From Process Development to Manufacturing: Optimize and Scale up the AAV Enrichment Step

Adeno-associated viruses (AAV) have emerged as leading vectors for gene therapy applications due to their low pathogenicity and ability to mediate long-term gene expression in a wide range of tissues. In each AAV downstream process, one of the key steps (and often a bottleneck) is enrichment of full capsids. Along with scalability and capsid separation challenges, one should account for sample heterogeneity and assess which analytics are adequate to distinguish between AAV sub-populations and deliver only the potent AAV product.
To address these needs, Sartorius BIA Separations developed new CIMmultus HR (High Reproducibility) line 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 iso-conductivity elution. Such columns allow for step gradient elution using the same buffer strength at any scale. Two order of magnitude removal of empty capsids should be possible.
A complete enrichment process design on AAV8 case study will be presented, starting from initial screening of conditions using 96-well plate or small monolithic columns, followed by the determination of column capacity, considerations for formation of step gradient, and finally a successful scale-up.
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