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.
Cygnus host cell DNA detection kits utilize PicoGreen® DNA binding dye and include DNA extraction reagents and cell-line specific DNA calibrators. The PCR amplification kits contain DNA extraction reagents, DNA calibrators, and validated specific primers.
Cygnus host cell DNA extraction kits employ a proprietary DNA extraction procedure that recovers <1 pg/ml residual DNA while eliminating contaminating proteins, salts, and detergents from downstream DNA detection or amplification procedures.
Reagents, DNA concentrates, and other host cell DNA kit components.