Application Note

Residual Plasmid Quantification In Gene Therapy Manufacturing Workflows Using The QuantStudio Absolute Q Digital PCR System

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This article details the design and application of the Applied Biosystems™ resDNASEQ™ Quantitative Plasmid DNA - Kanamycin Resistance Gene Kit for residual plasmid quantification in gene therapy manufacturing. The kit employs a qPCR-based system to detect residual plasmid DNA containing the kanamycin-resistance gene, providing high confidence in quantitation data. The QuantStudio™ Absolute Q™ Digital PCR System uses proprietary microfluidic array plate technology to conduct all stages of digital PCR (dPCR), parallel to qPCR, on a single instrument, thus reducing the risk of variability and sample contamination. The article further compares the data output from the qPCR and dPCR methods, demonstrating precision detection with the dPCR workflow and the feasibility of transitioning a critical assay to the QuantStudio Absolute Q Digital PCR System.

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