ES2993989T3 - Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay - Google Patents

Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay Download PDF

Info

Publication number
ES2993989T3
ES2993989T3 ES19749872T ES19749872T ES2993989T3 ES 2993989 T3 ES2993989 T3 ES 2993989T3 ES 19749872 T ES19749872 T ES 19749872T ES 19749872 T ES19749872 T ES 19749872T ES 2993989 T3 ES2993989 T3 ES 2993989T3
Authority
ES
Spain
Prior art keywords
drug
target
ada
antibody
drug target
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES19749872T
Other languages
English (en)
Spanish (es)
Inventor
Sumner Giane Oliveira
Jihua Chen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Regeneron Pharmaceuticals Inc
Original Assignee
Regeneron Pharmaceuticals Inc
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 Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Application granted granted Critical
Publication of ES2993989T3 publication Critical patent/ES2993989T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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)
ES19749872T 2018-07-10 2019-07-09 Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay Active ES2993989T3 (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 (1)

Publication Number Publication Date
ES2993989T3 true ES2993989T3 (en) 2025-01-15

Family

ID=67544324

Family Applications (1)

Application Number Title Priority Date Filing Date
ES19749872T Active ES2993989T3 (en) 2018-07-10 2019-07-09 Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay

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.

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
IL277888B2 (en) 2025-04-01
IL277888A (en) 2020-11-30
CN112384808B (zh) 2024-10-11
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
ES2993989T3 (en) Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay
ES2705403T3 (es) Ensayos para detectar la presencia o cantidad de un anticuerpo antifármaco
RU2674996C2 (ru) Иммуноферментный анализ с подавлением интерференции для определения антител к лекарствам в образцах сыворотки
JP7105970B1 (ja) SARS-CoV-2の免疫測定方法及び免疫測定キット
JP7216948B1 (ja) SARS-CoV-2の免疫測定方法及び免疫測定キット、並びにモノクローナル抗体又はその抗体断片
CN103109190A (zh) 用于测量结合治疗性单克隆抗体的抗体的测定法
US11150247B2 (en) Method for serological detection of viral antigens
US11327077B2 (en) Pretreatment method for rapid detection of HCV core antigen
CA3098206C (en) Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay
EA051332B1 (ru) Способы уменьшения мешающего влияния мишени лекарственного средства в иммунологическом анализе на антитела к лекарственному средству (ada)
EP3577460B1 (en) Immunoassay using at least two pegylated analyte-specific binding agents
US20250172570A1 (en) Immunoassay method for cross-linked n-telopeptide of type i collagen, immunoassay kit, and antibody or antibody fragment thereof
EA045148B1 (ru) Способы уменьшения мешающего влияния мишени лекарственного средства в иммунологическом анализе на антитела к лекарственному средству (ada)
US12467921B2 (en) Antibodies and assays for detection of Burkholderia mallei
JP7845752B2 (ja) I型コラーゲンc末端テロペプチドの免疫学的分析方法、分析キット、及びモノクローナル抗体
KR101539150B1 (ko) 자가면역 항체 검출방법 및 이를 이용한 자가면역 항체 검출키트
CN115925846A (zh) 用于检测针对Ses iPR-10变应原的抗体的方法和试剂
HK40129003A (en) Method for immunologically measuring hemoglobin using deglycosylated haptoglobin