーム・エルエルシー 単独のおよびプログラム死受容体１（ｐｄ－１）抗体と組み合わされた抗ｔｉｇｉｔ抗体の安定な製剤、ならびにその使用方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103429264A (zh) * 2011-03-31 2013-12-04 默沙东公司 针对人程序性死亡受体pd-1的抗体的稳定制剂和有关的治疗
CN107667115A (zh) * 2015-01-26 2018-02-06 瑞泽恩制药公司 针对埃博拉病毒糖蛋白的人抗体
WO2019206987A1 (en) * 2018-04-25 2019-10-31 Medimmune Limited Formulations of human anti-pd-l1 antibodies

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ROBERT J. FALCONER: "Advances in liquid formulations of parenteral therapeutic proteins", BIOTECHNOLOGY ADVANCES, vol. 37, no. 7, 15 November 2019 (2019-11-15), pages 2 *

Also Published As

Publication number Publication date
KR20220131923A (ko) 2022-09-29
CO2022010254A2 (es) 2022-08-09
IL294375B1 (en) 2026-02-01
JP2023511080A (ja) 2023-03-16
JP7674369B2 (ja) 2025-05-09
WO2021150829A1 (en) 2021-07-29
AU2021210942A1 (en) 2022-07-14
IL294375A (en) 2022-08-01
US12337199B2 (en) 2025-06-24
MX2022008949A (es) 2022-08-15
BR112022014240A2 (pt) 2022-12-13
JP2025090691A (ja) 2025-06-17
US20210252146A1 (en) 2021-08-19
CL2022001989A1 (es) 2023-03-31
CL2023002560A1 (es) 2024-03-01
CA3162569A1 (en) 2021-07-29
EP4093435A1 (en) 2022-11-30
US20250288665A1 (en) 2025-09-18

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