A new approach for high-resolution full and empty AAV capsid analysis utilizing a high-throughput method for comprehensive AAV evaluation on a single CE platform

To ensure the safety and efficacy of gene therapies delivered by adeno-associated virus (AAV) vectors, multiple critical quality attributes (CQAs) must be well characterized before regulatory submission. Different analytical platforms are currently being used to characterize multiple CQAs. However, these methods have limitations or cannot be used to analyze all serotypes without significant optimization. In this technical note, we present an approach for high-throughput multiple CQA analysis of AAVs using a single platform: the multi-capillary BioPhase 8800 system. High-accuracy analytical data were collected in a single day for multiple CQAs, including nucleic acid loading and titer, capsid protein profile and ratio, and capsid titer from the same samples.

Key features of the comprehensive AAV characterization workflow

High-definition full, partial, and empty analysis is accomplished with a new methodology
High-throughput, comprehensive analysis of multiple CQAs for the same AAV sample is performed on a single platform within a single day
High-resolution, serotype-independent capsid profile, ratio, and impurity analyses, and titer determination are achieved with a CE-SDS-LIF workflow

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