Activities of Serum Binding Antibody and Neutralizing Antibody on the Cynomolgus Undergoing Long-term Toxicity Study with Polyglycol Recombinant Consensus Interferon α

To study the titer of binding antibody and neutralizing antibody about m.fascicularis' serum after subcutaneous injected 1/7d,a total of 180 days with low,middile and high-dose(10ug/kg,30ug/kg,90ug/kg and control group)pegylated of recombinant interferon alfacon(codenamed PEG-SA) for 15th,29th,43th,57th,71th,92th,113th,134th,162th and 180th and 30th after drug withdrawal.Methods:Binding antibody was measured by the indirect ELISA.Neutralizing antibody was measured by the cytopathic effect inhibition assay.Judgments based on:binding antibody titers with OD values greater than the negative control group's 2.1 times as positive.Production of neutralizing antibody activity of protect 50% cells from virus encroachment as a judgment.50% cells has pathological change provided produce neutralizing antibody.Result:On the 57th,both binding antibody and neutralizing antibody of activity reach the peak,and their to diminish or disappear after withdrawal.Antibody activity in the middle and high-dose group is higher than the low-dose group at the same time.Conclusion: Subcutaneous injection with PEG-SA,may induce m.fascicularis produced binding antibody and neutralizing antibody,both titer of them has dose-dependent.