Abstract: AimTo establish methods and requirements for quality control of recombinant human tumor necrosis factor receptor Fc fusion protein (rhTNFR-Fc). MethodsBiological potency of rhTNFR-Fc was determined by neutralizing the bioactivity of TNF-α. rhTNFR-Fc samples were reduced by β-mercaptoethanol and the peptide map was performed by tryptic digestion. Residual protein A and the host cell protein content were detected by ELISA. Anti-TNFR and anti-Fc antibodies were used in ELISA for detection of the rhTNFR-Fc content. ResultsThe quality control methods, such as bioassay, peptide map, residual protein A detection, were established and used for quality control of rhTNFR-Fc. The unit of rhTNFR-Fc (AU) was defined according to the international unit of TNF-α. The specific activity was up to 8×10⁴ AU·mg^-1. The requirements for quality control of rhTNFR-Fc were established. ConclusionThe methods and requirement were used for quality control of rhTNFR-Fc products.