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Inventi Impact - Biosimilars

Articles

  • Inventi:pbs/70/14
    COMPARATIVE EVALUATION OF LOCALLY PRODUCED AND IMPORTED INTERFERON BIOACTIVITY AND RELATED MX GENE EXPRESSION POTENTIALS IN DIFFERENT CELL LINES
    Shereen Hamdy Mohamed, Nora Fahmy, Aly Fahmy Mohamed, Nahla Shehata

    The present work was aimed to study the biosimilarity of locally produced free IFN and innovated imported free one through evaluation of the antiviral activity of test interferons on different cell lines and related expression potentials of Mx protein producing gene. Evaluation of two alternative methods for evaluation the efficacy of antiviral interferon. Cytotoxicity of interferon was performed using different cell lines based on determination of residual live cells released lactate dehydrogenase (LDH) reactivity to MTT stain assay. Antiviral activity of locally produced and imported IFN was evaluated against vesicular stomatitis viruses (VSV). This assay was based on evaluation of the inhibitory activity to VSV grown on rh-IFN-? pretreated vero, MDBK and WISH cell lines. The potency of IFN was estimated by comparing inhibitory activity of the test interferons to standard one. Cytotoxicity evaluation results indicated that all types of test INF showed no toxicity to different cell lines. In the mean times tested IFN potency showed that locally produced one was not realized the international potency limits, while the imported one was accepted. Regarding the initiation of antiviral protein production was confirmed by detected Mx gene expressed in IFN pre treated cell lines and expression rate was related to cell type. Alternative way of evaluation of antiviral activity showed that there was a significant difference between local and imported products antiviral activity. Sensitivity of different cell lines showed that each tested product showed no significant difference (P>0.05) compared top each other. Different methodology could be established in the national regulatory authority (NRA) to evaluate interferon biosimillar bioactivity/ antiviral activity. Different cell lines could be used for evaluation of interferon antiviral activity in case of unavailability of recommended cell line.

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