Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation

Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation

To ensure the safety and to secure the approval of injectable medicinal products based on antigen-specific immunoglobulins of animal origin, it is necessary to exclude their contamination with adventitious human pathogens. Ensuring the viral safety of heterologous immunoglobulins presents a major ch...

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Bibliographic Details
Main Authors: V. V. Mashin, A. N. Sergeev, N. N. Martynova, T. V. Antipina, E. I. Sakanyan, V. V. Kataeva, N. V. Zagidullin
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2022-07-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
heterologous sеrum
heterologous immunoglobulin
viral contamination
state pharmacopoeia of the russian federation
european pharmacopoeia
united states pharmacopeia
british pharmacopoeia
japanese pharmacopoeia
european medicines agency
world health organisation
Online Access:https://www.biopreparations.ru/jour/article/view/385
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