Improved Capsid Purification in AAV Manufacturing

Aleš Štrancar, Sartorius BIA Separations


Adeno-associated virus (AAV) capsids are an effective mechanism for delivering gene therapies intended for therapeutic use. A critical production step is the separation of full capsids from empty ones, which are considered a product-related impurity in downstream processing. Partial and heavy AAV capsids in gene therapy products are problematic due to the potential carry-over of host cell DNA and plasmid DNA fragments. In large-scale vector manufacturing, separating full and empty AAV capsids requires high-resolution chromatography media and scale-to-scale reproducibility. To qualify chromatographic columns for separating capsids, it is important to use column release criteria that are based on the AAV elution profile.

In this GEN webinar, Dr. Aleš Štrancar will discuss various chromatographic methods to consistently separate empty, partial, and full capsids in large-scale AAV manufacturing. He will introduce the CIMmultus High Reproducibility columns by Sartorius BIA Separations, which have better resolution and use narrow acceptance criteria to ensure consistent results. These 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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