On assessing the viral safety of individual units of the substance "Human plasma for fractionation" by nucleic acid amplification

Scientific relevance. The absence of blood-borne viruses in human plasma-derived medicinal products must be ensured by the control of raw materials and the manufacturing process.Aim. This study aimed to analyse system suitability criteria for analytical procedures to assess the viral safety of indiv...

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Bibliographic Details
Main Authors: E. V. Elbert, V. V. Nozhko, R. A. Volkova, A. A. Movsesyants, V. A. Merkulov, V. V. Kosenko
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2023-10-01
Series:Биопрепараты: Профилактика, диагностика, лечение
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Online Access:https://www.biopreparations.ru/jour/article/view/498
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