Quantitation of Residual DNA in Final Product Biopharmaceutical using the Threshold Total DNA Assay System

In this application note by Molecular Devices, the precision, accuracy, and detection limit of the Threshold® Total DNA Assay was evaluated for the analysis of biopharmaceuticals products. Using the Threshold System and DNA Assay Kit, quantitation accuracy was assessed by evaluating the recovery of DNA added to an unknown sample relative to buffer controls treated in the same manner. Recovery experiments included sample pre-treatment steps to ascertain whether exogenous DNA was introduced while handling the sample. Suggestions are presented on how to determine both the quantity of residual DNA and the detection limit from biopharmaceutical products.