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