RU2015125739A - Тесты детекции нейтрализующих аутоантител для биологической терапии - Google Patents
Тесты детекции нейтрализующих аутоантител для биологической терапии Download PDFInfo
- Publication number
- RU2015125739A RU2015125739A RU2015125739A RU2015125739A RU2015125739A RU 2015125739 A RU2015125739 A RU 2015125739A RU 2015125739 A RU2015125739 A RU 2015125739A RU 2015125739 A RU2015125739 A RU 2015125739A RU 2015125739 A RU2015125739 A RU 2015125739A
- Authority
- RU
- Russia
- Prior art keywords
- tnfα
- autoantibody
- labeled
- tnfα drug
- therapy
- Prior art date
Links
- 230000003472 neutralizing effect Effects 0.000 title claims 26
- 238000001514 detection method Methods 0.000 title claims 2
- 238000001815 biotherapy Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 36
- 229940079593 drug Drugs 0.000 claims 33
- 239000003814 drug Substances 0.000 claims 33
- 238000002560 therapeutic procedure Methods 0.000 claims 16
- 239000000523 sample Substances 0.000 claims 15
- 108060008682 Tumor Necrosis Factor Proteins 0.000 claims 14
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims 14
- 229960001743 golimumab Drugs 0.000 claims 8
- 108010008165 Etanercept Proteins 0.000 claims 4
- 241001325209 Nama Species 0.000 claims 4
- 229960002964 adalimumab Drugs 0.000 claims 4
- 229960003115 certolizumab pegol Drugs 0.000 claims 4
- 239000013068 control sample Substances 0.000 claims 4
- 238000002651 drug therapy Methods 0.000 claims 4
- 229960000403 etanercept Drugs 0.000 claims 4
- 229940048921 humira Drugs 0.000 claims 4
- 229960000598 infliximab Drugs 0.000 claims 4
- 229940068638 simponi Drugs 0.000 claims 4
- 238000001542 size-exclusion chromatography Methods 0.000 claims 4
- 239000007850 fluorescent dye Substances 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 210000002966 serum Anatomy 0.000 claims 2
- 102000010781 Interleukin-6 Receptors Human genes 0.000 claims 1
- 108010038501 Interleukin-6 Receptors Proteins 0.000 claims 1
- 229940121730 Janus kinase 2 inhibitor Drugs 0.000 claims 1
- 241001529936 Murinae Species 0.000 claims 1
- 230000007423 decrease Effects 0.000 claims 1
- 230000003247 decreasing effect Effects 0.000 claims 1
- 238000002270 exclusion chromatography Methods 0.000 claims 1
- 229940125721 immunosuppressive agent Drugs 0.000 claims 1
- 239000003018 immunosuppressive agent Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 238000012544 monitoring process Methods 0.000 claims 1
- 239000013074 reference sample Substances 0.000 claims 1
- 230000001988 toxicity Effects 0.000 claims 1
- 231100000419 toxicity Toxicity 0.000 claims 1
- 229940121358 tyrosine kinase inhibitor Drugs 0.000 claims 1
- 239000005483 tyrosine kinase inhibitor Substances 0.000 claims 1
- 150000004917 tyrosine kinase inhibitor derivatives Chemical class 0.000 claims 1
Classifications
-
- 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
- G01N33/564—Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
-
- 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
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
- G01N33/502—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing non-proliferative effects
-
- 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
- G01N2333/525—Tumor necrosis factor [TNF]
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Chemical & Material Sciences (AREA)
- Urology & Nephrology (AREA)
- Food Science & Technology (AREA)
- General Physics & Mathematics (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Pathology (AREA)
- Microbiology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Rehabilitation Therapy (AREA)
- Rheumatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Toxicology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261732251P | 2012-11-30 | 2012-11-30 | |
| US61/732,251 | 2012-11-30 | ||
| US13/802,117 US20130266963A1 (en) | 2011-07-06 | 2013-03-13 | Assay for detecting neutralizing autoantibodies to biologic therapy |
| US13/802,117 | 2013-03-13 | ||
| PCT/IB2013/060458 WO2014083520A2 (en) | 2012-11-30 | 2013-11-27 | Assays for detecting neutralizing autoantibodies to biologic therapy |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2015125739A true RU2015125739A (ru) | 2017-01-13 |
Family
ID=50828561
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015125739A RU2015125739A (ru) | 2012-11-30 | 2013-11-27 | Тесты детекции нейтрализующих аутоантител для биологической терапии |
Country Status (13)
| Country | Link |
|---|---|
| EP (1) | EP2926136A2 (enExample) |
| JP (1) | JP2016502091A (enExample) |
| KR (1) | KR20150088890A (enExample) |
| CN (1) | CN105074461A (enExample) |
| AU (1) | AU2013350817A1 (enExample) |
| BR (1) | BR112015012482A2 (enExample) |
| CA (1) | CA2892766A1 (enExample) |
| HK (1) | HK1215969A1 (enExample) |
| IL (1) | IL238995A0 (enExample) |
| MX (1) | MX2015006852A (enExample) |
| RU (1) | RU2015125739A (enExample) |
| SG (2) | SG11201504097PA (enExample) |
| WO (1) | WO2014083520A2 (enExample) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2010315547C1 (en) | 2009-10-26 | 2015-06-04 | Société des Produits Nestlé S.A. | Assays for the detection of anti-TNF drugs and autoantibodies |
| AU2011317149B2 (en) | 2010-10-18 | 2015-05-07 | Société des Produits Nestlé S.A. | Methods for determining anti-drug antibody isotypes |
| RU2013158256A (ru) | 2011-07-06 | 2015-07-10 | Нестек С.А. | АНАЛИЗЫ ДЛЯ ОБНАРУЖЕНИЯ НЕЙТРАЛИЗУЮЩИХ АУТОАНТИТЕЛ ДЛЯ БИОЛОГИЧЕСКОЙ ТЕРАПИИ TNFα |
| ES2735085T3 (es) | 2014-12-05 | 2019-12-16 | Nestle Sa | Ensayos de cambio de movilidad homogéneos indirectos para la detección de agentes biológicos en muestras de pacientes |
| US11085931B2 (en) | 2015-01-09 | 2021-08-10 | W. Health L.P. | Universal assay for determining the quantity of TNFα inhibitory drugs and their corresponding anti-drug-antibodies |
| EP3482199A1 (en) * | 2016-07-08 | 2019-05-15 | Atonomics A/S | A universal assay for determining the quantity of therapeutic monoclonal antibodies and their corresponding anti-drug-antibodies in samples |
| AU2018241286B2 (en) | 2017-03-31 | 2025-03-13 | Ablynx N.V. | Improved immunogenicity assays |
| JP7570421B2 (ja) * | 2020-01-02 | 2024-10-21 | エフ. ホフマン-ラ ロシュ アーゲー | Ada応答特定アッセイ |
| CN111024958B (zh) * | 2020-03-11 | 2020-06-23 | 同昕生物技术(北京)有限公司 | 用于检测单抗药物和抗单抗药物抗体的试剂及其应用 |
| 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 |
| 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 |
| CN117871856A (zh) * | 2023-12-15 | 2024-04-12 | 首都医科大学附属北京地坛医院 | 可溶性因子在无症状神经梅毒检测中的应用 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2010315547C1 (en) * | 2009-10-26 | 2015-06-04 | Société des Produits Nestlé S.A. | Assays for the detection of anti-TNF drugs and autoantibodies |
| CN102884433A (zh) * | 2010-04-29 | 2013-01-16 | 塞拉蒂亚戈公司 | 用于检测抗体的方法 |
| AU2011317149B2 (en) * | 2010-10-18 | 2015-05-07 | Société des Produits Nestlé S.A. | Methods for determining anti-drug antibody isotypes |
| ES2530175T3 (es) * | 2011-02-17 | 2015-02-26 | Nestec S.A. | Ensayos para la detección de autoanticuerpos contra fármacos anti-TNF |
| RU2013158256A (ru) * | 2011-07-06 | 2015-07-10 | Нестек С.А. | АНАЛИЗЫ ДЛЯ ОБНАРУЖЕНИЯ НЕЙТРАЛИЗУЮЩИХ АУТОАНТИТЕЛ ДЛЯ БИОЛОГИЧЕСКОЙ ТЕРАПИИ TNFα |
-
2013
- 2013-11-21 BR BR112015012482A patent/BR112015012482A2/pt not_active IP Right Cessation
- 2013-11-27 CN CN201380071748.4A patent/CN105074461A/zh active Pending
- 2013-11-27 MX MX2015006852A patent/MX2015006852A/es unknown
- 2013-11-27 SG SG11201504097PA patent/SG11201504097PA/en unknown
- 2013-11-27 RU RU2015125739A patent/RU2015125739A/ru not_active Application Discontinuation
- 2013-11-27 AU AU2013350817A patent/AU2013350817A1/en not_active Abandoned
- 2013-11-27 CA CA2892766A patent/CA2892766A1/en not_active Abandoned
- 2013-11-27 HK HK16103834.6A patent/HK1215969A1/zh unknown
- 2013-11-27 KR KR1020157017311A patent/KR20150088890A/ko not_active Withdrawn
- 2013-11-27 EP EP13820955.6A patent/EP2926136A2/en not_active Withdrawn
- 2013-11-27 WO PCT/IB2013/060458 patent/WO2014083520A2/en not_active Ceased
- 2013-11-27 JP JP2015544592A patent/JP2016502091A/ja active Pending
- 2013-11-27 SG SG10201703210XA patent/SG10201703210XA/en unknown
-
2015
- 2015-05-25 IL IL238995A patent/IL238995A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2014083520A3 (en) | 2014-07-31 |
| JP2016502091A (ja) | 2016-01-21 |
| IL238995A0 (en) | 2015-07-30 |
| MX2015006852A (es) | 2015-09-16 |
| WO2014083520A2 (en) | 2014-06-05 |
| BR112015012482A2 (pt) | 2017-07-11 |
| CN105074461A (zh) | 2015-11-18 |
| KR20150088890A (ko) | 2015-08-03 |
| SG11201504097PA (en) | 2015-06-29 |
| AU2013350817A1 (en) | 2015-06-11 |
| SG10201703210XA (en) | 2017-06-29 |
| CA2892766A1 (en) | 2014-06-05 |
| EP2926136A2 (en) | 2015-10-07 |
| HK1215969A1 (zh) | 2016-09-30 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA93 | Acknowledgement of application withdrawn (no request for examination) |
Effective date: 20161128 |