Orthogonal Characterization of AAV Samples by Simultaneous Monitoring of Multiple Analytical Parameters During Chromatography

Fast, accurate, and meaningful characterization of cell culture harvests and in process samples is critical for both process development and for documentation of in process control. UV analysis of chromatography profiles has been a valuable tool for decades, but it has major limitations with respect to sensitivity and its ability to discriminate the product of interest from particular contaminant classes.

In this study we use filtered lysate containing AAV 8 to demonstrate the ability of a strong cation exchange monolith (CIMac SO3-0.1) coupled with multiple monitors to enable high sensitivity detection of AAV capsids while characterizing the relative distributions of DNA and protein contaminants. This approach can be used to evaluate cell culture methods, influence of harvest time, lysis methods, and effectivity of purification methods across a process.

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