Host Cell DNA Extraction, Detection, and Quantification Kits

Removal of Host Cell DNA during biotherapeutic production is a crucial step to ensure patient safety and therapeutic efficacy. Regulatory agencies have set an upper threshold of 10-100 pg host cell DNA/dose, depending on the dose and therapeutic regimen. To ensure compliance, host cell DNA levels must be carefully monitored using robust yet sensitive extraction and quantification methods. Cygnus Technologies offers a variety of solutions to recover, detect and quantify host cell DNA throughout process development and in the final drug substance.

• Cygnus Technologies’ AccuRes™ Host Cell DNA Quantification Kits combine our proprietary DNA extraction procedure with a high-quality probe-based master mix that can detect as little as 0.6 fg per microliter of host cell DNA.
• DNA Extraction kits harness a proprietary extraction method to ensure maximum recovery of residual Host Cell DNA from in-process samples or drug substances
• Our PicoGreen® dye-based DNA detection kits enable qualitative analysis of residual DNA, which can be suitable for evaluating samples during process development.
• Host Cell DNA Amplification kits combine our DNA extraction procedure and include standards/reagents that are designed to be compatible with your qPCR master mix of choice.