Efficient rAAV8 Capsid Quantification in Upstream Process Development With Two-Dimensional Liquid Chromatography

Obtaining a high concentration and a significant proportion of full recombinant adeno-associated viruses (rAAV) capsids during production is important for the success of the entire AAV bioprocess. Analyzing complex upstream samples is challenging and typically involves a combination of analytical methodologies, such as PCR and ELISA. However, this approach is known for being time-consuming and frequently prone to higher standard deviations. To overcome these limitations, the PATfix® AAV Switcher, an automated two-column analytical device, was developed.

The PATfix AAV Switcher system enables rapid and accurate detection of rAAV empty (E) and full (F) capsids in harvest samples. The method showcased in this poster efficiently binds and polishes rAAV8 on the CIMac SO3 1 mL column, before directing it to the CIMac QA HR 0.1 mL column where different capsid species are separated. The method relies on an innovative patent-pending baseline separation.

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