AAV Analytics


Analytical characterization of AAV for clinical and commercial applications is rudimentary, although health authorities have been pushing sponsors to make these assays more discerning and robust. The Wilson lab has been at the forefront of this evolving story, driving the analytical and regulatory science. Examples include the development of digital PCR for assessment of genome titers and the definition of post-translational modifications and its analysis by mass spectrometry. The Wilson lab has provided analytical support to numerous alliance partners.

Specific AAV Analytic Services

Compendial Assays

Appearance

Osmolarity

pH

Titer

ddPCR

Biodistribution

Shedding

Mass Spectrometry

Serotype ID

PTMs

Transgene Expression

Host Cell Protein ID

Particle Characterization

% Full (AUC and Mass Photometry)

Sizing/aggregation (DLS and SEC-MALS)

Purity (SDS-PAGE and CE-SDS)

Cell-Based Potency

Expression (ELISA and in-cell Western)

Functional (various)

TCID50

Safety

rcAAV

Endotoxin

Residuals

Host Cell Protein

Host Cell DNA (E1A and 18S)

BSA

PEI

LDAO

SAN-HQ

Leached Affinity Ligand

KanR

Excipient Analysis

Magnesium Concentration

Calcium Concentration

Phosphate Concentration

P188 Concentration