CA2913687C - Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples - Google Patents

Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples Download PDF

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Publication number
CA2913687C
CA2913687C CA2913687A CA2913687A CA2913687C CA 2913687 C CA2913687 C CA 2913687C CA 2913687 A CA2913687 A CA 2913687A CA 2913687 A CA2913687 A CA 2913687A CA 2913687 C CA2913687 C CA 2913687C
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Prior art keywords
antibody
drug
assay
tcz
drug antibody
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CA2913687A
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English (en)
French (fr)
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CA2913687A1 (en
Inventor
Kay-Gunnar Stubenrauch
Rudolf Vogel
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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Publication of CA2913687A1 publication Critical patent/CA2913687A1/en
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54393—Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • 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
    • C07K16/2866—Immunoglobulins [IGs], 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • 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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Cell Biology (AREA)
  • Analytical Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Rheumatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Oncology (AREA)
  • Mycology (AREA)
CA2913687A 2013-07-04 2014-07-01 Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples Active CA2913687C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13175091.1 2013-07-04
EP13175091 2013-07-04
PCT/EP2014/063891 WO2015000865A1 (en) 2013-07-04 2014-07-01 Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples

Publications (2)

Publication Number Publication Date
CA2913687A1 CA2913687A1 (en) 2015-01-08
CA2913687C true CA2913687C (en) 2022-12-13

Family

ID=48703341

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2913687A Active CA2913687C (en) 2013-07-04 2014-07-01 Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples

Country Status (10)

Country Link
US (2) US10168326B2 (cg-RX-API-DMAC7.html)
EP (1) EP3017303B1 (cg-RX-API-DMAC7.html)
JP (2) JP6563910B2 (cg-RX-API-DMAC7.html)
KR (1) KR102248581B1 (cg-RX-API-DMAC7.html)
CN (1) CN105378480B (cg-RX-API-DMAC7.html)
BR (1) BR112015032960B1 (cg-RX-API-DMAC7.html)
CA (1) CA2913687C (cg-RX-API-DMAC7.html)
MX (1) MX363403B (cg-RX-API-DMAC7.html)
RU (1) RU2674996C2 (cg-RX-API-DMAC7.html)
WO (1) WO2015000865A1 (cg-RX-API-DMAC7.html)

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EP3667321B1 (en) * 2014-02-11 2022-07-27 Genzyme Corporation Assays for detecting the presence or amount of an anti-drug antibody
EP3391050B1 (en) 2015-12-16 2020-09-16 F. Hoffmann-La Roche AG Three-step acid dissociation enzyme linked immunosorbent (tadelis) assay
EP3592367B1 (en) * 2017-03-07 2025-04-23 Roche Diagnostics GmbH Stable formulations for immune-modulatory macrolides
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MX2021000331A (es) * 2018-07-10 2021-03-25 Regeneron Pharma Metodos para mitigar la interferencia de la diana farmacologica en un inmunoensayo de anticuerpos antifarmaco (ada).
WO2020229378A1 (en) * 2019-05-13 2020-11-19 F. Hoffmann-La Roche Ag Interference-suppressed pharmacokinetic immunoassay
US11913945B2 (en) * 2020-01-02 2024-02-27 Hoffmann-La Roche Inc. Method for determining the amount of a therapeutic antibody in the brain
CN113495141A (zh) * 2020-03-20 2021-10-12 迈克生物股份有限公司 2019新型冠状病毒IgM抗体检测试剂盒
KR20230009502A (ko) * 2020-05-18 2023-01-17 바이오션, 인코포레이티드 Il6r에 결합하는 항체 및 이의 용도
KR102626197B1 (ko) * 2020-11-19 2024-01-18 바디텍메드(주) 항 약물 항체의 수준을 정확하게 정량화하는 방법
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
WO2024165456A1 (en) * 2023-02-07 2024-08-15 F. Hoffmann-La Roche Ag Method for the detection of anti-aav particle antibodies
WO2024220763A1 (en) * 2023-04-20 2024-10-24 Xentria, Inc. Methods for detecting an anti-drug antibody (ada) against an anti-tnf alpha antibody
CN120761634B (zh) * 2025-09-02 2025-12-05 宁波熙宁检测技术有限公司 一种针对多特异性单克隆抗体药物的ada检测方法

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