Study on methods and requirements for quality control of recombinant human tumor necrosis factor receptor Fc fusion protein
Zhang, Y.; Gao, K.; Han, C-mei.; Rao, C-ming.; Wang, J-zhi.
Yao Xue Xue Bao 38(3): 165-168
2003
ISSN/ISBN: 0513-4870 PMID: 12830708 Document Number: 561972
Aim: To establish methods and requirements for quality control of recombinant human tumor necrosis factor receptor Fc fusion protein (rhTNFR-Fc). Methods: Biological potency of rhTNFR-Fc was determined by neutralizing the bioactivity of TNF-alpha. rhTNFR-Fc samples were reduced by beta-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. Results: The 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-alpha. The specific activity was up to 8X104 AUcntdotmg-1. The requirements for quality control of rhTNFR-Fc were established. Conclusion: The methods and requirement were used for quality control of rhTNFR-Fc products.