Abstract
Herein we describe a platform method to study the charge heterogeneity of adeno-associated virus (AAV) capsid proteins. The method, based on imaged capillary isoelectric focusing (icIEF) with native fluorescence imaging detection, was validated, and can be used as an identity assay and stability indication assay. The protocol was also evaluated following the White Analytical Chemistry principle, its score is 89.7. The method is shown to be platform, with eight different AAV serotypes successfully analyzed. The resulting AAV serotype ‘fingerprints’ can be used for AAV identity and stability indication. • It is a platform method to study the charge heterogeneity of adeno-associated virus (AAV) capsid proteins. The method, based on imaged capillary isoelectric focusing (icIEF) with native fluorescence imaging detection, was validated, and evaluated as an identity assay and stability indication assay for AAVs of different serotypes. The score of the protocol is well balanced in the White Analytical Chemistry principle is 89.7. The method is shown to be platform, with eight different AAV serotypes successfully analyzed. The resulting AAV serotype ‘fingerprints’ (electropherograms) can be used for AAV identity and stability indicator
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