Artist rendering of digital PCR residual DNA quantitation

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

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Applied Biosystems resDNASEQ dPCR E1A DNA Fragment Length Kit

Table 1. Performance specification for the resDNASEQ dPCR E1A DNA Fragment Length Kit

Specifications
AccuracyR2 >0.99
PCR efficiency100% ± 10%
Precision≤20% CV
Limit of detection (LOD)9 copies
Limit of quantitation (LOQ)27 copies
Assay range9–90,000 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

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Applied Biosystems resDNASEQ dPCR E. coli DNA Kit

Table 2. Specifications of the resDNASEQ Quantitative dPCR E. coli Residual DNA Kit.

Specifications
LinearityR2 >0.99
PrecisionCV ≤30%
Limit of detection (LOD)1 copy/μL
Limit of quantitation (LOQ)3 copies/μL
Assay range1–10,000 copies/μL
Assay accuracy50–150%

Validated workflow solution


           Sample Prep                                                               Assay                                           Quantitation                                          Results

Applied Biosystems resDNASEQ dPCR integrated workflow


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.

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Learn how digital PCR compares to qPCR ›

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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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Bioprocessing resources

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

For Research Use Only. Not for use in diagnostic procedures.