Ensure your purification process reduces host cell DNA

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Host cell DNA must be carefully monitored and removed during production and processing of biotherapeutics to minimize risk of exposing patients to unwanted genetic material. Regulatory guidelines have established acceptable ranges from 10-100 pg/dose, depending on the cell line used for expression and dosing regimen.

Cygnus Technologies’ new CHO 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 Cygnus’ proprietary DNA 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 compared to other established Quantitative CHO DNA Kits available. With a limit of detection (LOD) of 0.6 fg/µL, this kit also offers the highest degree of sensitivity available.

The CHO AccuRes™ DNA Quantification Kit in Tubes (D1555T) includes reagents to extract, precipitate and resuspend residual host cell DNA for downstream qPCR analysis, as well as all the necessary reagents and consumables for quantitative PCR. The qPCR reagents include a state-of-the-art master mix containing CleanAmp® dNTPs and Hot Start Taq DNA Polymerase to prevent non-specific priming during PCR setup, and a CHO cell line-specific primer/probe mix containing FAM-labeled probes that are quenched with BHQ-1™ until PCR extension. Plates can be run on a variety of qPCR instruments, enabling analysis using your software of choice.