Residual Host Cell DNA

Measurement of Host Cell DNA, also known as residual DNA can be a critical requirement for product specification and will require an assay validated to the ICH Guidelines for quantitative measurement. There are a number of methods which can be used to measure Host cell DNA; Picogreen and DNA Threshold being two of the historical means of determining DNA levels. Today however the most common means of detecting and quantitating Host Cell DNA is by Quantitative PCR (qPCR) technology. BioOutsource offers the Applied Biosystems 7900HT to quantitate the level of contaminating Host Cell DNA in the Drug Substance or Drug Product.

BioOutsource offers sensitive assays to assay residual DNA levels in drug substance and drug product.

Species Assay Sensitivity
Vero TSOP155 3 pg/µL
Human TSOP070 16 pg/µL
CHO TSOP048 30 fg/µL
Mouse TSOP207 30 fg/µL
E.coli TSOP003 50 fg/reaction

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