BR112012009846B8 - método in vitro e kit para detecção de um anticorpo antifármaco de isotipo ige, e uso de um anticorpo antifármaco de isotipo ige no tratamento de distúrbio mediado por ige - Google Patents

método in vitro e kit para detecção de um anticorpo antifármaco de isotipo ige, e uso de um anticorpo antifármaco de isotipo ige no tratamento de distúrbio mediado por ige

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Publication number
BR112012009846B8
BR112012009846B8 BR112012009846A BR112012009846A BR112012009846B8 BR 112012009846 B8 BR112012009846 B8 BR 112012009846B8 BR 112012009846 A BR112012009846 A BR 112012009846A BR 112012009846 A BR112012009846 A BR 112012009846A BR 112012009846 B8 BR112012009846 B8 BR 112012009846B8
Authority
BR
Brazil
Prior art keywords
ige
drug antibody
isotype anti
detecting
ige isotype
Prior art date
Application number
BR112012009846A
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English (en)
Other versions
BR112012009846B1 (pt
BR112012009846A2 (pt
Inventor
L Baker Dana
R Nakamura Gerald
B Lowman Henry
Fischer Saloumeh
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Genentech Inc
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Publication date
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of BR112012009846A2 publication Critical patent/BR112012009846A2/pt
Publication of BR112012009846B1 publication Critical patent/BR112012009846B1/pt
Publication of BR112012009846B8 publication Critical patent/BR112012009846B8/pt

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4208Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an idiotypic determinant on Ig
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4208Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an idiotypic determinant on Ig
    • C07K16/4241Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an idiotypic determinant on Ig against anti-human or anti-animal Ig
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/564Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • G01N33/686Anti-idiotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/24Immunology or allergic disorders

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  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Rheumatology (AREA)
  • Rehabilitation Therapy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

métodos e kits para detecção de um anticorpo antifármaco de isotipo ige, bem como composição para o tratamento de distúrbio mediado por ige. a invenção provê métodos e reagentes úteis para detecção de anticorpos antifármaco de isotipo lge para anticorpos anti-lge terapêuticos e métodos para avaliação do risco de anafilaxia para administração de um anticorpo anti-lge terapêutico.
BR112012009846A 2009-10-26 2010-10-26 método in vitro e kit para detecção de um anticorpo antifármaco de isotipo ige, e uso de um anticorpo antifármaco de isotipo ige no tratamento de distúrbio mediado por ige BR112012009846B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25505209P 2009-10-26 2009-10-26
US61/255,052 2009-10-26
PCT/US2010/054160 WO2011056606A1 (en) 2009-10-26 2010-10-26 Assays for detecting antibodies specific to therapeutic anti-ige antibodies and their use in anaphylaxis

Publications (3)

Publication Number Publication Date
BR112012009846A2 BR112012009846A2 (pt) 2017-02-21
BR112012009846B1 BR112012009846B1 (pt) 2021-04-20
BR112012009846B8 true BR112012009846B8 (pt) 2021-05-25

Family

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BR112012009846A BR112012009846B8 (pt) 2009-10-26 2010-10-26 método in vitro e kit para detecção de um anticorpo antifármaco de isotipo ige, e uso de um anticorpo antifármaco de isotipo ige no tratamento de distúrbio mediado por ige

Country Status (19)

Country Link
US (1) US9315583B2 (pt)
EP (1) EP2494356B1 (pt)
JP (1) JP6139885B2 (pt)
KR (1) KR101832510B1 (pt)
CN (1) CN102695956B (pt)
AU (1) AU2010315470B2 (pt)
BR (1) BR112012009846B8 (pt)
CA (1) CA2778810C (pt)
DK (1) DK2494356T3 (pt)
HK (1) HK1175538A1 (pt)
HU (1) HUE033492T2 (pt)
IL (1) IL219337A (pt)
MX (1) MX344935B (pt)
MY (1) MY182750A (pt)
NZ (1) NZ599600A (pt)
RU (1) RU2642295C2 (pt)
SI (1) SI2494356T1 (pt)
WO (1) WO2011056606A1 (pt)
ZA (1) ZA201202999B (pt)

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BR112022000246A2 (pt) * 2019-07-08 2022-02-22 Gi Innovation Inc Dímero polipeptídico com elevado teor de ácido siálico, compreendendo o domínio extracelular da subunidade alfa do receptor fc de ige e composição farmacêutica compreendendo o mesmo
CN112285351A (zh) * 2019-07-22 2021-01-29 上海益诺思生物技术股份有限公司 一种抗IgE单抗的ELISA检测方法
CN110358738B (zh) * 2019-08-22 2021-08-13 中国食品药品检定研究院 一种稳定测定抗IgE抗体药物生物学活性的方法
EP4229391A1 (en) * 2020-10-14 2023-08-23 I-Mab Biopharma Co., Ltd. Methods for mitigating interference by therapeutic anti-cd47 antibodies in pre-transfusion assays
JP7062803B1 (ja) * 2021-03-31 2022-05-06 積水メディカル株式会社 抗薬物抗体測定方法
CN114047343B (zh) * 2022-01-13 2022-05-31 美迪西普亚医药科技(上海)有限公司 双耐受型抗IgE单抗药物的免疫原性分析试剂盒及其使用方法和应用
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Publication number Publication date
IL219337A0 (en) 2012-06-28
MY182750A (en) 2021-02-05
EP2494356A1 (en) 2012-09-05
MX2012004833A (es) 2012-07-04
RU2642295C2 (ru) 2018-01-24
MX344935B (es) 2017-01-11
JP2013508740A (ja) 2013-03-07
NZ599600A (en) 2015-04-24
RU2012121559A (ru) 2013-12-10
CA2778810A1 (en) 2011-05-12
BR112012009846B1 (pt) 2021-04-20
AU2010315470B2 (en) 2016-05-05
US20110183363A1 (en) 2011-07-28
EP2494356A4 (en) 2013-07-03
CN102695956B (zh) 2015-12-09
KR101832510B1 (ko) 2018-02-26
SI2494356T1 (sl) 2017-07-31
BR112012009846A2 (pt) 2017-02-21
HK1175538A1 (zh) 2013-07-05
IL219337A (en) 2017-06-29
WO2011056606A1 (en) 2011-05-12
WO2011056606A8 (en) 2012-05-18
US9315583B2 (en) 2016-04-19
ZA201202999B (en) 2013-06-26
CN102695956A (zh) 2012-09-26
KR20120116400A (ko) 2012-10-22
AU2010315470A1 (en) 2012-05-24
CA2778810C (en) 2018-09-04
JP6139885B2 (ja) 2017-05-31
EP2494356B1 (en) 2017-03-15
HUE033492T2 (en) 2017-12-28
DK2494356T3 (en) 2017-05-15

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