MX2016005686A - Ensayo de union competitiva al ligando para detectar anticuerpos neutralizantes. - Google Patents

Ensayo de union competitiva al ligando para detectar anticuerpos neutralizantes.

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Publication number
MX2016005686A
MX2016005686A MX2016005686A MX2016005686A MX2016005686A MX 2016005686 A MX2016005686 A MX 2016005686A MX 2016005686 A MX2016005686 A MX 2016005686A MX 2016005686 A MX2016005686 A MX 2016005686A MX 2016005686 A MX2016005686 A MX 2016005686A
Authority
MX
Mexico
Prior art keywords
neutralizing antibodies
ligand binding
binding assay
competitive ligand
detecting
Prior art date
Application number
MX2016005686A
Other languages
English (en)
Inventor
Rajadhyaksha Manoj
SHYU Gary
GEORGAROS Camille
Partridge Michael
Torri Albert
Original Assignee
Regeneron Pharma
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51905411&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2016005686(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Regeneron Pharma filed Critical Regeneron Pharma
Publication of MX2016005686A publication Critical patent/MX2016005686A/es

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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
    • G01N33/68—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • 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
    • 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
    • G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
    • G01N33/6869—Interleukin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G01N2333/5412—IL-6
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/705—Assays involving receptors, cell surface antigens or cell surface determinants

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cell Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • Biotechnology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Neurology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Neurosurgery (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Psychiatry (AREA)

Abstract

La presente invención se refiere a un ensayo de inmunogenicidad, para detectar la presencia de anticuerpos neutralizantes contra una proteína bioterapéutica, en donde la proteína bioterapéutica ha sido administrada a un paciente que la necesita, que comprende los pasos de: (a) obtener una muestra del paciente; (b) incubar la muestra en presencia de un reactivo de captura; y (c) agregar un reactivo de detección, en donde una disminución de la señal en relación con una muestra de control, indica la presencia de un anticuerpo neutralizante contra el agente bioterapéutico.
MX2016005686A 2013-10-31 2014-10-30 Ensayo de union competitiva al ligando para detectar anticuerpos neutralizantes. MX2016005686A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361898046P 2013-10-31 2013-10-31
PCT/US2014/063034 WO2015066259A1 (en) 2013-10-31 2014-10-30 Competitive ligand binding assay for detecting neutralizing antibodies

Publications (1)

Publication Number Publication Date
MX2016005686A true MX2016005686A (es) 2016-08-11

Family

ID=51905411

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016005686A MX2016005686A (es) 2013-10-31 2014-10-30 Ensayo de union competitiva al ligando para detectar anticuerpos neutralizantes.

Country Status (12)

Country Link
US (1) US10261094B2 (es)
EP (1) EP3063543B1 (es)
JP (1) JP6756611B2 (es)
KR (1) KR102101987B1 (es)
CN (1) CN105765386B (es)
AU (1) AU2014342316B2 (es)
BR (1) BR112016009460B1 (es)
CA (1) CA2928730C (es)
IL (2) IL245188A0 (es)
MX (1) MX2016005686A (es)
RU (1) RU2701684C2 (es)
WO (1) WO2015066259A1 (es)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3063543B1 (en) 2013-10-31 2020-03-11 Regeneron Pharmaceuticals, Inc. Competitive ligand binding assay for detecting neutralizing antibodies
PL3509624T3 (pl) * 2016-09-12 2024-03-25 Amryt Pharmaceuticals Inc. Sposób wykrywania przeciwciał neutralizujących przeciwko leptynie
IL277890B2 (en) * 2018-04-11 2024-03-01 Regeneron Pharma Methods for quantifying il-33
AU2020275406A1 (en) * 2019-05-13 2021-11-18 Regeneron Pharmaceuticals, Inc. Improved competitive ligand binding assays
CN111983226A (zh) * 2020-03-25 2020-11-24 新加坡国立大学 SARSr-CoV抗体的检测
JP7809650B2 (ja) * 2020-05-01 2026-02-02 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 治療用タンパク質に対する中和抗体アッセイ
US20210364506A1 (en) * 2020-05-22 2021-11-25 Robert Bosch Gmbh Methods for detecting an amount of an analyte in a solution
CN112730846B (zh) * 2020-12-18 2023-12-15 安渡生物医药(杭州)有限公司 一种用于小鼠血样检测免疫复合物的方法
CN116930475A (zh) * 2022-03-31 2023-10-24 上海细胞治疗集团药物技术有限公司 中和抗体检测方法
CN115078733A (zh) * 2022-06-10 2022-09-20 苏州方达新药开发有限公司 检测细胞因子融合蛋白的中性抗体的方法
EP4591064A1 (en) * 2022-09-23 2025-07-30 Merck Sharp & Dohme LLC Neutralization antibody assay method
CN115561355B (zh) * 2022-09-26 2024-04-30 重庆迪纳利医药科技有限责任公司 羧肽酶g2的中和抗体检测方法以及基于lc-ms/ms的检测系统
CN119881340B (zh) * 2025-03-26 2025-08-12 军科正源(北京)药物研究有限责任公司 检测抗HBV preS1单抗候选药物中和抗体的方法

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Also Published As

Publication number Publication date
CA2928730C (en) 2020-06-02
AU2014342316B2 (en) 2019-07-25
JP6756611B2 (ja) 2020-09-16
JP2016536587A (ja) 2016-11-24
RU2701684C2 (ru) 2019-09-30
CA2928730A1 (en) 2015-05-07
KR102101987B1 (ko) 2020-04-20
US20160252520A1 (en) 2016-09-01
IL245188A0 (en) 2016-06-30
BR112016009460B1 (pt) 2020-09-29
AU2014342316A1 (en) 2016-05-19
WO2015066259A1 (en) 2015-05-07
BR112016009460A8 (pt) 2020-05-12
EP3063543A1 (en) 2016-09-07
CN105765386A (zh) 2016-07-13
KR20160070111A (ko) 2016-06-17
CN105765386B (zh) 2019-07-16
US10261094B2 (en) 2019-04-16
EP3063543B1 (en) 2020-03-11
RU2016121151A3 (es) 2018-07-31
IL269870B (en) 2020-08-31
RU2016121151A (ru) 2017-12-05

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