Viral Vector Quality: No Estimates. Only Evidence

Key Takeaways

• Viral titer alone can mask clinically relevant differences in empty/full ratios, fragmented genomes, and higher-order aggregates that influence potency, safety, and regulatory defensibility.
• Charge detection mass spectrometry provides direct capsid mass distributions, enabling streamlined characterization and relative quantitation of AAV subpopulations across development and QC workflows.
• Alignment with USP AAV8 reference standards supports method benchmarking, comparability claims, and more reproducible interpretation of capsid occupancy profiles.
• SEC-MALS-UV-dRI offers quantitative aggregation and heterogeneity readouts, improving confidence in purity assessments and lot-to-lot consistency evaluations.
• RT-MALS enables in-line/at-line tracking of chromatographic enrichment, facilitating real-time monitoring and tighter control of manufacturing performance.