RU2669769C2 - Способ получения продукта глатирамера ацетата - Google Patents

Способ получения продукта глатирамера ацетата Download PDF

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Publication number
RU2669769C2
RU2669769C2 RU2017104222A RU2017104222A RU2669769C2 RU 2669769 C2 RU2669769 C2 RU 2669769C2 RU 2017104222 A RU2017104222 A RU 2017104222A RU 2017104222 A RU2017104222 A RU 2017104222A RU 2669769 C2 RU2669769 C2 RU 2669769C2
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temperature
filter
aqueous pharmaceutical
pharmaceutical solution
solution
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RU2017104222A
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English (en)
Russian (ru)
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Ракефет Коэн
Сассон Хаббах
Мухаммад Сафади
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Тева Фармасьютикал Индастриз Лтд.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/03—Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
RU2017104222A 2015-01-28 2015-09-21 Способ получения продукта глатирамера ацетата RU2669769C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14/608,126 US9155775B1 (en) 2015-01-28 2015-01-28 Process for manufacturing glatiramer acetate product
US14/608,126 2015-01-28
PCT/US2015/051203 WO2016122722A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Publications (1)

Publication Number Publication Date
RU2669769C2 true RU2669769C2 (ru) 2018-10-16

Family

ID=54199060

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2017104222A RU2669769C2 (ru) 2015-01-28 2015-09-21 Способ получения продукта глатирамера ацетата

Country Status (31)

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US (6) US9155775B1 (enExample)
EP (3) EP3113785A4 (enExample)
JP (2) JP2018503627A (enExample)
KR (2) KR101737295B1 (enExample)
CN (1) CN107530394B (enExample)
AR (1) AR102096A1 (enExample)
AU (4) AU2015380381B2 (enExample)
BR (1) BR112016023736A2 (enExample)
CA (2) CA2965890A1 (enExample)
CL (1) CL2016002607A1 (enExample)
CY (1) CY1118826T1 (enExample)
DK (1) DK3050556T3 (enExample)
EA (3) EA028484B1 (enExample)
ES (1) ES2584190T3 (enExample)
HK (1) HK1225309B (enExample)
HR (1) HRP20170625T1 (enExample)
HU (1) HUE034059T2 (enExample)
IL (3) IL247851A0 (enExample)
LT (1) LT3050556T (enExample)
ME (1) ME02721B (enExample)
MX (1) MX352734B (enExample)
PE (1) PE20170296A1 (enExample)
PL (1) PL3050556T3 (enExample)
PT (1) PT3050556T (enExample)
RS (1) RS55959B1 (enExample)
RU (1) RU2669769C2 (enExample)
SI (1) SI3050556T1 (enExample)
SM (1) SMT201700227T1 (enExample)
UA (1) UA116060C2 (enExample)
WO (1) WO2016122722A1 (enExample)
ZA (1) ZA201606903B (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE49251E1 (en) 2010-01-04 2022-10-18 Mapi Pharma Ltd. Depot systems comprising glatiramer or pharmacologically acceptable salt thereof
EA025780B1 (ru) 2010-10-11 2017-01-30 Тева Фармасьютикал Индастриз Лтд. Цитокиновые биомаркеры в качестве биомаркеров, прогнозирующих клинический ответ на глатирамер ацетат
MX2014004309A (es) 2011-10-10 2015-07-06 Teva Pharma Polimorfismos de nucleotidos individuales utiles para predecir una respuesta clinica para el acetato de glatiramer.
WO2014058976A2 (en) 2012-10-10 2014-04-17 Teva Pharmaceutical Industries Ltd. Biomarkers predictive for clinical response for glatiramer acetate
UY35790A (es) 2013-10-21 2015-05-29 Teva Pharma Marcadores genéticos que predicen la respuesta al acetato de glatiramer
US9155775B1 (en) 2015-01-28 2015-10-13 Teva Pharmaceutical Industries, Ltd. Process for manufacturing glatiramer acetate product
CN107550853B (zh) * 2016-06-30 2020-06-12 深圳翰宇药业股份有限公司 一种醋酸格拉替雷注射液的制备方法
US12097292B2 (en) 2016-08-28 2024-09-24 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
AU2017319728B2 (en) 2016-08-31 2024-09-05 Mapi Pharma Ltd Depot systems comprising glatiramer acetate
CA3045944A1 (en) 2016-12-07 2018-06-14 Progenity, Inc. Gastrointestinal tract detection methods, devices and systems
IL316573A (en) 2017-03-26 2024-12-01 Mapi Pharma Ltd Storage systems containing glatiramer acetate for the treatment of multiple sclerosis
AU2017420758A1 (en) 2017-06-29 2020-01-02 Regeneron Pharmaceuticals Inc. Devices and methods for overfilling drug containers
WO2019036363A1 (en) 2017-08-14 2019-02-21 Progenity Inc. TREATMENT OF GASTROINTESTINAL TRACT DISEASE WITH GLATIRAMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
CN112933210A (zh) * 2019-12-11 2021-06-11 深圳翰宇药业股份有限公司 一种西曲瑞克冻干药物组合物的制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050013912A1 (en) * 2001-11-21 2005-01-20 Gunther Geiger Method for reducing the total bacteria count in aqueous dispersions of non-homogeneous two-phase or multi-phase mixtures
US20070161566A1 (en) * 2006-01-11 2007-07-12 Teva Pharmaceutical Industries, Ltd. Method of treating multiple sclerosis
WO2011008274A2 (en) * 2009-07-15 2011-01-20 Teva Pharmaceutical Industries Ltd. Reduced volume formulation of glatiramer acetate and methods of administration
WO2011022063A1 (en) * 2009-08-20 2011-02-24 Teva Pharmaceutical Industries Ltd. Low frequency glatiramer acetate therapy
WO2014128079A1 (en) * 2013-02-19 2014-08-28 Synthon B.V. Glatiramer acetate multidose formulation

Family Cites Families (66)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL36670A (en) 1971-04-21 1974-09-10 Sela M Therapeutic basic copolymers of amino acids
FR2459619B1 (fr) 1979-06-26 1983-07-29 Agronomique Inst Nat Rech Procede pour l'obtention a partir de lactoserum, d'un produit enrichi en alpha-lactalbumine et applications dudit procede
US4350156A (en) 1980-05-29 1982-09-21 Japan Foundation For Artificial Organs Method and apparatus for on-line filtration removal of macromolecules from a physiological fluid
US4455256A (en) 1981-05-05 1984-06-19 The Regents Of The University Of California Bone morphogenetic protein
US5599309A (en) 1993-03-24 1997-02-04 Owen Mumford Limited Injection devices
IL113812A (en) 1994-05-24 2000-06-29 Yeda Res & Dev Copolymer-1 pharmaceutical compositions containing it and its use
US5631347A (en) 1995-06-07 1997-05-20 Eli Lilly And Company Reducing gelation of a fatty acid-acylated protein
DE19543737A1 (de) 1995-11-24 1997-05-28 Hoechst Ag Verfahren zur Ultrafiltration von Peptide oder Proteine enthaltender biologischer Matrices
US6214791B1 (en) 1997-01-10 2001-04-10 Yeda Research And Development Co. Ltd. Treatment of multiple sclerosis through ingestion or inhalation of copolymer-1
IL119989A0 (en) 1997-01-10 1997-04-15 Yeda Res & Dev Pharmaceutical compositions for oral treatment of multiple sclerosis
JP2003521448A (ja) 1998-07-23 2003-07-15 ザ・プレジデント・アンド・フェローズ・オブ・ハーバード・カレッジ 合成ペプチドおよび自己免疫疾患治療のための使用方法
EP1098902A4 (en) 1998-07-23 2002-07-24 Yeda Res & Dev TREATMENT OF AUTOIMMUNE DISEASES WITH COPOLYMER 1 AND RELATED COPOLYMERS AND PEPTIDES
ES2527760T3 (es) 1998-07-23 2015-01-29 Yeda Research And Development Co., Ltd. Tratamiento de enfermedad de Crohn con copolímero 1 y polipéptidos
US6514938B1 (en) 1998-09-25 2003-02-04 Yeda Research And Development Co. Ltd. At The Weizmann Institute Of Science Copolymer 1 related polypeptides for use as molecular weight markers and for therapeutic use
ES2408706T3 (es) 1998-09-25 2013-06-21 Yeda Research And Development Co., Ltd. Polipéptidos relacionados con el copolímero 1 para su uso como marcadores de pesos moleculares y para uso terapéutico
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
WO2000020010A1 (en) 1998-10-02 2000-04-13 Yeda Research And Development Co., Ltd. Alternate day administration of copolymer 1 for treating autoimmune diseases
AU775073C (en) 1998-11-12 2007-05-03 Yeda Research And Development Co. Ltd. Pharmaceutical compositions comprising synthetic peptide copolymers and methods for preventing and treating GVHD and HVGD
MXPA02008023A (es) 2000-02-18 2005-06-30 Yeda Res & Dev Formulaciones de copolimero 1 para dosificacion oral, nasal y pulmonar.
US7022663B2 (en) 2000-02-18 2006-04-04 Yeda Research And Development Co., Ltd. Oral, nasal and pulmonary dosage formulations of copolymer 1
US20020077278A1 (en) 2000-06-05 2002-06-20 Yong V. Wee Use of glatiramer acetate (copolymer 1) in the treatment of central nervous system disorders
CA2411536A1 (en) 2000-06-05 2001-12-13 V. Wee Yong The use of glatiramer acetate (copolymer 1) in the treatment of central nervous system disorders
WO2002076503A1 (en) 2000-06-20 2002-10-03 Mayo Foundation For Medical Education And Research Treatment of central nervous system diseases by antibodies against glatiramer acetate
EP1459065B1 (en) 2001-12-04 2010-07-28 Teva Pharmaceutical Industries, Ltd. Processes for the measurement of the potency of glatiramer acetate
CA2411786C (en) 2002-11-13 2009-01-27 Brantford Chemicals Inc. A process for the preparation of polypeptides from n-carboxyanhydrides of amino acids
US7777006B2 (en) 2002-12-31 2010-08-17 Csl Behring L.L.C. Method for purification of alpha-1-antitrypsin
NZ569331A (en) 2003-01-21 2010-08-27 Yeda Res & Dev COP 1 for treatment of inflammatory bowel diseases
CA2518079A1 (en) 2003-03-04 2004-10-28 Teva Pharmaceutical Industries, Ltd. Combination therapy with glatiramer acetate and alphacalcidol for the treatment of multiple sclerosis
CA2525771A1 (en) 2003-05-14 2004-12-02 Teva Pharmaceutical Industries Ltd. Combination therapy with glatiramer acetate and mitoxantrone for the treatment of multiple sclerosis
US8075919B2 (en) 2003-07-18 2011-12-13 Baxter International Inc. Methods for fabrication, uses and compositions of small spherical particles prepared by controlled phase separation
JP2007509981A (ja) 2003-10-31 2007-04-19 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 薬物デリバリー用ナノ粒子
EP1701971A2 (en) 2003-12-31 2006-09-20 F.Hoffmann-La Roche Ag Peptide synthesis using decanting filter
EP1778286A4 (en) 2004-03-03 2009-04-08 Teva Pharma COMBINATION THERAPY WITH ACETATE OF GLATIRAMER AND RILUZOLE
US20060194725A1 (en) 2004-05-07 2006-08-31 James Rasmussen Methods of treating disease with random copolymers
US7655221B2 (en) 2004-05-07 2010-02-02 Peptimmune, Inc. Methods of treating disease with random copolymers
CA2579038A1 (en) 2004-09-02 2006-03-16 Teva Pharmaceutical Industries, Ltd. Combination therapy with glatiramer acetate and n-acetylcysteine for the treatment of multiple sclerosis
HRP20160455T1 (hr) 2004-09-09 2016-07-15 Yeda Research And Development Co., Ltd. Smjese polipeptida, sastavi koji ih sadrže i postupci za njihovu pripremu, te njihove primjene
DK1799703T3 (da) 2004-09-09 2010-04-19 Teva Pharma Fremgangsmåde til fremstilling af blandinger af polypeptider ved hjælp af oprenset hydrogenbromid
DE602005016292D1 (de) 2004-10-29 2009-10-08 Sandoz Ag Verfahren zur herstellung von glatiramer
US20060172942A1 (en) 2005-02-02 2006-08-03 Teva Pharmaceutical Industries, Ltd. Process for producing polypeptide mixtures using hydrogenolysis
RS52867B (sr) 2005-02-17 2013-12-31 Teva Pharmaceutical Industries Ltd. Kombinovana terapija glatiramer acetatom i razagilinom za lečenje multiple skleroze
US20100167983A1 (en) 2007-10-22 2010-07-01 Teva Pharmaceutical Industries, Ltd. Combination therapy with glatiramer acetate and rasagiline for the treatment of multiple sclerosis
US20060240463A1 (en) 2005-04-25 2006-10-26 Rappaport Family Institute For Research In The Medical Sciences Markers associated with the therapeutic efficacy of glatiramer acetate
WO2007030573A2 (en) 2005-09-09 2007-03-15 Yeda Research And Development Co. Ltd. Polypeptides useful for molecular weight determinations
WO2007146331A1 (en) 2006-06-12 2007-12-21 Teva Pharmaceutical Industries, Ltd. Tannate salt form of polypeptide mixtures, their preparation and use
SI2046817T1 (sl) 2006-07-05 2010-04-30 Momenta Pharmaceuticals Inc Izboljšani postopek za pripravo kopolimera-1
CN100569282C (zh) 2006-10-13 2009-12-16 俞嘉林 注射用骨肽冻干剂及其制备方法
ES2477232T5 (es) 2007-06-21 2017-11-23 Momenta Pharmaceuticals, Inc. Análisis de copolímeros
EP2173766A1 (en) 2007-07-31 2010-04-14 Natco Pharma Limited Process for the preparation glatiramer acetate (copolymer-1)
WO2009070298A1 (en) 2007-11-28 2009-06-04 Teva Pharmaceutical Industries, Ltd. Method of delaying the onset of clinically definite multiple sclerosis
MY161021A (en) 2008-05-14 2017-03-31 Otonomy Inc Controlled release corticosteroid and methods for the treatment of otic disorders
US8323685B2 (en) 2008-08-20 2012-12-04 Baxter International Inc. Methods of processing compositions containing microparticles
US8920373B2 (en) 2009-07-15 2014-12-30 Teva Pharmaceutical Industries, Ltd. Reduced volume formulation of glatiramer acetate and methods of administration
ITMI20092069A1 (it) 2009-11-25 2011-05-26 Biofer Spa Metodo per ottenere una miscela di fattori biologici isolati da colostro e miscela di fattori biologici attivi derivata da colostro.
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
EA025780B1 (ru) 2010-10-11 2017-01-30 Тева Фармасьютикал Индастриз Лтд. Цитокиновые биомаркеры в качестве биомаркеров, прогнозирующих клинический ответ на глатирамер ацетат
ES2654291T3 (es) 2011-02-14 2018-02-13 Usv Private Limited Copolímero-1, proceso para la preparación y sus métodos de análisis
US8575198B1 (en) * 2011-09-07 2013-11-05 Momenta Pharmaceuticals, Inc. In-process control for the manufacture of glatiramer acetate
MX2014004309A (es) 2011-10-10 2015-07-06 Teva Pharma Polimorfismos de nucleotidos individuales utiles para predecir una respuesta clinica para el acetato de glatiramer.
EP2869903B1 (en) * 2012-07-06 2018-11-28 3-D Matrix Ltd. Fill-finish process for peptide solutions
WO2014058976A2 (en) 2012-10-10 2014-04-17 Teva Pharmaceutical Industries Ltd. Biomarkers predictive for clinical response for glatiramer acetate
JP2016504039A (ja) 2013-01-04 2016-02-12 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 グラチラマーアセテート関連医薬品の特性決定
CN105188751A (zh) 2013-03-12 2015-12-23 泰华制药工业有限公司 利妥昔单抗诱导疗法继而醋酸格拉替雷疗法
CN103169670B (zh) * 2013-03-22 2016-07-06 深圳翰宇药业股份有限公司 一种醋酸格拉替雷微球及其制备方法
UY35790A (es) 2013-10-21 2015-05-29 Teva Pharma Marcadores genéticos que predicen la respuesta al acetato de glatiramer
US9155775B1 (en) 2015-01-28 2015-10-13 Teva Pharmaceutical Industries, Ltd. Process for manufacturing glatiramer acetate product

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050013912A1 (en) * 2001-11-21 2005-01-20 Gunther Geiger Method for reducing the total bacteria count in aqueous dispersions of non-homogeneous two-phase or multi-phase mixtures
US20070161566A1 (en) * 2006-01-11 2007-07-12 Teva Pharmaceutical Industries, Ltd. Method of treating multiple sclerosis
WO2011008274A2 (en) * 2009-07-15 2011-01-20 Teva Pharmaceutical Industries Ltd. Reduced volume formulation of glatiramer acetate and methods of administration
WO2011022063A1 (en) * 2009-08-20 2011-02-24 Teva Pharmaceutical Industries Ltd. Low frequency glatiramer acetate therapy
WO2014128079A1 (en) * 2013-02-19 2014-08-28 Synthon B.V. Glatiramer acetate multidose formulation

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Elix Essential 3, 5, 10, 15 water purification systems // Merck Brochure, 2012. *
Сираев Р.Р. Фильтрация жидкости в неоднородной пористой среде // Фундаментальные исследования, 2013, 11 (3), 451-455. *

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WO2016122722A1 (en) 2016-08-04
CA2945537A1 (en) 2016-08-04
CA2965890A1 (en) 2016-08-04
DK3050556T3 (en) 2017-04-24
AR102096A1 (es) 2017-02-01
KR102268210B1 (ko) 2021-06-23
MX352734B (es) 2017-12-06
US20160213734A1 (en) 2016-07-28
AU2016273881A1 (en) 2017-01-05
IL267152A (en) 2019-08-29
KR20170101891A (ko) 2017-09-06
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EA028811B1 (ru) 2018-01-31
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US9155775B1 (en) 2015-10-13
EA201791555A2 (ru) 2017-12-29
IL277601A (en) 2020-11-30
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US9763993B2 (en) 2017-09-19
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AU2016101453A4 (en) 2016-09-15
BR112016023736A2 (pt) 2017-10-10
UA116060C2 (uk) 2018-01-25
AU2015380381B2 (en) 2016-10-20
JP2018503627A (ja) 2018-02-08
ES2584190T3 (es) 2017-07-20
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PE20170296A1 (es) 2017-04-14
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ME02721B (me) 2017-10-20
MX2016011219A (es) 2016-11-30
EP3113785A1 (en) 2017-01-11
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AU2018200518A1 (en) 2018-02-15
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