Are you meeting safety standards for residual host cell DNA?
To realise the incredible potential of cell and gene therapies, scientists must overcome many challenges specific to creating these products. One persistent challenge is residual host cell DNA contamination.
HEK293 cells are a dominant platform for cell and gene therapy production. However, if traces of these host cells are not removed before the final treatment is administered, there can be dangerous immune responses or oncogenic effects.
To ensure patient safety when it comes to host cell DNA contamination, the Food and Drug Administration (FDA) published industry guidance for cell and gene therapy manufacturing:
“Limit the amount of residual DNA for continuous non-tumorigenic cells to less than 10ng/dose and the DNA size to below approximately 200 base pairs. If you are using cells that … have tumorigenic phenotypes (e.g., HEK293, HEK293T), the limitation of specific residual DNA quantities may be needed to assure product safety.”
To ensure adherence to these rigorous guidelines, biopharmaceutical manufacturers need cutting-edge solutions. The traditional method for quantifying residual host cell DNA is quantitative PCR (qPCR), which relies on a standard curve and presents other limitations such as nonspecific signals and lack of reproducibility. In addition, BioAnalyzer technology, widely used for DNA sizing, fails to deliver cell line-specific results and is unable to analyze fragments larger than 7 kilobases.
In contrast, Droplet Digital™ PCR technology (ddPCR™) delivers the high-quality data you need to meet FDA standards. ddPCR technology provides an absolute count of target DNA copies per input sample without relying on standard curves. This capability makes the technique simpler, more precise, and highly sensitive.
The Vericheck ddPCR HEK293 Residual DNA Detection Kits are the first digital PCR HEK293-specific kits, providing an elegant solution that enables absolute quantification and accurate sizing of residual HEK293 DNA on the same instrument. In addition, the kits offer an extraction-free workflow—minimising hands-on time and sample manipulation—and reproducible, quantitative readouts for precise measurement of residual HEK293 DNA.
With these easy-to-use ddPCR assays, you can confirm that the precise amount of residual HEK293 DNA in your cell and gene products falls within the FDA guidelines for every batch. Then, empowered with the knowledge that your products are clear of dangerous contaminants, you can have greater confidence in your work.
