Residual plasmid quantification in gene therapy manufacturing workflows using the QuantStudio Absolute Q Digital PCR System

Residual DNA testing is an established method that is routinely used for the assessment of product quality and safety in the development of gene therapies, vaccines, and similar biotherapeutics. The amount of residual DNA in a biologic’s final dosage form must meet regulatory guidelines established by the World Health Organization (WHO), the European Pharmacopoeia, the US Food and Drug Administration (FDA), and other global regulatory agencies. The resDNASEQ Quantitative Plasmid DNA - Kanamycin Resistance Gene (pDNA-KanR) Kit utilizes aqPCR-based system for the detection of residual plasmid DNA containing the kanamycin-resistance gene. The resDNASEQ system enables rapid, sensitive, and specific quantitation of plasmid DNA containing the kanamycin resistance gene by targeting multiple KanR variants present in commonly used plasmids. This performance helps ensure a high degree of confidence in quantitation data obtained from a broad range of sample types—from in-process samples with different sample matrices, to bulk drug substances

QuantStudio Absolute Q Digital PCR System for analytical applications in cell and gene therapies

Accuracy and consistency are critical factors in providing high confidence in the detection and quantification of residual plasmid DNA in biotherapeutic products. While dPCR is becoming a standard in precise nucleic acid quantification, many available dPCR technologies suffer from several limitations that hinder its broad adoption, such as tedious workflows, long time-to-results, and inconsistent reagent digitization resulting in high sample waste.