JP2015525763A5 - - Google Patents
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- Publication number
- JP2015525763A5 JP2015525763A5 JP2015521752A JP2015521752A JP2015525763A5 JP 2015525763 A5 JP2015525763 A5 JP 2015525763A5 JP 2015521752 A JP2015521752 A JP 2015521752A JP 2015521752 A JP2015521752 A JP 2015521752A JP 2015525763 A5 JP2015525763 A5 JP 2015525763A5
- Authority
- JP
- Japan
- Prior art keywords
- surfactant
- polysorbate
- composition
- formulation
- etanercept
- 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.)
- Granted
Links
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261669480P | 2012-07-09 | 2012-07-09 | |
| US61/669,480 | 2012-07-09 | ||
| US201361806235P | 2013-03-28 | 2013-03-28 | |
| US61/806,235 | 2013-03-28 | ||
| PCT/US2013/049778 WO2014011672A1 (en) | 2012-07-09 | 2013-07-09 | Etanercept formulations exhibiting marked reduction in sub-visible particles |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015525763A JP2015525763A (ja) | 2015-09-07 |
| JP2015525763A5 true JP2015525763A5 (enExample) | 2016-09-01 |
| JP6271536B2 JP6271536B2 (ja) | 2018-01-31 |
Family
ID=49916504
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015521752A Expired - Fee Related JP6271536B2 (ja) | 2012-07-09 | 2013-07-09 | 肉眼不可視粒子の著しい低減を示すエタネルセプト製剤 |
| JP2015521742A Pending JP2015525762A (ja) | 2012-07-09 | 2013-07-09 | エタネルセプトの安定な水性製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015521742A Pending JP2015525762A (ja) | 2012-07-09 | 2013-07-09 | エタネルセプトの安定な水性製剤 |
Country Status (19)
| Country | Link |
|---|---|
| US (3) | US9662396B2 (enExample) |
| EP (2) | EP2869817A4 (enExample) |
| JP (2) | JP6271536B2 (enExample) |
| KR (1) | KR20150030704A (enExample) |
| CN (1) | CN104661651A (enExample) |
| AU (1) | AU2013290289B2 (enExample) |
| BR (2) | BR112015000203A2 (enExample) |
| CA (1) | CA2878508A1 (enExample) |
| CL (1) | CL2015000051A1 (enExample) |
| DO (1) | DOP2015000006A (enExample) |
| EA (1) | EA029193B1 (enExample) |
| EC (1) | ECSP15004752A (enExample) |
| HK (2) | HK1209343A1 (enExample) |
| IL (1) | IL236527A0 (enExample) |
| IN (1) | IN2015KN00005A (enExample) |
| MX (1) | MX2015000337A (enExample) |
| PE (1) | PE20150762A1 (enExample) |
| SG (1) | SG11201500138VA (enExample) |
| WO (2) | WO2014011629A1 (enExample) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008543839A (ja) | 2005-06-14 | 2008-12-04 | アムジェン インコーポレーテッド | 自己緩衝タンパク質製剤 |
| KR102250937B1 (ko) * | 2012-09-11 | 2021-05-12 | 코히러스 바이오사이언시즈, 인코포레이티드 | 고순도 및 탁월한 수율의 정확하게 폴딩된 에타너셉트 |
| HK1221163A1 (zh) * | 2013-05-02 | 2017-05-26 | Mabxience, S.A. | Tnfr:fc融合多肽的替代配方 |
| BR112016022056B1 (pt) | 2014-03-26 | 2023-04-11 | Astex Therapeutics Limited | Combinação, composição farmacêutica, uso de uma combinação ou uma composição farmacêutica, e, produto farmacêutico |
| US20180200325A1 (en) * | 2014-11-18 | 2018-07-19 | Shionogi & Co., Ltd. | Stabilized peptide composition |
| TWI719960B (zh) | 2015-02-10 | 2021-03-01 | 英商阿斯迪克治療公司 | 新穎組成物 |
| US10478494B2 (en) | 2015-04-03 | 2019-11-19 | Astex Therapeutics Ltd | FGFR/PD-1 combination therapy for the treatment of cancer |
| MX389818B (es) * | 2015-08-13 | 2025-03-20 | Landsteiner Scient S A De C V | Composicion de estabilidad mejorada de etanercept. |
| JP6877196B2 (ja) * | 2016-03-14 | 2021-05-26 | 参天製薬株式会社 | メグルミン又はその塩からなる防腐剤 |
| ES3064802T3 (en) | 2016-10-21 | 2026-04-29 | Amgen Inc | Pharmaceutical formulations and methods of making the same |
| CN109937034B (zh) * | 2016-11-21 | 2022-09-16 | 济世-伊沃泰克生物制品有限公司 | 阿柏西普制剂及其用途 |
| MX2017013995A (es) * | 2017-10-31 | 2019-05-01 | Probiomed S A De C V | Formulacion farmaceutica estable de una proteina de fusion. |
| KR20200083564A (ko) * | 2017-11-13 | 2020-07-08 | 암젠 인크 | 단백질 산물을 제조하는 방법 |
| JP2021521232A (ja) * | 2018-04-16 | 2021-08-26 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツングＭｅｒｃｋ Ｐａｔｅｎｔ Ｇｅｓｅｌｌｓｃｈａｆｔ ｍｉｔ ｂｅｓｃｈｒａｅｎｋｔｅｒ Ｈａｆｔｕｎｇ | メグルミン塩を使用して製剤を含むタンパク質を安定化するための方法 |
| CN112105344B (zh) * | 2018-04-24 | 2024-10-15 | 安进公司 | 用于制备可注射药物组合物的方法 |
| CA3042126A1 (en) | 2018-05-03 | 2019-11-03 | Seattle Children's Hospital (dba Seattle Children's Research Institute) | Methods of treating kawasaki disease |
| TR201808283A2 (tr) * | 2018-06-11 | 2018-07-23 | Centurion Ilac San Ve Tic A S | Sulu farmasöti̇k etenersept bi̇leşi̇mi̇ |
| GB201911461D0 (en) * | 2019-08-09 | 2019-09-25 | Arecor Ltd | Novel composition |
| EP4051245A1 (en) * | 2019-10-28 | 2022-09-07 | Astrazeneca AB | Dry powder formulations containing leucine and trileucine |
| IL305010A (en) | 2021-02-17 | 2023-10-01 | Arecor Ltd | An aqueous preparation of a transgenic protein structure that includes an FC domain |
| WO2026159667A1 (en) * | 2025-01-24 | 2026-07-30 | Hovione Farmaciência Sa | Synthetic sugars as enablers for viscosity reduction of highly concentrated biological molecules |
Family Cites Families (50)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5580856A (en) | 1994-07-15 | 1996-12-03 | Prestrelski; Steven J. | Formulation of a reconstituted protein, and method and kit for the production thereof |
| EP0852951A1 (de) | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US7294481B1 (en) | 1999-01-05 | 2007-11-13 | Immunex Corporation | Method for producing recombinant proteins |
| US20040220103A1 (en) | 1999-04-19 | 2004-11-04 | Immunex Corporation | Soluble tumor necrosis factor receptor treatment of medical disorders |
| CA2366785C (en) * | 1999-04-19 | 2012-02-07 | Immunex Corporation | Soluble tumor necrosis factor receptor treatment of medical disorders |
| US20010021380A1 (en) | 1999-04-19 | 2001-09-13 | Pluenneke John D. | Soluble tumor necrosis factor receptor treatment of medical disorders |
| BR0108193A (pt) | 2000-02-10 | 2003-02-25 | Wyeth Corp | Processo para tratamento ou inibição de dano celular ou morte celular |
| US20030138417A1 (en) * | 2001-11-08 | 2003-07-24 | Kaisheva Elizabet A. | Stable liquid pharmaceutical formulation of IgG antibodies |
| CA2476934C (en) * | 2002-02-27 | 2009-06-16 | Immunex Corporation | Stabilized tnfr-fc composition comprising arginine |
| EA009079B1 (ru) | 2003-02-28 | 2007-10-26 | Арес Трейдинг С.А. | Жидкие составы фактор некроза опухоли-связывающих белков |
| WO2004082715A1 (ja) | 2003-03-20 | 2004-09-30 | Eisai Co., Ltd. | 炎症性腸疾患治療剤としての併用医薬 |
| SG145712A1 (en) | 2003-08-01 | 2008-09-29 | Amgen Inc | Crystalline tumor necrosis factor receptor 2 polypeptides |
| WO2005037214A2 (en) * | 2003-10-14 | 2005-04-28 | Intermune, Inc. | Macrocyclic carboxylic acids and acylsulfonamides as inhibitors of hcv replication |
| JP5554466B2 (ja) | 2004-03-01 | 2014-07-23 | 味の素株式会社 | 抗ヒトＴＮＦ−α抗体活性低下抑制剤 |
| PL1720972T3 (pl) | 2004-03-05 | 2014-06-30 | Dpx Holdings Bv | Proces hodowli komórek poprzez ciągłą perfuzję i zmienny przepływ styczny |
| US20060008415A1 (en) * | 2004-06-25 | 2006-01-12 | Protein Design Labs, Inc. | Stable liquid and lyophilized formulation of proteins |
| US20070196364A1 (en) | 2004-07-27 | 2007-08-23 | Human Genome Sciences, Inc. | Pharmaceutical Formulation and Process |
| US7300773B2 (en) | 2004-08-27 | 2007-11-27 | Wyeth Research Ireland Limited | Production of TNFR-Ig |
| CN101237890A (zh) | 2005-06-10 | 2008-08-06 | 中外制药株式会社 | 含有葡甲胺的蛋白质制剂的稳定剂及其利用 |
| TW200738261A (en) | 2005-12-20 | 2007-10-16 | Bristol Myers Squibb Co | Stable protein formulations |
| JP5405122B2 (ja) | 2005-12-21 | 2014-02-05 | ワイス・エルエルシー | 低粘度のタンパク質製剤およびその用途 |
| EA015992B1 (ru) | 2006-03-17 | 2012-01-30 | Байоджен Айдек Эмэй Инк. | Стабилизированное антитело и многовалентная антигенсвязывающая молекула на его основе, способы получения и использования вышеназванного стабилизированного антитела |
| CA2649538C (en) * | 2006-04-21 | 2014-06-03 | Yatin Gokarn | Buffering agents for biopharmaceutical formulations |
| CA2665567C (en) | 2006-10-06 | 2012-07-03 | Amgen Inc. | Stable formulations |
| US7705132B2 (en) | 2006-10-20 | 2010-04-27 | Amgen Inc. | Stable polypeptide formulations |
| MX2009004519A (es) | 2006-11-03 | 2009-05-12 | Wyeth Corp | Sustancias que inhiben la glucolisis en un cultivo de celulas. |
| EP2129401B8 (en) | 2006-12-21 | 2020-01-15 | Amgen Inc. | Stable buffered formulations containing polypeptides |
| CA2679941C (en) | 2007-03-02 | 2016-09-20 | Wyeth | Use of copper and glutamate in cell culture for production of polypeptides |
| EP2014760A1 (en) | 2007-06-13 | 2009-01-14 | CMC Biopharmaceuticals A/S | A method for producing a biopolymer (e.g. polypeptide) in a continuous fermentation process |
| CA2690382A1 (en) | 2007-06-14 | 2008-12-24 | Biogen Idec Ma Inc. | Antibody formulations |
| US8420081B2 (en) | 2007-11-30 | 2013-04-16 | Abbvie, Inc. | Antibody formulations and methods of making same |
| EP2249801A2 (en) * | 2008-02-07 | 2010-11-17 | Amgen Inc. | Stabilized protein compositions |
| JP2011514895A (ja) | 2008-02-29 | 2011-05-12 | バイオジェン・アイデック・エムエイ・インコーポレイテッド | 精製免疫グロブリン融合タンパク質およびその精製方法 |
| SI2331090T1 (en) * | 2008-09-19 | 2018-04-30 | Pfizer Inc. | Stable liquid antibody formulation |
| WO2011015926A1 (en) | 2009-08-03 | 2011-02-10 | Avesthagen Limited | A process of fermentation, purification and production of recombinant soluble tumour necrosis factor alfa receptor (tnfr) - human igg fc fusion protein |
| MX355650B (es) | 2009-08-11 | 2018-04-26 | Genentech Inc | Produccion de proteinas en medios de cultivo de celulas libres de glutamina. |
| WO2011049798A1 (en) | 2009-10-20 | 2011-04-28 | Merck Sharp & Dohme Corp. | Use of mixed mode chromatography for the capture and purification of basic antibody products |
| EP2516467A2 (en) | 2009-12-23 | 2012-10-31 | Emergent Product Development Seattle, LLC | Compositions comprising tnf-alpha and il-6 antagonists and methods of use thereof |
| AU2011246503B2 (en) | 2010-04-26 | 2013-09-26 | Novartis Ag | Improved cell culture medium |
| RU2600847C2 (ru) * | 2010-05-10 | 2016-10-27 | Интас Биофармасьютикалс Лимитед | Жидкий состав полипептидов, содержащих fc-домен иммуноглобулина |
| EP2598167B1 (en) | 2010-07-30 | 2015-04-01 | Arecor Limited | Stabilized aqueous antibody compositions |
| EP2606119A1 (en) | 2010-08-20 | 2013-06-26 | Wyeth LLC | Cell culture of growth factor-free adapted cells |
| JP2012049074A (ja) | 2010-08-30 | 2012-03-08 | Makita Corp | 電動工具のバッテリパック |
| KR20130101034A (ko) | 2010-08-31 | 2013-09-12 | 프리슬랜드 브랜즈 비브이 | 진핵 세포를 위한 배양 배지 |
| RU2614257C2 (ru) * | 2011-04-20 | 2017-03-24 | Сандоз Аг | СТАБИЛЬНЫЕ ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ ПРЕПАРАТЫ СЛИТОГО БЕЛКА TNFR:Fc |
| UY34105A (es) * | 2011-06-03 | 2012-07-31 | Lg Life Sciences Ltd | Formulación líquida estable de etanercept |
| EA026226B1 (ru) | 2011-07-01 | 2017-03-31 | Байоджен Айдек Ма Инк. | Не содержащие аргинина композиции слитого fc-полипептида и способы их применения |
| SI2726600T1 (sl) | 2011-07-01 | 2017-07-31 | Amgen Inc. | Sesalska celična kultura |
| AU2012326170B2 (en) * | 2011-10-18 | 2016-12-22 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with metal ions |
-
2013
- 2013-07-09 WO PCT/US2013/049716 patent/WO2014011629A1/en not_active Ceased
- 2013-07-09 IN IN5KON2015 patent/IN2015KN00005A/en unknown
- 2013-07-09 WO PCT/US2013/049778 patent/WO2014011672A1/en not_active Ceased
- 2013-07-09 EP EP13817186.3A patent/EP2869817A4/en not_active Withdrawn
- 2013-07-09 BR BR112015000203A patent/BR112015000203A2/pt not_active IP Right Cessation
- 2013-07-09 JP JP2015521752A patent/JP6271536B2/ja not_active Expired - Fee Related
- 2013-07-09 MX MX2015000337A patent/MX2015000337A/es unknown
- 2013-07-09 HK HK15110117.0A patent/HK1209343A1/xx unknown
- 2013-07-09 SG SG11201500138VA patent/SG11201500138VA/en unknown
- 2013-07-09 PE PE2015000026A patent/PE20150762A1/es not_active Application Discontinuation
- 2013-07-09 JP JP2015521742A patent/JP2015525762A/ja active Pending
- 2013-07-09 KR KR1020157000510A patent/KR20150030704A/ko not_active Withdrawn
- 2013-07-09 HK HK15110120.5A patent/HK1213174A1/zh unknown
- 2013-07-09 CA CA2878508A patent/CA2878508A1/en not_active Abandoned
- 2013-07-09 BR BR112015000229A patent/BR112015000229A2/pt not_active IP Right Cessation
- 2013-07-09 EA EA201590161A patent/EA029193B1/ru not_active IP Right Cessation
- 2013-07-09 CN CN201380046666.4A patent/CN104661651A/zh active Pending
- 2013-07-09 EP EP13816429.8A patent/EP2869816A4/en not_active Withdrawn
- 2013-07-09 AU AU2013290289A patent/AU2013290289B2/en not_active Expired - Fee Related
-
2014
- 2014-12-31 IL IL236527A patent/IL236527A0/en unknown
-
2015
- 2015-01-08 CL CL2015000051A patent/CL2015000051A1/es unknown
- 2015-01-08 US US14/592,654 patent/US9662396B2/en not_active Expired - Fee Related
- 2015-01-08 US US14/592,569 patent/US10822429B2/en not_active Expired - Fee Related
- 2015-01-09 DO DO2015000006A patent/DOP2015000006A/es unknown
- 2015-02-09 EC ECIEPI20154752A patent/ECSP15004752A/es unknown
-
2020
- 2020-09-28 US US17/034,134 patent/US20210007991A1/en not_active Abandoned
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