DK1794524T3 - Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler) - Google Patents

Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler)

Info

Publication number
DK1794524T3
DK1794524T3 DK05769919.1T DK05769919T DK1794524T3 DK 1794524 T3 DK1794524 T3 DK 1794524T3 DK 05769919 T DK05769919 T DK 05769919T DK 1794524 T3 DK1794524 T3 DK 1794524T3
Authority
DK
Denmark
Prior art keywords
drying
sfd
parenteral
freezing
analyzing
Prior art date
Application number
DK05769919.1T
Other languages
English (en)
Inventor
Dietrich Gehrmann
Thomas Daun
Heinz Mueller
Deqian Wang
Ariane Firus
Original Assignee
Bayer Technology Services Gmbh
Bayer Healthcare Llc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Bayer Technology Services Gmbh, Bayer Healthcare Llc filed Critical Bayer Technology Services Gmbh
Application granted granted Critical
Publication of DK1794524T3 publication Critical patent/DK1794524T3/da

Links

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)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
DK05769919.1T 2004-07-23 2005-07-09 Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler) DK1794524T3 (da)

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
DK1794524T3 true DK1794524T3 (da) 2012-04-16

Family

ID=35426977

Family Applications (1)

Application Number Title Priority Date Filing Date
DK05769919.1T DK1794524T3 (da) 2004-07-23 2005-07-09 Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler)

Country Status (9)

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

Families Citing this family (41)

* Cited by examiner, † Cited by third party
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
EP2069699A2 (en) * 2006-10-03 2009-06-17 Wyeth Lyophilization methods and apparatuses
AU2006351500B2 (en) * 2006-12-07 2012-05-24 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
BRPI0909820A2 (pt) 2008-03-05 2015-08-11 Sanofi Pasteur Processo para estabilização de composição de vacina contra gripe, para estabilização de composição de vacina contendo adjuvante e para preparação de vacina, composições de vacina, kit de vacina e método de estocagem de uma matéria prima
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
WO2010117976A1 (en) 2009-04-09 2010-10-14 Entegrion, Inc Spray-dried blood products and methods of making same
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
CA3107195C (en) 2009-11-02 2023-02-14 Mannkind Corporation Apparatus and method for cryogranulating a pharmaceutical composition
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
US9945611B2 (en) 2010-08-04 2018-04-17 Ima Life North America Inc. Bulk freeze drying using spray freezing and agitated drying
CA2816090A1 (en) 2010-10-29 2012-05-03 Velico Medical, Inc. System and method for spray drying a liquid
US20140083628A1 (en) 2012-09-27 2014-03-27 Velico Medical, Inc. Spray drier assembly for automated spray drying
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
JP6166006B1 (ja) 2014-07-21 2017-07-19 サノフィ パスツール エスエー 液滴生成のための液体供給装置
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
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
JP7071582B2 (ja) * 2018-04-05 2022-05-19 ペヒナッツ・トルステン 凍結乾燥システム及びそのための方法
CN112543627A (zh) * 2018-07-05 2021-03-23 拜耳公司 新型稳定的高浓度抗FXIa抗体制剂
EP3944867B1 (de) * 2020-07-31 2023-02-22 CUP Laboratorien Dr. Freitag GmbH Anlage und verfahren zur sterilitätsprüfung von radioaktiven stoffen
US11874060B2 (en) * 2020-11-16 2024-01-16 Sublime Stericeuticals Corporation Continuous throughput lyophilizer-powder filler within a sterile boundary
CA3236340A1 (en) * 2021-10-28 2023-05-04 Alessandro Brunetti System and method for rapid and sterile transfer of a vial into an isolator
IT202100027668A1 (it) * 2021-10-28 2023-04-28 Comecer Spa Metodo per trasferire in modo rapido e sterile una fiala in un isolatore
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

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
AU680727B2 (en) 1994-02-09 1997-08-07 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
WO2002101412A2 (en) * 2001-06-08 2002-12-19 Powderject Vaccines, Inc. Spray freeze-dried compositions
AU2002366267B2 (en) * 2001-11-19 2007-05-10 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)
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

Also Published As

Publication number Publication date
JP2008507307A (ja) 2008-03-13
JP4829229B2 (ja) 2011-12-07
EP1794524A1 (en) 2007-06-13
CA2574614C (en) 2013-12-03
AU2005263465B2 (en) 2010-07-29
ATE542095T1 (de) 2012-02-15
IL180898A (en) 2011-10-31
IL180898A0 (en) 2007-07-04
WO2006008006A1 (en) 2006-01-26
AU2005263465A1 (en) 2006-01-26
US20080060213A1 (en) 2008-03-13
US7836606B2 (en) 2010-11-23
CA2574614A1 (en) 2006-01-26
EP1794524B1 (en) 2012-01-18

Similar Documents

Publication Publication Date Title
DK1794524T3 (da) Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler)
DE112005000154A5 (de) Transportbehälter zur Kühlhaltung von gefrorenem Gut
WO2007033051A3 (en) Thermally insulated transport container for cell-based products and related methods
WO2007095033A3 (en) Lyophilization system and method
WO2007059084A3 (en) Methods for preparing cord matrix stem cells (cmsc) for long term storage and for preparing a segment of umbilical cord for cryopreservation
EA200800887A1 (ru) Система и способ для хранения и перемещения бурового шлама
WO2005067687A8 (en) A passive, portable blood storage system
WO2008067274A3 (en) System and method for packaging of mass-fabricated custom items
WO2008115548A3 (en) Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma
WO2007002588A3 (en) Thermal-cycling pipette tip
AR055561A1 (es) Comprimidos con dispersion mejorada de la sustancia farmacologica
WO2008140568A3 (en) High density self-contained biological analysis
WO2008002751A3 (en) Methods and apparatus for providing edible substances with a beverage
EP1864641A4 (en) FROZEN STORAGE CONTAINER PACKAGE AND METHOD FOR MANUFACTURING THE SAME
ATE469847T1 (de) Verfahren zur lagerung von lagergut in einem lagerregal mit mehreren regaleinheiten und einem transportschacht sowie ein solches lagerregal
ES2520027T3 (es) Procedimiento de obtención de un producto que sufre consecutivamente una gasificación y una ultracongelación criogénica
CY1108316T1 (el) Μεθοδος και συσκευη επεξεργασιας φυτικων προϊοντων
EP1957918A4 (en) FREEZING AND STORAGE CONTAINERS FOR BIOPHARMACEUTICAL MEDICINAL PRODUCTS
ATE435158T1 (de) Behälter zum transportieren von waren unter kontrollierter oder modifizierter atmosphäre
DK2134607T3 (da) Stiv container til levnedsmidler omfattende fisk
SE0402159L (sv) Gastät transportbehållare för detonationsfarligt gods
DE602005014309D1 (de) Verfahren und Vorrichtung zur Handhabung und Verteilung von Flüssiggasflaschen
WO2006043835A3 (en) Processing, storage and distribution system for perishable food products
WO2007084983A3 (en) Morinda citrifolia enhanced products for administration to animal
WO2009147194A3 (en) Packaging, use of a packaging and method for assembling several packaging