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
- Standort
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Deutsche Nationalbibliothek Frankfurt am Main
- Umfang
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Online-Ressource
- Sprache
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Englisch
- Anmerkungen
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Processes. - 8, 10 (2020) , 1263, ISSN: 2227-9717
- Ereignis
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Veröffentlichung
- (wo)
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Freiburg
- (wer)
-
Universität
- (wann)
-
2021
- Urheber
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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
- Rechteinformation
-
Der Zugriff auf das Objekt ist unbeschränkt möglich.
- Letzte Aktualisierung
-
14.08.2025, 11:01 MESZ
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Beteiligte
- Allmendinger, Andrea Martina
- Butt, Yuen Li
- Mietzner, Raphael
- Schmidt, Felix
- Lümkemann, Jörg
- Lema Martinez, Carmen
- Universität
Entstanden
- 2021
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