Robust Adeno-Associated Virus Aggregate Analysis with Reduced Sample Consumption on BiozenTM dSEC-7 Size Exclusion Column Size Exclusion Chromatography (SEC) is widely accepted to separate adeno-associated virus (AAV) monomer from its aggregates but analysis with current SEC columns require high volume sample consumption and lack robustness. Herein, Biozen™ dSEC-7, a chromatographic (SEC) column, is described and tested for various AAV serotype aggregates. Its 700 Å pore size, inert particle chemistry, and applicable particle size(s) are found to enable highly reproducible baseline separation and recoveries of the AAV monomer and its aggregates, even amongst batches of columns, within 10 minutes. The percentage relative standard deviations of the peak area, retention time, and % monomer were all < 1="" %="" WITH="" AS="" LITTLE="" AS="" 0.5="" ΜL="" OF="" SAMPLE.="" THIS="" PERFORMANCE="" ENABLES="" FASTER="" AND="" MORE="" ACCURATE="" DETERMINATION="" OF="" AAV="" AGGREGATES,="" A="" CRITICAL="" QUALITY="" ATTRIBUTE="" (CQA)="" IN="" DRUG="" SUBSTANCES="" AND="" DRUG="" PRODUCTS,="" WITHOUT="" COMPROMISING="" DATA="" QUALITY.="" 1="" %="" WITH="" AS="" LITTLE="" AS="" 0.5="" ΜL="" OF="" SAMPLE.="" THIS="" PERFORMANCE="" ENABLES="" FASTER="" AND="" MORE="" ACCURATE="" DETERMINATION="" OF="" AAV="" AGGREGATES,="" A="" CRITICAL="" QUALITY="" ATTRIBUTE="" (CQA)="" IN="" DRUG="" SUBSTANCES="" AND="" DRUG="" PRODUCTS,="" WITHOUT="" COMPROMISING="" DATA="">
