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Technology continues to evolve at lightning speed, and we’re committed to keeping up with its rapid pace to ensure our bioprocessing customers have the tools and technologies needed to deliver novel therapies to market quickly and safely, while confidently meeting global regulatory guidelines for product purity. To that end, we’re excited to expand our industry-leading portfolio of assays and kits for residual host cell DNA quantitation to support the growing use of digital PCR in cell and gene therapy analytics.
Our Applied Biosystems resDNASEQ digital PCR assays are based on the same gold-standard TaqMan chemistry used in real-time PCR and cited in more than 200K research publications. Highly efficient TaqMan Assays deliver the sensitivity, specificity, and reproducibility needed to ensure high confidence in your analytic testing results.
Get accurate absolute quantitation of residual DNA fragment sizes in HEK293 production systems and other cell lines transformed with the E1A gene, commonly used in gene therapy, cell-based vaccines, and other biologics production. Designed and internally validated to industry standards for manufacturing QC, this is a specially formulated version of our resDNASEQ kits for digital PCR.
Kit contains:
Table 1. Performance specification for the resDNASEQ dPCR E1A DNA Fragment Length Kit
Specifications | |
Accuracy | R2 >0.99 |
PCR efficiency | 100% ± 10% |
Precision | ≤20% CV |
Limit of detection (LOD) | 9 copies |
Limit of quantitation (LOQ) | 27 copies |
Assay range | 9–90,000 copies |
Experience sensitive and specific quantitation of E. coli DNA, commonly used for production of recombinant proteins and plasmids. The powerfulcombination of TaqMan chemistry and the QuantStudio Absolute Q system helps ensure a high degree of confidence in quantitation data from a broad rangeof sample types—from in-process testing with different sample matrices to formulations with final products.
Kit contains:
Table 2. Specifications of the resDNASEQ Quantitative dPCR E. coli Residual DNA Kit.
Specifications | |
Linearity | R2 >0.99 |
Precision | CV ≤30% |
Limit of detection (LOD) | 1 copy/μL |
Limit of quantitation (LOQ) | 3 copies/μL |
Assay range | 1–10,000 copies/μL |
Assay accuracy | 50–150% |
Sample Prep Assay Quantitation Results
The QuantStudio Absolute Q Digital PCR System is a plate-based digital PCR (dPCR) platform that enables all the necessary steps for dPCR—including data analysis. The dPCR workflow is identical to the qPCR workflow you are familiar with, allowing for ease-of-use, minimizing hands-on steps, and maximizing consistency. Sample preparation may or may not be required to achieve the required sensitivity and can be performed in a manual or automatic method using the PrepSEQ kit and Pharma KingFisher Flex system.
We are currently developing additional dPCR-optimized versions of our industry-leading resDNASEQ residual DNA assays. However, to enable more dPCR solutions in the meantime, we’ve demonstrated the utility of our qPCR kits for use in digital PCR in this application note featuring data obtained using our qPCR-based Applied Biosystems resDNASEQ Quantitative Plasmid DNA - Kanamycin Resistance Gene Kit on the QuantStudio Absolute Q Digital PCR system.
Prefer using real-time PCR? Explore our portfolio of robust and proven qPCR-based resDNASEQ residual DNA assays. Shop by cell line ›
Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing: