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 a state-of-the-art solution to precisely and accurately quantify host cell DNA remaining during process development or in final drug substances. This all-in-one kit combines our proprietary extraction procedure with a probe-based master mix containing high-quality reagents that can recover, amplify, and quantify femtogram levels of host cell DNA. AccuRes™ Host Cell DNA Quantification Kits are offered in well or tube-based extraction formats, and are compatible with a variety of qPCR instruments, offering flexibility and cost savings without compromising sensitivity.

AccuRes™ Quantification Kit Benefits:

• Accuracy—probe-based quantification ensures specificity for the target cell line (CHO, HEK, 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.
• All-in-one kit takes you from sample to PCR—Includes all reagents for DNA extraction in a plate or microfuge tube format, AccuRes™ PCR master mix, primer/probe mix, and DNA standard.
• Demonstrated sensitivity with an LOD of 0.6 fg/µL