Design and development of a simple method for the detection and quantification of residual host cell DNA in recombinant rotavirus vaccine

Rotavirus recombinant vaccine is usually produced in Vero cells. Residual host DNA may reside the final product and considered a source of contamination. WHO protocols indicate that biological products should be free any type impurity such as nucleic acids, endotoxins, cell intermediate materials. Therefore, all therapeutics assessed for residual DNA. In present study, sensitive specific real-time PCR method was developed to detect product. The Beta-actin gene cells selected One set primers TaqMan probe were designed using AlleleID 6 software. Real-time reactions up, efficiency 84% obtained. sensitivity limit detection assay determined 0.176 Fg/?l 0.044 Fg/?l, respectively. intra-assay inter-assay variations 4.4% 1.04%, Furthermore, specificity high enough, lower than FDA standards. This indicates our highly rotavirus vaccine.