Residual host cell DNA quantification

Residual host cell DNA (HCD) is carried over during the manufacturing processes of biopharmaceutical products. The acceptable levels are established by regulatory agencies such as the U.S. Food and Drug Administration and the World Health Organization. Digital residual DNA quantification kits are ideal for the highly precise quantification of HCD in complex bioprocesses. Common host cells used during the development of gene therapies, therapeutic proteins and other biotherapeutics include Human Embryonic Kidney 293 (HEK293), Chinse Hamster Ovary (CHO), and E. coli.  

Benefits of using nanoplate dPCR for residual host cell DNA quantification

  • Easy setup and detection of host cell DNA thanks to a premixed master mix and a positive/internal control
  • Accurate detection of E. coli, CHO and HEK293 residual DNA to the low femtograms, even in the presence of PCR contaminants and inhibitors  
  • Multicopy species-specific target assays ensure results are unaffected by the fragmentation level of the resDNA
  • Validation of quantitation accuracy or bridging studies possible using the dPCR-verified standards

Direct quantification of residual host cell DNA using the QIAcuity Digital PCR Platform

Residual host cell DNA (resDNA or HCD) monitoring is an important step in the process of manufacturing proteins, vaccines and other biopharmaceuticals. The potential carryover of HCD poses a safety concern and is carefully monitored by regulatory agencies. In this scientific poster, discover how digital PCR has emerged as the method of choice for resDNA quantification due to its unmatched sensitivity and accuracy of detection at a low template input range in complex bioprocess intermediates.

Download scientific poster