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为了对治疗用抗ＨＦＲＳ病毒单克隆抗体３批中试产品进行全面的质量分析，我们参照国家药品监督管理局颁布的《人用鼠源性单克隆抗体制造及检定规程》进行检定。结果所有指标均合格，其中单抗纯度＞９５％，单抗体单体纯度＞９５％，残余骨髓瘤细胞（ＳＰ２／０）ＤＮＡ含量＜
In order to conduct a comprehensive quality analysis of three batches of pilot products of anti-HFRS virus monoclonal antibodies, we refer to the “Procedure for the Production and Validation of Human-derived Murine Monoclonal Antibodies” promulgated by the State Drug Administration. Results All the indexes were qualified, in which the purity of monoclonal antibody was> 95%, the purity of single antibody was> 95%, the DNA content of residual myeloma cells (SP2 / 0)