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
- 239000000203 mixture Substances 0.000 claims 35
- 239000004094 surface-active agent Substances 0.000 claims 20
- 238000009472 formulation Methods 0.000 claims 12
- 108010008165 Etanercept Proteins 0.000 claims 10
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 10
- 229960000403 etanercept Drugs 0.000 claims 10
- 239000002245 particle Substances 0.000 claims 9
- 229920001983 poloxamer Polymers 0.000 claims 9
- 229960000502 poloxamer Drugs 0.000 claims 9
- 229920000136 polysorbate Polymers 0.000 claims 9
- 229950008882 polysorbate Drugs 0.000 claims 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 8
- 239000003381 stabilizer Substances 0.000 claims 6
- 229930006000 Sucrose Natural products 0.000 claims 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 4
- 239000011780 sodium chloride Substances 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- 239000004475 Arginine Substances 0.000 claims 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 229940068968 polysorbate 80 Drugs 0.000 claims 3
- 239000001488 sodium phosphate Substances 0.000 claims 3
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 3
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 2
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 238000003860 storage Methods 0.000 claims 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 229920001219 Polysorbate 40 Polymers 0.000 claims 1
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 230000007774 longterm Effects 0.000 claims 1
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 1
- 229960003194 meglumine Drugs 0.000 claims 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 1
- 239000000178 monomer Substances 0.000 claims 1
- 229920001993 poloxamer 188 Polymers 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 claims 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 claims 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 claims 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 229940101027 polysorbate 40 Drugs 0.000 claims 1
- 229940113124 polysorbate 60 Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 230000008646 thermal stress Effects 0.000 claims 1
- 239000012905 visible particle Substances 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
- 229960002675 xylitol Drugs 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
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 |
|---|---|---|---|
| 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 |
| 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 |
Family Applications Before (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) | JP2015525762A (enExample) |
| KR (1) | KR20150030704A (enExample) |
| CN (1) | CN104661651A (enExample) |
| AU (1) | AU2013290289B2 (enExample) |
| BR (2) | BR112015000229A2 (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) | WO2014011672A1 (enExample) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1909831A4 (en) | 2005-06-14 | 2013-02-20 | Amgen Inc | SELF-BUFFING PROTEIN FORMULATIONS |
| LT2895188T (lt) * | 2012-09-11 | 2018-04-10 | Coherus Biosciences, Inc. | Aukšto grynumo ir geros išeigos teisingos struktūros etanerceptas |
| JP2016518386A (ja) * | 2013-05-02 | 2016-06-23 | マブキシェンス エス．アー． | ＴＮＦＲ：Ｆｃ融合ポリペプチドの代替配合物 |
| MX370099B (es) | 2014-03-26 | 2019-12-02 | Astex Therapeutics Ltd | Combinación que comprende un inhibidor de fgfr y un inhibidor de cmet para el tratamiento del cáncer. |
| 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. |
| WO2017159585A1 (ja) * | 2016-03-14 | 2017-09-21 | 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 |
| AU2017345490B2 (en) | 2016-10-21 | 2022-07-07 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| WO2018094316A1 (en) * | 2016-11-21 | 2018-05-24 | 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. |
| US20200323958A1 (en) * | 2017-11-13 | 2020-10-15 | Amgen Inc. | Methods for producing protein products |
| WO2019201899A1 (en) * | 2018-04-16 | 2019-10-24 | Merck Patent Gmbh | Method for stabilizing protein comprising formulations by using a meglumine salt. |
| US11576856B2 (en) * | 2018-04-24 | 2023-02-14 | Amgen Inc. | Method for making injectable pharmaceutical compositions |
| US11253569B2 (en) | 2018-05-03 | 2022-02-22 | Seattle Children's Hospital | 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 |
| WO2021083910A1 (en) * | 2019-10-28 | 2021-05-06 | 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 |
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| 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 |
| WO2000062790A2 (en) | 1999-04-19 | 2000-10-26 | 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 |
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| US20030138417A1 (en) * | 2001-11-08 | 2003-07-24 | Kaisheva Elizabet A. | Stable liquid pharmaceutical formulation of IgG antibodies |
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| 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. |
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| CN103145715B (zh) * | 2003-10-14 | 2016-08-03 | F·霍夫曼-罗须公司 | 作为hcv复制抑制剂的巨环羧酸和酰基磺酰胺 |
| 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 |
| CN104593277A (zh) | 2004-03-05 | 2015-05-06 | 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 |
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| KR20090127326A (ko) | 2007-03-02 | 2009-12-10 | 와이어쓰 | 폴리펩티드의 생산을 위한 세포 배양물 중에서 구리 및 글루타메이트의 용도 |
| 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 |
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| TWI661833B (zh) | 2007-11-30 | 2019-06-11 | 百慕達商艾伯維生物技術有限責任公司 | 蛋白質調配物及製造其之方法 |
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| BRPI0908270A2 (pt) | 2008-02-29 | 2019-09-10 | Biogen Idec Inc | proteínas de fusão de imunoglobulinas purificadas e método para a sua purificação |
| MX2011003013A (es) * | 2008-09-19 | 2011-04-11 | Pfizer | Formulacion liquida estable de anticuerpos. |
| 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 |
| SI2464725T2 (sl) | 2009-08-11 | 2025-06-30 | F. Hoffmann-La Roche Ag | Proizvodnja beljakovin v medijih za celične kulture brez glutamina |
| 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 |
| WO2011079308A2 (en) | 2009-12-23 | 2011-06-30 | 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 |
| RU2600847C2 (ru) * | 2010-05-10 | 2016-10-27 | Интас Биофармасьютикалс Лимитед | Жидкий состав полипептидов, содержащих fc-домен иммуноглобулина |
| US20130209465A1 (en) | 2010-07-30 | 2013-08-15 | Arecor Ltd. | Stabilized Aqueous Antibody Compositions |
| JP2013535981A (ja) | 2010-08-20 | 2013-09-19 | ワイス・エルエルシー | 成長因子不含適合細胞の細胞培養 |
| JP2012049074A (ja) | 2010-08-30 | 2012-03-08 | Makita Corp | 電動工具のバッテリパック |
| EP2611904A2 (en) | 2010-08-31 | 2013-07-10 | Friesland Brands B.V. | Culture medium for eukaryotic cells |
| US9453067B2 (en) | 2011-04-20 | 2016-09-27 | 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 |
| WO2013006454A1 (en) * | 2011-07-01 | 2013-01-10 | Biogen Idec Ma Inc. | Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use |
| HUE033279T2 (en) | 2011-07-01 | 2017-11-28 | Amgen Inc | Mammalian cell culture |
| BR112014009031A2 (pt) * | 2011-10-18 | 2017-05-09 | Coherus Biosciences Inc | formulações de etanercept estabilizadas com íons de metais |
-
2013
- 2013-07-09 MX MX2015000337A patent/MX2015000337A/es unknown
- 2013-07-09 EP EP13817186.3A patent/EP2869817A4/en not_active Withdrawn
- 2013-07-09 SG SG11201500138VA patent/SG11201500138VA/en unknown
- 2013-07-09 HK HK15110120.5A patent/HK1213174A1/zh unknown
- 2013-07-09 CN CN201380046666.4A patent/CN104661651A/zh active Pending
- 2013-07-09 JP JP2015521742A patent/JP2015525762A/ja active Pending
- 2013-07-09 HK HK15110117.0A patent/HK1209343A1/xx unknown
- 2013-07-09 JP JP2015521752A patent/JP6271536B2/ja not_active Expired - Fee Related
- 2013-07-09 BR BR112015000229A patent/BR112015000229A2/pt not_active IP Right Cessation
- 2013-07-09 PE PE2015000026A patent/PE20150762A1/es not_active Application Discontinuation
- 2013-07-09 BR BR112015000203A patent/BR112015000203A2/pt not_active IP Right Cessation
- 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 KR KR1020157000510A patent/KR20150030704A/ko not_active Withdrawn
- 2013-07-09 AU AU2013290289A patent/AU2013290289B2/en not_active Expired - Fee Related
- 2013-07-09 EP EP13816429.8A patent/EP2869816A4/en not_active Withdrawn
- 2013-07-09 EA EA201590161A patent/EA029193B1/ru not_active IP Right Cessation
- 2013-07-09 WO PCT/US2013/049716 patent/WO2014011629A1/en not_active Ceased
- 2013-07-09 CA CA2878508A patent/CA2878508A1/en not_active Abandoned
-
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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