Whitepaper: Development and Validation of a Versatile and Robust Method for Measuring Residual Plasmid DNA

The clearance of residual plasmid DNA must be verified during lot release testing or process
development. This is a regulatory requirement and ensures patient safety and product quality.
What is needed for lot release testing is a highly sensitive quantitation assay to confirm
clearance of residual plasmid DNA.

Here we describe the development and validation of the Applied Biosystems resDNASEQ™
Quantitative Plasmid DNA - Kanamycin Resistance Gene Kit, a multiplex qPCR assay for the
quantitation of residual plasmid DNA, designed to meet regulatory guidance and cover the
vast majority of plasmids used in biotherapeutic production by targeting various kanamycin
resistance gene families.

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