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Scalable purification of full capsid AAV by chromatography.

Introducing a scalable AAV purification process and a method for separating full capsids and empty capsids using anion exchange chromatography.

Adeno-associated virus (AAV) is widely used as a vector for gene therapy. While it is often purified using ultracentrifugation at the lab scale, this method becomes difficult to scale up. A scalable method for purification is chromatography; however, separating full capsids (hereafter referred to as "full") that contain the genome from empty capsids (hereafter referred to as "empty") that do not contain the genome and do not contribute to titer has been challenging. When using AAV as a vector for gene therapy, it is desirable to remove empty capsids as much as possible due to their impact on titer and issues related to immunogenicity. This application note introduces a scalable AAV purification process and presents a method for separating empty and full capsids using anion exchange chromatography across multiple serotypes.

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