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
JP7058940B2 (ja
JP2017510585A (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 (OSRAM) 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 (OSRAM)
EP (1) EP3123090A4 (OSRAM)
JP (4) JP7058940B2 (OSRAM)
KR (1) KR102385372B1 (OSRAM)
AR (1) AR099838A1 (OSRAM)
AU (3) AU2015236340B2 (OSRAM)
CA (1) CA2943034C (OSRAM)
CL (1) CL2016002386A1 (OSRAM)
EA (2) EA038573B1 (OSRAM)
IL (3) IL247869B (OSRAM)
MA (1) MA39779A (OSRAM)
MX (2) MX387269B (OSRAM)
PH (1) PH12016501877A1 (OSRAM)
SG (3) SG10201808249VA (OSRAM)
TW (1) TWI700101B (OSRAM)
WO (1) WO2015148444A1 (OSRAM)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI745671B (zh) 2013-03-15 2021-11-11 美商百歐維拉提夫治療公司 因子ｉｘ多肽調配物
EA038573B1 (ru) * 2014-03-24 2021-09-16 Биовератив Терапьютикс Инк. Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения
IL308416B2 (en) * 2016-12-02 2025-08-01 Bioverativ Therapeutics Inc Methods of treating hemophilic arthropathy using chimeric clotting factors
AU2018301395B2 (en) * 2017-07-11 2024-11-14 Universal Stabilization Technologies, Inc. Method for Preserving Biological Materials
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
CA3168873A1 (en) 2020-02-04 2021-08-12 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
KR20230008759A (ko) * 2020-05-11 2023-01-16 엘커메스 파마 아일랜드 리미티드 Il-2 융합 폴리펩티드 조성물 및 그의 제조 및 사용 방법
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
DE3572982D1 (en) 1984-03-06 1989-10-19 Takeda Chemical Industries Ltd Chemically modified lymphokine and production thereof
CA2006596C (en) 1988-12-22 2000-09-05 Rika Ishikawa Chemically-modified g-csf
EP0461200B1 (en) 1989-02-21 1997-01-22 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.
CA2124690C (en) 1992-10-02 2007-09-11 Thomas Osterberg 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 (OSRAM) 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
US6723347B1 (en) 1999-09-17 2004-04-20 Takeda Chemical Industries, Ltd. Proces 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
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
JP2005501547A (ja) 2001-09-04 2005-01-20 メルク　パテント　ゲゼルシャフト　ミット　ベシュレンクテル　ハフトング 修飾された第ｉｘ因子
JP5424521B2 (ja) 2001-12-21 2014-02-26 ヒューマン ジノーム サイエンシーズ， インコーポレイテッド アルブミン融合タンパク質
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
ATE497783T1 (de) 2003-05-06 2011-02-15 Syntonix Pharmaceuticals Inc Gerinnungsfaktor vii-fc chimäre proteine zur behandlung von hämostatischen krankheiten
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
ATE507822T1 (de) 2003-12-19 2011-05-15 Novo Nordisk Healthcare Ag Stabilisierte zusammensetzungen von faktor-vii- polypeptiden
US20050226893A1 (en) 2004-03-04 2005-10-13 Jennifer Juneau Lyophilization method to improve excipient crystallization
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
KR101483917B1 (ko) 2004-11-12 2015-01-16 바이엘 헬스케어 엘엘씨 Ｆｖｉｉｉ의 부위 지향 변형
ES2504441T3 (es) 2004-12-15 2014-10-08 Swedish Orphan Biovitrum Ab (Publ) Formulaciones terapéuticas del factor de crecimiento de queratinocitos
AU2006272804B2 (en) 2005-07-22 2011-02-24 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
NZ567685A (en) 2005-11-01 2011-07-29 Wyeth Corp A Factor IX formulation for injection comprising sodium chloride
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
ES2987558T3 (es) 2006-03-24 2024-11-15 Bioverativ Therapeutics Inc PC5 como enzima de procesamiento de propéptido de factor IX
NZ582045A (en) 2006-04-04 2011-07-29 Zymenex As A pharmaceutical composition comprising at least 10mg/mL of alfa mannosidase and less that 5% total protein aggregates
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
PL2173890T3 (pl) 2007-06-21 2011-07-29 Univ Muenchen Tech Białka czynne biologicznie o zwiększonej stabilności in vivo i (lub) in vitro
CA2702363A1 (en) 2007-10-15 2009-04-23 The University Of North Carolina At Chapel Hill Human factor ix variants with an extended half life
WO2009082648A1 (en) 2007-12-21 2009-07-02 Inspiration Biopharmaceuticals, Inc. Stabilized factor ix formulations containing trehalose
CA2709960A1 (en) 2007-12-27 2009-07-09 Baxter International Inc. Chemically modified factor ix
CA2721362A1 (en) 2008-04-16 2009-11-19 Bayer Healthcare Llc Site-directed modification of factor ix
BRPI0910702A2 (pt) 2008-04-16 2016-07-05 Bayer Healthcare Llc polipeptídeos de fator ix modificados e usos dos mesmos
EP2444491B1 (en) 2008-04-21 2016-11-16 Novo Nordisk Healthcare Ag Hyperglycosylated human coagulation factor IX
CN102046205A (zh) 2008-04-24 2011-05-04 凯尔特药物Peg有限公司 具有延长的半衰期的因子ix缀合物
CA2729972C (en) * 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
GB2479069B (en) 2008-09-24 2012-07-25 Stabilitech Ltd Method for preserving polypeptides using a sugar and polyethyleneimine
MX2011013722A (es) 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
WO2011017070A1 (en) 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
AU2011274414B2 (en) 2010-07-09 2016-10-06 Bioverativ Therapeutics Inc. Factor IX polypeptides and methods of use thereof
SG188662A1 (en) 2010-09-30 2013-05-31 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
JP2015521589A (ja) 2012-06-08 2015-07-30 バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． プロコアグラント化合物
HK1213521A1 (zh) * 2012-09-25 2016-07-08 Bioverativ Therapeutics Inc. Fix多肽的應用
TWI745671B (zh) 2013-03-15 2021-11-11 美商百歐維拉提夫治療公司 因子ｉｘ多肽調配物
EA038573B1 (ru) 2014-03-24 2021-09-16 Биовератив Терапьютикс Инк. Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения

Similar Documents

Publication Publication Date Title
JP2017510585A5 (OSRAM)
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 (OSRAM)
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
TW201424748A (zh) 高濃度抗體及蛋白質調配物
JP2016516722A5 (OSRAM)
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
JP2001524360A (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
EA026064B1 (ru) Твердая фармацевтическая композиция, полученная с помощью предварительной стадии замораживания и стадии лиофилизации