Enhancing Host Cell DNA Testing With Digital PCR: Efficiency Gains For Biopharmaceutical Manufacturing

By Jamie Betker, David Abraham, Nikolette McCombs, and Jason Duex

Residual host cell DNA remains a critical impurity to monitor in biopharmaceutical production, with increasing pressure to improve accuracy, speed, and consistency across workflows. In this collaborative study, KBI Biopharma and QIAGEN demonstrate how digital PCR can simplify residual DNA testing while maintaining robust analytical performance across CHO- and E. coli-derived bioprocesses. Advances in digital PCR are redefining how residual DNA is quantified, enabling absolute measurement without the need for standard curves while reducing susceptibility to inhibitors found in complex sample matrices.

By leveraging partitioned reactions and endpoint analysis, this approach delivers strong linearity, high accuracy, and reproducible results across both CHO- and E. coli-derived processes. The workflow also supports direct analysis of unextracted samples, reducing hands-on time, workflow complexity, and overall testing time without compromising data quality. For teams focused on process efficiency and regulatory compliance, these capabilities open the door to faster decision-making and more robust in-process monitoring.

Access the full white paper to see how digital PCR can optimize residual DNA testing strategies.