MX2016005686A - Ensayo de union competitiva al ligando para detectar anticuerpos neutralizantes. - Google Patents
Ensayo de union competitiva al ligando para detectar anticuerpos neutralizantes.Info
- 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
Links
- 230000003472 neutralizing effect Effects 0.000 title abstract 3
- 230000002860 competitive effect Effects 0.000 title 1
- 238000000670 ligand binding assay Methods 0.000 title 1
- 239000003153 chemical reaction reagent Substances 0.000 abstract 2
- 102000004169 proteins and genes Human genes 0.000 abstract 2
- 108090000623 proteins and genes Proteins 0.000 abstract 2
- 239000000523 sample Substances 0.000 abstract 2
- 238000003556 assay Methods 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000013068 control sample Substances 0.000 abstract 1
- 230000003247 decreasing effect Effects 0.000 abstract 1
- 230000005847 immunogenicity Effects 0.000 abstract 1
Classifications
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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
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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
- G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
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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
- G01N33/58—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)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- General Health & Medical Sciences (AREA)
- Microbiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cell Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Pathology (AREA)
- Physics & Mathematics (AREA)
- Biotechnology (AREA)
- Food Science & Technology (AREA)
- General Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Diabetes (AREA)
- Neurology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Endocrinology (AREA)
- Neurosurgery (AREA)
- Vascular Medicine (AREA)
- Emergency Medicine (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (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.
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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6756611B2 (ja) | 2013-10-31 | 2020-09-16 | 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 | 中和抗体を検出するための競合リガンド結合アッセイ |
| US10775386B2 (en) | 2016-09-12 | 2020-09-15 | Aegerion Pharmaceuticals, Inc. | Methods of detecting anti-leptin neutralizing antibodies |
| IL277890B2 (en) * | 2018-04-11 | 2024-03-01 | Regeneron Pharma | Methods for quantifying il-33 |
| CN113785203A (zh) * | 2019-05-13 | 2021-12-10 | 里珍纳龙药品有限公司 | 改进的竞争性配体结合测定 |
| CN111983226A (zh) * | 2020-03-25 | 2020-11-24 | 新加坡国立大学 | SARSr-CoV抗体的检测 |
| AU2021263487A1 (en) * | 2020-05-01 | 2022-11-17 | Regeneron Pharmaceuticals, Inc. | Neutralizing antibody assay for therapeutic proteins |
| 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 |
| 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 |
| 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 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4208479A (en) * | 1977-07-14 | 1980-06-17 | Syva Company | Label modified immunoassays |
| FR2813606B1 (fr) | 2000-09-01 | 2004-04-30 | Inst Nat Sante Rech Med | Proteine bard1 tronquee, et ses applications diagnostiques et therapeutiques |
| EP1649288A1 (en) | 2003-07-29 | 2006-04-26 | Genentech, Inc. | Assay for human anti cd20 antibodies and uses therefor |
| HRP20120175T1 (hr) | 2006-06-02 | 2012-03-31 | Regeneron Pharmaceuticals | Antitijela s visokim afinitetom za humani il-6 receptor |
| JP4148367B1 (ja) * | 2007-08-02 | 2008-09-10 | 富山県 | 細胞のスクリーニング方法 |
| WO2009020142A1 (ja) * | 2007-08-06 | 2009-02-12 | Chugai Seiyaku Kabushiki Kaisha | リガンド-レセプター結合阻害活性の測定方法 |
| CA2700831A1 (en) * | 2007-09-28 | 2009-04-09 | Stryker Corporation | Methods for detecting neutralizing antibodies for bone morphogenetic proteins |
| EP2391384A4 (en) * | 2009-01-29 | 2012-12-26 | Medimmune Llc | HUMAN ANTI-IL-6 ANTIBODIES WITH EXTENDED IN VIVO HALF-TIME AND USE THEREOF FOR TREATMENTS IN ONCOLOGY AND FOR AUTOIMMUNE AND IGNITION |
| CA2769407A1 (en) | 2009-08-21 | 2011-02-24 | Dana-Farber Cancer Institute, Inc. | Mimotopes of hiv and uses thereof |
| WO2011113013A2 (en) | 2010-03-11 | 2011-09-15 | Hemaquest Pharmaceuticals, Inc. | Methods and compositions for treating viral or virally-induced conditions |
| US9063151B2 (en) * | 2010-04-29 | 2015-06-23 | Theradiag Sa | Methods for detecting antibodies |
| US20130266963A1 (en) * | 2011-07-06 | 2013-10-10 | Nestec S.A. | Assay for detecting neutralizing autoantibodies to biologic therapy |
| TWI589299B (zh) | 2011-10-11 | 2017-07-01 | 再生元醫藥公司 | 用於治療類風濕性關節炎之組成物及其使用方法 |
| WO2013071055A1 (en) * | 2011-11-10 | 2013-05-16 | Wellstat Diagnostics, Llc | Assay for diabetes-associated autoantibodies |
| EA038645B1 (ru) * | 2012-12-21 | 2021-09-28 | Авео Фармасьютикалз, Инк. | Антитела к gdf15 |
| JP6756611B2 (ja) | 2013-10-31 | 2020-09-16 | 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 | 中和抗体を検出するための競合リガンド結合アッセイ |
-
2014
- 2014-10-30 JP JP2016527452A patent/JP6756611B2/ja active Active
- 2014-10-30 EP EP14799930.4A patent/EP3063543B1/en active Active
- 2014-10-30 AU AU2014342316A patent/AU2014342316B2/en active Active
- 2014-10-30 CN CN201480059578.2A patent/CN105765386B/zh active Active
- 2014-10-30 KR KR1020167012246A patent/KR102101987B1/ko active Active
- 2014-10-30 CA CA2928730A patent/CA2928730C/en active Active
- 2014-10-30 BR BR112016009460-3A patent/BR112016009460B1/pt active IP Right Grant
- 2014-10-30 WO PCT/US2014/063034 patent/WO2015066259A1/en not_active Ceased
- 2014-10-30 RU RU2016121151A patent/RU2701684C2/ru active
- 2014-10-30 US US15/031,126 patent/US10261094B2/en active Active
- 2014-10-30 MX MX2016005686A patent/MX2016005686A/es active IP Right Grant
-
2016
- 2016-04-18 IL IL245188A patent/IL245188A0/en unknown
-
2019
- 2019-10-07 IL IL269870A patent/IL269870B/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| CN105765386B (zh) | 2019-07-16 |
| CA2928730C (en) | 2020-06-02 |
| WO2015066259A1 (en) | 2015-05-07 |
| JP2016536587A (ja) | 2016-11-24 |
| RU2016121151A3 (es) | 2018-07-31 |
| KR20160070111A (ko) | 2016-06-17 |
| US10261094B2 (en) | 2019-04-16 |
| CA2928730A1 (en) | 2015-05-07 |
| RU2016121151A (ru) | 2017-12-05 |
| AU2014342316B2 (en) | 2019-07-25 |
| EP3063543B1 (en) | 2020-03-11 |
| CN105765386A (zh) | 2016-07-13 |
| EP3063543A1 (en) | 2016-09-07 |
| IL245188A0 (en) | 2016-06-30 |
| IL269870B (en) | 2020-08-31 |
| KR102101987B1 (ko) | 2020-04-20 |
| BR112016009460A8 (pt) | 2020-05-12 |
| RU2701684C2 (ru) | 2019-09-30 |
| BR112016009460B1 (pt) | 2020-09-29 |
| JP6756611B2 (ja) | 2020-09-16 |
| AU2014342316A1 (en) | 2016-05-19 |
| US20160252520A1 (en) | 2016-09-01 |
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Legal Events
| Date | Code | Title | Description |
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| FG | Grant or registration |