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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Veröffentlicht in:	Current research in biotechnology Jg. 10; S. 100333
Hauptverfasser:	Poelsler, Gerhard, Asper, Marcel, Lülf, Sebastian, Zirkel, Florian
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Elsevier B.V 2025 Elsevier
Schlagworte:	Biological safety IVIG Virus reduction Biological safety Virus reduction IVIG
ISSN:	2590-2628, 2590-2628
Online-Zugang:	Volltext
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