Validation of adventitious agent safety in Yimmugo®, a novel IVIG preparation for human use

[Display omitted] •A novel process for IgG isolation from human plasma has been evaluated concerning safety.•Plasma samples were spiked with infectious agents and infectivity was evaluated.•Four individual preparation steps were found to provide robust elimination of infectivity.•The novel procedure...

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Bibliographic Details

Published in:	Current research in biotechnology Vol. 10; p. 100333
Main Authors:	Poelsler, Gerhard, Asper, Marcel, Lülf, Sebastian, Zirkel, Florian
Format:	Journal Article
Language:	English
Published:	Elsevier B.V 2025 Elsevier
Subjects:	Biological safety IVIG Virus reduction Biological safety Virus reduction IVIG
ISSN:	2590-2628, 2590-2628
Online Access:	Get full text
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