重组单抗药物亲和层析病毒去除工艺验证

Validation of Process for Virus Removal from Recombinant Monoclonal Antibody Product by Affinity Chromatography

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 process for virus removal from recombinant monoclonal antibody product by affinity chromatography.Methods The efficacies of virus removal from recombinant monoclonal antibody against rabies virus by novel and traditional rProtein A Sepharose Fast Flow（rProtein A SFF） chromatography were evaluated using influenza virus subtype H1N1,herpes simplex virus type 1 and adenovirus type 5 as model viruses.Results All the titers of three kinds of model viruses decreased by more than 4.0 log10 after purification by novel and traditional rProtein A SFF chromatography.Conclusion The rProtein A SFF affinity chromatography is effective in removal of potential virus contamination from recombinant monoclonal antibody products.