RU2015148676A - Способы выявления препаратов и аутоантител против tnf - Google Patents
Способы выявления препаратов и аутоантител против tnf Download PDFInfo
- Publication number
- RU2015148676A RU2015148676A RU2015148676A RU2015148676A RU2015148676A RU 2015148676 A RU2015148676 A RU 2015148676A RU 2015148676 A RU2015148676 A RU 2015148676A RU 2015148676 A RU2015148676 A RU 2015148676A RU 2015148676 A RU2015148676 A RU 2015148676A
- Authority
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- Russia
- Prior art keywords
- labeled
- tnfα
- complex
- drug
- labeled complex
- Prior art date
Links
- 239000003814 drug Substances 0.000 title claims 20
- 238000000034 method Methods 0.000 title claims 19
- 229940079593 drug Drugs 0.000 title claims 18
- 108060008682 Tumor Necrosis Factor Proteins 0.000 claims 14
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims 14
- 238000001542 size-exclusion chromatography Methods 0.000 claims 5
- 108010008165 Etanercept Proteins 0.000 claims 4
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 claims 4
- 230000003472 neutralizing effect Effects 0.000 claims 3
- 239000012099 Alexa Fluor family Substances 0.000 claims 2
- 241001325209 Nama Species 0.000 claims 2
- 229960002964 adalimumab Drugs 0.000 claims 2
- 229960003115 certolizumab pegol Drugs 0.000 claims 2
- 229940090100 cimzia Drugs 0.000 claims 2
- 239000000975 dye Substances 0.000 claims 2
- 229940073621 enbrel Drugs 0.000 claims 2
- 229960000403 etanercept Drugs 0.000 claims 2
- 229940048921 humira Drugs 0.000 claims 2
- 229960000598 infliximab Drugs 0.000 claims 2
- 229940116176 remicade Drugs 0.000 claims 2
- 210000002966 serum Anatomy 0.000 claims 2
- 229940046728 tumor necrosis factor alpha inhibitor Drugs 0.000 claims 1
- 239000002452 tumor necrosis factor alpha inhibitor Substances 0.000 claims 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
- G01N33/53—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P33/00—Antiparasitic agents
-
- 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
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
- G01N33/5091—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing the pathological state of an organism
-
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography
-
- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Public Health (AREA)
- Biotechnology (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Rheumatology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Rehabilitation Therapy (AREA)
- Physiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Physical Education & Sports Medicine (AREA)
- Pain & Pain Management (AREA)
- Neurology (AREA)
- Ophthalmology & Optometry (AREA)
Applications Claiming Priority (14)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25504809P | 2009-10-26 | 2009-10-26 | |
| US61/255,048 | 2009-10-26 | ||
| US26287709P | 2009-11-19 | 2009-11-19 | |
| US61/262,877 | 2009-11-19 | ||
| US32463510P | 2010-04-15 | 2010-04-15 | |
| US61/324,635 | 2010-04-15 | ||
| US34556710P | 2010-05-17 | 2010-05-17 | |
| US61/345,567 | 2010-05-17 | ||
| US35126910P | 2010-06-03 | 2010-06-03 | |
| US61/351,269 | 2010-06-03 | ||
| US38967210P | 2010-10-04 | 2010-10-04 | |
| US61/389,672 | 2010-10-04 | ||
| US39358110P | 2010-10-15 | 2010-10-15 | |
| US61/393,581 | 2010-10-15 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2012121710/15A Division RU2571489C2 (ru) | 2009-10-26 | 2010-10-26 | Способы выявления препаратов и аутоантител против tnf |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2015148676A true RU2015148676A (ru) | 2019-01-15 |
| RU2015148676A3 RU2015148676A3 (https=) | 2019-06-18 |
Family
ID=43618083
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015148676A RU2015148676A (ru) | 2009-10-26 | 2010-10-26 | Способы выявления препаратов и аутоантител против tnf |
| RU2012121710/15A RU2571489C2 (ru) | 2009-10-26 | 2010-10-26 | Способы выявления препаратов и аутоантител против tnf |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2012121710/15A RU2571489C2 (ru) | 2009-10-26 | 2010-10-26 | Способы выявления препаратов и аутоантител против tnf |
Country Status (15)
| Country | Link |
|---|---|
| US (5) | US8574855B2 (https=) |
| EP (1) | EP2494352B1 (https=) |
| JP (3) | JP5697677B2 (https=) |
| KR (2) | KR101881714B1 (https=) |
| CN (2) | CN102695955B (https=) |
| AU (4) | AU2010315547C1 (https=) |
| BR (1) | BR112012009855A2 (https=) |
| CA (2) | CA2778454C (https=) |
| ES (1) | ES2796530T3 (https=) |
| IL (2) | IL219315B (https=) |
| MX (2) | MX2012004877A (https=) |
| NZ (3) | NZ706187A (https=) |
| RU (2) | RU2015148676A (https=) |
| WO (1) | WO2011056590A1 (https=) |
| ZA (2) | ZA201203717B (https=) |
Families Citing this family (39)
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| EP3225625A1 (en) | 2002-09-11 | 2017-10-04 | Chugai Seiyaku Kabushiki Kaisha | Protein purification method |
| US7612181B2 (en) | 2005-08-19 | 2009-11-03 | Abbott Laboratories | Dual variable domain immunoglobulin and uses thereof |
| JP5697677B2 (ja) | 2009-10-26 | 2015-04-08 | ネステク ソシエテ アノニム | 抗ｔｎｆ薬及び自己抗体の検出用アッセイ |
| NZ609363A (en) | 2010-10-18 | 2015-04-24 | Nestec Sa | Methods for determining anti-drug antibody isotypes |
| CA2827609A1 (en) * | 2011-02-17 | 2012-11-15 | Nestec S.A. | Assays for detecting autoantibodies to anti-tnf.alpha. drugs |
| AU2012253422B2 (en) | 2011-05-10 | 2015-08-13 | Société des Produits Nestlé S.A. | Methods of disease activity profiling for personalized therapy management |
| KR20140047628A (ko) * | 2011-07-06 | 2014-04-22 | 네스텍 소시에테아노님 | Ｔｎｆ알파로의 생물학적 치료요법에 대한 중화 자가항체의 검출을 위한 검정 |
| EP2786156A2 (en) * | 2011-11-30 | 2014-10-08 | AbbVie Deutschland GmbH & Co KG | Methods and compositions for determining responsiveness to treatment with a tnf-alpha inhibitor |
| KR102084805B1 (ko) * | 2012-03-08 | 2020-03-04 | 에프. 호프만-라 로슈 아게 | 순환 면역 복합체의 특성화를 위한 다중 크로마토그래피-면역분석 방법 |
| US20130295685A1 (en) * | 2012-04-10 | 2013-11-07 | Nestec S.A. | Mobility shift assays for detecting anti-tnf alpha drugs and autoantibodies |
| US10132736B2 (en) | 2012-05-24 | 2018-11-20 | Abbvie Inc. | Methods for inspection of protein particles in a liquid beneficial agent |
| WO2014046474A2 (ko) * | 2012-09-21 | 2014-03-27 | 가톨릭대학교 산학협력단 | 메트포민을 유효성분으로 함유하는 염증성 장질환의 예방 또는 치료용 조성물 |
| KR101501375B1 (ko) | 2012-09-21 | 2015-03-10 | 가톨릭대학교 산학협력단 | 메트포민을 유효성분으로 함유하는 염증성 장질환의 예방 또는 치료용 조성물 |
| EP2904405B1 (en) | 2012-10-05 | 2017-05-31 | Nestec S.A. | Methods for predicting and monitoring mucosal healing |
| BR112015012482A2 (pt) * | 2012-11-30 | 2017-07-11 | Nestec Sa | ensaios para detecção de autoanticorpos neutralizantes à terapia com produtos biológicos |
| WO2014122600A1 (en) | 2013-02-05 | 2014-08-14 | Nestec S.A. | Methods of selecting combination therapy for colorectal cancer patients |
| WO2014184768A1 (en) * | 2013-05-16 | 2014-11-20 | University Of Pretoria | A method of diagnosing tuberculosis |
| WO2015083087A1 (en) | 2013-12-03 | 2015-06-11 | Nestec S.A. | Methods for predicting post-operative recurrence of crohn's disease |
| CA2932569A1 (en) | 2013-12-03 | 2015-06-11 | Societe Des Produits Nestle S.A. | Signaling pathways in tissues from inflammatory bowel disease patients |
| WO2015110989A1 (en) | 2014-01-23 | 2015-07-30 | Nestec S.A. | Biomarker panel for assessment of mucosal healing |
| WO2015166461A1 (en) | 2014-05-01 | 2015-11-05 | Nestec S.A. | Methods of selecting treatment regimen using tnf alpha and anti-tnf alpha drug levels |
| MX2017004816A (es) | 2014-10-20 | 2017-08-02 | Nestec Sa | Métodos para predecir resultados clínicos en sujetos afectados con colitis ulcerosa. |
| CA2964857A1 (en) | 2014-10-20 | 2016-04-28 | Nestec S.A. | Methods for prediction of anti-tnf alpha drug levels and autoantibody formation |
| HK1244881A1 (zh) | 2014-12-02 | 2018-08-17 | Société des Produits Nestlé S.A. | 建立维多珠单坑给药方案以治疗患有易激惹肠病的患者的方法 |
| CN107250798A (zh) | 2014-12-05 | 2017-10-13 | 雀巢产品技术援助有限公司 | 用于检测患者样品中的生物制品的间接均相迁移率变动试验 |
| CN107110853A (zh) * | 2015-01-09 | 2017-08-29 | 阿通诺米斯公司 | 确定TNFα抑制药及其相应抗药抗体的量的通用测定法 |
| WO2016135707A1 (en) | 2015-02-27 | 2016-09-01 | Nestec S.A. | Diagnosis of major depressive disorder, mild cognitive impairment, and alzheimer's disease and other neurologic and psychiatric disorders |
| ES2716900T3 (es) | 2015-11-06 | 2019-06-17 | Promise Advanced Proteomics | Un método para cuantificar anticuerpos anti-TNF |
| EP3165922B1 (en) | 2015-11-06 | 2020-06-17 | Promise Proteomics | A method for quantifying therapeutic antibodies |
| WO2017201142A1 (en) * | 2016-05-17 | 2017-11-23 | Memorial Sloan Kettering Cancer Center | Treatment of lung adenocarcinoma |
| WO2018007327A1 (en) * | 2016-07-08 | 2018-01-11 | Atonomics A/S | A universal assay for determining the quantity of therapeutic monoclonal antibodies and their corresponding anti-drug-antibodies in samples |
| KR20200069333A (ko) | 2017-10-10 | 2020-06-16 | 프로메테우스 바이오사이언시즈, 인크. | 베돌리주맙 치료를 모니터링하는 방법 |
| EP3514541A1 (de) * | 2018-01-17 | 2019-07-24 | Siemens Healthcare Diagnostics Products GmbH | Verfahren zur quantitativen bestimmung eines therapeutischen tnf-alpha inhibitors |
| EP3781941B1 (en) * | 2018-04-20 | 2026-01-14 | Janssen Biotech, Inc. | Chromatography column qualification in manufacturing methods for producing anti-tnf antibody compositions |
| WO2020112890A1 (en) | 2018-11-29 | 2020-06-04 | Cedars-Sinai Medical Center | Rnaset2 compositions and methods of treatment therewith |
| US20230035363A1 (en) * | 2019-03-04 | 2023-02-02 | Amgen Inc. | In vivo reversibility of high molecular weight species |
| KR102562006B1 (ko) | 2020-11-09 | 2023-08-02 | 바디텍메드(주) | 항tnf-알파 약물 모니터링을 위한 신속 검출 키트 |
| WO2024249568A1 (en) | 2023-05-30 | 2024-12-05 | Paragon Therapeutics, Inc. | Alpha4beta7 integrin antibody compositions and methods of use |
| CN121889424A (zh) | 2023-08-14 | 2026-04-17 | 派拉冈医疗公司 | α4β7整联蛋白结合蛋白及使用方法 |
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