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[Study on methods and requirements for quality control of recombinant human tumor necrosis factor receptor Fc fusion
Yi Zhang1, Kai Gao, Chun-mei Han
1Department of Biochemistry, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
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 8 x 10(4) AU.mg-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.
