Direct Quantification Of Residual Host Cell DNA Using The QIAcuity® Digital PCR Platform

By Oezlem Karalay, Julius Albers, Corinna Hochstein, Robert Boeddecker, Ronny Kellner, Domenica Martorana, Colin Donohoe, Francesca Di Pasquale, Andreas Missel, Andreas Hecker, and Daniel Heinz Löfgren, QIAGEN

Monitoring residual host cell DNA (HCD) is a critical component in the manufacturing of therapeutic proteins and vaccines. Even trace amounts of HCD carried over from production cell lines can pose significant safety risks to patients. To address this, regulatory bodies such as the U.S. FDA and WHO have established stringent limits on residual DNA levels, such as <10 ng/dose for parenteral products and <100 µg/dose for oral vaccines.

To meet these standards, it is essential to apply highly sensitive and accurate analytical technologies. Digital PCR (dPCR) has emerged as a preferred method due to its ability to detect extremely low quantities of specific DNA targets with precision, even in challenging sample matrices.

The QIAcuity® Digital PCR System and QIAcuity Residual DNA Quantification Kits are optimized for the direct, absolute quantification of host cell DNA from CHO, E. coli, and HEK293 cells. The platform supports extraction-free workflows, includes species-specific assays, and offers validated internal controls, enabling robust, reproducible results even in the presence of PCR inhibitors. Compared to qPCR, dPCR also eliminates the need for standard curves and delivers superior performance at low template concentrations.

Read more to discover how this technology simplifies workflows and strengthens confidence in biomanufacturing quality control.