目的 构建人源化抗人表皮生长因子受体3（human epidermal growth factor receptor 3，HER3）单克隆抗体（单抗）并对其成药性进行初步评估。方法 通过互补决定区（complementarity-determining region，CDR）移植对鼠抗HER3单抗进行人源化，然后对骨架区一些位点氨基酸进行回复突变以恢复人源化抗体的亲和力。对重组表达的人源化抗体用聚乙二醇沉淀法检测其在不同缓冲液中的溶解度，并通过测定内源荧光评估其高级结构。结果 经CDR移植及回复突变的抗HER3人源化抗体具有与嵌合抗体相当的亲和力，且人源化抗体具有较好的溶解度及典型的抗体内源荧光特性。结论 成功人源化了鼠抗HER3单抗，人源化后的抗体具有开发成临床药物的潜力。

Objective  To construct humanized anti-human epidermal growth factor receptor 3 (HER3) monoclonal antibody and preliminarily assess the druggability. Methods  The mouse anti-HER3 monoclonal antibody was humanized by complementarity-determining region (CDR) grafting and several framework residues were back mutated to retain affinity. The solubility of recombinant humanized antibody was detected by polyethylene glycol precipitation method in different buffer solution, and its higher order structures was evaluated by intrinsic fluorescence. Results  The humanized antibody achieved affinity equivalent to the chimeric antibody after CDR grafting and back mutation, and had good solubility and typical antibody intrinsic fluorescence characteristic. Conclusion  Mouse anti-HER3 monoclonal antibody is successfully humanized, and humanized antibody has the potential to be a valuable therapeutic in the clinical setting.