Collaborative Study of the National Standard for Recombinant Human Tumor Necrosis Factor ?(rhTNF-?) / 中国肿瘤生物治疗杂志

ABSTRACT

Objective: To establish National Standard of rhTNF-? complying with the requirements of research and quality control. Methods: National Standard of rhTNF-? were assayed against international standard (NIBSC) of rhTNF-? by cytotoxicity bioassay (L929 ) in vitro. The collaborative study has been carried out among four laboratories. Results: Based on the statistical analysis the results show that mean pf 95 % confidence interval is 3 289 ~ 4 266 IU per ampoule; the 95 % reference range is 1 735 ~ 8 087 IU per ampoule. Based on this study, the potency of rhTNF-? standard is defined as 3500 IU per ampoule. Stability tests indicate that the bioactivity has not been changed significandy under the storage of four different temperautres for 27 monthes. Conclusion: The preparation of rhTNF-? met the requirement of quality and could be used as a National Standard.