resDNASEQ™ dPCR Sf9 and Baculovirus DNA Kit (Applied Biosystems™)

The Applied Biosystems resDNASEQ dPCR Sf9/Baculovirus DNA Kit is a digital PCR (dPCR)-based solution to quantitate residual DNA from Sf9/baculovirus 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 Sf9/baculovirus DNA. This not only ensures the sensitivity and specificity of the assay but also helps instill a high level of confidence in the quantitation data obtained from diverse sample types, including in-process samples with varying sample matrices and final product formulations.

Features of the resDNASEQ dPCR Sf9/Baculovirus DNA Kit include:

• Accurate, absolute quantitation of residual Sf9/baculovirus 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 Sf9/Baculovirus 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.