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Establishment of quality control methods and standards for recombinant antitumorantivirusprotein novaferon
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Abstract:
Objective:To establish the quality control methods and standards for recombinant antitumorantivirusprotein novaferon. Methods: Antitumor activity of novaferon was evaluated by determining its inhibitory effect on the proliferation of Daudi cells using WST1 staining. The antivirus activity of novaferon was examined by cytopathic inhibition assay on WISH cells. The peptide map of novaferon was obtained by trypsin digestion and HPLC assay. Other routine tests were all performed according to the pharmacopoeia of the People′s Republic of China.Results: The antitumor and antivirus activities of three batches of novaferon bulk and final products were ≥2.0×106 U/mg and ≥1.0×109 IU/mg, respectively. HPLC peptide maps of three batches of novaferon paralleled with that of standard product. Quantity, purity, molecular mass, isoelectic point and Nterminal amino acid sequence of three batches of novaferon bulk products and bacterial endotoxin content, benzyl alcohol content, acetonitrile of three final products were consistent with the quality standards. Results of other routine tests all complied with the standard requirements. The quality control methods and standards for recombinant antitumorantivirusprotein novaferon were established accordingly.Conclusion: The established quality control methods and standards for novaferon are safe and effective, which can be used for routine quality control of novaferon.
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