Acceleration Of Method Optimization For AAV Capsid Purity Analysis Using Multi-Capillary Electrophoresis Platform

By Tingting Li and Sahana Mollah, Biopharma, SCIEX/Brea

Adeno associated viruses (AAV) are a popular viral vector in gene therapy and are composed of capsid proteins which have critical implications in the efficacy of the viral vector. A robust analytical method for assessing capsid purity that can provide reliable results in a timely fashion is desirable. CE-SDS (capillary electrophoresis sodium dodecyl sulfate) is a popular application technique for protein analysis, quantitation, and profiling in the biopharmaceutical industry because it offers high specificity, resolution, reproducibility and is automation-friendly. More specifically to AAV analysis, CE-SDS assay results are consistent across serotypes, an important quality to consider when parameters, such as temperature and sample buffer conditions, affect the stability and assembly of the capsid proteins.3,4 Method optimization for these studies was done using a single capillary format, which can limit throughput.

This technical note highlights how a multi-parameter approach using CE-SDS with laser-induced fluorescence detection (LIF) on BioPhase 8800 system can significantly expedite methods development and optimization of AAV capsid purity analysis and thus improve throughput.