Collaborative Study of the National Standard for Recombinant Human Tumor Necrosis Factor ?(rhTNF-?)
- VernacularTitle:重组人肿瘤坏死因子(rhTNF-?)国家标准品的研制
- Author:
Junzhi WANG
;
Kai GAO
;
Chunming RAO
- Publication Type:Journal Article
- Keywords:
rhTNF;
standardization;
bioassay
- From:
Chinese Journal of Cancer Biotherapy
1996;0(04):-
- CountryChina
- Language:Chinese
-
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.
