JP2017510585A5 - - Google Patents

Download PDF

Info

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
Authority
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.)
Granted
Application number
JP2016558751A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017510585A (ja
JP7058940B2 (ja
Filing date
Publication date
Application filed filed Critical
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

Links

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 (cg-RX-API-DMAC7.html) 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 (cg-RX-API-DMAC7.html)
EP (1) EP3123090A4 (cg-RX-API-DMAC7.html)
JP (4) JP7058940B2 (cg-RX-API-DMAC7.html)
KR (1) KR102385372B1 (cg-RX-API-DMAC7.html)
AR (1) AR099838A1 (cg-RX-API-DMAC7.html)
AU (3) AU2015236340B2 (cg-RX-API-DMAC7.html)
CA (1) CA2943034C (cg-RX-API-DMAC7.html)
CL (1) CL2016002386A1 (cg-RX-API-DMAC7.html)
EA (2) EA202092926A3 (cg-RX-API-DMAC7.html)
IL (3) IL247869B (cg-RX-API-DMAC7.html)
MA (1) MA39779A (cg-RX-API-DMAC7.html)
MX (2) MX387269B (cg-RX-API-DMAC7.html)
PH (1) PH12016501877A1 (cg-RX-API-DMAC7.html)
SG (3) SG10201808249VA (cg-RX-API-DMAC7.html)
TW (1) TWI700101B (cg-RX-API-DMAC7.html)
WO (1) WO2015148444A1 (cg-RX-API-DMAC7.html)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10201707600XA (en) * 2013-03-15 2017-11-29 Biogen Ma Inc Factor ix polypeptide formulations
US10772942B2 (en) * 2014-03-24 2020-09-15 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations
CN110520150A (zh) * 2016-12-02 2019-11-29 比奥维拉迪维治疗股份有限公司 使用嵌合凝血因子治疗血友病性关节病的方法
MX421254B (es) * 2017-07-11 2025-02-10 Universal Stabilization Tech Inc Método para la conservación de material biológico.
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
JP2023514540A (ja) 2020-02-04 2023-04-06 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 凍結乾燥医薬品の目標残留水分含有量
MX2022014163A (es) * 2020-05-11 2023-02-22 Alkermes Pharma Ireland Ltd Composiciones de polipeptido de fusion il-2 y metodos para fabricarlas y usarlas.
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
ATE148171T1 (de) 1989-02-21 1997-02-15 Univ Washington Modifizierte formen von fortpflanzungshormonen
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
SG89295A1 (en) 1991-03-15 2002-06-18 Amgen Inc Pegylation of polypeptides
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
EP0627924B1 (en) * 1992-10-02 2000-12-27 Genetics Institute, Inc. Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
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 (cg-RX-API-DMAC7.html) 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
JP2001151694A (ja) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd タンパク質粉体の製造法
EP1219298A4 (en) 1999-09-17 2003-06-11 Takeda Chemical Industries Ltd METHOD FOR PRODUCING PROTEIN POWDER
HUP0204475A2 (en) 2000-02-11 2003-04-28 Merck Patent Gmbh Enhancing the circulating half-life of antibody-based fusion proteins
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
HUP0401534A3 (en) 2001-09-04 2006-01-30 Merck Patent Gmbh Modified factor ix
AU2002364586A1 (en) 2001-12-21 2003-07-30 Delta Biotechnology Limited Albumin fusion proteins
ES2558102T3 (es) 2003-05-06 2016-02-02 Biogen Hemophilia Inc. Proteínas quiméricas del factor de coagulación para el tratamiento de un trastorno hemostático
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
TWI353991B (en) * 2003-05-06 2011-12-11 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
WO2005058283A2 (en) 2003-12-19 2005-06-30 Novo Nordisk Health Care Ag Stabilised compositions of factor vii polypeptides
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
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
KR101468345B1 (ko) 2004-11-12 2014-12-03 바이엘 헬스케어 엘엘씨 Ｆｖｉｉｉ의 부위 지향 변형
PT1827483E (pt) 2004-12-15 2014-09-25 Swedish Orphan Biovitrum Ab Publ Formulações terapêuticas do fator de crescimento de queratinócitos
US7956160B2 (en) 2005-07-22 2011-06-07 Amgen Inc. Concentrated protein lyophilates, methods, and uses
JP4860703B2 (ja) * 2005-10-06 2012-01-25 ゼンコー・インコーポレイテッド 最適化された抗ｃｄ３０抗体
PL3225233T3 (pl) * 2005-11-01 2019-12-31 Wyeth Llc Roztwór chlorku sodu do odtwarzania leku
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
HUE030567T2 (en) 2006-03-24 2017-05-29 Biogen Hemophilia Inc PC5 is a factor IX propeptide processing enzyme
NZ568728A (en) 2006-04-04 2011-09-30 Shire Pharmaceuticals Ireland Ltd A process for concentration of a aryl sulfatase A
EP2423305A1 (en) 2006-06-19 2012-02-29 Catalyst Biosciences, Inc. 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
EA021222B8 (ru) 2007-06-21 2015-11-30 ИксЭль-ПРОТЕИН ГМБХ Биологически активные белки, имеющие повышенную стабильность in vivo и/или in vitro
US20110154516A1 (en) 2007-10-15 2011-06-23 Stafford Darrel W Human factor ix variants with an extended half life
RU2481823C2 (ru) 2007-12-21 2013-05-20 Инспирейшн Биофармасьютикалс, Инк. Стабилизированные составы, содержащие фактор ix и трегалозу
CA2709960A1 (en) 2007-12-27 2009-07-09 Baxter International Inc. Chemically modified factor ix
CN102083856A (zh) 2008-04-16 2011-06-01 拜耳医药保健有限公司 经修饰的因子ix多肽及其用途
KR20110015551A (ko) 2008-04-16 2011-02-16 바이엘 헬스케어 엘엘씨 제ｉｘ인자의 부위-지정 변형
US20110137011A1 (en) 2008-04-21 2011-06-09 Novo Nordisk A/S Hyperglycosylated human coagulation factor ix
NZ588854A (en) 2008-04-24 2011-12-22 Celtic Pharma Peg Ltd Factor ix-polyethylene conjugates with extended half-lives
EP3572073B1 (en) 2008-08-05 2023-12-20 Wyeth LLC Lyophilization above collapse
GB2479069B (en) 2008-09-24 2012-07-25 Stabilitech Ltd Method for preserving polypeptides using a sugar and polyethyleneimine
WO2010148337A1 (en) 2009-06-18 2010-12-23 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
US20120121580A1 (en) * 2009-07-28 2012-05-17 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
EP2623497B1 (en) 2010-09-30 2016-01-20 Toyama Chemical Co., Ltd. Meglumine salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide
WO2012109429A2 (en) 2011-02-09 2012-08-16 Glaxosmithkline Llc Lyophilized formulations
EP4079316A1 (en) 2012-06-08 2022-10-26 Bioverativ Therapeutics Inc. Procoagulant compounds
US20150252345A1 (en) * 2012-09-25 2015-09-10 Biogen Idec Ma Inc. Methods of Using FIX Polypeptides
SG10201707600XA (en) 2013-03-15 2017-11-29 Biogen Ma Inc Factor ix polypeptide formulations
US10772942B2 (en) 2014-03-24 2020-09-15 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations

Similar Documents

Publication Publication Date Title
JP2017510585A5 (cg-RX-API-DMAC7.html)
EP2373293B2 (en) Compositions with reduced dimer formation
US7879805B2 (en) High temperature stable peptide formulation
CN102869373B (zh) 不含白蛋白的肉毒杆菌毒素制剂
CN1152713C (zh) 含有海藻糖的干燥的血液因子组合物
JP4902103B2 (ja) 凍結乾燥フォームによる生物活性材料の保存
JP2005526084A5 (cg-RX-API-DMAC7.html)
CN110022855B (zh) 室温稳定的冻干蛋白质
CN104159614A (zh) TNF-α抗体的药物制剂
JP2012121894A (ja) Ｉｌ−１アンタゴニスト製剤
JP2016516722A5 (cg-RX-API-DMAC7.html)
CN106687126B (zh) 因子viii制剂
TWI243057B (en) Formulations for protection of peg-interferon alpha conjugates
TW201605468A (zh) 長效人類生長激素接合物之製劑
ES2365832T3 (es) Composiciones que comprenden conjugados de peg-interferón alfa y rafinosa como crioprotector.
CA2683317A1 (en) Stabilization of liquid solutions of recombinant protein for frozen storage
JP6166470B2 (ja) ゴナドトロピンのための新規製剤
JP4564652B2 (ja) ０．５ｍｌ未満の容量を投与するための凍結乾燥タンパク質組成物を含む１回量注射器
KR20110015552A (ko) 건조한 트랜스글루타미나제 조성물
AU2021227095B2 (en) Daptomycin formulation
JP2022514942A (ja) ペグアスパラガーゼの凍結乾燥組成物
CN108348458A (zh) Fviii制剂
JPWO2016080367A1 (ja) 安定化されたペプチド組成物
KR20230146515A (ko) 개선된 동결건조 제형
WO2024133908A1 (en) Stable pharmaceutical compositions comprising romiplostim