JP2017510585A5 - - Google Patents

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Publication number
JP2017510585A5
JP2017510585A5 JP2016558751A JP2016558751A JP2017510585A5 JP 2017510585 A5 JP2017510585 A5 JP 2017510585A5 JP 2016558751 A JP2016558751 A JP 2016558751A JP 2016558751 A JP2016558751 A JP 2016558751A JP 2017510585 A5 JP2017510585 A5 JP 2017510585A5
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JP
Japan
Prior art keywords
formulation
item
lyophilized
less
temperature
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.)
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Application number
JP2016558751A
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English (en)
Japanese (ja)
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JP7058940B2 (ja
JP2017510585A (ja
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Priority claimed from PCT/US2015/022141 external-priority patent/WO2015148444A1/en
Publication of JP2017510585A publication Critical patent/JP2017510585A/ja
Publication of JP2017510585A5 publication Critical patent/JP2017510585A5/ja
Priority to JP2022007013A priority Critical patent/JP7503583B2/ja
Application granted granted Critical
Publication of JP7058940B2 publication Critical patent/JP7058940B2/ja
Priority to JP2024033771A priority patent/JP7759978B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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JP2016558751A 2014-03-24 2015-03-24 凍結乾燥第ｉｘ因子製剤 Active JP7058940B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022007013A JP7503583B2 (ja) 2014-03-24 2022-01-20 凍結乾燥第ｉｘ因子製剤
JP2024033771A JP7759978B2 (ja) 2014-03-24 2024-03-06 凍結乾燥第ｉｘ因子製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24
US61/969,801 2014-03-24
PCT/US2015/022141 WO2015148444A1 (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Related Child Applications (2)

Application Number Title Priority Date Filing Date
JP2020016131A Division JP2020063313A (ja) 2014-03-24 2020-02-03 凍結乾燥第ｉｘ因子製剤
JP2022007013A Division JP7503583B2 (ja) 2014-03-24 2022-01-20 凍結乾燥第ｉｘ因子製剤

Publications (3)

Publication Number Publication Date
JP2017510585A JP2017510585A (ja) 2017-04-13
JP2017510585A5 true JP2017510585A5 (enExample) 2018-05-10
JP7058940B2 JP7058940B2 (ja) 2022-04-25

Family

ID=54196282

Family Applications (4)

Application Number Title Priority Date Filing Date
JP2016558751A Active JP7058940B2 (ja) 2014-03-24 2015-03-24 凍結乾燥第ｉｘ因子製剤
JP2020016131A Pending JP2020063313A (ja) 2014-03-24 2020-02-03 凍結乾燥第ｉｘ因子製剤
JP2022007013A Active JP7503583B2 (ja) 2014-03-24 2022-01-20 凍結乾燥第ｉｘ因子製剤
JP2024033771A Active JP7759978B2 (ja) 2014-03-24 2024-03-06 凍結乾燥第ｉｘ因子製剤

Family Applications After (3)

Application Number Title Priority Date Filing Date
JP2020016131A Pending JP2020063313A (ja) 2014-03-24 2020-02-03 凍結乾燥第ｉｘ因子製剤
JP2022007013A Active JP7503583B2 (ja) 2014-03-24 2022-01-20 凍結乾燥第ｉｘ因子製剤
JP2024033771A Active JP7759978B2 (ja) 2014-03-24 2024-03-06 凍結乾燥第ｉｘ因子製剤

Country Status (16)

Country Link
US (3) US10772942B2 (enExample)
EP (1) EP3123090A4 (enExample)
JP (4) JP7058940B2 (enExample)
KR (1) KR102385372B1 (enExample)
AR (1) AR099838A1 (enExample)
AU (3) AU2015236340B2 (enExample)
CA (1) CA2943034C (enExample)
CL (1) CL2016002386A1 (enExample)
EA (2) EA038573B1 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG11201607642RA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI788044B (zh) 2013-03-15 2022-12-21 美商百歐維拉提夫治療公司 因子ｉｘ多肽調配物
US10772942B2 (en) 2014-03-24 2020-09-15 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations
IL319473A (en) * 2016-12-02 2025-05-01 Bioverativ Therapeutics Inc Methods for treating hemophilic arthritis using chimeric blood clotting factors
BR112020000592A2 (pt) * 2017-07-11 2020-07-14 Universal Stabilization Technologies, Inc. método para conservar materiais biológicos
CN112175088B (zh) * 2019-07-02 2023-03-28 江苏晟斯生物制药有限公司 改进的fix融合蛋白、缀合物及其应用
WO2021158759A2 (en) 2020-02-04 2021-08-12 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
BR112022022869A2 (pt) * 2020-05-11 2023-01-31 Alkermes Pharma Ireland Ltd Composições de polipeptídeo de fusão de il-2 e métodos de fabricação e uso destas
CN118557531B (zh) * 2024-08-02 2024-10-18 成都蓉生药业有限责任公司 一种重组人凝血因子VIII-Fc融合蛋白冻干制剂的制备方法

Family Cites Families (58)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0154316B1 (en) 1984-03-06 1989-09-13 Takeda Chemical Industries, Ltd. Chemically modified lymphokine and production thereof
JP2989002B2 (ja) 1988-12-22 1999-12-13 キリン―アムジエン・インコーポレーテツド 化学修飾顆粒球コロニー刺激因子
AU648020B2 (en) 1989-02-21 1994-04-14 Washington University Modified forms of reproductive hormones
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
ATE240740T1 (de) 1991-03-15 2003-06-15 Amgen Inc Pegylation von polypeptiden
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
MX9306133A (es) * 1992-10-02 1994-04-29 Kabi Pharmacia Ab Composicion que comprende una formulacion del factor de coagulacion viii, proceso para su preparacion y uso de un surfactante como estabilizador.
DE4405426A1 (de) 1994-02-21 1995-08-24 Boehringer Mannheim Gmbh Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate
US6372716B1 (en) 1994-04-26 2002-04-16 Genetics Institute, Inc. Formulations for factor IX
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US5770700A (en) * 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
IN184589B (enExample) * 1996-10-16 2000-09-09 Alza Corp
US20010031721A1 (en) 1999-05-05 2001-10-18 Chandra Webb Highly concentrated, lyophilized, and liquid factor IX formulations
AU7313400A (en) * 1999-09-17 2001-04-24 Takeda Chemical Industries Ltd. Process for producing protein powder
JP2001151694A (ja) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd タンパク質粉体の製造法
MXPA02007733A (es) 2000-02-11 2004-09-10 Merck Patent Gmbh Mejoramiento de la vida media circulante de proteinas de fusion basadas en anticuerpos.
WO2002040544A2 (en) 2000-11-14 2002-05-23 Board Of Regents, University Of Texas Systems Mutant human factor ix with an increased resistance to inhibition by heparin
PL369065A1 (en) 2001-09-04 2005-04-18 Merck Patent Gmbh Modified factor ix
EP2277888A3 (en) 2001-12-21 2011-04-27 Human Genome Sciences, Inc. Fusion proteins of albumin and erythropoietin
EP3002012A1 (en) 2003-05-06 2016-04-06 Biogen Hemophilia Inc. Clotting factor-fc chimeric proteins to treat hemophilia
TWI353991B (en) * 2003-05-06 2011-12-11 Syntonix Pharmaceuticals Inc Immunoglobulin chimeric monomer-dimer hybrids
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
JP2005060378A (ja) 2003-07-28 2005-03-10 Yamanouchi Pharmaceut Co Ltd 生理活性蛋白質含有凍結乾燥製剤
US20050152979A1 (en) 2003-09-05 2005-07-14 Cell Therapeutics, Inc. Hydrophobic drug compositions containing reconstitution enhancer
ATE507822T1 (de) 2003-12-19 2011-05-15 Novo Nordisk Healthcare Ag Stabilisierte zusammensetzungen von faktor-vii- polypeptiden
BRPI0509117A (pt) 2004-03-04 2007-08-28 Wyeth Corp método de liofilização para melhorar a cristalização de excipientes
WO2006029467A1 (en) * 2004-09-16 2006-03-23 Btf Pty Ltd Rapid freeze drying process
PT2371856T (pt) 2004-11-12 2022-08-12 Bayer Healthcare Llc Modificação de fviii direcionada a sítio
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
NZ555503A (en) 2004-12-15 2010-01-29 Biovitrum Ab Publ Therapeutic formulations of keratinocyte growth factor
AU2006272804B2 (en) * 2005-07-22 2011-02-24 Amgen Inc. Concentrated protein lyophilates, methods, and uses
EP1951757B1 (en) * 2005-10-06 2014-05-14 Xencor, Inc. Optimized anti-cd30 antibodies
PT3225233T (pt) * 2005-11-01 2019-10-24 Wyeth Llc Solução de cloreto de sódio para reconstituição de fármacos.
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
PL2650305T3 (pl) 2006-03-24 2024-09-16 Bioverativ Therapeutics Inc. PC5 jako enzym przetwarzający propeptyd czynnika IX
US20090246187A1 (en) 2006-04-04 2009-10-01 Shire Pharmaceuticals Ireland Limited Process for concentration of a polypeptide
TW200804416A (en) 2006-06-19 2008-01-16 Nautilus Technology Llc Modified coagulation factor IX polypeptides and use thereof for treatment
US8015841B2 (en) * 2006-09-08 2011-09-13 Praxair Technology, Inc. Cryogenic refrigeration system for lyophilization
US7700734B2 (en) 2007-01-09 2010-04-20 Shu-Wha Lin Recombinant human factor IX and use thereof
CN101970678B (zh) 2007-06-21 2014-08-20 慕尼黑科技大学 具有增加的体内和/或体外稳定性的生物学活性蛋白
AU2008311973B2 (en) 2007-10-15 2013-10-03 Cangene Corporation Human Factor IX variants with an extended half life
BRPI0821591A2 (pt) 2007-12-21 2016-05-03 Inspiration Biopharmaceuticals Inc composição liofilizada e métodos de preparação de composição seca estável do fator ix e de liofilização de formulação farmacêutica
NZ603997A (en) 2007-12-27 2013-02-22 Baxter Int Chemically Modified Factor IX
JP2011517950A (ja) 2008-04-16 2011-06-23 バイエル・ヘルスケア・エルエルシー 第ｉｘ因子の部位特異的修飾
EP2288622A4 (en) 2008-04-16 2012-04-18 Bayer Healthcare Llc FACTOR IX MODIFIED POLYPEPTIDES AND USES THEREOF
EP2444491B1 (en) 2008-04-21 2016-11-16 Novo Nordisk Healthcare Ag Hyperglycosylated human coagulation factor IX
CA2722169A1 (en) 2008-04-24 2009-10-29 Celtic Pharma Peg Ltd. Factor ix conjugates with extended half-lives
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
CA2737407A1 (en) 2008-09-24 2010-04-01 Stabilitech Ltd. Method for preserving polypeptides using a sugar and polyethyleneimine
MX2011013722A (es) 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
EP2458990B1 (en) 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
CN103140237A (zh) * 2010-07-09 2013-06-05 比奥根艾迪克依蒙菲利亚公司 因子ix多肽及其使用方法
TWI507397B (zh) 2010-09-30 2015-11-11 Toyama Chemical Co Ltd ６－氟－３－羥－２－吡羧醯胺之美洛明鹽
EA029972B1 (ru) 2011-02-09 2018-06-29 ГЛЭКСОСМИТКЛАЙН ЭлЭлСи Способы получения полипептидных композиций
AU2013270682A1 (en) 2012-06-08 2014-12-11 Biogen Ma Inc. Procoagulant compounds
EP3542861A1 (en) * 2012-09-25 2019-09-25 Bioverativ Therapeutics Inc. Methods of using fix polypeptides
TWI788044B (zh) 2013-03-15 2022-12-21 美商百歐維拉提夫治療公司 因子ｉｘ多肽調配物
US10772942B2 (en) 2014-03-24 2020-09-15 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations

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