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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Vydané v:	Current research in biotechnology Ročník 10; s. 100333
Hlavní autori:	Poelsler, Gerhard, Asper, Marcel, Lülf, Sebastian, Zirkel, Florian
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Elsevier B.V 2025 Elsevier
Predmet:	Biological safety IVIG Virus reduction Biological safety Virus reduction IVIG
ISSN:	2590-2628, 2590-2628
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