New Empty|Full AAV Method Supported With Novel CIMmultus HR Columns to Enable Robust Manufacturing of AAV Products

Aleš Štrancar, Sartorius BIA Separations

Separation of empty and full AAV capsids with almost same chromatographic characteristic request very high-resolution chromatography media and scale-to scale reproducibility within just few percent. Qualification of chromatographic columns using small molecules might be misleading when separation of big molecules or virus particles is in question. Column release criteria based on the AAV elution profile therefore needs to be adopted and used for all column sizes. Recently the presence of partial and heavy AAV capsids in gene therapy products gathered more attention due to potential carry-over of the hcDNA and plasmid DNA fragments. Their removal from the product is therefore becoming crucial. To address the recent needs Sartorius BIA Separations developed new CIMmultus HR line (HR stands for High Reproducibility) columns with better resolution and narrower acceptance criteria. These columns allow for batch-to-batch and scale-to-scale reproducibility within just 3% of the AAV8 empty capsid isoconductivity elution. Such columns allow for step gradient elution using the same buffer strength at any scale. Two order of magnitude removal of empty capsid should be possible at any scale.

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