resDNASEQ™ dPCR HEK293 DNA Kit

The Applied Biosystems resDNASEQ dPCR HEK293 DNA Kit is a digital PCR (dPCR)-based solution to quantitate residual DNA from HEK293 expression systems, which are commonly used for production of gene therapies, cell-based vaccines, and similar therapeutics. The resDNASEQ assay offers a fast and dependable method for accurately quantifying residual HEK293 DNA. This assay offers exceptional sensitivity and specificity, helping ensure that the quantitation data obtained from a wide range of sample types, including in-process samples with varying sample matrices and final product formulations, is reliable and consistent, instilling confidence in the results.

Features of the resDNASEQ dPCR HEK293 DNA Kit include:

• Accurate, absolute quantitation of residual HEK293 DNA
• Easy-to-use, integrated sample-to-results system features TaqMan dPCR master mix and TaqMan primer/probe set
• Highly sensitive quantitation delivers results in about three hours
• Optional manual or automated sample preparation, optimized for quantitative recovery of samples from complex matrices

Digital PCR workflow

The resDNASEQ dPCR HEK293 DNA Kit is part of an integrated dPCR workflow for impurity testing during biopharmaceutical manufacturing. Optional use of the Pharma KingFisher Apex 96 Deep-Well Magnetic Particle Processor with the PrepSEQ Nucleic Acid Sample Preparation Kit helps ensure high recovery of residual DNA with less labor and error than manual processing. The Pharma KingFisher Apex instrument can process up to 24 samples in triplicate, compared to three samples in triplicate using a manual method.

To help ensure performance that meets or exceeds regulatory compliance, the resDNASEQ kit has been internally validated on the QuantStudio Absolute Q Digital PCR System. Data analysis is streamlined using the QuantStudio Absolute Q dPCR Software, which includes accurate quantitation and security, audit, and e-signature capabilities to help enable 21 CFR Part 11 compliance.