MX2020005630A - Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6. - Google Patents

Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6.

Info

Publication number
MX2020005630A
MX2020005630A MX2020005630A MX2020005630A MX2020005630A MX 2020005630 A MX2020005630 A MX 2020005630A MX 2020005630 A MX2020005630 A MX 2020005630A MX 2020005630 A MX2020005630 A MX 2020005630A MX 2020005630 A MX2020005630 A MX 2020005630A
Authority
MX
Mexico
Prior art keywords
liquid preparation
antibody
treating
humanized antibody
related disease
Prior art date
Application number
MX2020005630A
Other languages
English (en)
Inventor
Jian Lin
Fan Liu
Rui Yue
Zhihao Wu
Shengwu Wang
Shengfeng Li
Original Assignee
Bio Thera Solutions Ltd
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 Bio Thera Solutions Ltd filed Critical Bio Thera Solutions Ltd
Publication of MX2020005630A publication Critical patent/MX2020005630A/es

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, 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
    • A61K39/39533—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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La invención se refiere a una formulación liquida de anticuerpo humanizado para tratar enfermedades relacionadas con IL-6. La formulación liquida contiene 2-100 mg/ml de anticuerpo monoclonal recombinante humanizado contra el receptor de interleucina-6 humano, tampón de sal de histidina 5-20 mM (o un tampón de una combinación de sal de histidina 5-20 mM y acetato de sodio 5-20 mM), 0,025-0,075 % (en volumen) de tensioactivo y 3-5 % (en masa a volumen) de estabilizador y agua para inyección. La formulación de anticuerpos mejora la estabilidad del anticuerpo monoclonal contra el receptor de interleucina-6 humano y evita que el anticuerpo monoclonal se agregue, que se degrade y que aumente el isómero acido. Esta formulación se puede utilizar para estabilizar la estructura y la función del anticuerpo humanizado.
MX2020005630A 2017-11-30 2018-11-30 Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6. MX2020005630A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201711239538 2017-11-30
PCT/CN2018/118503 WO2019105450A1 (zh) 2017-11-30 2018-11-30 一种治疗il-6相关疾病的人源化抗体的液体制剂

Publications (1)

Publication Number Publication Date
MX2020005630A true MX2020005630A (es) 2020-08-20

Family

ID=65330616

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2020005630A MX2020005630A (es) 2017-11-30 2018-11-30 Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6.

Country Status (12)

Country Link
US (2) US20220071901A1 (es)
EP (1) EP3718531A4 (es)
JP (1) JP2021504482A (es)
KR (1) KR20200093628A (es)
CN (2) CN111110842B (es)
AU (1) AU2018374232A1 (es)
BR (1) BR112020010761A2 (es)
CA (1) CA3083971A1 (es)
IL (2) IL297354A (es)
MX (1) MX2020005630A (es)
RU (1) RU2020121415A (es)
WO (1) WO2019105450A1 (es)

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PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
AU2017333367A1 (en) * 2016-09-27 2019-04-04 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
CN110151988A (zh) * 2018-02-11 2019-08-23 百奥泰生物制药股份有限公司 一种靶向治疗TNF-α相关疾病的人抗体制剂
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
CN110124029B (zh) * 2019-04-19 2023-08-11 中山大学附属第六医院 Il-6r抗体及羊水干细胞在制备用于治疗nec的药物中的应用
CN113769081A (zh) * 2020-06-10 2021-12-10 三生国健药业（上海）股份有限公司 一种稳定的高浓度抗人il-5单克隆抗体液体制剂
EP4199965A4 (en) * 2020-08-19 2025-03-26 Bio-Thera Solutions, Ltd. LIQUID FORMULATIONS CONTAINING HIGHLY CONCENTRATED HUMANIZED ANTIBODIES FOR THE TREATMENT OF IL-6-ASSOCIATED DISEASES
CN113267390B (zh) * 2021-05-11 2023-05-05 北京丹大生物技术有限公司 一种用于滤纸干血片的检测标志物洗脱液及其应用
CN113274494B (zh) * 2021-06-07 2022-09-20 武汉生物制品研究所有限责任公司 一种抗SARS-CoV-2的重组全人源单克隆抗体的液体制剂
WO2023020563A1 (en) * 2021-08-18 2023-02-23 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases
CN114306576B (zh) * 2022-01-11 2025-02-11 北京志道生物科技有限公司 一种防止il-2衍生物蛋白复合体聚集及非共价连接蛋白亚基脱落的制剂
CN121240883A (zh) * 2023-05-26 2025-12-30 百奥泰生物制药股份有限公司 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂
WO2026092379A1 (zh) * 2024-10-28 2026-05-07 信达生物制药(苏州)有限公司 抗cd40l抗体的制剂及其制备方法

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JP5485489B2 (ja) * 2000-08-11 2014-05-07 中外製薬株式会社 抗体含有安定化製剤
AU2004229335C1 (en) * 2003-04-04 2010-06-17 Genentech, Inc. High concentration antibody and protein formulations
WO2005090405A1 (ja) * 2004-03-24 2005-09-29 Chugai Seiyaku Kabushiki Kaisha インターロイキン－６受容体に対するヒト型化抗体のサブタイプ
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Also Published As

Publication number Publication date
CN109350740B (zh) 2023-06-20
CN111110842B (zh) 2020-12-11
KR20200093628A (ko) 2020-08-05
CN111110842A (zh) 2020-05-08
CN109350740A (zh) 2019-02-19
EP3718531A1 (en) 2020-10-07
BR112020010761A2 (pt) 2020-11-24
RU2020121415A (ru) 2021-12-30
US20230190649A1 (en) 2023-06-22
CA3083971A1 (en) 2019-06-06
IL297354A (en) 2022-12-01
EP3718531A4 (en) 2023-08-16
US20220071901A1 (en) 2022-03-10
IL274813A (en) 2020-07-30
JP2021504482A (ja) 2021-02-15
WO2019105450A1 (zh) 2019-06-06
AU2018374232A1 (en) 2020-07-23

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