Validation of a test procedure for determination of specific activity of human recombinant interferon beta (Infibeta®) using various cell/virus combinations

Validation of a test procedure for determination of specific activity of human recombinant interferon beta (Infibeta®) using various cell/virus combinations

Interferon beta preparations have demonstrated efficacy in the treatment of multiple sclerosis. One of the most important quality attributes that support efficacy and safety of interferon beta preparations is specific antiviral activity. Interferon beta activity is determined by the biological test...

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Bibliographic Details
Main Authors: Yu. N. Lebedeva, N. A. Litvinova, T. N. Lobanova, R. R. Shukurov, R. A. Khamitov, L. A. Gaiderova
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2022-04-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
interferon beta
specific activity
cell cultures
virus
dose-response curve
validation
acceptance criteria
assessment of validation parameters
Online Access:https://www.biopreparations.ru/jour/article/view/337
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