Titer alone does not describe what is inside the capsids, whether the particles are intact, or what else is in the tube. A preparation can have an acceptable qPCR titer and still carry empty or partial capsids, aggregates, truncated genomes, or an impurity signal that only matters in vivo.

No single method resolves this. Orthogonal methods are usually needed.

This guide maps AAV QC methods onto the FDA critical quality attributes: identity, purity, product strength, potency, safety, and stability. It covers what a method measures, why it matters, what it can and cannot assess, and how Vector Biolabs runs it.

Whole-plasmid sequencing, qPCR, Stunner particle analysis, and SDS-PAGE form the standard layer. Viral genome sequencing, dPCR, TEM, AUC, ES-DMA, and LAL endotoxin testing cover genome integrity, titer, particle morphology, aggregation, capsid composition, and endotoxin burden. A closing table pairs every method with the failure mode it detects.

Download this 19-page practical guide, written for anyone who designs, manufactures, orders, or uses AAV vectors.