JP2018184433A5 - - Google Patents

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JP2018184433A5
JP2018184433A5 JP2018134124A JP2018134124A JP2018184433A5 JP 2018184433 A5 JP2018184433 A5 JP 2018184433A5 JP 2018134124 A JP2018134124 A JP 2018134124A JP 2018134124 A JP2018134124 A JP 2018134124A JP 2018184433 A5 JP2018184433 A5 JP 2018184433A5
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ultra
temperature
aqueous pharmaceutical
pharmaceutical solution
super
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JP2018134124A
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JP6592150B2 (ja
JP2018184433A (ja
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Priority claimed from US14/608,126 external-priority patent/US9155775B1/en
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JP2018134124A 2015-01-28 2018-07-17 酢酸グラチラマーの製造方法 Active JP6592150B2 (ja)

Applications Claiming Priority (2)

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

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
JP2017534813A Division JP2018503627A (ja) 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法

Publications (3)

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JP2018184433A JP2018184433A (ja) 2018-11-22
JP2018184433A5 true JP2018184433A5 (enExample) 2019-09-12
JP6592150B2 JP6592150B2 (ja) 2019-10-16

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Family Applications (2)

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JP2017534813A Withdrawn JP2018503627A (ja) 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法
JP2018134124A Active JP6592150B2 (ja) 2015-01-28 2018-07-17 酢酸グラチラマーの製造方法

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JP2017534813A Withdrawn JP2018503627A (ja) 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法

Country Status (31)

Country Link
US (6) US9155775B1 (enExample)
EP (3) EP3113785A4 (enExample)
JP (2) JP2018503627A (enExample)
KR (2) KR102268210B1 (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
PT2627669T (pt) 2010-10-11 2016-11-24 Teva Pharma Biomarcadores de citocina como biomarcadores preditivos de resposta clínica para acetato de glatirâmero
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.
US9617596B2 (en) 2012-10-10 2017-04-11 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
SI3506921T1 (sl) 2016-08-31 2023-10-30 Mapi Pharma Ltd. Depojski sistemi, ki vsebujejo glatiramer acetat
JP2020513554A (ja) 2016-12-07 2020-05-14 プロジェニティ, インコーポレイテッド 胃腸管の検出方法、装置およびシステム
JP7602322B2 (ja) 2017-03-26 2024-12-18 マピ ファーマ リミテッド 進行型の多発性硬化症を治療するためのグラチラマーデポシステム
IL271434B2 (en) 2017-06-29 2025-11-01 Regeneron Pharma 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

Family Cites Families (71)

* 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
EP0693946B1 (en) 1993-03-24 2001-05-16 Owen Mumford Limited Improvements relating to injection devices
US5800808A (en) 1994-05-24 1998-09-01 Veda Research And Development Co., Ltd. Copolymer-1 improvements in compositions of copolymers
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
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 (en) 1998-07-23 2016-04-05 Yeda Research And Development Co., Ltd. Treatment of autoimmune conditions with copolymer 1 and related copolymers
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
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
PT2090583E (pt) 1998-09-25 2011-09-14 Yeda Res & Dev Polipéptidos relacionados com o copolímero 1 para utilização a título de marcadores de massas moleculares e em terapêutica
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
AU6281599A (en) 1998-10-02 2000-04-26 Yeda Research And Development Co. Ltd. Alternate day administration of copolymer 1 for treating autoimmune diseases
WO2000027417A1 (en) 1998-11-12 2000-05-18 Yeda Research And Development Co. Ltd. Pharmaceutical compositions comprising synthetic peptide copolymers and methods for preventing and treating gvhd and hvgd
EP1261361B1 (en) 2000-02-18 2006-06-14 Yeda Research And Development Company, Ltd. Oral, nasal and pulmonary dosage formulations of copolymer 1 (glatiramer acetate)
ZA200206457B (en) 2000-02-18 2003-08-13 Yeda Res & Dev Oral, nasal and pulmonary dosage formulations of copolymer 1.
PL363431A1 (en) 2000-06-05 2004-11-15 Teva Pharmaceuticals Industries, Ltd. The use of glatiramer acetate (copolymer 1) in the treatment of central nervous system disorders
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
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
DE10158009A1 (de) * 2001-11-21 2003-05-28 Begerow E Gmbh & Co Verfahren zur Reduzierung der Gesamtkeimzahl in wäßrigen Dispersionen
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
RU2339397C2 (ru) 2003-01-21 2008-11-27 Йеда Рисерч Энд Дивелопмент Ко.Лтд. Сор1 для лечения воспалительных заболеваний кишечника
EP1603530A1 (en) 2003-03-04 2005-12-14 Teva Pharmaceutical Industries Limited Combination therapy with glatiramer acetate and alphacalcidol for the treatment of multiple sclerosis
PL1638589T3 (pl) 2003-05-14 2014-10-31 Teva Pharmaceutical Industries Ltd Terapia kombinowana obejmująca octan glatirameru i mitoksantron do leczenia stwardnienia rozsianego
RU2426590C2 (ru) 2003-07-18 2011-08-20 Бакстер Интернэшнл Инк. Способы изготовления, применение и композиции небольших сферических частиц, приготовленных регулируемым фазовым разделением
WO2005041933A1 (en) 2003-10-31 2005-05-12 Teva Pharmaceutical Industries, Ltd. Nanoparticles for drug delivery
EP1701971A2 (en) 2003-12-31 2006-09-20 F.Hoffmann-La Roche Ag Peptide synthesis using decanting filter
US20070244056A1 (en) 2004-03-03 2007-10-18 Liat Hayardeny Combination Therapy With Glatiramer Acetate and Riluzole
US7655221B2 (en) 2004-05-07 2010-02-02 Peptimmune, Inc. Methods of treating disease with random copolymers
US20060194725A1 (en) 2004-05-07 2006-08-31 James Rasmussen Methods of treating disease with random copolymers
US20090048181A1 (en) 2004-09-02 2009-02-19 Schipper Hyman M 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
CA2579656C (en) 2004-09-09 2014-11-04 Teva Pharmaceutical Industries, Ltd. Process for preparation of mixtures of polypeptides using purified hydrobromic acid
ATE440888T1 (de) 2004-10-29 2009-09-15 Sandoz Ag Verfahren zur herstellung von glatiramer
AU2006211510B8 (en) 2005-02-02 2011-04-21 Teva Pharmaceutical Industries, Ltd. Process for producing polypeptide mixtures using hydrogenolysis
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
RS52867B (sr) 2005-02-17 2013-12-31 Teva Pharmaceutical Industries Ltd. Kombinovana terapija glatiramer acetatom i razagilinom za lečenje multiple skleroze
EP1891233A4 (en) 2005-04-25 2010-03-24 Yeda Res & Dev MARKERS ASSOCIATED WITH THERAPY EFFECTIVENESS OF GLATIRAMERATE ACETATE
US20070059798A1 (en) 2005-09-09 2007-03-15 Alexander Gad Polypeptides useful for molecular weight determinations
US20070161566A1 (en) * 2006-01-11 2007-07-12 Teva Pharmaceutical Industries, Ltd. Method of treating multiple sclerosis
US20080118553A1 (en) 2006-06-12 2008-05-22 Anton Frenkel Tannate salt form of polypeptide mixtures, their preparation and use
DE602007003848D1 (de) 2006-07-05 2010-01-28 Momenta Pharmaceuticals Inc Verbessertes verfahren zur herstellung von copolymer-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
AU2008265692A1 (en) 2007-06-21 2008-12-24 Momenta Pharmaceuticals, Inc. Copolymer assay
EP2173766A1 (en) 2007-07-31 2010-04-14 Natco Pharma Limited Process for the preparation glatiramer acetate (copolymer-1)
BRPI0819001A2 (pt) 2007-11-28 2014-10-07 Teva Pharma "método para retardar o acesso de esclerose múltipla clinicamente defenitiva em um paciente correndo o risco de desenvolver clinicamente a esclerose múltipla definitiva, método para reduzir a progressão da atividade de doença monitorada por imagem latente de ressonância magnética (mri) em um paciente correndo o risco de desenvolver clinicamente a esclerose múltipla definitiva, método para reduzir a progressão dos sintomas de esclerose múltipla definitiva em um paciente, método para reduzir a freqüência de recidiva em um paciente que experimentou um ataque clínico simples sugestivo de esclerose múltipla e que tem pelo menos uma lesão sugestiva de esclerose múltipla, método para retardar a progressão para a esclerose múltipla clinicamente definitiva em um paciente que apresenta um primeiro evento clínico sugestivo de esclerose múltipla e pelo menos uma lesão sugestiva de esclerose múltipla, uso de acetato de glatiramer e acetato de glatiramer
RU2469726C2 (ru) 2008-05-14 2012-12-20 Отономи, Инк. Композиции с контролируемым высвобождением на основе кортикостероидов для лечения ушных болезней
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
PT2275086E (pt) 2009-07-15 2012-05-18 Teva Pharma Formulação de volume reduzido de acetato de glatirâmero e métodos de administração
SI2405749T1 (sl) 2009-08-20 2013-10-30 Yeda Research And Development Co., Ltd. Nizkofrekventna terapija z glatiramer acetatom
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
PT2627669T (pt) 2010-10-11 2016-11-24 Teva Pharma Biomarcadores de citocina como biomarcadores preditivos de resposta clínica para acetato de glatirâmero
WO2012123959A2 (en) 2011-02-14 2012-09-20 Usv Limited Copolymer-1, process for preparation and analytical methods thereof
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.
EP3466964A1 (en) * 2012-07-06 2019-04-10 3-D Matrix Ltd. Fill-finish process for peptide solutions
US9617596B2 (en) 2012-10-10 2017-04-11 Teva Pharmaceutical Industries, Ltd. Biomarkers predictive for clinical response for glatiramer acetate
MX2015008754A (es) 2013-01-04 2016-04-11 Teva Pharma Caracterizacion de un medicamento relacionado con acetato de glatiramer.
WO2014128079A1 (en) 2013-02-19 2014-08-28 Synthon B.V. Glatiramer acetate multidose formulation
CA2903127A1 (en) 2013-03-12 2014-10-09 Teva Pharmaceutical Industries Ltd. Rituximab induction therapy followed by glatiramer acetate therapy
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

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