By Will McElroy and Chris Heger, Ph.D.
Adeno-associated viruses (AAV) are promising vectors for the delivery of genetic material in gene therapy. During the manufacture of AAV, critical quality attributes (CQAs) like charge heterogeneity, purity, and empty/full status must be carefully monitored because they can impact the product’s safety and efficacy. Imaged capillary isoelectric focusing (icIEF) and capillary electrophoresis sodium dodecyl sulfate (CE-SDS) are two powerful methods to respectively characterize and quantitate charge heterogeneity and purity, but, traditionally, two separate platforms are required to perform these analyses. Here, we used a single Maurice platform to analyze AAVs by icIEF and CE-SDS methods to ensure product stability, identity, and purity. In addition, we show that the icIEF mode on Maurice, coupled with dual wavelength detection, affords insights into the empty/full status of AAVs. Taken together, the poster will show that Maurice is a powerful fully integrated analytical tool for gene therapy development.