List of Quality Analysis

Our comprehensive testing services cover a wide range of areas for gene therapy products such as AAV vectors and lentiviruses, from routine testing to physicochemical characterization including ultracentrifugation analysis and mass spectrometry. Method development experts will create the optimal analytical method for your samples. We also have a proven track record in reliability standard testing and plan to commence GMP-compliant testing in fiscal year 2025.

AAV Quality Analysis Checklist
Category	Item	Method
General Examination	Visual inspection	visual inspection
	pH	pH meter
	Osmotic pressure	Osmometer
	Sampling Capacity Test	Analytical balance
	Insoluble particles	LO、FIA
Purity	Full/Empty particle ratio	SV-AUC、MP
	VP Purity/VP Ratio	CE-SDS、SDS-PAGE
	Aggregate	SEC、DLS
	Post-translation modification	Peptide mapping
	Surfactant concentration	UHPLC
Identity	Genome identity	CE-LIF、dPCR
	Capsid identity	Intact MS
	Capsid identity	Peptide mapping
Impurities	Host-derived protein	ELISA
	Residual Benzonazole	ELISA
	Host-derived DNA	qPCR
	Residual plasmid DNA	dPCR
	Residual TF Reagent	UHPLC
	Residual BSA	ELISA
Potency	Genome titer	dPCR
	Capsid titer	SV-AUC
	Gene expression	FCM
Safety	endotoxin	Colorimetric method

LO, Light obscuration; FIA, Flow imaging analysis; SV-AUC, Sedimentation velocity analytical ultracentrifugation; MP, Mass photometry; VP, viral protein; CE-SDS, Capillary electrophoresis sodium dodecyl sulfate; SDS-PAGE, Sodium dodecyl sulfate–polyacrylamide gel electrophoresis; SEC, Size exclusion chromatography; DLS, Dynamic light scattering; UHPLC, Ultra high performance liquid chromatography; CE-LIF, Capillary electrophoresis with laser induced fluorescence; dPCR, Digital polymerase chain reaction; ELISA, Enzyme-linked immunosorbent assay; qPCR, Quantitative polymerase chain reaction; TF, transfection; FCM, Flow cytometry.