Bio-Rad ddPCR CHO and E. coli Residual DNA Quantification Kits

Bio-Rad Laboratories has announced the launch of two residual DNA quantification (RDQ) kits to simplify the quantification of host-cell DNA (HCD) in process development, quality control and biomanufacturing processes.

The ddPCR CHO Residual DNA Quantification Kit and ddPCR 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 the company’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.

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

The assays also work well with fragmented DNA, which is generated during the manufacturing process and is therefore as important to detect and measure as intact DNA.

Both kits are extensively validated and come with the company’s ddPCR Supermix for Residual DNA Quantification, which is produced under strict quality controlled conditions to ensure low background of E. coli, mouse, human, yeast and CHO cell DNA.