JP6511609B2 - 抗体製剤 - Google Patents

抗体製剤 Download PDF

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Publication number
JP6511609B2
JP6511609B2 JP2016502256A JP2016502256A JP6511609B2 JP 6511609 B2 JP6511609 B2 JP 6511609B2 JP 2016502256 A JP2016502256 A JP 2016502256A JP 2016502256 A JP2016502256 A JP 2016502256A JP 6511609 B2 JP6511609 B2 JP 6511609B2
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Japan
Prior art keywords
antibody
formulation
amount
months
antibodies
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JP2016502256A
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English (en)
Japanese (ja)
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JP2016515124A (ja
JP2016515124A5 (cg-RX-API-DMAC7.html
Inventor
ヤタン ゴカーナ，
ヤタン ゴカーナ，
イシードロ イー． ザラガ，
イシードロ イー． ザラガ，
ジョナサン ザザー，
ジョナサン ザザー，
トーマス パタポフ，
トーマス パタポフ，
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Genentech Inc
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Genentech 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
    • 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
    • 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
    • A61K47/16—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
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'

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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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Endocrinology (AREA)
JP2016502256A 2013-03-13 2014-03-13 抗体製剤 Active JP6511609B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361780899P 2013-03-13 2013-03-13
US61/780,899 2013-03-13
PCT/US2014/026824 WO2014160490A1 (en) 2013-03-13 2014-03-13 Antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2018208122A Division JP6814962B2 (ja) 2013-03-13 2018-11-05 抗体製剤

Publications (3)

Publication Number Publication Date
JP2016515124A JP2016515124A (ja) 2016-05-26
JP2016515124A5 JP2016515124A5 (cg-RX-API-DMAC7.html) 2017-04-13
JP6511609B2 true JP6511609B2 (ja) 2019-05-22

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ID=51625441

Family Applications (2)

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JP2016502256A Active JP6511609B2 (ja) 2013-03-13 2014-03-13 抗体製剤
JP2018208122A Active JP6814962B2 (ja) 2013-03-13 2018-11-05 抗体製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
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Country Status (17)

Country Link
US (3) US10010611B2 (cg-RX-API-DMAC7.html)
EP (2) EP2968553B1 (cg-RX-API-DMAC7.html)
JP (2) JP6511609B2 (cg-RX-API-DMAC7.html)
KR (2) KR102127085B1 (cg-RX-API-DMAC7.html)
CN (2) CN105209069B (cg-RX-API-DMAC7.html)
AR (1) AR095396A1 (cg-RX-API-DMAC7.html)
AU (2) AU2014243783B2 (cg-RX-API-DMAC7.html)
BR (1) BR112015022210A8 (cg-RX-API-DMAC7.html)
CA (1) CA2906057A1 (cg-RX-API-DMAC7.html)
IL (2) IL240886B (cg-RX-API-DMAC7.html)
MX (2) MX365567B (cg-RX-API-DMAC7.html)
MY (2) MY189047A (cg-RX-API-DMAC7.html)
NZ (2) NZ751452A (cg-RX-API-DMAC7.html)
RU (2) RU2019120404A (cg-RX-API-DMAC7.html)
SG (2) SG11201507475UA (cg-RX-API-DMAC7.html)
WO (1) WO2014160490A1 (cg-RX-API-DMAC7.html)
ZA (2) ZA201506981B (cg-RX-API-DMAC7.html)

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SG11201507475UA (en) 2013-03-13 2015-10-29 Genentech Inc Antibody formulations
RU2704611C2 (ru) 2014-09-15 2019-10-30 Дженентек, Инк. Составы на основе антител
TWI806150B (zh) 2014-11-07 2023-06-21 瑞士商諾華公司 穩定的含有高濃度抗vegf抗體之蛋白質溶液調配物
EP3250596A1 (en) 2015-01-28 2017-12-06 Pfizer Inc Stable aqueous anti- vascular endothelial growth factor (vegf) antibody formulation
US11149091B2 (en) * 2015-12-09 2021-10-19 Cedars-Sinai Medical Center Methods for treating nephrotic syndrome
CN105920600A (zh) * 2016-04-19 2016-09-07 上海景泽生物技术有限公司 一种稳定的抗vegf抗体制剂及其用途
CN115998859A (zh) 2016-06-27 2023-04-25 莫佛塞斯公司 抗-cd19抗体制剂
CN107384932B (zh) 2016-08-31 2020-10-20 北京天广实生物技术股份有限公司 抗人cd20人源化单克隆抗体mil62、其制备方法及用途
WO2018091729A2 (en) 2016-11-21 2018-05-24 Zaklady Farmaceutyczne Polpharma Sa Aqueous pharmaceutical formulations
CN108686204A (zh) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 包含组氨酸缓冲体系的英夫利西单抗组合物
US11865175B1 (en) 2017-04-28 2024-01-09 Cedars-Sinai Medical Center Post-transplantation prophylaxis and treatments for antibody-mediated rejection of solid organ transplant
CN107899020A (zh) * 2017-08-11 2018-04-13 百奥泰生物科技(广州)有限公司 Cd20阳性疾病治疗的化合物及方法
CN107881160A (zh) * 2017-08-11 2018-04-06 百奥泰生物科技(广州)有限公司 一种由基因组被编辑的cho宿主细胞产生的具有独特糖谱的重组抗体及其制备方法
WO2019064263A1 (en) * 2017-09-29 2019-04-04 Janssen Biotech, Inc. NOVEL FORMULATIONS FOR STABILIZING LOW DOSE ANTIBODY COMPOSITIONS
KR102494021B1 (ko) * 2017-12-22 2023-02-06 삼성바이오에피스 주식회사 Vegf 길항제를 포함하는 액상 조성물
CA3107770C (en) 2018-08-16 2023-09-05 Emd Millipore Corporation Closed bioprocessing device
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
WO2021068971A1 (en) * 2019-10-12 2021-04-15 Bio-Thera Solutions, Ltd. Anti-cd20 antibody formulation and use of anti-cd20 antibody for treatment of cd20 positive diseases
EP4115903A4 (en) * 2020-03-04 2023-12-20 Shanghai Henlius Biotech, Inc. Pharmaceutical formulation comprising bevacizumab
WO2022265591A1 (en) * 2021-06-18 2022-12-22 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical compositions of bevacizumab

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