Controlling ice nucleation during lyophilization: process optimization of vacuum-induced surface freezing
Abstract: Biopharmaceuticals are often lyophilized to improve their storage stability. Controlling ice nucleation during the freezing step of the lyophilization process is desired to increase homogeneity of product properties across a drug product batch and shorten the primary drying time. The present communication summarizes the process optimization of the freezing process when using vacuum-induced surface freezing to control ice nucleation, in particular for amorphous samples. We characterized freeze-dried samples for solid state properties, and compared these to uncontrolled nucleated samples using bovine serum albumin (BSA) as a model protein. Freezing parameters were optimized to obtain complete nucleation, adequate cake resistance during the subsequent lyophilization cycle, and elegant cakes. We highlight the challenges associated with vacuum-induced surface freezing and propose optimized freezing parameters to control ice nucleation, enabling manufacturing of amorphous samples
- Location
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Deutsche Nationalbibliothek Frankfurt am Main
- Extent
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Online-Ressource
- Language
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Englisch
- Notes
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Processes. - 8, 10 (2020) , 1263, ISSN: 2227-9717
- Event
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Veröffentlichung
- (where)
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Freiburg
- (who)
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Universität
- (when)
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2021
- Creator
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Allmendinger, Andrea Martina
Butt, Yuen Li
Mietzner, Raphael
Schmidt, Felix
Lümkemann, Jörg
Lema Martinez, Carmen
- DOI
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10.3390/pr8101263
- URN
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urn:nbn:de:bsz:25-freidok-1949282
- Rights
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Der Zugriff auf das Objekt ist unbeschränkt möglich.
- Last update
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14.08.2025, 11:01 AM CEST
Data provider
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Associated
- Allmendinger, Andrea Martina
- Butt, Yuen Li
- Mietzner, Raphael
- Schmidt, Felix
- Lümkemann, Jörg
- Lema Martinez, Carmen
- Universität
Time of origin
- 2021
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Heterogeneous ice nucleation on dust particles sourced from nine deserts worldwide – Part 1: Immersion freezing
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BINARY: an optical freezing array for assessing temperature and time dependence of heterogeneous ice nucleation
An instrument for quantifying heterogeneous ice nucleation in multiwell plates using infrared emissions to detect freezing
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Prior heterogeneous ice nucleation events increase likelihood of homogeneous freezing during the evolution of synoptic cirrus
Analysis of isothermal and cooling-rate-dependent immersion freezing by a unifying stochastic ice nucleation model
Technical note: Fundamental aspects of ice nucleation via pore condensation and freezing including Laplace pressure and growth into macroscopic ice
Representing time-dependent freezing behaviour in immersion mode ice nucleation
Factors contributing to ice nucleation and sequential freezing of leaves in wheat
Repeatability and randomness in heterogeneous freezing nucleation
Freezing nucleation apparatus puts new slant on study of biological ice nucleators in precipitation
Heterogeneous ice nucleation on dust particles sourced from nine deserts worldwide – Part 1: Immersion freezing
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BINARY: an optical freezing array for assessing temperature and time dependence of heterogeneous ice nucleation
An instrument for quantifying heterogeneous ice nucleation in multiwell plates using infrared emissions to detect freezing
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