JP2008507307A5 - - Google Patents

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Publication number
JP2008507307A5
JP2008507307A5 JP2007521842A JP2007521842A JP2008507307A5 JP 2008507307 A5 JP2008507307 A5 JP 2008507307A5 JP 2007521842 A JP2007521842 A JP 2007521842A JP 2007521842 A JP2007521842 A JP 2007521842A JP 2008507307 A5 JP2008507307 A5 JP 2008507307A5
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JP
Japan
Prior art keywords
pellet
container
product
lyophilized
single dose
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
JP2007521842A
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English (en)
Japanese (ja)
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JP2008507307A (ja
JP4829229B2 (ja
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Publication date
Application filed filed Critical
Priority claimed from PCT/EP2005/007455 external-priority patent/WO2006008006A1/en
Publication of JP2008507307A publication Critical patent/JP2008507307A/ja
Publication of JP2008507307A5 publication Critical patent/JP2008507307A5/ja
Application granted granted Critical
Publication of JP4829229B2 publication Critical patent/JP4829229B2/ja
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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JP2007521842A 2004-07-23 2005-07-09 無菌凍結、乾燥、保存、分析及び充填方法(sfd−saf法)(非経口生物薬剤用のペレット凍結乾燥法) Expired - Fee Related JP4829229B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US59088104P 2004-07-23 2004-07-23
US60/590,881 2004-07-23
PCT/EP2005/007455 WO2006008006A1 (en) 2004-07-23 2005-07-09 Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals)

Publications (3)

Publication Number Publication Date
JP2008507307A JP2008507307A (ja) 2008-03-13
JP2008507307A5 true JP2008507307A5 (enExample) 2008-09-04
JP4829229B2 JP4829229B2 (ja) 2011-12-07

Family

ID=35426977

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2007521842A Expired - Fee Related JP4829229B2 (ja) 2004-07-23 2005-07-09 無菌凍結、乾燥、保存、分析及び充填方法(sfd−saf法)(非経口生物薬剤用のペレット凍結乾燥法)

Country Status (9)

Country Link
US (1) US7836606B2 (enExample)
EP (1) EP1794524B1 (enExample)
JP (1) JP4829229B2 (enExample)
AT (1) ATE542095T1 (enExample)
AU (1) AU2005263465B2 (enExample)
CA (1) CA2574614C (enExample)
DK (1) DK1794524T3 (enExample)
IL (1) IL180898A (enExample)
WO (1) WO2006008006A1 (enExample)

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AU2013202805B2 (en) 2013-03-14 2015-07-16 Gen-Probe Incorporated System and method for extending the capabilities of a diagnostic analyzer
BR112016031039B1 (pt) * 2014-07-21 2022-02-15 Sanofi Pasteur Sa Dispositivo de alimentação de líquido para a geração de gotículas, linha de processo para a produção de partículas liofilizadas e processos para preparar uma composição de vacina compreendendo
US9561184B2 (en) 2014-09-19 2017-02-07 Velico Medical, Inc. Methods and systems for multi-stage drying of plasma
JP5837670B2 (ja) * 2014-10-24 2015-12-24 アイエムエー ライフ ノース アメリカ インコーポレーテッド 噴霧凍結および撹拌乾燥を使用するバルク・フリーズドライ
RU2578010C1 (ru) * 2014-11-13 2016-03-20 Федеральное государственное бюджетное научное учреждение "Всероссийский научно-исследовательский институт механизации животноводства" (ФГБНУ ВНИИМЖ) Вакуум-сублимационная сушилка
CN107683398B (zh) 2015-06-01 2020-05-05 Ima生命北美股份有限公司 使用带电介质加热的喷雾冷冻和搅拌干燥的散装冷冻干燥
US10605527B2 (en) * 2015-09-22 2020-03-31 Millrock Technology, Inc. Apparatus and method for developing freeze drying protocols using small batches of product
EP3167877A1 (en) * 2015-11-12 2017-05-17 Bayer Pharma Aktiengesellschaft Method for the production of freeze-dried pellets comprising factor viii
CN110476031A (zh) * 2017-04-04 2019-11-19 日东电工株式会社 冷冻干燥体的制造方法及其制造装置
EP3775739B1 (de) * 2018-04-05 2022-08-24 Pächnatz, Torsten Gefriertrocknungsanlage und verfahren hierzu
JP2021529800A (ja) * 2018-07-05 2021-11-04 バイエル アクチェンゲゼルシャフトBayer Aktiengesellschaft 抗FXIa抗体のための新規な安定した高濃度製剤
DK3944867T3 (da) * 2020-07-31 2023-04-11 Cup Laboratorien Dr Freitag Gmbh Anlæg og fremgangsmåde til sterilitetskontrol af radioaktive stoffer
US11874060B2 (en) * 2020-11-16 2024-01-16 Sublime Stericeuticals Corporation Continuous throughput lyophilizer-powder filler within a sterile boundary
DE202021101537U1 (de) * 2021-03-24 2021-05-18 Torsten Pächnatz Gefriertrocknungsanlage
IT202100027668A1 (it) * 2021-10-28 2023-04-28 Comecer Spa Metodo per trasferire in modo rapido e sterile una fiala in un isolatore
US20240415995A1 (en) * 2021-10-28 2024-12-19 Comecer S.P.A. System and method for rapid and sterile transfer of a vial into an isolator
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US12246266B2 (en) 2022-09-15 2025-03-11 Velico Medical, Inc. Disposable for a spray drying system
US12246093B2 (en) 2022-09-15 2025-03-11 Velico Medical, Inc. Methods for making spray dried plasma
US12083447B2 (en) 2022-09-15 2024-09-10 Velico Medical, Inc. Alignment of a disposable for a spray drying plasma system

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