BR112017017854A2 - método para detecção de anticorpo monoclonal utilizando espectrometria de massa - Google Patents

método para detecção de anticorpo monoclonal utilizando espectrometria de massa

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Publication number
BR112017017854A2
BR112017017854A2 BR112017017854-0A BR112017017854A BR112017017854A2 BR 112017017854 A2 BR112017017854 A2 BR 112017017854A2 BR 112017017854 A BR112017017854 A BR 112017017854A BR 112017017854 A2 BR112017017854 A2 BR 112017017854A2
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Brazil
Prior art keywords
monoclonal antibody
mass spectrometry
immobilized
amino acid
detected
Prior art date
Application number
BR112017017854-0A
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English (en)
Japanese (ja)
Inventor
Shimada Takashi
Iwamoto Noriko
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Shimadzu Corporation
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Publication date
Application filed by Shimadzu Corporation filed Critical Shimadzu Corporation
Publication of BR112017017854A2 publication Critical patent/BR112017017854A2/pt

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    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
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    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
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    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • C12Q1/37—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving peptidase or proteinase
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    • G—PHYSICS
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
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    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
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    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • G01N33/6857—Antibody fragments
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    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
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    • G01N2030/8818—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving amino acids
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    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins
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    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
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    • H—ELECTRICITY
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  • Life Sciences & Earth Sciences (AREA)
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  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
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  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Biophysics (AREA)
  • Wood Science & Technology (AREA)
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  • Electrochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

a presente invenção fornece um processo para detecção e quantificação mais fáceis de uma proteína através da digestão de forma regiosseletiva de uma região variável de um domínio fab de um anticorpo monoclonal enquanto é suprimida a proteólise de um domínio fc. no processo, um corpo poroso no qual um anticorpo monoclonal é imobilizado em poros e nanopartículas sobre as quais uma protease é imobilizada são colocadas em contato uma com as outras em um líquido para realizar proteólise seletiva do anticorpo monoclonal e um fragmento peptídico resultante é detectado utilizando cromatografia líquida-espectrometria de massa (lc-ms) e um peptídeo que possui uma sequência de aminoácidos que inclui um aminoácido derivado de uma região cdr2 de uma cadeia pesada ou uma cadeia leve do anticorpo monoclonal é detectado.
BR112017017854-0A 2015-03-09 2015-12-18 método para detecção de anticorpo monoclonal utilizando espectrometria de massa BR112017017854A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2015046059 2015-03-09
JP2015-046059 2015-03-09
PCT/JP2015/085445 WO2016143224A1 (ja) 2015-03-09 2015-12-18 質量分析を用いたモノクローナル抗体の検出方法

Publications (1)

Publication Number Publication Date
BR112017017854A2 true BR112017017854A2 (pt) 2018-04-10

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Country Status (8)

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US (1) US10338039B2 (pt)
EP (1) EP3270154B1 (pt)
JP (1) JP6428911B2 (pt)
KR (1) KR102000862B1 (pt)
CN (1) CN107407666A (pt)
BR (1) BR112017017854A2 (pt)
SG (1) SG11201707318PA (pt)
WO (1) WO2016143224A1 (pt)

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US11209439B2 (en) 2015-09-24 2021-12-28 Mayo Foundation For Medical Education And Research Identification of immunoglobulin free light chains by mass spectrometry
CN109863395B (zh) 2016-09-07 2023-05-23 梅约医学教育与研究基金会 分子量法鉴定和监测裂解免疫球蛋白
WO2018235228A1 (ja) * 2017-06-22 2018-12-27 株式会社島津製作所 抗原または抗抗体が結合したモノクローナル抗体の定量方法
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US20210215690A1 (en) * 2018-02-08 2021-07-15 Shimadzu Corporation Method for improving result of monoclonal antibody detection
JP7215467B2 (ja) * 2019-08-19 2023-01-31 株式会社島津製作所 ホルマリン固定パラフィン包埋組織試料からの抗体の分離、検出及び／又は分析方法
CN110608981A (zh) * 2019-09-09 2019-12-24 中国科学院高能物理研究所 一种测定植物中硫化汞纳米颗粒的方法
CN111024862B (zh) * 2019-12-31 2022-09-13 上海博威生物医药有限公司 一种奥马珠单抗疏水性的检测方法
CN111735869A (zh) * 2020-05-29 2020-10-02 中山大学 一种蛋白质的检测试剂及检测方法
WO2022270126A1 (ja) 2021-06-23 2022-12-29 株式会社島津製作所 抗体を分析する方法
CN113804804A (zh) * 2021-09-08 2021-12-17 杭州佰辰医学检验所有限公司 一种超高效液相色谱串联质谱法快速测定血浆中单克隆抗体药物的监测方法
CN113899894B (zh) * 2021-09-14 2023-11-14 上海中科新生命生物科技有限公司 一种同时检测贝伐珠单抗和曲妥珠单抗药物浓度的方法

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JP5924455B2 (ja) 2013-09-09 2016-05-25 株式会社島津製作所 ペプチド断片の調製方法およびそれに用いられるペプチド断片調製用キット、ならびに分析方法
KR20170120178A (ko) * 2015-03-10 2017-10-30 가부시키가이샤 시마즈세이사쿠쇼 모노클로날 항체의 검출을 위한 샘플 조제용 키트
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Publication number Publication date
JP6428911B2 (ja) 2018-11-28
US10338039B2 (en) 2019-07-02
KR102000862B1 (ko) 2019-07-16
EP3270154A4 (en) 2019-01-09
EP3270154A1 (en) 2018-01-17
US20180059074A1 (en) 2018-03-01
JPWO2016143224A1 (ja) 2017-12-28
WO2016143224A1 (ja) 2016-09-15
SG11201707318PA (en) 2017-10-30
KR20170121265A (ko) 2017-11-01
CN107407666A (zh) 2017-11-28
EP3270154B1 (en) 2020-03-04

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