Kits Allow for Direct Quantification of Host-cell DNA Impurities

Bio-Rad’s new ddPCR CHO Residual DNA Quantification Kit and PCR E. coli Residual DNA Quantification Kit allow for direct quantification of host-cell DNA impurities in biopharmaceuticals purified from bacteria (E. coli) or mammalian cells (Chinese hamster ovary) without the need for upfront nucleic acid purification steps.

The kits are designed for use with Bio-Rad’s Droplet Digital PCR Systems. HCD levels are tightly regulated in biopharmaceutical products, as high concentrations can potentially pose a safety risk for consumers. Removal of HCD and close monitoring of residual levels throughout the production process must be established to ensure quality and safety of the final biopharmaceutical.

The kits combined with ddPCR technology provide a convenient system for quantifying HCD with high reproducibility and sensitivity. The system bypasses the need for DNA extraction, thanks to the inherent tolerance of ddPCR to PCR inhibitors, as end-point analysis directly quantifies target molecules and does not depend on amplification efficiency.