IL277888B2 - Methods for reducing drug target interference in anti-drug antibody (ADA) immunoassays - Google Patents

Methods for reducing drug target interference in anti-drug antibody (ADA) immunoassays

Info

Publication number
IL277888B2
IL277888B2 IL277888A IL27788820A IL277888B2 IL 277888 B2 IL277888 B2 IL 277888B2 IL 277888 A IL277888 A IL 277888A IL 27788820 A IL27788820 A IL 27788820A IL 277888 B2 IL277888 B2 IL 277888B2
Authority
IL
Israel
Prior art keywords
drug
drug target
label
antibody
ada
Prior art date
Application number
IL277888A
Other languages
English (en)
Hebrew (he)
Other versions
IL277888B1 (en
IL277888A (en
Inventor
Giane Sumner
Jihua Chen
Original Assignee
Regeneron Pharma
Giane Sumner
Jihua Chen
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 Regeneron Pharma, Giane Sumner, Jihua Chen filed Critical Regeneron Pharma
Publication of IL277888A publication Critical patent/IL277888A/en
Publication of IL277888B1 publication Critical patent/IL277888B1/en
Publication of IL277888B2 publication Critical patent/IL277888B2/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • G01N33/5306Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
    • 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
    • G01N33/577Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies
    • 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
    • G01N33/58Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • 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
    • G01N33/94Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
    • 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
    • C07K2317/52Constant or Fc region; Isotype

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Physics & Mathematics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
IL277888A 2018-07-10 2019-07-09 Methods for reducing drug target interference in anti-drug antibody (ADA) immunoassays IL277888B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862696016P 2018-07-10 2018-07-10
PCT/US2019/040950 WO2020014194A1 (en) 2018-07-10 2019-07-09 Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay

Publications (3)

Publication Number Publication Date
IL277888A IL277888A (en) 2020-11-30
IL277888B1 IL277888B1 (en) 2024-12-01
IL277888B2 true IL277888B2 (en) 2025-04-01

Family

ID=67544324

Family Applications (1)

Application Number Title Priority Date Filing Date
IL277888A IL277888B2 (en) 2018-07-10 2019-07-09 Methods for reducing drug target interference in anti-drug antibody (ADA) immunoassays

Country Status (16)

Country Link
US (2) US12055551B2 (https=)
EP (1) EP3821255B1 (https=)
JP (3) JP7493459B2 (https=)
KR (1) KR102754704B1 (https=)
CN (1) CN112384808B (https=)
AU (1) AU2019301614B2 (https=)
BR (1) BR112020022912A2 (https=)
EA (1) EA202190237A1 (https=)
ES (1) ES2993989T3 (https=)
IL (1) IL277888B2 (https=)
MA (1) MA53130A (https=)
MX (1) MX2021000331A (https=)
MY (1) MY207418A (https=)
SG (1) SG11202011283TA (https=)
WO (1) WO2020014194A1 (https=)
ZA (1) ZA202006409B (https=)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2022011336A (es) * 2020-03-17 2022-10-07 Regeneron Pharma Atenuacion de la interferencia de dianas en ensayo de anticuerpos antifarmacos.
CN114264814B (zh) * 2021-12-30 2025-03-14 苏州和锐生物科技有限公司 一种pd-1生物制剂的抗体检测试剂盒及制备方法
CN114324894A (zh) * 2021-12-31 2022-04-12 军科正源(北京)药物研究有限责任公司 一种检测贝伐珠单抗抗药性抗体的新型分析方法
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
JP2025514738A (ja) * 2022-04-19 2025-05-09 ソングァン メディカル ファンデーション 血液中の抗薬物抗体濃度測定による生物学的薬物に対する治療反応性の予測方法
WO2024044622A1 (en) * 2022-08-24 2024-02-29 Amgen Inc. Anti-drug antibody assays
CN115586337A (zh) * 2022-09-14 2023-01-10 杭州赛基生物科技有限公司 检测肿瘤伴随诊断相关因子的试剂盒及其制备方法
CN120239821A (zh) * 2022-09-23 2025-07-01 默沙东有限责任公司 中和抗体测定方法
CN115575468B (zh) * 2022-09-30 2025-08-26 华润生物医药有限公司 一种检测抗重组人GLP-1-Fc融合蛋白抗体的方法
CN115856322A (zh) * 2022-12-23 2023-03-28 同昕生物技术(北京)有限公司 用于抗奥马株单抗药物抗体检测的试剂及其应用
CN117805382B (zh) * 2024-02-28 2024-05-03 军科正源(北京)药物研究有限责任公司 检测抗利妥昔单抗中和抗体的方法
WO2025224166A1 (en) * 2024-04-23 2025-10-30 F. Hoffmann-La Roche Ag Anti-drug antibody assays

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3856469A (en) 1973-01-02 1974-12-24 Syva Corp Interferant removal from amphetamine immunoassay
JPS55145690A (en) 1979-05-04 1980-11-13 Toyama Chem Co Ltd Novel penicillin and cephalosporin, and its salt
JPS6454356A (en) * 1987-08-26 1989-03-01 Meidensha Electric Mfg Co Ltd Method for suppressing non-specific adsorption of antibody to solid phase antigen
JPH02138872A (ja) * 1988-11-18 1990-05-28 Asahi Chem Ind Co Ltd 癌関連物質のための免疫測定方法
US20060281132A1 (en) * 2003-09-26 2006-12-14 Fumihisa Kitawaki Method of immunoreaction measurement and, for use therein, reagent, kit and optical cell
CN101680880A (zh) 2007-05-07 2010-03-24 惠氏公司 免疫检定中由抗碳水化合物抗体引起的干扰的消除
WO2009022001A1 (en) 2007-08-16 2009-02-19 Novartis Ag Improvement of drug tolerance in immunogenicity testing
DK2723769T4 (da) * 2011-06-23 2022-09-05 Ablynx Nv Teknikker til at forudsige, påvise og reducere uspecifik proteininterferens i assays, som involverer variable immunglobulin-enkeltdomæner
CN105378480B (zh) * 2013-07-04 2018-06-12 豪夫迈·罗氏有限公司 检测血清样品中抗药物抗体的干扰抑制性免疫测定
CA2939080A1 (en) * 2014-02-11 2015-08-20 Genzyme Corporation Assays for detecting the presence or amount of an anti-drug antibody
WO2017096262A1 (en) * 2015-12-04 2017-06-08 Jomoco, Corp. Compositions and methods to mitigate or prevent an immune response to an immunogenic therapeutic molecule in non-human primates
US20190145985A1 (en) 2017-11-10 2019-05-16 BioAgilytix Labs, LLC Method for eliminating target interference
AU2018374469B2 (en) 2017-11-29 2022-06-16 F. Hoffmann-La Roche Ag Target interference suppressed anti-drug antibody assay
MX2022011336A (es) * 2020-03-17 2022-10-07 Regeneron Pharma Atenuacion de la interferencia de dianas en ensayo de anticuerpos antifarmacos.

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DAI S. ET AL.,, DEVELOPMENT OF A METHOD THAT ELIMINATES FALSE-POSITIVE RESULTS DUE TO NERVE GROWTH FACTOR INTERFERENCE IN THE ASSESSMENT OF FULRANUMAB IMMUNOGENICITY, 3 May 2014 (2014-05-03) *

Also Published As

Publication number Publication date
CN112384808A (zh) 2021-02-19
IL277888B1 (en) 2024-12-01
MY207418A (en) 2025-02-26
US20240353423A1 (en) 2024-10-24
ZA202006409B (en) 2025-07-30
KR20210031854A (ko) 2021-03-23
AU2019301614B2 (en) 2025-11-20
JP2026012856A (ja) 2026-01-27
JP2024045646A (ja) 2024-04-02
EP3821255B1 (en) 2024-08-28
BR112020022912A2 (pt) 2021-02-23
KR102754704B1 (ko) 2025-01-20
MA53130A (fr) 2021-05-19
JP7493459B2 (ja) 2024-05-31
US12055551B2 (en) 2024-08-06
WO2020014194A1 (en) 2020-01-16
IL277888A (en) 2020-11-30
CN112384808B (zh) 2024-10-11
ES2993989T3 (en) 2025-01-15
MX2021000331A (es) 2021-03-25
EP3821255A1 (en) 2021-05-19
CA3098206A1 (en) 2020-01-16
AU2019301614A1 (en) 2020-10-22
US20200018770A1 (en) 2020-01-16
JP2021531448A (ja) 2021-11-18
SG11202011283TA (en) 2020-12-30
EA202190237A1 (ru) 2021-04-15

Similar Documents

Publication Publication Date Title
IL277888B2 (en) Methods for reducing drug target interference in anti-drug antibody (ADA) immunoassays
Tadesse et al. Submicroscopic carriage of Plasmodium falciparum and Plasmodium vivax in a low endemic area in Ethiopia where no parasitaemia was detected by microscopy or rapid diagnostic test
Wang et al. Detection of okadaic acid (OA) using ELISA and colloidal gold immunoassay based on monoclonal antibody
Yang et al. Quantitative determination of major capsaicinoids in serum by ELISA and time-resolved fluorescent immunoassay based on monoclonal antibodies
Jiang et al. A highly sensitive and quantitative time resolved fluorescent microspheres lateral flow immunoassay for streptomycin and dihydrostreptomycin in milk, honey, muscle, liver, and kidney
JP2021531448A5 (https=)
Yao et al. Colloidal gold‐McAb probe‐based rapid immunoassay strip for simultaneous detection of fumonisins in maize
Cunha et al. Serologically defined variations in malaria endemicity in Pará state, Brazil
CA3068673A1 (en) Assays for assessing neutralizing antibodies levels in subjects treated with a biological drug and uses thereof in personalized medicine
Li et al. Visible and eco‐friendly immunoassays for the detection of cyclopiazonic acid in maize and rice
Lu et al. Production of monoclonal antibody and application in indirect competitive ELISA for detecting okadaic acid and dinophytoxin-1 in seafood
O'Kennedy et al. Don't blame it all on antibodies–The need for exhaustive characterisation, appropriate handling, and addressing the issues that affect specificity
Wu et al. Development of an immunochromatographic test strip for rapid simultaneous detection of enrofloxacin and ofloxacin in tissue of chicken muscle and pork
Yang et al. A lateral flow immunochromato-graphic strip test for rapid detection of oseltamivir phosphate in egg and chicken meat
Širović et al. Using passive acoustics to model blue whale habitat off the Western Antarctic Peninsula
MX2008000277A (es) Deteccion de un antigeno diana independientemente de la presencia o ausencia de un anticuerpo terapeutico correspondiente.
JP2011509079A5 (https=)
Galvidis et al. Broadening the detection spectrum of small analytes using a two-antibody-designed hybrid immunoassay
Galatas et al. Field performance of ultrasensitive and conventional malaria rapid diagnostic tests in southern Mozambique
Xu et al. Production of monoclonal antibody and development of a new immunoassay for apramycin in food
Na et al. A highly sensitive monoclonal antibody− based paper sensor for simultaneously detecting valnemulin and tiamulin in porcine liver
Zeng et al. Development of a monoclonal antibody–based time-resolved fluorescence immunochromatographic assay strip for sensitively detecting florfenicol residues in milk and eggs: Theoretical chemical insights into unexpected high specificity
Díaz-Avello et al. Aptamer-antibody sandwich lateral flow test for rapid visual detection of tetrodotoxin in pufferfish
Wang et al. Rapid enzyme-linked immunosorbent assay and colloidal gold immunoassay for assessing okadaic acid and its derivatives in shellfish
Craig et al. Integrating post-validation surveillance of lymphatic filariasis with the WHO STEPwise approach to non-communicable disease risk factor surveillance in Niue, a study protocol