How early Phase I decisions can shape or compromise the regulatory and financing outcomes that define a biotech program's future.
News|Articles|September 2, 2026
Viral Vector Quality: No Estimates. Only Evidence
Author(s)Waters Corporation
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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.
Move beyond inferred measurements and gain direct insight into the viral vector quality attributes that drive efficacy, safety, and manufacturing confidence.
AAV quality depends on more than viral titer alone. Capsid occupancy, aggregation, genome integrity, and product heterogeneity all impact therapeutic performance and regulatory readiness. Explore how CDMS and MALS help scientists generate direct, defensible evidence to support development, manufacturing, and QC decisions.
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