AccuRes™ Kits Quantify Residual DNA in Your Bioprocess

Host cell DNA must be monitored and removed from manufactured biotherapeutics to minimize risk to patients and meet regulatory requirements, which ranges from 10-100 ng/dose depending on the therapeutic regimen. Probe-based DNA quantification is a validated, sensitive method recommended by regulatory agencies for testing recombinant therapeutic products produced in either Chinese hamster ovary (CHO) or Escherichia coli (E. coli) cell lines, ensuring better accuracy.

AccuRes™ Host Cell DNA Quantification Kits are designed to combine Cygnus Technologies’ proprietary DNA extraction procedure (offered in deep-well or tube-based extraction formats, depending on sample throughput needs) with a probe-based qPCR master mix containing premium quality hot start reagents that can recover, amplify, and quantify femtogram levels of host cell DNA. The probe-based quantification ensures specificity for the target cell line (CHO, E. coli) and not off-target DNA, with a demonstrated LOD of 0.6 fg/µL for the CHO assay. Inclusion of CleanAmp® dNTPs and Hot Start Taq DNA Polymerase, which are conjugated to thermolabile protecting groups, provide additional measures to prevent non-specific priming, improving sensitivity and assay robustness. AccuRes™ kits include all reagents, standards, and consumables for DNA extraction and qPCR, and are compatible with a variety of qPCR instruments that detect FAM signal, offering flexibility and cost savings without compromising sensitivity.

Contact your Bio-Connect account manager to learn how AccuRes™ Host Cell DNA kits can improve your residual DNA testing capabilities.