Polymerase Chain Reaction (PCR) has been used in the testing of pharmaceutical products for biosafety and characterization testing since the 1990’s. PCR-based assays, including both standard PCR and quantitative PCR (QPCR) utilize a DNA amplification technique in order to detect and/or quantify the template DNA in a reaction. PCR-based testing provides accurate and rapid test results, and its use in pharmaceutical-based testing has been accepted by regulatory agencies around the world.
Droplet Digital PCR (ddPCR) is a hybrid methodology which utilizes aspects of both standard PCR and QPCR. Absolute quantitation is achieved by utilizing fluorescent-based technology coupled with reading at reaction end-point, instead of during the exponential amplification. The use of this technology produces data of superior accuracy of quantitation compared to that of QPCR.