Improved Separation of AAV Capsids using AEX Chromatography

Strong anion exchange (AEX) chromatography is commonly used for separation of AAV capsids. The gold standard for target entities elution in ion exchange (IEX) chromatography is using an increasing salt gradient or an increasing or decreasing pH gradient, typically in a linear mode. Although AEX chromatography is a powerful tool in many manufacturing processes, it sometimes reaches its limits in purifying and separating complex samples comprising different AAV capsids or product related impurities such as empty, partially filled, overfilled AAV capsids, or aggregates.

Recently, Sartorius BIA Separations (Slovenia) has developed new high-resolution strategies to more selectively separate not only empty and full but also other product related impurities. As part of well known liquid chromatography, these strategies are, in contrast to some recently developed innovative techniques, robust and scalable to a preparative scale. Together with the new CIM QA HR column line, new AEX methods represent a powerful tool to meet increasingly stringent safety and efficacy criteria for the final AAV products.