Study on methods and requirements for quality control of recombinant human serum albumin-interferon α2a fusion protein

Objective:To establish methods and requirements for quality control of recombinant human serum albumin-interferon α2a fusion protein(rHSA-IFNα2a).Methods:Western blotting was carried out using anti-HSA antibody and anti-IFNα2a antibody.Biological activity was assayed by WISH-VSV system.The peptide map was obtained by trypsin digestion and HPLC assay.Other routine tests were all fulfilled according to the ChP(2010).Results:Western blotting was positive.Biological activities were more than 1.5×105 IU·mg-1.HPLC peptide maps paralleled that of reference.Results of other routine tests all complied with the standard requirements.The quality control methods and standards for rHSA-IFNα2a were established accordingly.Conclusion:The established quality control methods and standards for rHSA-IFNα2a are safe and effective,which can be used for routine quality control of rHSA-IFNα2a.