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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.
Benefit from:
- Technical expertise developing widely adopted resDNASEQ assays designed and internally validated to industry standards to help biopharmaceutical manufactures meet regulatory requirements for lot-release testing
- Complete all-in-one kit including highly characterized E1A DNA standard for qualification and validation
- Sensitive and accurate absolute quantitation of residual DNA using digital PCR
Proven chemistry, proven performance
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.
New resDNASEQ dPCR kits
Applied Biosystems resDNASEQ dPCR E1A DNA Fragment Length Kit
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:
- Absolute Q™ DNA Digital PCR Master Mix
- E1A dPCR Short Fragment Assay
- E1A dPCR Medium Fragment Assay
- E1A dPCR Long Fragment Assay
- E1A DNA Control
- DNA Dilution Buffer
- Nuclease-free Water
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 |
Applied Biosystems resDNASEQ dPCR E. coli. DNA Kit
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:
- Absolute Q DNA Digital PCR Master Mix
- TaqMan E. coli DNA Assay
- E. coli DNA Control
- DNA Dilution Buffer
- Nuclease-free Water
- Optional PrepSEQ Nucleic Acid Extraction Kit
- Optional PrepSEQ Residual DNA Sample Prep Kit
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% |
Validated workflow solution
Sample Prep Assay Quantitation Results
Powerfully simple digital PCR
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.
Additional residual host cell and plasmid DNA resDNASEQ kits
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.
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Prefer using real-time PCR? Explore our portfolio of robust and proven qPCR-based resDNASEQ residual DNA assays. Shop by cell line ›
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