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| Study on reporter gene assay for determination of the bioactivity of polyethylene glycol typeⅠinterferon |
| PEI Dening YU Lei GUO Ying SHI Xinchang RAO Chunming |
| Division of Recombinant Biological Products, National Institutes for Food and Drug Control, Beijing 100050, China |
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Abstract Objective To investigate the applicability of reporter gene assay in Chinese Pharmacopoeia (2015 edition) for determination of the bioactivity of polyethylene glycol (PEG) type Ⅰ interferon. Methods According to ICH guidelines, specificity, linearity, accuracy (recovery) and precision (repeatability and intermediate precisions) of reporter gene assay were validated. The determination results of reporter gene assay and cytopathic inhibition assay were also compared. Results Application of reporter gene assay for determination of the bioactivity of PEG type Ⅰ interferon had good specificity, the dose-response of which was fitted to 4-parameter logistic model. The recovery rate was 85%-115%, the repeatability of the assay was 6.66%-7.70%. The intermediate precision of different dates, laboratory technicians and cell passages was 10.64%-11.01%, 13.04%-15.12% and 7.61%-8.54% respectively. The difference of the determination results between reporter gene assay and cytopathic inhibition assay was not statistically significant (P ＞ 0.05). Conclusion The reporter gene assay is applicable for bioactivity determination of PEG type Ⅰ interferon.
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