JP4829229B2 - 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） - Google Patents

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） Download PDF

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Publication number
JP4829229B2
JP4829229B2 JP2007521842A JP2007521842A JP4829229B2 JP 4829229 B2 JP4829229 B2 JP 4829229B2 JP 2007521842 A JP2007521842 A JP 2007521842A JP 2007521842 A JP2007521842 A JP 2007521842A JP 4829229 B2 JP4829229 B2 JP 4829229B2
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Japan
Prior art keywords
pellet
frozen
pellets
container
lyophilized
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Japanese (ja)
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JP2008507307A5 (enExample
JP2008507307A (ja
Inventor
ディートリッヒ・ゲーアマン
アリアーネ・フィルス
トーマス・ダウン
ハインツ・ミューラー
デキアン・ワン
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Bayer AG
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Bayer Technology Services GmbH
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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)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
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 JP2008507307A5 (enExample) 2008-09-04
JP4829229B2 true JP4829229B2 (ja) 2011-12-07

Family

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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)

* Cited by examiner, † Cited by third party
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
CA2665902A1 (en) * 2006-10-03 2008-04-10 Wyeth Lyophilization methods and apparatuses
CN101652170B (zh) * 2006-12-07 2013-06-05 菲仕兰品牌公司 用于喷雾干燥的方法和设备以及使用所述方法制备的粉末
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
ES2615390T3 (es) 2008-03-05 2017-06-06 Sanofi Pasteur Proceso para estabilizar una composición 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
BRPI1006722A2 (pt) 2009-04-09 2017-10-10 Entegrion Inc "método de preparação de hemoderivados desidratado, hemoderivados desidratados, bandagem ou auxílio cirúrgico, método para a preparação de plaquetas sanguíneas fixas desidratadas, plaquetas sanguíneas fixas desidratadas, método para o tratamento de um paciente que sofre de um distúrbio sanguíneo e plaquetas de sangue fixas secas por atomização tendo geometria com cavidades esféricas"
US8407912B2 (en) * 2010-09-16 2013-04-02 Velico Medical, Inc. Spray dried human plasma
WO2011035062A2 (en) 2009-09-16 2011-03-24 Velico Medical, Inc. Spray dried human plasma
RU2638794C2 (ru) 2009-11-02 2017-12-15 Мэннкайнд Корпорэйшн Способ криогрануляции фармацевтической композиции
DK2601466T3 (en) * 2010-08-04 2018-01-02 Ima Life North America Inc BULK FREEZING DURING USING SPRAY FREEZING AND DRYING UNDER STIRRING
US9945611B2 (en) 2010-08-04 2018-04-17 Ima Life North America Inc. Bulk freeze drying using spray freezing and agitated drying
US20140083628A1 (en) 2012-09-27 2014-03-27 Velico Medical, Inc. Spray drier assembly for automated spray drying
EP2745923A3 (en) 2010-10-29 2014-10-01 Velico Medical, Inc. System and Method for Spray Drying a Liquid
EP2578974A1 (en) * 2011-10-05 2013-04-10 Sanofi Pasteur Sa Process line for the production of freeze-dried particles
EP2578975A1 (en) 2011-10-05 2013-04-10 Sanofi Pasteur Sa Rotary drum freeze-dryer
US10183968B2 (en) 2011-10-31 2019-01-22 Merck Sharp & Dohme Corp. Methods of preparing lyophilized spherical-shaped pellets of biological materials
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
AU2015293983B2 (en) * 2014-07-21 2017-02-09 Sanofi Pasteur Sa Liquid feeding device for the generation of droplets
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
DK3303958T3 (da) 2015-06-01 2020-01-02 Ima Life North America Inc Massegodsfrysetørring ved anvendelse af sprøjtefrysning og tørring under omrøring med varme
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
EP3608615A4 (en) * 2017-04-04 2021-01-20 Nitto Denko Corporation LYOPHILIZED BODY MANUFACTURING PROCESS AND ITS MANUFACTURING DEVICE
CN111971519A (zh) * 2018-04-05 2020-11-20 托尔斯滕·帕奇纳茨 冷冻干燥系统和用于冷冻干燥系统的方法
BR112020026492A2 (pt) 2018-07-05 2021-04-06 Bayer Aktiengesellschaft Método para a produção de péletes liofilizados compreendendo um anticorpo antifator de coagulação xia (fxia)
DK3944867T3 (da) * 2020-07-31 2023-04-11 Cup Laboratorien Dr Freitag Gmbh Anlæg og fremgangsmåde til sterilitetskontrol af radioaktive stoffer
WO2022104274A1 (en) * 2020-11-16 2022-05-19 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
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
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
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

Family Cites Families (37)

* Cited by examiner, † Cited by third party
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
NZ279549A (en) 1994-02-09 1996-11-26 Kinerton Ltd Obtaining solid material by drying a solution thereof, supercooled spray of solution expanded into vacuum and frozen droplets collected
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
WO2002101412A2 (en) * 2001-06-08 2002-12-19 Powderject Vaccines, Inc. Spray freeze-dried compositions
AU2002346424A1 (en) * 2001-11-19 2003-06-10 Becton, Dickinson And Company Pharmaceutical compositions in particulate form
CN1685039B (zh) * 2002-10-09 2010-07-21 成都永安制药有限公司 只存在于病原性分枝杆菌并选择表达于吞噬体pH值下的分泌型酸性磷酸酶(SAPM)
WO2004060354A1 (en) * 2002-12-31 2004-07-22 Augsburger Larry L Methods for making pharmaceutical dosage forms containing active cushioning components

Also Published As

Publication number Publication date
ATE542095T1 (de) 2012-02-15
EP1794524A1 (en) 2007-06-13
EP1794524B1 (en) 2012-01-18
IL180898A (en) 2011-10-31
IL180898A0 (en) 2007-07-04
AU2005263465A1 (en) 2006-01-26
DK1794524T3 (da) 2012-04-16
CA2574614C (en) 2013-12-03
AU2005263465B2 (en) 2010-07-29
WO2006008006A1 (en) 2006-01-26
US20080060213A1 (en) 2008-03-13
JP2008507307A (ja) 2008-03-13
US7836606B2 (en) 2010-11-23
CA2574614A1 (en) 2006-01-26

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