ViralSEQ™ dPCR AAV Titer Kit (Applied Biosystems™)

The Applied Biosystems ViralSEQ dPCR AAV Titer Kit is a digital PCR (dPCR) assay for the reproducible quantitation of AAV particles independent of the serotype. AAV titer quantitation is a critical quality attribute (CQA) in viral vector manufacturing for gene therapy development. This probe-based dPCR assay delivers superior sensitivity and consistency, outperforming conventional DNA blotting or ELISA methods.

Features of the ViralSEQ dPCR AAV Titer Kit include:

• Accurate quantitation of viral particles by dPCR targeting ITR and SV40
• Assay design compatible with more than 80% of AAV transfer plasmids
• 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 from bioproduction samples

The high sensitivity and specificity provided by the ViralSEQ dPCR AAV Titer Kit make it suitable for viral quantitation in process development and lot release testing.

Digital PCR workflow

The ViralSEQ dPCR AAV Titer Kit is part of an integrated dPCR workflow for viral vector characterization 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 viral 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 ViralSEQ 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.