GB2516191A - Optimization of nucleation and crystallization for lyophilization using gap freezing - Google Patents

Optimization of nucleation and crystallization for lyophilization using gap freezing Download PDF

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Publication number
GB2516191A
GB2516191A GB1419097.9A GB201419097A GB2516191A GB 2516191 A GB2516191 A GB 2516191A GB 201419097 A GB201419097 A GB 201419097A GB 2516191 A GB2516191 A GB 2516191A
Authority
GB
United Kingdom
Prior art keywords
nucleation
lyophilization
crystallization
optimization
solutes
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.)
Pending
Application number
GB1419097.9A
Other versions
GB201419097D0 (en
Inventor
Wei-Youh Kuu
Mark J Doty
William S Hurst
Christine L Rebbeck
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter Healthcare SA
Baxter International Inc
Original Assignee
Baxter Healthcare SA
Baxter International Inc
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 Baxter Healthcare SA, Baxter International Inc filed Critical Baxter Healthcare SA
Publication of GB201419097D0 publication Critical patent/GB201419097D0/en
Publication of GB2516191A publication Critical patent/GB2516191A/en
Pending legal-status Critical Current

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

Abstract

This application discloses devices, articles, and methods useful for producing lyophilized cakes of solutes. The devices and articles provide for a method of freezing liquid solutions of the solute by the top and the bottom of the solution simultaneously and at approximately the same rate. The as frozen solution can then provide a lyophilized cake of the solutes with large and uniform pores.
GB1419097.9A 2012-03-28 2012-03-28 Optimization of nucleation and crystallization for lyophilization using gap freezing Pending GB2516191A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2012/030854 WO2013147759A1 (en) 2012-03-28 2012-03-28 Optimization of nucleation and crystallization for lyophilization using gap freezing

Publications (2)

Publication Number Publication Date
GB201419097D0 GB201419097D0 (en) 2014-12-10
GB2516191A true GB2516191A (en) 2015-01-14

Family

ID=46001741

Family Applications (1)

Application Number Title Priority Date Filing Date
GB1419097.9A Pending GB2516191A (en) 2012-03-28 2012-03-28 Optimization of nucleation and crystallization for lyophilization using gap freezing

Country Status (5)

Country Link
EP (2) EP3171109B1 (en)
DE (1) DE112012006137T8 (en)
ES (1) ES2626001T3 (en)
GB (1) GB2516191A (en)
WO (1) WO2013147759A1 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8689460B2 (en) * 2010-09-28 2014-04-08 Baxter International Inc. Optimization of nucleation and crystallization for lyophilization using gap freezing
WO2016075647A1 (en) 2014-11-14 2016-05-19 Project Pharmaceutics Gmbh Freeze drying of nested vials
CN107429969B (en) * 2015-01-28 2019-08-27 Ima生命北美股份有限公司 It is monitored and controlled using the processing that no battery multipoint wireless product specification senses
US10641661B2 (en) 2015-01-28 2020-05-05 Ima Life North America Inc. Process control using non-invasive printed product sensors

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2235483A1 (en) * 1972-07-20 1974-01-31 Boehringer Mannheim Gmbh Freeze drying plant - for flasks or ampoules of biological fluids or pharma-ceuticals
US4501719A (en) * 1981-05-04 1985-02-26 Marquest Medical Products, Inc. Tray apparatus for freeze-drying biologicals having a predetermined unit dosage
US4953299A (en) * 1987-11-17 1990-09-04 Societe Anonyme, Bioetica Process and apparatus for freeze-drying comprising means forming an active thermal shield between the freeze-drying shelves
US20110154681A1 (en) * 2009-12-30 2011-06-30 Baxter International Inc. Thermal shielding to optimize lyophilization process for pre-filled syringes or vials
WO2012054194A1 (en) * 2010-09-28 2012-04-26 Baxter International Inc. Optimization of nucleation and crystallization for lyophilization using gap freezing

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2235483A1 (en) * 1972-07-20 1974-01-31 Boehringer Mannheim Gmbh Freeze drying plant - for flasks or ampoules of biological fluids or pharma-ceuticals
US4501719A (en) * 1981-05-04 1985-02-26 Marquest Medical Products, Inc. Tray apparatus for freeze-drying biologicals having a predetermined unit dosage
US4953299A (en) * 1987-11-17 1990-09-04 Societe Anonyme, Bioetica Process and apparatus for freeze-drying comprising means forming an active thermal shield between the freeze-drying shelves
US20110154681A1 (en) * 2009-12-30 2011-06-30 Baxter International Inc. Thermal shielding to optimize lyophilization process for pre-filled syringes or vials
WO2012054194A1 (en) * 2010-09-28 2012-04-26 Baxter International Inc. Optimization of nucleation and crystallization for lyophilization using gap freezing

Also Published As

Publication number Publication date
EP2831526B1 (en) 2017-02-22
DE112012006137T8 (en) 2015-02-19
WO2013147759A1 (en) 2013-10-03
EP3171109A1 (en) 2017-05-24
EP2831526A1 (en) 2015-02-04
DE112012006137T5 (en) 2015-01-15
GB201419097D0 (en) 2014-12-10
ES2626001T3 (en) 2017-07-21
EP3171109B1 (en) 2018-11-14

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