CN112384808B - 用于减轻抗药物抗体(ada)免疫测定中的药物靶标干扰的方法 - Google Patents

用于减轻抗药物抗体(ada)免疫测定中的药物靶标干扰的方法 Download PDF

Info

Publication number
CN112384808B
CN112384808B CN201980046236.XA CN201980046236A CN112384808B CN 112384808 B CN112384808 B CN 112384808B CN 201980046236 A CN201980046236 A CN 201980046236A CN 112384808 B CN112384808 B CN 112384808B
Authority
CN
China
Prior art keywords
drug
target
ada
drug target
antibody
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
CN201980046236.XA
Other languages
English (en)
Chinese (zh)
Other versions
CN112384808A (zh
Inventor
G·奥里弗拉·萨姆纳
陈继华
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
Publication of CN112384808A publication Critical patent/CN112384808A/zh
Application granted granted Critical
Publication of CN112384808B publication Critical patent/CN112384808B/zh
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)
CN201980046236.XA 2018-07-10 2019-07-09 用于减轻抗药物抗体(ada)免疫测定中的药物靶标干扰的方法 Active CN112384808B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862696016P 2018-07-10 2018-07-10
US62/696,016 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 (2)

Publication Number Publication Date
CN112384808A CN112384808A (zh) 2021-02-19
CN112384808B true CN112384808B (zh) 2024-10-11

Family

ID=67544324

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201980046236.XA Active CN112384808B (zh) 2018-07-10 2019-07-09 用于减轻抗药物抗体(ada)免疫测定中的药物靶标干扰的方法

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
Development of a method that eliminates false-positive results due to nerve growth factor interference in the assessment of fulranumab immunogenicity;Dai S等;AAPS J;第16卷(第03期);第464-477页 *

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
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
CN112384808B (zh) 用于减轻抗药物抗体(ada)免疫测定中的药物靶标干扰的方法
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
CN103109190B (zh) 用于测量结合治疗性单克隆抗体的抗体的测定法
WO2018227643A1 (zh) 一种用于脂肪性肝炎检测的靶标志物gp73及检测应用方法
CN108535490A (zh) 生物制剂血药浓度检测方法及试剂
KR20180135071A (ko) 바이러스 항원의 혈청학적 탐지 방법
KR20190010636A (ko) Hcv 코어 항원의 신속한 검출을 위한 전처리 방법
CA3098206C (en) Methods for mitigating drug target interference in an anti-drug antibody (ada) immunoassay
JP2024534638A (ja) 薬物濃度及び標的濃度を定量化するためのアッセイ
EA051332B1 (ru) Способы уменьшения мешающего влияния мишени лекарственного средства в иммунологическом анализе на антитела к лекарственному средству (ada)
EA045148B1 (ru) Способы уменьшения мешающего влияния мишени лекарственного средства в иммунологическом анализе на антитела к лекарственному средству (ada)
CN111316100B (zh) 检测急性博尔纳病病毒(bdv)感染的方法及其诊断试剂盒,特别是组合区分急性及慢性和潜伏性bdv感染的方法及其诊断试剂盒
US20250052768A1 (en) In vitro methods for detecting dll1
JP6329127B2 (ja) 細胞フィブロネクチンについての迅速な検査
WO2022202876A1 (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
KR101539150B1 (ko) 자가면역 항체 검출방법 및 이를 이용한 자가면역 항체 검출키트
WO2017033846A1 (ja) 免疫試験方法および免疫試験キット
HK40109436A (zh) 抑制靶干扰作用的抗药物抗体测定法
CN115925846A (zh) 用于检测针对Ses iPR-10变应原的抗体的方法和试剂
HK40031674A (en) Target interference suppressed anti-drug antibody assay
HK40031674B (zh) 抑制靶干扰作用的抗药物抗体测定法
HK1180767B (en) An assay for measurement of antibodies binding to a therapeutic monoclonal antibody

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant