Key Findings
A peer-reviewed study published in Separation and Purification Technology reports that the PAK PD™ Process Development Scale Continuous Purification System can maintain reproducible AAV8 purification for 12 hours. The integrated process achieved a final full-capsid enrichment of 79%, starting from 34% after the initial affinity capture. Vector genome recovery from feed to final pool was 44%.
Technical Details
The research team, collaborating with iBET (Instituto de Biologia Experimental e Tecnológica), implemented a cyclic integrated capture–polishing chromatography workflow. The technical configuration included:
- Capture Stage: AAVX affinity capture using two alternating columns.
- Polishing Stage: Mustang® Q anion-exchange membrane polishing using two alternating columns.
- Automation: The PAK system coordinated column switching, inline dilution of capture eluate, and parallel transfer between stages.
- Impurity Reduction: dsDNA was reduced to below the assay detection limit after capture, and host cell protein was reduced to below the detection limit after polishing.
The final full-capsid content of 79% is consistent with the 68–81% range typically reported for batch anion-exchange polishing of AAV8.
Background and Context
As in vivo gene therapies move toward commercialization, higher dosing requirements necessitate increased throughput without sacrificing quality. While continuous operation has previously been limited to individual steps—typically pairing continuous capture with batch polishing—this study integrates both into a single continuous process. This builds on PAK BioSolutions’ previous work with monoclonal antibodies (mAbs), including a 14-day integrated run with AstraZeneca.
Significance and Outlook
The study demonstrates that batch AAV purification workflows can be translated into an integrated continuous format through defined process adaptation, without requiring bespoke system engineering. The PAK system architecture—spanning the PAK PD™, PAK Pilot™, and PAK K-Series™—allows these processes to transition from development to commercial manufacturing on the same technology platform.
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