Developing unbiased assays to detect replication competent AAV in clinical vector products

Detection of rcAAV is a critical quality and safety requirement for adeno associated virus vector programs. Current assay formats vary in sensitivity, specificity, and reproducibility, creating challenges for consistent risk assessment. This spotlight session outlines considerations for developing unbiased assays that provide accurate quantification, support regulatory expectations, and strengthen confidence in vector product release.

Key takeaways

• Define analytical limitations of existing rcAAV detection methods
• Establish criteria for developing unbiased assays with improved sensitivity and specificity
• Align assay performance with regulatory expectations for clinical vector products
• Assess how rcAAV quantification influences safety margins and translational decision making
• Implement validation approaches that support reproducibility and batch to batch comparability