Chromatographic Modalities, Buffer Selection and Other Considerations for Enrichment of AAV Product

Rok Žigon, Head of Product-Application Area (AAV|Adeno), Process Development Viruses

Adeno-associated virus (AAV) is go-to vector for gene therapy treatments. In each AAV downstream process, one of the key and often a bottleneck step is enrichment of full capsids.  Along with scalability and capsid’s separation challenges one must account for sample heterogeneity and asses which analytics are adequate to distinguish between AAV sub-populations to deliver only the potent AAV product.
Chromatography on monolith columns offers efficient and scalable downstream processes.  Case study using Design-of-experiment approach of buffer selection and robust preparation for improved separation of empty and full capsids will be presented along with paramount considerations for scaling up. In addition, residual host cell proteins, host cell DNA, plasmid DNA, and endotoxin removal efficiency will be discussed.

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