国产与进口DMEM培养基培养CHO-C28细胞效果比较

目的比较国产与进口DMEM培养基培养CHO-C28细胞的效果。方法采用国产DMEM培养基与进口DMEM培养基培养同批CHO-C28细胞,收集培养上清,检测HBsAg表达水平。采用相同条件纯化培养上清中的HBsAg,比较二者的层析图谱及纯化抗原的电泳图谱。并用其抗原制备疫苗,进行异常毒性和效力试验。结果培养上清中HBsAg表达水平,国产培养基略好于进口培养基,二者纯化图谱和抗原电泳图谱一致。两种培养基制备的疫苗异常毒性试验均合格,小鼠效力试验结果差异无显著意义。结论国产培养基在细胞培养中安全、有效,达到进口培养基水平,可用于规模化生产。

Culture of CHO-C28 Cells by Domestic and Imported DMEM

Objective To compare the culture effects of CHO-C28 cells by domestic and imported DMEM.Methods Culture the CHO-C28 cells of the same batch by domestic and imported DMEM respectively and collect the culture supernatant for determination of expressed HBsAg.The HBsAg in culture supernatant was purified by the same method,and their chromatographic and electrophoretic profiles were compared.Hepatitis B(HB) vaccine was prepared with the purified HBsAg and tested for abnormal toxicity and potency.Results The expression level of HBsAg in culture supernatant of domestic DMEM was slightly higher than that of imported DMEM.Both the chromatographic and electrophoretic profiles of HBsAg expressed in culture supernatants of domestic and imported DMEM were in agreement.Both the HB vaccines prepared by domestic and imported DMEM were qualified in abnormal toxicity test,and showed no significant difference in potency.Conclusion Domestic DMEM was safe and effective for cell culture and reached the level of imported DMEM,thus was suitable for large-scale production of HB vaccine.