[Development and validation of an anion-exchange high-performance liquid chromatography method for determining the empty-to-full capsid ratio in recombinant adeno-associated virus].

=0.156). The AEX-HPLC method established in this study has been fully validated, and all performance indicators meet the requirements for the quality control of rAAV empty-to-full capsid ratio. The method can be directly applied to the detection of the empty-to-full capsid ratio in marketed rAAV drugs. The results obtained by this method are consistent with those obtained by the gold standard AUC method, demonstrating reliable accuracy. By virtue of its charge separation principle, the method possesses unique detection advantages and is simple to operate. Furthermore, it overcomes the limitations of the AUC method, such as high equipment cost, low detection throughput, time-consuming detection, and limited accessibility. It is suitable for the detection of rAAV drug intermediates and the release of final products, and holds significant practical value for promoting the establishment of the quality control system for rAAV drug industrialization.