– موضوع : Universal real-time PCR assay for quantitation and size evaluation of residual cell DNA in human viral vaccines زمان : یک شنبه 24 آذر 1398 ساعت 15-17
ژورنال کلاب

– موضوع : Universal real-time PCR assay for quantitation and size evaluation of residual cell DNA in human viral vaccines
زمان :
یک شنبه 24 آذر 1398
ساعت 15-17

Universal real-time PCR assay for quantitation and size evaluation of residual cell DNA in human viral vaccines

Residual host cellular DNA (rcDNA) is one of the principal risk associated with continuous cell lines derived medicines such as viral vaccines.

To assess rcDNA degradation, we suggest two quantitative real-time PCR assays designed to separately quantify target sequences shorter and longer than the 200 bp risk limit, the relative abundance of both targets reflecting the extent of rcDNA fragmentation. The conserved multicopy ribosomal 18S RNA gene was targeted to detect host cell templates from most mammalian cell substrates commonly used in the manufacture of human viral vaccines.

The method was successfully applied to a panel of Vero cell derived vaccines and could be used as a universal method for determination of both content and size distribution of rcDNA in vaccines.