Biopharmaceuticals produced in live cell systems such as bacteria and eukaryotic cell lines contain some level of host cell DNA at the time the product is harvested from bioreactors. The host DNA constitutes a potential threat to human health, and manufacturing regulations stipulate that host DNA must be below a certain level in each dose. DNA removal is achieved by sequential purification steps, and accurate quantification of residual DNA at each step is essential in evaluating how efficiently the DNA is being removed and in characterizing the final bulk drug product. Quantitative and consistent recovery of DNA from challenging matrices, including samples that have high protein concentration, low pH, or high salt, presents a technical challenge.
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