EP3164710A4 - Biological characterization of a glatiramer acetate related drug product using mammalian and human cells - Google Patents
Biological characterization of a glatiramer acetate related drug product using mammalian and human cells Download PDFInfo
- Publication number
- EP3164710A4 EP3164710A4 EP15814349.5A EP15814349A EP3164710A4 EP 3164710 A4 EP3164710 A4 EP 3164710A4 EP 15814349 A EP15814349 A EP 15814349A EP 3164710 A4 EP3164710 A4 EP 3164710A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- mammalian
- human cells
- drug product
- glatiramer acetate
- related drug
- Prior art date
- Legal status (The legal status 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 status listed.)
- Withdrawn
Links
- 108010072051 Glatiramer Acetate Proteins 0.000 title 1
- FHEAIOHRHQGZPC-KIWGSFCNSA-N acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid Chemical compound CC(O)=O.C[C@H](N)C(O)=O.NCCCC[C@H](N)C(O)=O.OC(=O)[C@@H](N)CCC(O)=O.OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 FHEAIOHRHQGZPC-KIWGSFCNSA-N 0.000 title 1
- 238000012512 characterization method Methods 0.000 title 1
- 229940126534 drug product Drugs 0.000 title 1
- 229960003776 glatiramer acetate Drugs 0.000 title 1
- 210000005260 human cell Anatomy 0.000 title 1
- 210000004962 mammalian cell Anatomy 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 title 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
- G01N33/5005—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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Immunology (AREA)
- Hematology (AREA)
- Chemical & Material Sciences (AREA)
- Urology & Nephrology (AREA)
- Molecular Biology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Medicinal Chemistry (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Toxicology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Food Science & Technology (AREA)
- Cell Biology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Applications Claiming Priority (8)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462019857P | 2014-07-01 | 2014-07-01 | |
| US201462020358P | 2014-07-02 | 2014-07-02 | |
| US201462025953P | 2014-07-17 | 2014-07-17 | |
| US201462047437P | 2014-09-08 | 2014-09-08 | |
| US201462078369P | 2014-11-11 | 2014-11-11 | |
| US201562134245P | 2015-03-17 | 2015-03-17 | |
| US201562162308P | 2015-05-15 | 2015-05-15 | |
| PCT/US2015/038901 WO2016004250A2 (en) | 2014-07-01 | 2015-07-01 | Biological characterization of a glatiramer acetate related drug product using mammalian and human cells |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP3164710A2 EP3164710A2 (en) | 2017-05-10 |
| EP3164710A4 true EP3164710A4 (en) | 2018-04-11 |
Family
ID=55020098
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP15814349.5A Withdrawn EP3164710A4 (en) | 2014-07-01 | 2015-07-01 | Biological characterization of a glatiramer acetate related drug product using mammalian and human cells |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP3164710A4 (en) |
| CA (1) | CA2952849A1 (en) |
| IL (1) | IL249686A0 (en) |
| TW (1) | TW201610169A (en) |
| UY (1) | UY36197A (en) |
| WO (1) | WO2016004250A2 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018053109A1 (en) * | 2016-09-14 | 2018-03-22 | Teva Pharmaceutical Industries Ltd. | Gene expression characterization of a glatiramer acetate related drug product in mammalian and human cells |
| CN116637123B (en) * | 2023-06-07 | 2024-02-13 | 上海市东方医院（同济大学附属东方医院） | Application of reagent for knocking down or down expression of C15orf39 gene in preparation of medicines for treating gastric cancer |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2477232T5 (en) * | 2007-06-21 | 2017-11-23 | Momenta Pharmaceuticals, Inc. | Copolymer Analysis |
-
2015
- 2015-06-24 TW TW104120408A patent/TW201610169A/en unknown
- 2015-06-29 UY UY0001036197A patent/UY36197A/en not_active Application Discontinuation
- 2015-07-01 CA CA2952849A patent/CA2952849A1/en not_active Abandoned
- 2015-07-01 EP EP15814349.5A patent/EP3164710A4/en not_active Withdrawn
- 2015-07-01 WO PCT/US2015/038901 patent/WO2016004250A2/en active Application Filing
-
2016
- 2016-12-21 IL IL249686A patent/IL249686A0/en unknown
Non-Patent Citations (5)
| Title |
|---|
| ANAT ACHIRON ET AL: "Molecular Profiling of Glatiramer Acetate Early Treatment Effects in Multiple Sclerosis", DISEASE MARKERS, 1 January 2009 (2009-01-01), Netherlands, pages 63 - 73, XP055287188, Retrieved from the Internet <URL:http://downloads.hindawi.com/journals/dm/2009/267581.pdf> DOI: 10.1155/2009/267581 * |
| FADI TOWFIC ET AL: "Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic", PLOS ONE, vol. 9, no. 1, 8 January 2014 (2014-01-08), pages e83757, XP055264014, DOI: 10.1371/journal.pone.0083757 * |
| MADHAN THAMILARASAN ET AL: "Glatiramer acetate treatment effects on gene expression in monocytes of multiple sclerosis patients", JOURNAL OF NEUROINFLAMMATION, vol. 10, no. 1, 17 October 2013 (2013-10-17), pages 126, XP055170927, ISSN: 1742-2094, DOI: 10.1186/1742-2094-10-126 * |
| SARAH KOLITZ ET AL: "Gene expression studies of a human monocyte cell line identify dissimilarities between differently manufactured glatiramoids", SCIENTIFIC REPORTS, vol. 5, no. 1, 22 May 2015 (2015-05-22), XP055423415, DOI: 10.1038/srep10191 * |
| SHLOMO BAKSHI ET AL: "Gene expression analysis reveals functional pathways of glatiramer acetate activation", EXPERT OPINION ON THERAPEUTIC TARGETS, vol. 17, no. 4, 8 March 2013 (2013-03-08), UK, pages 351 - 362, XP055286871, ISSN: 1472-8222, DOI: 10.1517/14728222.2013.778829 * |
Also Published As
| Publication number | Publication date |
|---|---|
| EP3164710A2 (en) | 2017-05-10 |
| WO2016004250A3 (en) | 2016-03-17 |
| UY36197A (en) | 2016-01-29 |
| TW201610169A (en) | 2016-03-16 |
| CA2952849A1 (en) | 2016-01-07 |
| IL249686A0 (en) | 2017-02-28 |
| WO2016004250A2 (en) | 2016-01-07 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
|
| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE |
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| 17P | Request for examination filed |
Effective date: 20161219 |
|
| AK | Designated contracting states |
Kind code of ref document: A2 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
| AX | Request for extension of the european patent |
Extension state: BA ME |
|
| DAV | Request for validation of the european patent (deleted) | ||
| RIC1 | Information provided on ipc code assigned before grant |
Ipc: C12Q 1/68 20060101ALI20171121BHEP Ipc: G01N 33/50 20060101AFI20171121BHEP |
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| REG | Reference to a national code |
Ref country code: HK Ref legal event code: DE Ref document number: 1235460 Country of ref document: HK |
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| A4 | Supplementary search report drawn up and despatched |
Effective date: 20180312 |
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| RIC1 | Information provided on ipc code assigned before grant |
Ipc: C12Q 1/68 20060101ALI20180306BHEP Ipc: G01N 33/50 20060101AFI20180306BHEP |
|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN |
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| 18D | Application deemed to be withdrawn |
Effective date: 20181009 |
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| REG | Reference to a national code |
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