Separation of empty and full AAV capsids with almost identical chromatographic characteristics requires 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 large molecules or virus particles is in question. Column release criteria based on the AAV elution profile therefore need to be adopted and used for all column sizes.
Recently, the presence of partial and heavy AAV capsids in gene therapy products has attracted more attention due to potential carry-over of the host cell (hc)DNA and plasmid DNA fragments. Their removal from the product is therefore becoming crucial.
To address this important need, Sartorius BIA Separations developed the new CIMmultus HR (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 orders of magnitude removal of empty capsid should be possible at any scale.
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