CN115768799A - 抗her2单克隆抗体冻干制剂及制备方法 - Google Patents

抗her2单克隆抗体冻干制剂及制备方法 Download PDF

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Publication number
CN115768799A
CN115768799A CN202180040139.7A CN202180040139A CN115768799A CN 115768799 A CN115768799 A CN 115768799A CN 202180040139 A CN202180040139 A CN 202180040139A CN 115768799 A CN115768799 A CN 115768799A
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concentration
drying
buffer solution
preparation
monoclonal antibody
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CN202180040139.7A
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English (en)
Inventor
杨泗兴
张士荣
苏研
黄浩旻
朱祯平
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Sunshine Guojian Pharmaceutical Shanghai Co Ltd
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Sunshine Guojian Pharmaceutical Shanghai Co Ltd
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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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • 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
    • A61K9/14—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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

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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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Cell Biology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

一种稳定的抗HER2单克隆抗体冻干制剂及制备方法，通过优化制剂配方及冻干工艺极大地改进了蛋白溶液不稳定的缺陷，所述冻干制剂配方和制备方法生产的药品25℃稳定性至少6个月，5℃稳定性至少60个月。

Description

PCT国内申请，说明书已公开。

Claims (12)

  1. PCT国内申请，权利要求书已公开。
CN202180040139.7A 2020-06-23 2021-06-16 抗her2单克隆抗体冻干制剂及制备方法 Pending CN115768799A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202010577294X 2020-06-23
CN202010577294.XA CN113827717A (zh) 2020-06-23 2020-06-23 抗her2单克隆抗体冻干制剂及制备方法
PCT/CN2021/100338 WO2021259101A1 (zh) 2020-06-23 2021-06-16 抗her2单克隆抗体冻干制剂及制备方法

Publications (1)

Publication Number Publication Date
CN115768799A true CN115768799A (zh) 2023-03-07

Family

ID=78963944

Family Applications (2)

Application Number Title Priority Date Filing Date
CN202010577294.XA Pending CN113827717A (zh) 2020-06-23 2020-06-23 抗her2单克隆抗体冻干制剂及制备方法
CN202180040139.7A Pending CN115768799A (zh) 2020-06-23 2021-06-16 抗her2单克隆抗体冻干制剂及制备方法

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CN202010577294.XA Pending CN113827717A (zh) 2020-06-23 2020-06-23 抗her2单克隆抗体冻干制剂及制备方法

Country Status (2)

Country Link
CN (2) CN113827717A (zh)
WO (1) WO2021259101A1 (zh)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114893956A (zh) * 2022-06-01 2022-08-12 恺佧生物科技(上海)有限公司 一种Claudin18.2 VLP产品的冻干方法
CN117825688B (zh) * 2024-01-19 2024-05-31 武汉鹰达生物科技有限公司 一种动物IgG抗体冻干粉制剂及其制备工艺

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU716785B2 (en) * 1995-07-27 2000-03-09 Genentech Inc. Stabile isotonic lyophilized protein formulation
CN101199483B (zh) * 2006-12-14 2011-01-26 上海中信国健药业股份有限公司 一种稳定的抗her2人源化抗体制剂
US9345661B2 (en) * 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
CN102309754A (zh) * 2010-07-07 2012-01-11 上海中信国健药业股份有限公司 一种稳定的重组人源化抗体的药物组合物
AU2018210312B2 (en) * 2017-01-17 2020-03-19 F. Hoffmann-La Roche Ag Subcutaneous HER2 antibody formulations
CN110732023B (zh) * 2018-07-18 2023-06-16 江苏恒瑞医药股份有限公司 一种her2抗体药物组合物及其用途
CN110790840A (zh) * 2018-08-01 2020-02-14 三生国健药业（上海）股份有限公司 结合人her2的抗体、其制备方法和用途

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WO2021259101A1 (zh) 2021-12-30
CN113827717A (zh) 2021-12-24

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