Background: Cirrhosis is regarded as a possible end stage of many liver diseases, including viral infection.It occurs when healthy liver tissue becomes damaged and is replaced by scar tissue and finally may lead tohepatocellular carcinoma. Interferons (IFNs)are two general categories, type I and II. Type I includes onebeta interferon and over 20 different alpha interferons. Alpha interferons are very similar in how they work,interacting with other proteins on cells like receptors. The main objective of this study was to compare Mx geneproductivity post different cell line treatment with imported and Egyptian biosimilar locally produced IFNs,as well as the efficacy of those tested IFNs. Also, an assessment was made of sensitivity of different cell linesas alternatives to that recommended for evaluation of antiviral activity. Materials and
Methods: Different celllines (Vero, MDBK and Wish) were employed to evaluate cytotoxicity using the MTT assay. Antiviral activitywas evaluated compared with standard IFN against VSV, Indiana strain -156, on tested rh-IFNs (imported;innovated and Egyptian biosimilar locally produced IFNs) in the pre-treated cell lines previously mentioned.The virus was propagated in the Wish cell line as recommended. Finally we estimated up-regulation of the Mxgene as a biomarker.
Results: Data recorded revealed that test IFNs were safe in test cell lines. Viability wasaround 100%. Locally tested interferon did not realize the international potency limits, while the importedone was accepted compared with the standard IFN. These results were the same either using infectivity titerreduction assay or crystal violet staining of residual non- infected cells. Mx protein production was cell typerelated and confirmed by the detected Mx gene expressed in imported and locally produced IFN pre-treatedcell lines. The expression of the gene was arranged in the order of Vero> wish > MDBK for the imported IFN,while for the Egyptian biosimillar locally produced one it was MDBK> Vero> wish. With regard to the antiviralactivity there was a significant difference of imported IFN potency compared with the locally produced IFN(P<0.05), the IFN potential (antiviral activity) was not cell line related and showed non-significant differencefor each separate product.
Conclusions: Vero cells can be used as an alternative cell line for evaluation of IFNpotency in case of unavailable USP recommended cell lines. Alternative potency evaluation assay could be usedand proved significant difference in IFN potency in case of local and imported agents. Evaluation of antiviralactivity could be used in parallel to viral infectivity reduction assay for better accuracy. Mx gene can be used asa marker for IFN potential.