AAV empty capsids |
Ultracentrifugation; electron microscopy; spectrophotometry [32]; ion exchange chromatography [33] |
Immunotoxicity |
Encapsidated host cell nucleic acids (nuclease-resistant) |
qPCR using amplicons to generic host cell genome sequences |
Genotoxicity, Immunotoxicity |
qPCR using amplicons to specific sequences of concern (e.g., E1A) |
Encapsidated helper component DNA (nuclease-resistant) |
qPCR using amplicons for helper backbone sequences |
Genotoxicity, Immunotoxicity |
Replication-competent AAV |
Ad-dependent amplification |
Immunotoxicity |
Noninfectious AAV particles |
Ad-dependent infectivity in susceptible cells |
Immunotoxicity |
Other, including aggregated, degraded, and oxidized AAV vectors |
Various, including size exclusion chromatography; dynamic light scattering; electrophoresis, etc.
|
Immunotoxicity |