HRP20100164T1 - Postupak za pripremu smjesa polipeptida uz primjenu pročišćene bromovodične kiseline - Google Patents
Postupak za pripremu smjesa polipeptida uz primjenu pročišćene bromovodične kiseline Download PDFInfo
- Publication number
- HRP20100164T1 HRP20100164T1 HR20100164T HRP20100164T HRP20100164T1 HR P20100164 T1 HRP20100164 T1 HR P20100164T1 HR 20100164 T HR20100164 T HR 20100164T HR P20100164 T HRP20100164 T HR P20100164T HR P20100164 T1 HRP20100164 T1 HR P20100164T1
- Authority
- HR
- Croatia
- Prior art keywords
- glatiramer acetate
- solution
- hydrobromic acid
- acetic acid
- batch
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract 17
- 229920001184 polypeptide Polymers 0.000 title claims abstract 6
- 108090000765 processed proteins & peptides Proteins 0.000 title claims abstract 6
- 102000004196 processed proteins & peptides Human genes 0.000 title claims abstract 6
- 239000000203 mixture Substances 0.000 title claims abstract 4
- BMYNFMYTOJXKLE-UHFFFAOYSA-N 3-azaniumyl-2-hydroxypropanoate Chemical compound NCC(O)C(O)=O BMYNFMYTOJXKLE-UHFFFAOYSA-N 0.000 title claims 15
- 150000003668 tyrosines Chemical class 0.000 claims abstract 9
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims abstract 3
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 claims abstract 3
- 235000004279 alanine Nutrition 0.000 claims abstract 3
- 239000012535 impurity Substances 0.000 claims abstract 3
- 229910021645 metal ion Inorganic materials 0.000 claims abstract 3
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 claims abstract 3
- 150000001413 amino acids Chemical group 0.000 claims abstract 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 39
- 108010072051 Glatiramer Acetate Proteins 0.000 claims 18
- 229960003776 glatiramer acetate Drugs 0.000 claims 18
- 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 claims 13
- WKBOTKDWSSQWDR-UHFFFAOYSA-N Bromine atom Chemical compound [Br] WKBOTKDWSSQWDR-UHFFFAOYSA-N 0.000 claims 6
- GDTBXPJZTBHREO-UHFFFAOYSA-N bromine Substances BrBr GDTBXPJZTBHREO-UHFFFAOYSA-N 0.000 claims 6
- 229910052794 bromium Inorganic materials 0.000 claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 6
- -1 trifluoroacetyl glatiramer acetate Chemical compound 0.000 claims 6
- 239000002516 radical scavenger Substances 0.000 claims 4
- RLRYVSYUAHQYLS-QMMMGPOBSA-N (2s)-2-(bromoamino)-3-(4-hydroxyphenyl)propanoic acid Chemical compound OC(=O)[C@@H](NBr)CC1=CC=C(O)C=C1 RLRYVSYUAHQYLS-QMMMGPOBSA-N 0.000 claims 2
- KNCHTBNNSQSLRV-YFKPBYRVSA-N (2s)-6-amino-2-[(2,2,2-trifluoroacetyl)amino]hexanoic acid Chemical compound NCCCC[C@@H](C(O)=O)NC(=O)C(F)(F)F KNCHTBNNSQSLRV-YFKPBYRVSA-N 0.000 claims 2
- NQRYJNQNLNOLGT-UHFFFAOYSA-N Piperidine Chemical compound C1CCNCC1 NQRYJNQNLNOLGT-UHFFFAOYSA-N 0.000 claims 2
- 238000010828 elution Methods 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000012488 sample solution Substances 0.000 claims 2
- 241001550224 Apha Species 0.000 claims 1
- 235000001014 amino acid Nutrition 0.000 claims 1
- 238000010511 deprotection reaction Methods 0.000 claims 1
- 230000003301 hydrolyzing effect Effects 0.000 claims 1
- 238000005259 measurement Methods 0.000 claims 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 1
- 238000006116 polymerization reaction Methods 0.000 claims 1
- 238000002203 pretreatment Methods 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
- 241000894007 species Species 0.000 claims 1
- 238000000108 ultra-filtration Methods 0.000 claims 1
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 abstract 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 abstract 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 abstract 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 abstract 1
- 239000004472 Lysine Substances 0.000 abstract 1
- 235000013922 glutamic acid Nutrition 0.000 abstract 1
- 239000004220 glutamic acid Substances 0.000 abstract 1
- 235000018977 lysine Nutrition 0.000 abstract 1
- 235000002374 tyrosine Nutrition 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/001—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof by chemical synthesis
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
- C07K14/4701—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
- C07K14/4713—Autoimmune diseases, e.g. Insulin-dependent diabetes mellitus, multiple sclerosis, rheumathoid arthritis, systemic lupus erythematosus; Autoantigens
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Zoology (AREA)
- Toxicology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Rehabilitation Therapy (AREA)
- Transplantation (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Peptides Or Proteins (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US60884304P | 2004-09-09 | 2004-09-09 | |
PCT/US2005/032395 WO2006029393A2 (fr) | 2004-09-09 | 2005-09-09 | Procede de preparation de melange de polypeptides au moyen d'acide bromhydrique purifie |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20100164T1 true HRP20100164T1 (hr) | 2010-07-31 |
Family
ID=36037047
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HR20100164T HRP20100164T1 (hr) | 2004-09-09 | 2010-03-19 | Postupak za pripremu smjesa polipeptida uz primjenu pročišćene bromovodične kiseline |
HRP20120209TT HRP20120209T1 (hr) | 2004-09-09 | 2012-03-02 | Postupak za pripremu smjesa trifluoracetil glatirameracetata korištenjem pročišćene bromovodične kiseline |
HRP20140216TT HRP20140216T1 (hr) | 2004-09-09 | 2014-03-10 | Postupak za pripremu smjesa trifluoroacetil glatiramer acetata korištenjem proäśišä†ene bromovodiäśne kiseline |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20120209TT HRP20120209T1 (hr) | 2004-09-09 | 2012-03-02 | Postupak za pripremu smjesa trifluoracetil glatirameracetata korištenjem pročišćene bromovodične kiseline |
HRP20140216TT HRP20140216T1 (hr) | 2004-09-09 | 2014-03-10 | Postupak za pripremu smjesa trifluoroacetil glatiramer acetata korištenjem proäśišä†ene bromovodiäśne kiseline |
Country Status (28)
Country | Link |
---|---|
US (2) | US7495072B2 (fr) |
EP (3) | EP2177528B1 (fr) |
JP (1) | JP5149008B2 (fr) |
KR (1) | KR101317131B1 (fr) |
CN (1) | CN101166754B (fr) |
AT (2) | ATE454396T1 (fr) |
AU (1) | AU2005282249B2 (fr) |
BR (1) | BRPI0515033B1 (fr) |
CA (1) | CA2579656C (fr) |
CY (1) | CY1110280T1 (fr) |
DE (1) | DE602005018800D1 (fr) |
DK (3) | DK2361924T3 (fr) |
ES (3) | ES2382298T3 (fr) |
HK (3) | HK1100780A1 (fr) |
HR (3) | HRP20100164T1 (fr) |
IL (2) | IL181596A (fr) |
IS (1) | IS8622A (fr) |
MX (1) | MX2007002760A (fr) |
NO (1) | NO20071632L (fr) |
NZ (1) | NZ554018A (fr) |
PL (3) | PL2361924T3 (fr) |
PT (3) | PT1799703E (fr) |
RS (3) | RS52265B (fr) |
RU (1) | RU2388764C2 (fr) |
SI (3) | SI2177528T1 (fr) |
UA (1) | UA91029C2 (fr) |
WO (1) | WO2006029393A2 (fr) |
ZA (1) | ZA200702591B (fr) |
Families Citing this family (40)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2527760T3 (es) * | 1998-07-23 | 2015-01-29 | Yeda Research And Development Co., Ltd. | Tratamiento de enfermedad de Crohn con copolímero 1 y polipéptidos |
CA2337688C (fr) | 1998-07-23 | 2016-04-05 | Yeda Research And Development Co., Ltd. | Traitement de maladies auto-immunes a l'aide du copolymere 1 et copolymeres associes |
US6800287B2 (en) | 1998-09-25 | 2004-10-05 | Yeda Research And Development Co., Ltd. | Copolymer 1 related polypeptides for use as molecular weight markers and for therapeutic use |
WO2002076503A1 (fr) * | 2000-06-20 | 2002-10-03 | Mayo Foundation For Medical Education And Research | Traitement de maladies du systeme nerveux central au moyen d'anticorps diriges contre l'acetate de glatiramere |
WO2003048735A2 (fr) * | 2001-12-04 | 2003-06-12 | Teva Pharmaceutical Industries, Ltd. | Procedes pour mesurer la puissance de l'acetate de glatiramer |
WO2005084377A2 (fr) * | 2004-03-03 | 2005-09-15 | Teva Pharmaceutical Industries, Ltd. | Therapie de combinaison avec acetate de glatiramer et riluzole |
CA2579656C (fr) | 2004-09-09 | 2014-11-04 | Teva Pharmaceutical Industries, Ltd. | Procede de preparation de melange de polypeptides au moyen d'acide bromhydrique purifie |
US7560100B2 (en) * | 2004-09-09 | 2009-07-14 | Yeda Research And Development Co., Ltd. | Mixtures of polypeptides, compositions containing and processes for preparing same, for treating neurodegenerative diseases |
US8324641B2 (en) * | 2007-06-29 | 2012-12-04 | Ledengin, Inc. | Matrix material including an embedded dispersion of beads for a light-emitting device |
JP5297653B2 (ja) * | 2004-10-29 | 2013-09-25 | サンド・アクチエンゲゼルシヤフト | グラチラマーの製造法 |
UA93669C2 (ru) * | 2005-02-02 | 2011-03-10 | Тева Фармасьютикл Индастриз, Лтд. | Способ приготовления полипептидной смеси c использованием гидрогенолиза |
CA2596664A1 (fr) * | 2005-02-17 | 2006-08-24 | Teva Pharmaceutical Industries Ltd. | Therapie combinee avec de l'acetate de glatiramere et de rasagiline destinee au traitement de la sclerose en plaques |
CA2606194A1 (fr) * | 2005-04-25 | 2006-11-02 | Yeda Research And Development Company | Marqueurs associes a l'efficacite therapeutique d'acetate de glatiramere |
WO2009017775A2 (fr) * | 2007-08-02 | 2009-02-05 | Scinopharm Taiwan Ltd. | Procédé de préparation d'un polypeptide |
JP2011504925A (ja) * | 2007-11-28 | 2011-02-17 | テバ ファーマシューティカル インダストリーズ リミティド | 臨床的に確実な多発性硬化症の発症を遅延させる方法 |
EP2277050B2 (fr) * | 2008-04-16 | 2022-09-28 | Momenta Pharmaceuticals, Inc. | Analyse de compositions copolymères d'acides aminés |
WO2010017075A1 (fr) * | 2008-08-07 | 2010-02-11 | Sigma-Aldrich Co. | Préparation de polylysine et de polyornithine de faible masse moléculaire dans un rendement élevé |
AU2009279636A1 (en) * | 2008-08-07 | 2010-02-11 | Scinopharm Taiwan, Ltd. | Synthesis of glatiramer acetate |
ES2523732T5 (es) | 2009-04-03 | 2023-10-23 | Momenta Pharmaceuticals Inc | Control de composiciones de copolímeros |
CZ30474U1 (cs) | 2009-08-20 | 2017-03-14 | Yeda Research And Development Co., Ltd. | Glatiramer acetát a terapeutická kompozice s jeho obsahem pro použití k léčení s nízkou frekvencí ošetření |
USRE49251E1 (en) | 2010-01-04 | 2022-10-18 | Mapi Pharma Ltd. | Depot systems comprising glatiramer or pharmacologically acceptable salt thereof |
US8759302B2 (en) * | 2010-03-16 | 2014-06-24 | Teva Pharmaceutical Industries, Ltd. | Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis |
EP2563804A4 (fr) * | 2010-04-27 | 2014-09-17 | Reddys Lab Ltd Dr | Préparation de polypeptides et de leurs sels |
NZ609938A (en) | 2010-10-11 | 2015-11-27 | Teva Pharma | Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate |
WO2012123959A2 (fr) | 2011-02-14 | 2012-09-20 | Usv Limited | Copolymère-1, son procédé de préparation et méthodes d'analyse de celui-ci |
JP5701103B2 (ja) * | 2011-03-02 | 2015-04-15 | 昭和シェル石油株式会社 | 潤滑油のための消泡剤組成物及びそれを用いた消泡方法 |
EP2699317B1 (fr) | 2011-04-21 | 2016-08-10 | Mapi Pharma Limited | Pentapolymère statistique pour le traitement de maladies auto-immunes |
WO2013009885A2 (fr) | 2011-07-11 | 2013-01-17 | Momenta Pharmaceuticals, Inc. | Evaluation de diéthylamide de copolymère |
WO2013009864A1 (fr) | 2011-07-11 | 2013-01-17 | Momenta Pharmaceuticals, Inc. | Évaluation de structure de mélanges polypeptidiques hétérogènes |
US8575198B1 (en) | 2011-09-07 | 2013-11-05 | Momenta Pharmaceuticals, Inc. | In-process control for the manufacture of glatiramer acetate |
US8815511B2 (en) | 2011-10-10 | 2014-08-26 | Teva Pharmaceutical Industries, Ltd. | Determination of single nucleotide polymorphisms useful to predict response for glatiramer acetate |
CN102717992A (zh) * | 2012-05-30 | 2012-10-10 | 苏州市旭洋工业搪瓷厂 | 一种搪玻璃溴素贮罐 |
CN102718963B (zh) * | 2012-06-19 | 2014-10-15 | 深圳翰宇药业股份有限公司 | 聚合物多肽的制备方法 |
TW201420111A (zh) | 2012-10-10 | 2014-06-01 | Teva Pharma | 對格拉默醋酸鹽(glatiramer acetate)之臨床反應具預測性之生物標記 |
UY35790A (es) | 2013-10-21 | 2015-05-29 | Teva Pharma | Marcadores genéticos que predicen la respuesta al acetato de glatiramer |
EP3062792A1 (fr) | 2013-11-01 | 2016-09-07 | Celgene International II Sarl | Modulateurs sélectifs des récepteurs de la sphingosine-1-phosphate et traitement combiné les utilisant |
CN104844697B (zh) * | 2014-09-26 | 2018-10-23 | 深圳翰宇药业股份有限公司 | 醋酸格拉替雷的制备方法 |
US9155775B1 (en) | 2015-01-28 | 2015-10-13 | Teva Pharmaceutical Industries, Ltd. | Process for manufacturing glatiramer acetate product |
EP3600553A4 (fr) | 2017-03-26 | 2020-09-02 | Mapi Pharma Ltd. | Systèmes de dépôt de glatiramère pour le traitement de formes progressives de sclérose en plaques |
US20190202984A1 (en) * | 2018-01-03 | 2019-07-04 | Kinbio Ltd. | Process of preparing glatiramer acetate |
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CA2337688C (fr) | 1998-07-23 | 2016-04-05 | Yeda Research And Development Co., Ltd. | Traitement de maladies auto-immunes a l'aide du copolymere 1 et copolymeres associes |
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ZA200206457B (en) | 2000-02-18 | 2003-08-13 | Yeda Res & Dev | Oral, nasal and pulmonary dosage formulations of copolymer 1. |
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