ViralSEQ™ dPCR Lentivirus Physical Titer Kit (Applied Biosystems™)

The Applied Biosystems ViralSEQ dPCR Lentivirus Physical Titer Kit is a one-step digital PCR (dPCR) assay for the reproducible quantitation of lentiviral particles in supernatants from cell-based bioproduction systems. Lentiviral quantitation is a critical quality attribute (CQA) in viral vector manufacturing for cell therapy development. The assay targets a conserved region in the lentivirus genome and can be used with most lentiviral production systems. Compared to the p24 ELISA method, viral quantitation by dPCR has higher sensitivity and lower variance.

Features of the ViralSEQ dPCR Lentivirus Physical Titer Kit include:

• Accurate quantitation of viral particles by targeting a conserved region in the lentivirus genome
• Assay design compatibility with more than 200 lentiviral 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 approximately 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 Lentivirus Physical DNA Titer Kit make it suitable for proviral quantitation in process development and lot release testing.

Digital PCR workflow

The ViralSEQ dPCR Lentivirus Physical DNA 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.