AAPS 2024: A GxP-Qualified dPCR-Based RCL Assay to Quantify Replication Competent Lentivirus in Bioanalytical Samples

Frontage Laboratories has developed and validated a highly sensitive, GxP-qualified dPCR-based RCL (replication-competent lentivirus) assay to monitor the safety of clinical samples. Targeting the VSV-G gene, this assay offers absolute quantification with a LoD as low as 0.05 copies/µL. It delivers exceptional accuracy, precision, and cross-platform performance. With industry-leading sensitivity and compliance with FDA guidance, Frontage’s RCL assay ensures robust detection of rare recombination events and supports regulatory submission with exceptional analytical confidence.

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