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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JP2018184433A (ja
JP6592150B2 (ja
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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)

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

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JP2018184433A JP2018184433A (ja) 2018-11-22
JP2018184433A5 true JP2018184433A5 (cg-RX-API-DMAC7.html) 2019-09-12
JP6592150B2 JP6592150B2 (ja) 2019-10-16

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JP2017534813A Withdrawn JP2018503627A (ja) 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法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JP2017534813A Withdrawn JP2018503627A (ja) 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法

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US (6) US9155775B1 (cg-RX-API-DMAC7.html)
EP (3) EP3113785A4 (cg-RX-API-DMAC7.html)
JP (2) JP2018503627A (cg-RX-API-DMAC7.html)
KR (2) KR102268210B1 (cg-RX-API-DMAC7.html)
CN (1) CN107530394B (cg-RX-API-DMAC7.html)
AR (1) AR102096A1 (cg-RX-API-DMAC7.html)
AU (4) AU2015380381B2 (cg-RX-API-DMAC7.html)
BR (1) BR112016023736A2 (cg-RX-API-DMAC7.html)
CA (2) CA2945537C (cg-RX-API-DMAC7.html)
CL (1) CL2016002607A1 (cg-RX-API-DMAC7.html)
CY (1) CY1118826T1 (cg-RX-API-DMAC7.html)
DK (1) DK3050556T3 (cg-RX-API-DMAC7.html)
EA (3) EA028484B1 (cg-RX-API-DMAC7.html)
ES (1) ES2584190T3 (cg-RX-API-DMAC7.html)
HK (1) HK1225309B (cg-RX-API-DMAC7.html)
HR (1) HRP20170625T1 (cg-RX-API-DMAC7.html)
HU (1) HUE034059T2 (cg-RX-API-DMAC7.html)
IL (3) IL247851A0 (cg-RX-API-DMAC7.html)
LT (1) LT3050556T (cg-RX-API-DMAC7.html)
ME (1) ME02721B (cg-RX-API-DMAC7.html)
MX (1) MX352734B (cg-RX-API-DMAC7.html)
PE (1) PE20170296A1 (cg-RX-API-DMAC7.html)
PL (1) PL3050556T3 (cg-RX-API-DMAC7.html)
PT (1) PT3050556T (cg-RX-API-DMAC7.html)
RS (1) RS55959B1 (cg-RX-API-DMAC7.html)
RU (1) RU2669769C2 (cg-RX-API-DMAC7.html)
SI (1) SI3050556T1 (cg-RX-API-DMAC7.html)
SM (1) SMT201700227T1 (cg-RX-API-DMAC7.html)
UA (1) UA116060C2 (cg-RX-API-DMAC7.html)
WO (1) WO2016122722A1 (cg-RX-API-DMAC7.html)
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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
NZ703122A (en) 2010-10-11 2016-06-24 Teva Pharma Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate
KR20140101730A (ko) 2011-10-10 2014-08-20 테바 파마슈티컬 인더스트리즈 리미티드 글라티라머 아세테이트에 대한 임상 반응을 예측하는 데 유용한 단일 뉴클레오티드 다형성
HK1213830A1 (zh) 2012-10-10 2016-07-15 Teva Pharmaceutical Industries Ltd. 用於预测醋酸格拉替雷临床反应的生物标志物
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
DK3506921T3 (da) 2016-08-31 2023-07-31 Mapi Pharma Ltd Depotsystemer, der omfatter glatirameracetat
CN110087530A (zh) 2016-12-07 2019-08-02 普罗根尼蒂公司 胃肠道检测方法、装置和系统
US11167003B2 (en) 2017-03-26 2021-11-09 Mapi Pharma Ltd. Methods for suppressing or alleviating primary or secondary progressive multiple sclerosis (PPMS or SPMS) using sustained release glatiramer depot systems
KR20240096769A (ko) 2017-06-29 2024-06-26 리제너론 파아마슈티컬스, 인크. 약물 용기를 과충진하기 위한 디바이스 및 방법
US20200306516A1 (en) 2017-08-14 2020-10-01 Progenity, Inc. Treatment of a disease of the gastrointestinal tract 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
WO1994021316A1 (en) 1993-03-24 1994-09-29 Owen Mumford Limited Improvements relating to 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
WO2000005250A1 (en) 1998-07-23 2000-02-03 Yeda Research And Development Co., Ltd Treatment of autoimmune conditions 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
IL140592A0 (en) 1998-07-23 2002-02-10 Harvard College Synthetic peptides and methods of use for autoimmune disease therapies
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
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
EP2090583B1 (en) 1998-09-25 2011-07-13 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
EP1128839A4 (en) 1998-11-12 2002-10-09 Yeda Res & Dev PHARMACEUTICAL COMPOSITIONS CONTAINING COPOLYMERS OF SYNTHETIC PEPTIDES AND METHODS FOR PREVENTING AND TREATING GVHD AND HVGD
ATE329608T1 (de) 2000-02-18 2006-07-15 Yeda Res & Dev Formulierungen von copolymer 1 (glatirameracetat) zur oralen, nasalen und pulmonalen verabreichung
ZA200206457B (en) 2000-02-18 2003-08-13 Yeda Res & Dev 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
JP2003535118A (ja) 2000-06-05 2003-11-25 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 中枢神経系障害の治療におけるグラチラマーアセテート(共重合体1)の使用
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
MXPA04005433A (es) 2001-12-04 2004-10-11 Teva Pharma Proceso para la medicion de la potencia de acetato de glatiramero.
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
PT1592384E (pt) 2003-01-21 2013-01-28 Yeda Res & Dev Cop-1 para o tratamento de doenças inflamatórias do intestino
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
HRP20140524T1 (hr) 2003-05-14 2014-12-19 Teva Pharmaceutical Industries Ltd. Kombinacijska terapija glatiramer acetatom i mitoksantronom za lijeäśenje multiple skleroze
KR101137785B1 (ko) 2003-07-18 2012-04-25 백스터 인터내셔널 인코포레이티드 제어된 상 분리에 의해 제조된 작은 구형 입자의 제조방법, 이용 방법 및 조성물
EA200600877A1 (ru) 2003-10-31 2006-12-29 Тева Фармасьютикал Индастриз, Лтд. Наночастицы для доставки лекарств
EP1701971A2 (en) 2003-12-31 2006-09-20 F.Hoffmann-La Roche Ag Peptide synthesis using decanting filter
CA2558380A1 (en) 2004-03-03 2005-09-15 Teva Pharmaceutical Industries, Ltd. Combination therapy with glatiramer acetate 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
KR101317131B1 (ko) 2004-09-09 2013-10-10 테바 파마슈티컬 인더스트리즈 리미티드 정제된 브롬화 수소산을 이용한 폴리펩타이드류의 혼합물의제조방법
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
WO2006050122A1 (en) 2004-10-29 2006-05-11 Sandoz Ag Processes for preparing glatiramer
WO2006083608A1 (en) 2005-02-02 2006-08-10 Teva Pharmaceutical Industries, Ltd. Process for producing polypeptide mixtures using hydrogenolysis
US20080261894A1 (en) 2005-02-17 2008-10-23 Rivka Kreitman Combination Therapy with Glatiramer Acetate and Rasagiline for the Treatment of Multiple Sclerosis
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
CA2606194A1 (en) 2005-04-25 2006-11-02 Yeda Research And Development Company 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
WO2007081975A2 (en) 2006-01-11 2007-07-19 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
ATE452140T1 (de) 2006-07-05 2010-01-15 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
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)
US20090149541A1 (en) 2007-11-28 2009-06-11 Yafit Stark Method of delaying the onset of clinically definite multiple sclerosis
WO2009139924A2 (en) 2008-05-14 2009-11-19 Otonomy, Inc. Controlled release corticosteroid compositions 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
CA2697570C (en) * 2009-07-15 2011-11-01 Teva Pharmaceutical Industries, Ltd. Reduced volume formulation of glatiramer acetate and methods of administration
HUE031282T2 (hu) 2009-08-20 2017-06-28 Yeda Res & Dev Alacsony gyakoriságú glatiramer acetát terápia
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
NZ703122A (en) 2010-10-11 2016-06-24 Teva Pharma Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate
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
KR20140101730A (ko) 2011-10-10 2014-08-20 테바 파마슈티컬 인더스트리즈 리미티드 글라티라머 아세테이트에 대한 임상 반응을 예측하는 데 유용한 단일 뉴클레오티드 다형성
ES2706065T3 (es) * 2012-07-06 2019-03-27 3 D Matrix Ltd Proceso de llenado-acabado para soluciones de péptidos
HK1213830A1 (zh) 2012-10-10 2016-07-15 Teva Pharmaceutical Industries Ltd. 用於预测醋酸格拉替雷临床反应的生物标志物
EA201591251A1 (ru) 2013-01-04 2016-05-31 Тева Фармасьютикал Индастриз Лтд. Характеризация лекарственного продукта, родственного ацетату глатирамера
WO2014128079A1 (en) 2013-02-19 2014-08-28 Synthon B.V. Glatiramer acetate multidose formulation
EA201591687A1 (ru) 2013-03-12 2016-07-29 Тева Фармасьютикал Индастриз Лтд. Индукционная терапия ритуксимабом с последующим лечением с использованием глатирамера ацетата
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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