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) | US10822429B2 (enExample) |
| EP (2) | EP2869816A4 (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) | HK1213174A1 (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 (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2776657T3 (es) | 2005-06-14 | 2020-07-31 | Amgen Inc | Formulaciones de proteínas autotamponantes |
| RS57013B1 (sr) * | 2012-09-11 | 2018-05-31 | Coherus Biosciences Inc | Korektno savijeni etanercept sa visokom čistoćom i odličnim prinosom |
| HK1221163A1 (zh) * | 2013-05-02 | 2017-05-26 | Mabxience, S.A. | Tnfr:fc融合多肽的替代配方 |
| HUE053654T2 (hu) | 2014-03-26 | 2021-07-28 | Astex Therapeutics Ltd | FGFR- és CMET-inhibitorok kombinációi a rák kezelésére |
| WO2016080367A1 (ja) * | 2014-11-18 | 2016-05-26 | 塩野義製薬株式会社 | 安定化されたペプチド組成物 |
| JOP20200201A1 (ar) | 2015-02-10 | 2017-06-16 | Astex Therapeutics Ltd | تركيبات صيدلانية تشتمل على n-(3.5- ثنائي ميثوكسي فينيل)-n'-(1-ميثيل إيثيل)-n-[3-(ميثيل-1h-بيرازول-4-يل) كينوكسالين-6-يل]إيثان-1.2-ثنائي الأمين |
| MX389818B (es) * | 2015-08-13 | 2025-03-20 | Landsteiner Scient S A De C V | Composicion de estabilidad mejorada de etanercept. |
| CA3016809C (en) * | 2016-03-14 | 2024-03-12 | Santen Pharmaceutical Co., Ltd. | Antiseptic agent comprising meglumine or salt thereof |
| EP3528787B1 (en) | 2016-10-21 | 2026-01-07 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| EP3541365A1 (en) * | 2016-11-21 | 2019-09-25 | Just Biotherapeutics, Inc. | Aflibercept formulations and uses thereof |
| MX2017013995A (es) * | 2017-10-31 | 2019-05-01 | Probiomed S A De C V | Formulacion farmaceutica estable de una proteina de fusion. |
| EP3710139A4 (en) * | 2017-11-13 | 2021-09-08 | Amgen Inc. | PROTEIN PRODUCTS PRODUCTION PROCESSES |
| EP3781124A1 (en) * | 2018-04-16 | 2021-02-24 | Merck Patent GmbH | Method for stabilizing protein comprising formulations by using a meglumine salt |
| JP7395504B2 (ja) | 2018-04-24 | 2023-12-11 | アムジェン インコーポレイテッド | 注射可能医薬組成物の製造方法 |
| 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 |
| US20220401365A1 (en) * | 2019-10-28 | 2022-12-22 | Astrazeneca Ab | Dry powder formulations containing leucine and trileucine |
| US20240166718A1 (en) | 2021-02-17 | 2024-05-23 | Arecor Limited | Aqueous composition of an engineered protein construct comprising an fc domain |
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 |
| US20010021380A1 (en) | 1999-04-19 | 2001-09-13 | Pluenneke John D. | Soluble tumor necrosis factor receptor treatment of medical disorders |
| US20040220103A1 (en) | 1999-04-19 | 2004-11-04 | Immunex Corporation | Soluble tumor necrosis factor receptor treatment of medical disorders |
| WO2000062790A2 (en) * | 1999-04-19 | 2000-10-26 | Immunex Corporation | Soluble tumor necrosis factor receptor treatment of medical disorders |
| CN1406132A (zh) | 2000-02-10 | 2003-03-26 | 惠氏公司 | 处理或抑制细胞损伤或细胞死亡的方法 |
| IL161677A0 (en) * | 2001-11-08 | 2004-09-27 | Protein Design Labs | Stable liquid pharmaceutical formulation of igg antibodies |
| PL215168B1 (pl) | 2002-02-27 | 2013-10-31 | Immunex Corp | Formulacja polipeptydowa |
| ES2304602T3 (es) | 2003-02-28 | 2008-10-16 | Ares Trading S.A. | Formulaciones liquidas de la proteina de union al factor de necrosis tumoral tbp-1. |
| US20060177444A1 (en) | 2003-03-20 | 2006-08-10 | Tatsuo Horizoe | Concomitant drug as therapeutic agent for inflammatory bowel disease |
| CN100509847C (zh) | 2003-08-01 | 2009-07-08 | 安美基公司 | 结晶肿瘤坏死因子受体2多肽 |
| HRP20130098T1 (hr) * | 2003-10-14 | 2013-02-28 | F. Hoffmann - La Roche Ag | MAKROCIKLIÄŚKE KARBOKSILNE KISELINE I ACILSULFONAMIDNI SPOJEVI KAO INHIBITORI REPLIKACIJE HCV-a |
| WO2005082377A1 (ja) | 2004-03-01 | 2005-09-09 | Ajinomoto Co., Inc. | 抗ヒトTNF-α抗体活性低下抑制剤 |
| CN104388324A (zh) | 2004-03-05 | 2015-03-04 | 帝斯曼知识产权资产管理有限公司 | 用于通过连续灌注和交互切向流来培养细胞的方法 |
| 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 |
| TWI364458B (en) | 2004-08-27 | 2012-05-21 | Wyeth Res Ireland Ltd | Production of tnfr-lg |
| CA2610987C (en) * | 2005-06-10 | 2013-09-10 | Chugai Seiyaku Kabushiki Kaisha | Stabilizer for protein preparation comprising meglumine and use thereof |
| TW200738261A (en) * | 2005-12-20 | 2007-10-16 | Bristol Myers Squibb Co | Stable protein formulations |
| CN101378782A (zh) | 2005-12-21 | 2009-03-04 | 惠氏公司 | 粘度降低的蛋白质制剂及其用途 |
| GEP20135917B (en) | 2006-03-17 | 2013-09-10 | Biogen Idec Inc | Stabilized polypeptide compositions |
| MX2008013535A (es) * | 2006-04-21 | 2008-10-29 | Amgen Inc | Agentes amortiguadores para formulaciones biofarmaceuticas. |
| CA2665567C (en) * | 2006-10-06 | 2012-07-03 | Amgen Inc. | Stable formulations |
| CA2666492C (en) | 2006-10-20 | 2012-07-17 | Douglas Rehder | Stable polypeptide formulations |
| EP2395077A1 (en) | 2006-11-03 | 2011-12-14 | Wyeth LLC | Glycolysis-inhibiting substances in cell culture |
| CA2672902C (en) | 2006-12-21 | 2012-11-27 | Amgen Inc. | Formulations |
| JP5586235B2 (ja) | 2007-03-02 | 2014-09-10 | ワイス・エルエルシー | ポリペプチドの産生のための細胞培養における銅およびグルタミン酸塩の使用 |
| 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 |
| ES2707815T3 (es) | 2007-06-14 | 2019-04-05 | Biogen Ma Inc | Formulaciones de anticuerpo natalizumab |
| NZ622583A (en) | 2007-11-30 | 2015-08-28 | Abbvie Biotechnology Ltd | Protein formulations and methods of making same |
| SG10201402265YA (en) * | 2008-02-07 | 2014-08-28 | 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 |
| TR201802935T4 (tr) * | 2008-09-19 | 2018-03-21 | Pfizer | Stabil sıvı antikor formülasyonu. |
| 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 |
| BR112012002974B1 (pt) | 2009-08-11 | 2022-06-07 | Genentech, Inc | Processo para produzir um anticorpo em uma célula hospedeira de célula ovário de hamster chinês (cho) expressando o referido polipeptídeo |
| EP2490780A4 (en) | 2009-10-20 | 2014-04-09 | Merck Sharp & Dohme | USE OF A MIXED MODE CHROMATOGRAPHY FOR THE DETECTION AND PURIFICATION OF BASIC ANTIBODY PRODUCTS |
| US20130052195A1 (en) | 2009-12-23 | 2013-02-28 | Emergent Product Development Seattle,LLC | Compositions Comprising TNF-alpha and IL-6 Antagonists and Methods of Use Thereof |
| ES2533074T3 (es) | 2010-04-26 | 2015-04-07 | Novartis Ag | Medio de cultivo celular mejorado |
| EP2568960B1 (en) * | 2010-05-10 | 2018-06-06 | Intas Pharmaceuticals Ltd. | Liquid formulation of polypeptides containing an fc domain of an immunoglobulin |
| EP2598167B1 (en) | 2010-07-30 | 2015-04-01 | Arecor Limited | Stabilized aqueous antibody compositions |
| WO2012023085A1 (en) | 2010-08-20 | 2012-02-23 | 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 |
| SG187885A1 (en) | 2010-08-31 | 2013-03-28 | Friesland Brands Bv | Culture medium for eukaryotic cells |
| EP2699265B1 (en) * | 2011-04-20 | 2019-10-16 | Sandoz AG | STABLE PHARMACEUTICAL LIQUID FORMULATIONS OF THE FUSION PROTEIN TNFR:Fc |
| UY34105A (es) * | 2011-06-03 | 2012-07-31 | Lg Life Sciences Ltd | Formulación líquida estable de etanercept |
| CA2838695C (en) | 2011-07-01 | 2017-02-14 | Amgen Inc. | Mammalian cell culture |
| EP2726090B1 (en) * | 2011-07-01 | 2020-01-01 | Biogen MA Inc. | Arginine - free tnfr : fc- fusion polypeptide compositions |
| CN104011073B (zh) * | 2011-10-18 | 2017-08-25 | 科荣生生物科学公司 | 使用氨基酸稳定的依那西普制剂 |
-
2013
- 2013-07-09 EP EP13816429.8A patent/EP2869816A4/en not_active Withdrawn
- 2013-07-09 CN CN201380046666.4A patent/CN104661651A/zh active Pending
- 2013-07-09 EP EP13817186.3A patent/EP2869817A4/en not_active Withdrawn
- 2013-07-09 JP JP2015521752A patent/JP6271536B2/ja not_active Expired - Fee Related
- 2013-07-09 WO PCT/US2013/049716 patent/WO2014011629A1/en not_active Ceased
- 2013-07-09 EA EA201590161A patent/EA029193B1/ru not_active IP Right Cessation
- 2013-07-09 SG SG11201500138VA patent/SG11201500138VA/en unknown
- 2013-07-09 BR BR112015000203A patent/BR112015000203A2/pt not_active IP Right Cessation
- 2013-07-09 AU AU2013290289A patent/AU2013290289B2/en not_active Expired - Fee Related
- 2013-07-09 HK HK15110120.5A patent/HK1213174A1/zh unknown
- 2013-07-09 CA CA2878508A patent/CA2878508A1/en not_active Abandoned
- 2013-07-09 HK HK15110117.0A patent/HK1209343A1/xx unknown
- 2013-07-09 PE PE2015000026A patent/PE20150762A1/es not_active Application Discontinuation
- 2013-07-09 MX MX2015000337A patent/MX2015000337A/es unknown
- 2013-07-09 IN IN5KON2015 patent/IN2015KN00005A/en unknown
- 2013-07-09 BR BR112015000229A patent/BR112015000229A2/pt not_active IP Right Cessation
- 2013-07-09 KR KR1020157000510A patent/KR20150030704A/ko not_active Withdrawn
- 2013-07-09 WO PCT/US2013/049778 patent/WO2014011672A1/en not_active Ceased
- 2013-07-09 JP JP2015521742A patent/JP2015525762A/ja active Pending
-
2014
- 2014-12-31 IL IL236527A patent/IL236527A0/en unknown
-
2015
- 2015-01-08 US US14/592,569 patent/US10822429B2/en not_active Expired - Fee Related
- 2015-01-08 CL CL2015000051A patent/CL2015000051A1/es unknown
- 2015-01-08 US US14/592,654 patent/US9662396B2/en not_active Expired - Fee Related
- 2015-01-09 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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