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Impact of controlled vacuum induced surface freezing on the freeze drying of human plasma

Arsiccio, A; Matejtschuk, P; Ezeajughi, E; Riches-Duit, A; Bullen, A; Malik, K; Raut, S; (2020) Impact of controlled vacuum induced surface freezing on the freeze drying of human plasma. International Journal of Pharmaceutics , 582 , Article 119290. 10.1016/j.ijpharm.2020.119290. Green open access

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Abstract

During the freezing step of a typical freeze drying process, the temperature at which nucleation is induced is generally stochastically distributed, resulting in undesired within-batch heterogeneity. Controlled nucleation techniques have been developed to address this problem; these make it possible to trigger the formation of ice crystals at the same time and temperature in all the batch. Here, the controlled nucleation technique known as vacuum induced surface freezing is compared to spontaneous freezing for the freeze drying of human plasma, a highly concentrated system commonly stored in a dried state. The potency of Factor VIII (FVIII), a sensitive, labile protein present in plasma, and the reconstitution time of the dried cakes are evaluated immediately after freeze drying, and after 1, 3, 6 or 9 months storage at different degradation temperatures. We show that the application of controlled nucleation significantly reduces the reconstitution time and in addition helps to improve FVIII stability.

Type: Article
Title: Impact of controlled vacuum induced surface freezing on the freeze drying of human plasma
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.ijpharm.2020.119290
Publisher version: https://doi.org/10.1016/j.ijpharm.2020.119290
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Freeze drying; Controlled nucleation; Plasma; Biological activity
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > The Ear Institute
URI: https://discovery.ucl.ac.uk/id/eprint/10107585
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