Key Findings
The integrated continuous purification of adeno-associated virus serotype 8 (AAV8) achieved a final full-capsid enrichment of 79%, increasing from 34% after the initial affinity capture. Over 12 hours of reproducible, stable cycle-to-cycle operation, the process recovered 44% of vector genomes from feed to final pool. Impurity reduction was significant, with dsDNA reduced to below the assay detection limit after capture and host cell protein reduced to below the detection limit after polishing.
Technical Details
The study, published in Separation and Purification Technology, utilized the PAK PD™ Process Development Scale Continuous Purification System. The researchers implemented a cyclic integrated capture–polishing chromatography workflow combining AAVX affinity capture with Mustang® Q anion-exchange membrane polishing. The system employed two alternating columns at each step; while one column loaded, the other underwent elution and regeneration. Automation coordinated the column switching, inline dilution of the capture eluate, and the transfer to the polishing stage, allowing both steps to operate in parallel.
Background and Context
AAV vectors are critical for in vivo gene therapy, but increasing clinical adoption and higher dosing requirements have placed pressure on downstream processing. While process intensification has previously been limited to individual continuous steps paired with batch polishing, this study integrates both into a single continuous process. The final full-capsid content of 79% is consistent with the 68–81% range reported for batch anion-exchange polishing of AAV8.
Significance and Outlook
The results indicate that batch AAV purification workflows can be translated into an integrated continuous format through defined process adaptation without requiring bespoke system engineering. This builds on PAK BioSolutions’ previous work with monoclonal antibodies (mAbs), including a 14-day integrated continuous run with AstraZeneca. The technology is scalable across the PAK product line, from the benchtop PAK PD™ to the PAK Pilot™ and the commercial PAK K-Series™.
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