Abstract: AimTo establish methods and requirements for the quality control of recombinant human neu epitope peptide 12. MethodsBiological activity of recombinant human neu epitope peptide 12 was evaluated in FVB/N transgenic mice (TgN MMTVneu 202 Mul, Jackson Lab., USA) administered with samples. The percentage of antibody-positive mice detected by ELISA was used in the biological activity evaluation. The peptide map was performed by peptic digestion. The antigen content was determined by SEC-HPLC. Results and conclusionThe quality control methods, such as biological activity, peptide map, antigen content, and the requirements for the quality control of recombinant human neu epitope peptide 12 were established. The established methods and requirements were already used for the quality control of recombinant human neu epitope peptide 12 products.