Residual DNA Quantification Kit-E.coli

As biopharmaceutical and biotech applications expand, the use of E. coli as an expression system for recombinant protein production has become increasingly common. E. coli is favored for its rapid growth, well-characterized genetics, and ability to express a wide range of proteins. However, a major challenge in using E. coli to produce biologics is ensuring the purity and safety of the final product. Regulatory agencies such as the FDA and EMA have strict limits on impurities, including host cell DNA. If residual DNA is not adequately removed, it can cause serious safety issues such as carcinogenicity and immunogenicity. Therefore, quantification of residual DNA is a critical step in the purification process for biopharmaceutical production. Traditional DNA quantification methods, such as UV spectrophotometry and fluorescence, may not provide the specificity and sensitivity required for trace detection in complex mixtures. Therefore, more sophisticated techniques such as quantitative PCR (qPCR) have become the gold standard due to their sensitivity, specificity, and ability to quantify DNA at very low levels.