resDNASEQ™ dPCR CHO DNA Kit (Applied Biosystems™)

The Applied Biosystems resDNASEQ dPCR CHO DNA Kit is a powerful digital PCR (dPCR) solution for quantitating residual DNA from CHO expression systems, which are commonly utilized for the production of monoclonal antibodies (mAbs). By harnessing the capabilities of high-performance TaqMan chemistry, the resDNASEQ CHO assay provides a rapid and reliable approach for accurately quantifying residual CHO 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 CHO DNA Kit include:

• Accurate, absolute quantitation of residual CHO 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 CHO 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 dPCR 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.