Acceleration of AAV Manufacturing Process Development by Using Fast USP and DSP At-Line Biochromatography Analytics

Aleš Štrancar, Managing Director, Sartorius BIA Separations

Adeno associated virus (AAV) is the leading vector in the field of gene therapy because of its low toxicity, good overall safety profile, and ability to maintain stable expression for long periods of time. It is therefore crucial to develop a robust and high efficiency platform for its manufacturing.

One of the key challenges in manufacturing viral vectors is to increase the ratio between empty and full capsids. The most efficient way is to design the USP to result in less than 10% of empty capsids. This can be realised by process optimisation using at-line biochromatography analytics to allow for analysis of the full and empty capsids ratio directly in the harvest.

The residual empty capsids can be further removed by polishing purification step using different anion exchange columns.

Fast and reliable at-line analytical methods to allow for process optimisation and assessing the purity of the final product using PATfix system will be presented.

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