重组人血清白蛋白-干扰素α2a融合蛋白质控方法与质量标准的建立

目的: 建立重组人血清白蛋白-干扰素α2a融合蛋白(rHSA-IFNα2a)的质控方法和质量标准。 方法: 分别使用抗HSA抗体和抗IFNα2a抗体、采用免疫印迹法对成品进行鉴别试验,采用WISH细胞病变抑制法测定成品和原液的生物学活性,原液以胰蛋白酶酶切后,用HPLC分析肽图,其余项目按2010年版中国药典(三部)的规定进行检测。 结果: 样品与抗HSA抗体和抗IFNα2a抗体均呈阳性反应,比活性＞1.5×10⁵ IU·mg^-1,其肽图与参考品的一致,其余项目均符合2010年版中国药典(三部)的规定,根据检测结果建立了rHSA-IFNα2a的质量标准。 结论: 建立的质控方法和质量标准可以保证rHSA-IFNα2a的安全、有效和质量可控,可以用于rHSA-IFNα2a的常规检定。

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.