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目的对重组单抗药物亲和层析病毒去除工艺进行验证。方法以甲型流感病毒H1N1亚型、单纯疱疹病毒1型和腺病毒5型作为指示病毒,分别使用新、旧rProtein A Sepharose Fast Flow(rProtein A SFF)层析介质考察重组抗狂犬病病毒单抗亲和层析步骤对病毒的去除效果。结果经新、旧rProtein A SFF介质亲和层析后,3种指示病毒的滴度均下降4.0 log10以上。结论 rProtein A SFF亲和层析工艺能有效去除重组单抗药物的潜在病毒污染。
Objective To verify the recombinant monoclonal antibody affinity chromatography virus removal process. Methods Influenza A H1N1 subtype, herpes simplex virus type 1 and adenovirus type 5 were used as indicator viruses, and the recombinant anti-rabies monoclonal antibody And chromatographic steps on the removal of the virus. Results After the new rProtein A SFF medium affinity chromatography, the titers of the three kinds of indicator viruses decreased by more than 4.0 log10. Conclusion rProtein A SFF Affinity Chromatography can effectively remove the potential virus contamination of recombinant monoclonal antibody.