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
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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) EA202092926A3 (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)

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TWI828269B (zh) * 2013-03-15 2024-01-01 美商百歐維拉提夫治療公司 因子ix多肽調配物
SG11201605242YA (en) 2014-01-10 2016-07-28 Biogen Ma Inc Factor viii chimeric proteins and uses thereof
SG11201607642RA (en) 2014-03-24 2016-10-28 Biogen Ma Inc Lyophilized factor ix formulations
MX2019006444A (es) * 2016-12-02 2019-10-30 Bioverativ Therapeutics Inc Métodos de tratamiento de artropatía hemofílica utilizando factores de coagulación quiméricos.
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
CN115151772B (zh) 2020-02-04 2024-11-15 瑞泽恩制药公司 冻干药物产品的目标残留水分含量
CN115867307A (zh) * 2020-05-11 2023-03-28 奥克梅斯制药爱尔兰有限公司 Il-2融合多肽组合物以及其制备和使用方法
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

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