Residual DNA Testing

Biopharmaceutical final products derived form genetic engineering technologies cannot exceed a maximum quantity of residual DNA after elimination of the source material used to produce them (host cells or plasmids).

Different highly sensitive techniques can be used to detect residual DNA.

Quantitative PCR:

QPCR is a sequence-specific detection method targeting specific DNA contaminants. All assays are fully validated in compliance with ICH guidelines by the evaluation of specificity, linearity, accuracy, intra- and inter- assay precision, LOD and LOQ.