EA201591251A1 - Характеризация лекарственного продукта, родственного ацетату глатирамера - Google Patents
Характеризация лекарственного продукта, родственного ацетату глатирамераInfo
- Publication number
- EA201591251A1 EA201591251A1 EA201591251A EA201591251A EA201591251A1 EA 201591251 A1 EA201591251 A1 EA 201591251A1 EA 201591251 A EA201591251 A EA 201591251A EA 201591251 A EA201591251 A EA 201591251A EA 201591251 A1 EA201591251 A1 EA 201591251A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- drug
- acetate
- glatiramer
- product related
- drug product
- Prior art date
Links
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
- G01N33/5005—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
- G01N33/5023—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 on expression patterns
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- General Health & Medical Sciences (AREA)
- Analytical Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pathology (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- Biotechnology (AREA)
- Physics & Mathematics (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Tropical Medicine & Parasitology (AREA)
- General Physics & Mathematics (AREA)
- Toxicology (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Biophysics (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- General Engineering & Computer Science (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Настоящее изобретение относится к способу характеризации лекарственного вещества или лекарственного продукта, родственного ацетату глатирамера, включающему стадии: а) получения партии лекарственного вещества или лекарственного продукта, родственного ацетату глатирамера; b) иммунизации млекопитающего предварительно установленным количеством лекарственного вещества или лекарственного продукта, родственного ацетату глатирамера; с) получения культуры клеток от млекопитающего со стадии b) в предварительно установленное время после иммунизации; d) инкубации клеток из культуры со стадии с) с предварительно установленным количеством родственного ацетату глатирамера лекарственного вещества или лекарственного продукта со стадии а) и е) определения уровня экспрессии по меньшей мере одного гена, раскрытого в данном изобретении, или определения уровня биологической активности клеток со стадии с), как раскрыто в данном изобретении, причем посредством этого характеризуют родственные ацетату глатирамера лекарственное вещество или лекарственный продукт со стадии а).
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361749228P | 2013-01-04 | 2013-01-04 | |
| US201361819481P | 2013-05-03 | 2013-05-03 | |
| PCT/US2014/010103 WO2014107533A2 (en) | 2013-01-04 | 2014-01-02 | Characterizing a glatiramer acetate related drug product |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EA201591251A1 true EA201591251A1 (ru) | 2016-05-31 |
Family
ID=51061235
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201591251A EA201591251A1 (ru) | 2013-01-04 | 2014-01-02 | Характеризация лекарственного продукта, родственного ацетату глатирамера |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US20140193827A1 (ru) |
| EP (1) | EP2941274A4 (ru) |
| JP (1) | JP2016504039A (ru) |
| KR (1) | KR20150111945A (ru) |
| CN (1) | CN105228651A (ru) |
| AU (1) | AU2014204043A1 (ru) |
| BR (1) | BR112015016169A2 (ru) |
| CA (1) | CA2896957A1 (ru) |
| CL (1) | CL2015001915A1 (ru) |
| EA (1) | EA201591251A1 (ru) |
| HK (1) | HK1216299A1 (ru) |
| IL (2) | IL239692A0 (ru) |
| MX (1) | MX2015008754A (ru) |
| PE (1) | PE20151980A1 (ru) |
| SG (1) | SG11201505210RA (ru) |
| WO (1) | WO2014107533A2 (ru) |
| ZA (1) | ZA201505367B (ru) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| LT3199172T (lt) | 2009-08-20 | 2018-10-25 | Yeda Research And Development Co., Ltd. | Dozavimo režimas, skirtas išsėtinei sklerozei |
| USRE49251E1 (en) | 2010-01-04 | 2022-10-18 | Mapi Pharma Ltd. | Depot systems comprising glatiramer or pharmacologically acceptable salt thereof |
| PT2627669T (pt) | 2010-10-11 | 2016-11-24 | Teva Pharma | Biomarcadores de citocina como biomarcadores preditivos de resposta clínica para acetato de glatirâmero |
| WO2013055683A1 (en) | 2011-10-10 | 2013-04-18 | Teva Pharmaceutical Industries Ltd. | Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate |
| US9617596B2 (en) | 2012-10-10 | 2017-04-11 | Teva Pharmaceutical Industries, Ltd. | Biomarkers predictive for clinical response for glatiramer acetate |
| WO2014159685A2 (en) | 2013-03-14 | 2014-10-02 | Mylan Inc. | Glatiramer acetate response biomarker mrna potency assay |
| UY35790A (es) | 2013-10-21 | 2015-05-29 | Teva Pharma | Marcadores genéticos que predicen la respuesta al acetato de glatiramer |
| US9995734B2 (en) | 2013-10-24 | 2018-06-12 | Mylan Inc. | Human T cell line assay for evaluating the immunologic identity of glatiramer acetate preparations |
| US9155775B1 (en) | 2015-01-28 | 2015-10-13 | Teva Pharmaceutical Industries, Ltd. | Process for manufacturing glatiramer acetate product |
| CN107407677B (zh) * | 2015-01-28 | 2020-07-17 | 豪夫迈·罗氏有限公司 | 多发性硬化的基因表达标志和治疗 |
| US11111279B2 (en) | 2015-11-20 | 2021-09-07 | Grand Valley State University | Nato3 mutant polypeptides and uses thereof |
| US20190290698A1 (en) * | 2016-11-11 | 2019-09-26 | Longeveron Llc | Methods of Using Human Mesenchymal Stem Cells to Effect Cellular and Humoral Immunity |
| WO2018178973A1 (en) | 2017-03-26 | 2018-10-04 | Mapi Pharma Ltd. | Glatiramer depot systems for treating progressive forms of multiple sclerosis |
| CN115044684A (zh) * | 2022-06-22 | 2022-09-13 | 四川大学华西医院 | lcn2基因作为生物标记物在检测Stat5基因是否缺失中的用途 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2349033T3 (es) * | 2001-12-04 | 2010-12-22 | Teva Pharmaceutical Industries, Ltd. | Procedimientos para la medida de la actividad del acetato de glatiramer. |
| AU2003275029A1 (en) * | 2002-09-27 | 2004-04-19 | Brigham And Women's Hospital, Inc. | Treatment of patients with multiple sclerosis based on gene expression changes in central nervous system tissues |
| WO2007035551A1 (en) * | 2005-09-19 | 2007-03-29 | Eisai R & D Management Co., Ltd. | Methods for identifying gpr83 agonists and antagonists capable of modulating regulatory t cell function |
| US8753833B2 (en) * | 2007-06-21 | 2014-06-17 | Momenta Pharmaceuticals, Inc. | Copolymer assay |
| WO2010059046A1 (en) * | 2008-11-18 | 2010-05-27 | Crossbeta Biosciences B.V. | Cross-beta structures as carriers in vaccines |
| LT3199172T (lt) * | 2009-08-20 | 2018-10-25 | Yeda Research And Development Co., Ltd. | Dozavimo režimas, skirtas išsėtinei sklerozei |
-
2014
- 2014-01-02 CA CA2896957A patent/CA2896957A1/en not_active Abandoned
- 2014-01-02 MX MX2015008754A patent/MX2015008754A/es unknown
- 2014-01-02 SG SG11201505210RA patent/SG11201505210RA/en unknown
- 2014-01-02 EA EA201591251A patent/EA201591251A1/ru unknown
- 2014-01-02 EP EP14735255.3A patent/EP2941274A4/en not_active Withdrawn
- 2014-01-02 PE PE2015001246A patent/PE20151980A1/es not_active Application Discontinuation
- 2014-01-02 KR KR1020157021141A patent/KR20150111945A/ko not_active Application Discontinuation
- 2014-01-02 BR BR112015016169A patent/BR112015016169A2/pt not_active IP Right Cessation
- 2014-01-02 CN CN201480008231.5A patent/CN105228651A/zh active Pending
- 2014-01-02 JP JP2015551759A patent/JP2016504039A/ja active Pending
- 2014-01-02 WO PCT/US2014/010103 patent/WO2014107533A2/en active Application Filing
- 2014-01-02 AU AU2014204043A patent/AU2014204043A1/en not_active Abandoned
- 2014-01-03 US US14/147,167 patent/US20140193827A1/en not_active Abandoned
-
2015
- 2015-06-29 IL IL239692A patent/IL239692A0/en unknown
- 2015-07-03 CL CL2015001915A patent/CL2015001915A1/es unknown
- 2015-07-24 ZA ZA2015/05367A patent/ZA201505367B/en unknown
-
2016
- 2016-04-14 HK HK16104285.8A patent/HK1216299A1/zh unknown
-
2017
- 2017-05-28 IL IL252547A patent/IL252547A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| SG11201505210RA (en) | 2015-07-30 |
| BR112015016169A2 (pt) | 2017-07-11 |
| EP2941274A4 (en) | 2016-11-16 |
| JP2016504039A (ja) | 2016-02-12 |
| IL252547A0 (en) | 2017-07-31 |
| WO2014107533A2 (en) | 2014-07-10 |
| IL239692A0 (en) | 2015-08-31 |
| MX2015008754A (es) | 2016-04-11 |
| CA2896957A1 (en) | 2014-07-10 |
| ZA201505367B (en) | 2016-11-30 |
| PE20151980A1 (es) | 2016-01-15 |
| US20140193827A1 (en) | 2014-07-10 |
| CL2015001915A1 (es) | 2016-11-11 |
| CN105228651A (zh) | 2016-01-06 |
| WO2014107533A3 (en) | 2015-01-29 |
| AU2014204043A1 (en) | 2015-08-13 |
| HK1216299A1 (zh) | 2016-11-04 |
| KR20150111945A (ko) | 2015-10-06 |
| EP2941274A2 (en) | 2015-11-11 |
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