ATE542095T1 - Verfahren zum sterilen gefrieren, trocknen, lagern, analysieren und füllen (sfd-saf- verfahren) (verfahren zur gefriertrocknung von granulat für parenterale biopharmazeutika) - Google Patents
Verfahren zum sterilen gefrieren, trocknen, lagern, analysieren und füllen (sfd-saf- verfahren) (verfahren zur gefriertrocknung von granulat für parenterale biopharmazeutika)Info
- Publication number
- ATE542095T1 ATE542095T1 AT05769919T AT05769919T ATE542095T1 AT E542095 T1 ATE542095 T1 AT E542095T1 AT 05769919 T AT05769919 T AT 05769919T AT 05769919 T AT05769919 T AT 05769919T AT E542095 T1 ATE542095 T1 AT E542095T1
- Authority
- AT
- Austria
- Prior art keywords
- drying
- biopharmaceutics
- sfd
- parenteral
- analyzing
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 4
- 238000001035 drying Methods 0.000 title 1
- 238000004108 freeze drying Methods 0.000 title 1
- 238000007710 freezing Methods 0.000 title 1
- 230000008014 freezing Effects 0.000 title 1
- 239000008187 granular material Substances 0.000 title 1
- 238000003860 storage Methods 0.000 title 1
- 239000008188 pellet Substances 0.000 abstract 2
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
- F26B5/065—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing the product to be freeze-dried being sprayed, dispersed or pulverised
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
Landscapes
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Drying Of Solid Materials (AREA)
- Sampling And Sample Adjustment (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US59088104P | 2004-07-23 | 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 (1)
| Publication Number | Publication Date |
|---|---|
| ATE542095T1 true ATE542095T1 (de) | 2012-02-15 |
Family
ID=35426977
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AT05769919T ATE542095T1 (de) | 2004-07-23 | 2005-07-09 | Verfahren zum sterilen gefrieren, trocknen, lagern, analysieren und füllen (sfd-saf- verfahren) (verfahren zur gefriertrocknung von granulat für parenterale biopharmazeutika) |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US7836606B2 (de) |
| EP (1) | EP1794524B1 (de) |
| JP (1) | JP4829229B2 (de) |
| AT (1) | ATE542095T1 (de) |
| AU (1) | AU2005263465B2 (de) |
| CA (1) | CA2574614C (de) |
| DK (1) | DK1794524T3 (de) |
| IL (1) | IL180898A (de) |
| WO (1) | WO2006008006A1 (de) |
Families Citing this family (49)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5183068B2 (ja) * | 2003-12-22 | 2013-04-17 | フィンレイ，ウォーレン，エイチ | 大気噴出凍結乾燥法による粉末形成 |
| 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 |
| WO2008042408A2 (en) * | 2006-10-03 | 2008-04-10 | Wyeth | Lyophilization methods and apparatuses |
| US8689459B2 (en) * | 2006-12-07 | 2014-04-08 | Friesland Brands B.V. | Method and apparatus for spray drying and powder produced using said method |
| 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 |
| EP2254594B1 (de) | 2008-03-05 | 2015-06-03 | Sanofi Pasteur | Stabilisierungsverfahren für eine adjuvanshaltige impfstoffzusammensetzung |
| EP2143440A1 (de) | 2008-07-09 | 2010-01-13 | Sanofi Pasteur | Stabilisierungssubstanz und Impfzusammensetzung, die ein oder mehrere abgeschwächte lebende Flaviviridae enthält |
| TW201043267A (en) * | 2009-03-19 | 2010-12-16 | Intervet Int Bv | In situ constituting a vaccine for administration to a predetermined herd of animals |
| ES2684130T3 (es) | 2009-04-09 | 2018-10-01 | Entegrion, Inc. | Productos de la sangre secados por aspersión y métodos para elaborar los mismos |
| US8407912B2 (en) * | 2010-09-16 | 2013-04-02 | Velico Medical, Inc. | Spray dried human plasma |
| US20110142885A1 (en) | 2009-09-16 | 2011-06-16 | Velico Medical, Inc. | Spray-dried human plasma |
| EP3533517B1 (de) | 2009-11-02 | 2025-08-27 | MannKind Corporation | Verfahren zur kryogranulierung einer pharmazeutischen zusammensetzung |
| US9945611B2 (en) | 2010-08-04 | 2018-04-17 | Ima Life North America Inc. | Bulk freeze drying using spray freezing and agitated drying |
| CN103069240B (zh) * | 2010-08-04 | 2015-06-17 | Ima生命北美股份有限公司 | 利用喷洒冷冻和搅拌干燥的散装冷冻干燥系统及方法 |
| US20140083628A1 (en) | 2012-09-27 | 2014-03-27 | Velico Medical, Inc. | Spray drier assembly for automated spray drying |
| JP2013544181A (ja) | 2010-10-29 | 2013-12-12 | ベリコ メディカル インコーポレイティッド | 液体をスプレードライするためのシステム及び方法 |
| EP2578975A1 (de) | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Drehtrommel Gefriertrockner |
| EP2578974A1 (de) * | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Verfahrenslinie zur Herstellung von gefriergetrockneten Partikeln |
| 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 |
| CN107073350B (zh) * | 2014-07-21 | 2019-11-15 | 赛诺菲巴斯德股份公司 | 用于产生液滴的液体给送装置 |
| 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 |
| BR112017025819B1 (pt) | 2015-06-01 | 2022-03-15 | Ima Life North America Inc | Sistema de liofilização para produto a granel, método para liofilizar um produto e método para liofilizar produto a granel contendo líquido |
| 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 (de) | 2015-11-12 | 2017-05-17 | Bayer Pharma Aktiengesellschaft | Verfahren zur herstellung von gefriergetrockneten pellets mit faktor 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 |
| US11473839B2 (en) * | 2018-04-05 | 2022-10-18 | Torsten Pachnatz | Freeze-drying system and method therefor |
| AU2019297498A1 (en) | 2018-07-05 | 2021-01-21 | Bayer Aktiengesellschaft | Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (FXIa) antibody |
| PL3944867T3 (pl) * | 2020-07-31 | 2023-06-26 | Cup Laboratorien Dr. Freitag Gmbh | Instalacja i sposób badania sterylności substancji radioaktywnych |
| 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 |
| EP4422704A1 (de) * | 2021-10-28 | 2024-09-04 | Comecer S.p.A. | System und verfahren zum schnellen und sterilen transfer eines fläschchens in einen isolator |
| IT202100027668A1 (it) * | 2021-10-28 | 2023-04-28 | Comecer Spa | Metodo per trasferire in modo rapido e sterile una fiala in un isolatore |
| US12571587B2 (en) | 2022-09-15 | 2026-03-10 | Velico Medical, Inc. | Finishing apparatus 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 |
| US11841189B1 (en) | 2022-09-15 | 2023-12-12 | Velico Medical, Inc. | Disposable for a spray drying system |
| US12539355B2 (en) | 2022-09-15 | 2026-02-03 | Velico Medical, Inc. | Dryer for a spray drying system |
| US12083447B2 (en) | 2022-09-15 | 2024-09-10 | Velico Medical, Inc. | Alignment of a disposable for a spray drying plasma system |
| US11998861B2 (en) | 2022-09-15 | 2024-06-04 | Velico Medical, Inc. | Usability of a disposable for a spray drying plasma system |
| WO2024059770A1 (en) | 2022-09-15 | 2024-03-21 | Velico Medical, Inc. | Rapid spray drying system |
| US12246093B2 (en) | 2022-09-15 | 2025-03-11 | Velico Medical, Inc. | Methods for making spray dried plasma |
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|---|---|---|---|---|
| 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 |
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| 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 |
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| FR2093123A5 (en) | 1970-06-03 | 1972-01-28 | Sepial | Continuous lyophilizing plant - for granular materials dried under vacuum using a vibrated bed platform |
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| 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 |
| US4323478A (en) * | 1977-01-18 | 1982-04-06 | Baxter Travenol Laboratories, Inc. | Novel particulate compositions |
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| 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 |
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| 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 |
| WO1995022036A1 (en) | 1994-02-09 | 1995-08-17 | Kinerton Limited | Process for drying a material from solution |
| 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 |
| EP1257772B1 (de) | 2000-02-25 | 2018-10-10 | Glatt Gmbh | Verfahren zur herstellung eines teilchenförmigen gutes |
| US7229645B2 (en) * | 2001-06-08 | 2007-06-12 | Powderject Research Limited | Spray freeze-dried compositions |
| EP1458362A4 (de) * | 2001-11-19 | 2006-01-18 | Becton Dickinson Co | Pharmazeutische zusammensetzungen in teilchenform |
| JP2006501830A (ja) * | 2002-10-09 | 2006-01-19 | リウ、ジュン | 分泌酸性ホスファターゼ（ｓａｐＭ）は病原性マイコバクテリアのみに存在し、ファゴソームｐＨで選択的に発現する |
| EP1589950A4 (de) * | 2002-12-31 | 2010-07-28 | Larry L Augsburger | Verfahren zur herstellung pharmazeutischer darreichungsformen mit aktiven kompressionsbestandteilen |
-
2005
- 2005-07-09 AT AT05769919T patent/ATE542095T1/de active
- 2005-07-09 JP JP2007521842A patent/JP4829229B2/ja not_active Expired - Fee Related
- 2005-07-09 CA CA2574614A patent/CA2574614C/en not_active Expired - Fee Related
- 2005-07-09 EP EP05769919A patent/EP1794524B1/de not_active Expired - Lifetime
- 2005-07-09 WO PCT/EP2005/007455 patent/WO2006008006A1/en not_active Ceased
- 2005-07-09 AU AU2005263465A patent/AU2005263465B2/en not_active Ceased
- 2005-07-09 US US11/572,461 patent/US7836606B2/en not_active Expired - Lifetime
- 2005-07-09 DK DK05769919.1T patent/DK1794524T3/da active
-
2007
- 2007-01-23 IL IL180898A patent/IL180898A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| CA2574614A1 (en) | 2006-01-26 |
| JP4829229B2 (ja) | 2011-12-07 |
| WO2006008006A1 (en) | 2006-01-26 |
| US20080060213A1 (en) | 2008-03-13 |
| CA2574614C (en) | 2013-12-03 |
| US7836606B2 (en) | 2010-11-23 |
| EP1794524B1 (de) | 2012-01-18 |
| DK1794524T3 (da) | 2012-04-16 |
| IL180898A0 (en) | 2007-07-04 |
| IL180898A (en) | 2011-10-31 |
| AU2005263465A1 (en) | 2006-01-26 |
| AU2005263465B2 (en) | 2010-07-29 |
| EP1794524A1 (de) | 2007-06-13 |
| JP2008507307A (ja) | 2008-03-13 |
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