resDNASEQ-showcase2

Accurate, rapid, and reproducible quantitation of residual plasmid DNA is critical to the quality and safety of many biotherapeutic reagents. Save process development time with the Applied Biosystems resDNASEQ Quantitative Plasmid DNA ‑ Kanamycin Resistance Gene Kit. 

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Measure residual plasmid DNA in gene therapy and vaccine development

COL24792-Kanamy

Residual plasmid DNA testing is a method that is used in the development of gene therapies, vaccines, and similar biotherapeutics for assessment of product quality and safety. The resDNASEQ system utilizes highly sensitive quantitation from proven Applied BiosystemsTM TaqMan® Real-Time PCR technology rapid and specific quantitation of plasmid DNA containing antibiotic resistance genes by targeting multiple antibiotic resistance gene variants contained in commonly used plasmids.

Sensitivity and specificity for residual kanamycin resistance plasmid

Designed to meet the rigors of regulatory guidance in bioproduction, the Applied Biosystems resDNASEQ Quantitative Plasmid DNA ‑ Kanamycin Resistance Gene Kit is highly sensitive, with an limit of detection of 15 genome copies and a limit of quantitation of 30 genome copies.  A multiplexed assay that targets all common allele families of the kanamycin resistance gene, this performance helps to provide a high degree of confidence in quantitation data obtained from a broad range of sample types—from in-process to purified final products.

Table 1. Specifications table for resDNASEQ Quantitative Plasmid DNA – Kanamycin Resistance Gene Kit

Specification
Accuracy R2 >0.99
PCR efficiency 100% ± 10%
Precision ≤10% CV
Limit of detection (LOD) 15 copies
Limit of quantitation (LOQ) 30 copies
Assay range 30–300,000 copies

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Fully-integrated workflow from sample prep to analysis

Figure 1. Workflow using resDNASEQ Quantitate Plasmid DNA Kit – Kanamycin Resistance Gene Kit

Applied Biosystems Quantitative Plasmid DNA Kanamycin Resistance Gene Kit provides all the components you need to quantitate residual plasmid DNA that is introduced from the use of the kanamycin resistant gene in biotherapeutic development. As part of the broader, highly reproducible, sample‑to‑results Applied Biosystems’ workflow solution, this kit is fully compatible with: 

  • Sample preparation kits and automation—for highest DNA recovery with less work and error as compared to other DNA extraction sample preparation kits
  • Applied Biosystems real‑time PCR systems1—the gold‑standard in real‑time PCR Instrumentation
  • Validated analysis software2—streamlined data analysis with security, audit, and e‑signature capabilities to enable 21 CFR Part 11 compliance

Avoid the need to develop in‑house assays and track individually purchased assay components. Reduce your process development time with this integrated workflow solution.

Additional analytical solutions for gene therapy and vaccine development

Thermo Fisher Scientific is supporting the growing promise of gene therapy and vaccine production with additional rapid analytical solutions designed for both in-process and lot-release tests.  These include residual host cell DNA and residual plasmid DNA quantitation impurities, rapid real-time PCR detection of mycoplasma contamination, and genotypic microbial identification for environmental monitoring.


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References

1. Validated with Applied Biosystems 7500 Fast Real-Time PCR QST System and Applied Biosystems Pharmaceutical Analytics QuantStudio 5 Real-Time PCR System, 96-well, 0.1 mL.
2. Validated with Applied Biosystems AccuSEQ Software version 2.1.2 (for 7500 Fast system) and AccuSEQ Software version 3.1 (for QuantStudio 5 system, 0.1 mL block).

Bioprocessing resources

Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing: