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
- Authority
- 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
Links
- 239000008188 pellet Substances 0.000 claims 5
- 230000008014 freezing Effects 0.000 claims 1
- 238000007710 freezing Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
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) |
Families Citing this family (47)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005061088A1 (en) * | 2003-12-22 | 2005-07-07 | Finlay Warren H | Powder formation by atmospheric spray-freeze drying |
| DE102004007526A1 (de) * | 2004-02-17 | 2005-09-01 | Oetjen, Georg-Wilhelm, Dr. | Verfahren und Einrichtung zur Gefriertrocknung von Produkten |
| DE102005053695B4 (de) * | 2005-11-10 | 2008-04-30 | Airbus Deutschland Gmbh | Verfahren zum Handhaben einer Flüssigkeit |
| JP5173159B2 (ja) * | 2006-07-14 | 2013-03-27 | 株式会社モリモト医薬 | 凍結乾燥方法および凍結乾燥装置 |
| MX2009003389A (es) * | 2006-10-03 | 2009-04-09 | Wyeth Corp | Metodos y aparatos de liofilizacion. |
| EP2107934B1 (en) * | 2006-12-07 | 2019-11-20 | FrieslandCampina Nederland B.V. | Method and apparatus for spray drying |
| US7908765B2 (en) * | 2006-12-22 | 2011-03-22 | Collette Nv | Continuous granulating and drying apparatus |
| TWI436789B (zh) * | 2008-01-21 | 2014-05-11 | Intervet Int Bv | 含有藥學化合物的顆粒之冷凍乾燥方法及含有此顆粒的藥學包 |
| TWI444384B (zh) * | 2008-02-20 | 2014-07-11 | Gilead Sciences Inc | 核苷酸類似物及其在治療惡性腫瘤上的用途 |
| MX2010008799A (es) | 2008-03-05 | 2010-09-07 | Sanofi Pasteur | Proceso para estabilizar una composicion de vacuna que contiene adyuvante. |
| EP2143440A1 (fr) | 2008-07-09 | 2010-01-13 | Sanofi Pasteur | Agent stabilisant et composition vaccinale comprenant un ou plusieurs flavivirus vivants atténués |
| TW201043267A (en) * | 2009-03-19 | 2010-12-16 | Intervet Int Bv | In situ constituting a vaccine for administration to a predetermined herd of animals |
| CN102448475A (zh) | 2009-04-09 | 2012-05-09 | 恩特格利昂公司 | 喷雾干燥的血液产品和制造其的方法 |
| WO2011035062A2 (en) | 2009-09-16 | 2011-03-24 | Velico Medical, Inc. | Spray dried human plasma |
| US8407912B2 (en) | 2010-09-16 | 2013-04-02 | Velico Medical, Inc. | Spray dried human plasma |
| AU2010313173B2 (en) | 2009-11-02 | 2015-02-12 | Mannkind Corporation | Apparatus and method for cryogranulating a pharmaceutical composition |
| US9945611B2 (en) | 2010-08-04 | 2018-04-17 | Ima Life North America Inc. | Bulk freeze drying using spray freezing and agitated drying |
| WO2012018320A1 (en) * | 2010-08-04 | 2012-02-09 | Ima Life North America Inc. | Bulk freeze drying using spray freezing and stirred drying |
| US20140083628A1 (en) | 2012-09-27 | 2014-03-27 | Velico Medical, Inc. | Spray drier assembly for automated spray drying |
| AU2011320528A1 (en) | 2010-10-29 | 2013-05-23 | Velico Medical, Inc. | System and method for spray drying a liquid |
| EP2578975A1 (en) | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Rotary drum freeze-dryer |
| EP2578974A1 (en) * | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Process line for the production of freeze-dried particles |
| JP2014533240A (ja) | 2011-10-31 | 2014-12-11 | メルク・シャープ・アンド・ドーム・コーポレーションMerck Sharp & Dohme Corp. | 生物材料の凍結乾燥球形ペレットを調製する方法 |
| DE102012109406B4 (de) * | 2012-10-02 | 2016-04-28 | Richard Süverkrüp | Verfahren und Anlage zur kontinuierlichen Produktion von pharmazeutischen Lyophilisaten |
| 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 |
| WO2024059770A1 (en) | 2022-09-15 | 2024-03-21 | Velico Medical, Inc. | Rapid spray drying system |
| US11998861B2 (en) | 2022-09-15 | 2024-06-04 | Velico Medical, Inc. | Usability of a disposable for a spray drying plasma system |
| US11841189B1 (en) | 2022-09-15 | 2023-12-12 | Velico Medical, Inc. | Disposable for a spray drying system |
| US11975274B2 (en) | 2022-09-15 | 2024-05-07 | Velico Medical, Inc. | Blood plasma product |
| 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 |
Family Cites Families (37)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2441730A (en) | 1944-05-30 | 1948-05-18 | Us Director Of The Office Of S | Method and means for preservation of blood plasma and the like by freezing and drying |
| DE1625658U (de) | 1951-04-27 | 1951-07-19 | Fein C & E | Hebelschalter zur unterbrechung von zwei stromphasen in verbindung mit dem handgriff eines elektrowerkzeugs. |
| US3162019A (en) | 1962-11-16 | 1964-12-22 | Bethlehem Steel Corp | Method and apparatus for freezing liquids to be used in a freeze-drying process |
| FR1406556A (fr) | 1964-06-08 | 1965-07-23 | Thomson Houston Comp Francaise | Perfectionnements apportés aux installations de lyophilisation |
| US3397462A (en) | 1965-02-20 | 1968-08-20 | Edwards High Vacuum Int Ltd | Apparatus for lyophilization of substances containing an aqueous phase |
| US3449885A (en) | 1966-03-31 | 1969-06-17 | Ben Venue Lab Inc | Method of packaging viral antisera and other research diagnostic reagents |
| GB1195363A (en) * | 1966-06-17 | 1970-06-17 | Struthers Scientific Int Corp | Freeze Drying |
| US3313032A (en) * | 1966-07-28 | 1967-04-11 | George J Malecki | Freeze-drying process and apparatus |
| CH468606A (fr) | 1966-12-23 | 1969-02-15 | Nestle Sa | Appareil de cryodessiccation |
| US3613839A (en) | 1968-12-31 | 1971-10-19 | Bendix Corp | Vehicle brake system |
| DE1952381A1 (de) | 1969-10-17 | 1971-04-29 | Steinbach Gerhard Dipl Ing | Vorrichtung zur Gefriertrocknung von Granulaten |
| US3648379A (en) | 1970-03-16 | 1972-03-14 | Horton John T | Continuous freeze drying system |
| FR2093123A5 (en) | 1970-06-03 | 1972-01-28 | Sepial | Continuous lyophilizing plant - for granular materials dried under vacuum using a vibrated bed platform |
| GB1482785A (en) | 1974-10-30 | 1977-08-17 | Du Pont | Method of preparing a homogeneous lyophilised composition |
| DE2625658C2 (de) | 1976-06-08 | 1985-01-31 | Leybold-Heraeus GmbH, 5000 Köln | Vakuumtrockner für rieselfähige Produkte |
| US4077227A (en) | 1976-11-12 | 1978-03-07 | Regents Of The University Of Minnesota | Method of freezing liquid material in which agglomeration is inhibited |
| DE2659546A1 (de) | 1976-12-30 | 1978-07-13 | Boehringer Mannheim Gmbh | Verfahren zur herstellung von gefrorenen granulaten |
| US4211015A (en) * | 1978-01-18 | 1980-07-08 | Baxter Travenol Laboratories, Inc. | Method and apparatus for making novel particulate compositions |
| US4323478A (en) * | 1977-01-18 | 1982-04-06 | Baxter Travenol Laboratories, Inc. | Novel particulate compositions |
| SU901782A1 (ru) | 1980-04-29 | 1982-01-30 | Московский технологический институт мясной и молочной промышленности | Противень сублимационной сушилки |
| DE3105623A1 (de) | 1981-02-16 | 1982-09-02 | Erhard Dipl.-Ing.agr. 8000 München Grolitsch | Verfahren zur schonenden gefriertrocknung und pulverisierung von empfindlichen trocknungsguetern wie wasserhaltigen lebensmitteln |
| CH664005A5 (de) | 1984-05-19 | 1988-01-29 | Glatt Maschinen & Apparatebau | Verfahren zum trocknen eines teilchenfoermigen gutes und einrichtung zur durchfuehrung des verfahrens. |
| FR2580610B1 (fr) | 1985-04-18 | 1990-12-28 | Usifroid | Installation de transfert de plateaux, notamment pour lyophilisateur |
| DE3711169A1 (de) | 1987-04-02 | 1988-10-20 | Messer Griesheim Gmbh | Vorrichtung zum kontrollierten einfrieren von zaehfliessenden fluessigkeiten |
| US4829837A (en) | 1988-01-28 | 1989-05-16 | Shell Oil Company | Robotic liquid separation sensing using a cannula |
| DE69006457T2 (de) | 1989-11-20 | 1994-07-21 | Usifroid | Vorrichtung zum Be- und/oder Entladen der Regale eines Gefriertrocknungsraumes. |
| DE4007164A1 (de) | 1990-03-07 | 1991-09-12 | Linde Ag | Verfahren und vorrichtung zum gefrieren von fliessfaehiger materie |
| US5230162A (en) | 1992-06-26 | 1993-07-27 | Oyler Jr James R | Systems and methods for the deliquification of liquid-containing substances by flash sublimation |
| JPH09508695A (ja) | 1994-02-09 | 1997-09-02 | キナートン・リミテッド | 溶液から材料を乾燥する方法 |
| US5737333A (en) | 1995-06-23 | 1998-04-07 | Lucent Technologies Inc. | Method and apparatus for interconnecting ATM-attached hosts with telephone-network attached hosts |
| DE19654134C2 (de) | 1996-04-25 | 2003-08-07 | Messer Griesheim Gmbh | Verfahren und Einrichtung zum Gefriertrocknen |
| DE19750679B4 (de) | 1997-11-15 | 2004-10-21 | Institut für Lebensmittelwissenschaft, Lehrstuhl für Lebensmittelverfahrenstechnik | Verfahren zum Erzeugen von kaltgesprühten, verfestigten, lagerstabilen und rieselfähigen Mikrokapselsystemen sowie deren Verwendung |
| JP2003524142A (ja) | 2000-02-25 | 2003-08-12 | グラツト ゲゼルシヤフト ミツト ベシユレンクテル ハフツング | 粒子状の物品の製造方法 |
| AU2002302814A1 (en) * | 2001-06-08 | 2002-12-23 | Powderject Vaccines, Inc. | Spray freeze-dried compositions |
| WO2003072016A2 (en) * | 2001-11-19 | 2003-09-04 | Becton, Dickinson And Company | Pharmaceutical compositions in particulate form |
| CA2501941A1 (en) * | 2002-10-09 | 2004-04-22 | Jun Liu | Secreted acid phosphatase (sapm) is present only in pathogenic mycobacteria and expressed selectively at acidic ph |
| JP2006515320A (ja) * | 2002-12-31 | 2006-05-25 | ラリー エル オーグスバーガー | 活性クッション性成分を含有する医薬品剤形の製造方法 |
-
2005
- 2005-07-09 US US11/572,461 patent/US7836606B2/en not_active Expired - Lifetime
- 2005-07-09 JP JP2007521842A patent/JP4829229B2/ja not_active Expired - Fee Related
- 2005-07-09 EP EP05769919A patent/EP1794524B1/en not_active Expired - Lifetime
- 2005-07-09 AT AT05769919T patent/ATE542095T1/de active
- 2005-07-09 DK DK05769919.1T patent/DK1794524T3/da active
- 2005-07-09 CA CA2574614A patent/CA2574614C/en not_active Expired - Fee Related
- 2005-07-09 WO PCT/EP2005/007455 patent/WO2006008006A1/en not_active Ceased
- 2005-07-09 AU AU2005263465A patent/AU2005263465B2/en not_active Ceased
-
2007
- 2007-01-23 IL IL180898A patent/IL180898A/en active IP Right Grant
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