AccuRes™ Host Cell DNA Quantification Kits

Host cell DNA can persist during production and processing of biotherapeutics, and must be removed and monitored to minimize risk of introducing unwanted genetic material into patients. Regulatory agencies require host cell DNA levels of drug substances to be no greater than 10-100 pg/dose, depending on the dosing regimen and cell line used for production. USP General Chapter <509> “Residual DNA Testing” recommends use of probe-based DNA quantification as a validated method for testing recombinant therapeutic products produced in either Escherichia coli (E. coli) or Chinese hamster ovary (CHO) cell lines, ensuring better sensitivity and accuracy.

Cygnus Technologies’ new AccuRes™ Host Cell DNA quantification kits offer state-of-the-art solutions to precisely and accurately quantify host cell DNA remaining during process development or in final drug substances. AccuRes™ kits utilize hot start reagents and primer/probe-based amplification to detect femtogram levels of host cell DNA in a highly specific manner. These kits are compatible with a variety of qPCR instruments, offering flexibility and cost savings without compromising sensitivity.

• AccuRes™ Host Cell DNA Quantification kits combine our proprietary extraction procedure (offered in deep well or tube-based extraction formats) with AccuRes™ qPCR reagents and consumables for an all-in-one solution.  
• AccuRes™Quantitative DNA kits include reagents and consumables for qPCR, and are designed to be compatible with DNA samples extracted using a variety of methods. 
   

Benefits of our AccuRes™ Kits:

• Accuracy—probe-based quantification ensures specificity for the target cell line/species (CHO, human, E. coli) and not off-target DNA. The FAM-labeled nucleic acid probe is quenched by BHQ-1™ until PCR extension.
• Better precision— CleanAmp^® dNTPs and Hot Start Taq DNA Polymerase improve sensitivity, specificity and robustness of your assay. CleanAmp^® dNTPs are conjugated to a thermolabile protecting group, providing an additional measure to prevent mis-priming and PCR extension until the temperature of the reaction elevates.
• Flexibility— AccuRes™ Host Cell DNA kits are compatible with any qPCR instrument that detects FAM signal, eliminating the cost of purchasing additional equipment or reagents.
• Demonstrated sensitivity with an LOD ranging from 0.6 fg/µL (CHO) - 3 fg/µL (Human)
• Economical alternative to current quantitative host cell DNA kits