resDNASEQ - Quantitative Plasmid DNA - Kanamycin Resistance Gene Kit
qPCR system for quantitation of residual plasmid DNA. Multiplex assay that targets all kanamycin resistance (KanR) gene alleles common in bioproduction. Highly specifi c quantitation through innovative DNA-free master mix. Highly sensitive quantitation using proven Applied Biosystems TaqMan real-time PCR technology. Reproducible results with manual and automated sample preparation, optimized for quantitative recovery from common gene therapy sample matrices. Easy to use, with results in under 5 hours. Integrated sample-to-results system with sample preparation kit, master mix, Applied Biosystems™ TaqMan primer/probe mix, and plasmid DNA standard developed from plasmid carrying the KanR gene.
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Product Details
The Applied BiosystemsM resDNASECT Quantitative Plasmid DNA-Kanamycin Resistance Gene (pDNA-KanR) Kit utilizes a qPCR-based system for detection of residual plasmid DNA containing the kanamycin resistance gene. Residual DNA testing is an established method routinely used for assessment of product quality and safety in the development of gene therapies, vaccines, and similar biotherapeutics. The resDNASEQ system enables rapid, sensitive, and specific quantitation of plasmid DNA containing the kanamycin resistance gene (KanR) by targeting multiple KanR variants present on 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 (Figure 1).
Specifications
- Accuracy: R2 >0.99
- PCR efficiency: 100% ± 10%
- Precision: CV ≤10%
- Limit of detection (LOD): 15 copies
- Limit of quantitation (LOQ): 30 copies
- Assay range: 30–300,000 copies
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