The Threshold™ Total DNA Assay
quantitatively measures picograms of single-stranded DNA. Unlike hybridization techniques which require DNA probes or primers with a specific nucleic acid sequence, the Threshold Total DNA Assay measures DNA with broad sequence specificity. This enables the Threshold System to measure host cell DNA as well as other DNA that might have been introduced during the biopharmaceutical manufacturing process. In addition, since the assay does not require sequence specific probes or primers, the Threshold Total DNA Assay can easily be applied to different samples purified from different host organisms. The assay consists of three steps, reaction stage, separation stage and detection stage.
Established for over 10 years, Threshold Total DNA Assay is used by pharmaceutical and biotechnology companies worldwide and is recognized by the FDA for DNA contaminate testing. Using the Total DNA Assay Kit, the following applications have been demonstrated.
- Quantitation of residual DNA in final product, biopharmaceuticals using the Threshold Total DNA Assay System.
- Assay validation and determination of detection limit.