目的 评价马破伤风免疫球蛋白F(ab´)₂的免疫亲和层析纯化工艺对猪细小病毒（porcine parvovirus，PPV）的去除效果。方法  分别采用首次装填和重复使用100次的层析柱，对3批中试规模生产的中间品进行缩小规模的层析工艺去除病毒效果评价。将PPV指示病毒加至层析前的料液中，分别于层析纯化上样前、流穿、洗脱、在位清洗阶段取样进行病毒滴度检测。结果  新装填的免疫亲和层析柱对PPV的去除效果符合要求，洗脱液病毒平均降低量≥4.30 lgTCID₅₀/0.1 ml。免疫亲和层析柱重复使用100次，对PPV的去除效果仍符合要求，洗脱液病毒平均降低量≥4.33 lgTCID₅₀/0.1 ml。结论  马破伤风免疫球蛋白F(ab´)₂的免疫亲和层析纯化工艺具有良好的PPV去除效果，层析柱重复使用100次与首次使用的病毒去除效果无明显差别。

Objective  To evaluate the removal efficiency of porcine parvovirus (PPV) in the immunoaffinity chromatography purification process of equine tetanus immunoglobulin F(ab´)₂. Methods  The newly filled and 100-times used chromatography columns were applieed respectively，to evaluate the virus removal effect of chromatography process with reduced scale on intermediate products in 3 batches of pilot scale production. PPV indicator virus was added to the pre-chromatographic solution, and the virus titer was detected on samples taken at different stages of chromatographic purification including pre-loading, flow through, elution, and cleaning in place. Results  The PPV removal efficiency of newly filled immunoaffinity chromatography columns met the requirements, with the average reduction of virus titer in the eluent≥4.30 lgTCID₅₀/0.1 ml. When the immunoaffinity chromatography column was used 100 times, its removal effects of PPV still met the requirements,with the average reduction of virus titer in the eluent≥4.33 lgTCID₅₀/0.1 ml. Conclusion  The immunoaffinity chromatography purification process of equine tetanus immunoglobulin F(ab´)₂ has a good PPV removal effect, and there is no significant difference in virus removal efficiency between newly filled and 100-times used columns.