The resDNASEQ® NS0 Residual DNA Quantitation System is a quantitative PCR (qPCR)-based system for the detection of host cell DNA from NS0 (murine myeloma) cells, an expression system commonly used for the production of vaccines. Reliable and rapid, the resDNASEQ® system enables sensitive (as low as 1.5 pg DNA/mL test sample) and specific quantitation of NS0 cell DNA, typically in less than 4 hours. This performance helps ensure a high degree of confidence in quantitation data obtained from a broad range of sample types—from in-process samples to final product—whether the sample contains high molecular weight or sheared DNA.

• Highly sensitive quantitation using proven TaqMan® real-time qPCR technology
• Manual and automated sample preparation, optimized for quantitative recovery from complex sample matrices
• Consistent performance across the expected range of DNA fragment sizes
• Integrated system includes sample preparation kit, master mix, TaqMan® primer/probe mix, and NS0 genomic DNA standard

The resDNASEQ® NS0 Residual DNA Quantitation System provides highly sensitive detection of NS0 DNA, allowing you to use small sample volumes to generate accurate results. The broad linear range of TaqMan® real-time qPCR technology allows you to test samples with variable levels of NS0 DNA in the same assay, such as in-process samples with higher amounts of DNA or bulk drug substance with very low amounts.

Easy to Use, Results in Under 4 Hours
The easy workflow of the resDNASEQ® Quantitative NS0 DNA System consists of sample preparation, assay setup, and instrument run and data analysis—all of which you can perform in under 4 hours. Start by extracting DNA from your in-process purification and drug substance samples. Then perform qPCR analysis to compare the amount of NS0 DNA in your test samples to a standard curve generated with known amounts of purified NS0 genomic DNA standard. The resDNASEQ® system includes almost everything you need to carry out these steps, from sample preparation kit to master mix to TaqMan® primer/probe mix to NS0 genomic DNA standard, as well as step-by-step instructions.

Specific to NS0 DNA, No Cross-reactivity with Unrelated DNA
The target of the assay is highly specific—it only detects a NS0-specific region of a multicopy genetic element. We selected this region using extensive bioinformatic analysis of multiple related and unrelated species.

Consistent Performance Even with Fragmented DNA
For accurate quantitation of residual NS0 DNA, assay results must be unaffected by the size of the DNA molecules present in the test sample. To test the effect of DNA fragment size on assay performance, we fragmented high molecular weight NS0 genomic DNA into low molecular weight DNA by sonication. The figure below shows that the threshold cycle (Ct) values for the reactions with the sonicated low molecular weight DNA were comparable to those of the undigested high molecular weight DNA. These results demonstrate that consistent performance was obtained with the kit irrespective of DNA molecular weight.

Quantitative Recovery from Complex Sample Matrices
The system includes the PrepSEQ® Residual DNA Sample Preparation Kit, which is optimized for highly efficient DNA recovery from complex mixtures of proteins, buffers, and salts, typical of samples that need to be analyzed for residual host cell line DNA. Quantitative and consistent recovery of DNA can be achieved from challenging matrices, including samples that have high protein concentration, low pH, or high salt. The PrepSEQ® sample preparation protocol includes options for both manual and automated sample processing.