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HPV18 E6/E7 Residual DNA Fragment (qPCR) Detection Kit
Product Introduction
The Technical Guidance Principles for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial) issued by the CDE (Centre for Drug Evaluation, National Medical Products Administration) in May 2022 stipulate that for cell banks packaging viral vectors, while ensuring no residual intact viable cells remain, the residual DNA quantity and fragment size must be controlled. For specific transformation sequences within the product that are known to pose potential safety risks, such as the HPV (Human Papilloma virus) E6/E7 genes carried by HeLa cells, residual levels should be controlled separately. Therefore, to ensure the production quality of biological products, residual detections must be conducted not only for the HeLa cell line but also for risk factors such as E6 and E7.
This kit enables rapid and accurate quantification of HPV18 E6/E7 residual DNA fragments in various intermediate, semi-finished and final products derived from Hela cells.
Performance Indicators
Linear Range: 1×10⁷ copies/µL - 1×10² copies/µL;
Standard Curve Linearity:
R² ≥ 0.980
amplification efficiency 90% ≤ Eff (%) ≤ 110%
all concentration detection values CV < 15%
Accuracy (Spiked Recovery Rate): 70%–130%.
Limit of Quantification: 25 copies/µL, CV ≤ 20%, measurement deviation not exceeding |±20%|.
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