High Reproducibility, Homogeneity, and Scalability of CIM® QA HR Chromatographic Monoliths Demonstrated by Separation of Empty and Full AAV Capsids

Quaternary amine (QA) modified monolithic columns are frequently used for purification of therapeutically relevant adeno-associated virus (AAV) vectors, used in gene therapy. Beside process- and sample-derived variability, chromatographic material variability can influence the efficiency and scalability of AAV downstream processing. This study presents the high reproducibility, homogeneity, and scalability of CIM QA HR chromatographic monoliths by implementing a chromatographic AAV2/8 empty-full separation method as one of column release test methods in the production of CIMmultus® QA HR monolithic line.

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