PAK BioSolutions, a Vienna, Virginia-based bioprocessing technology company, announced on October 20, 2026 the publication of a peer-reviewed study demonstrating continuous purification of adeno-associated virus serotype 8 (AAV8), a viral vector used in gene therapy. Conducted in collaboration with iBET – Instituto de Biologia Experimental e Tecnológica in Portugal, the research demonstrated 12 hours of stable operation using PAK’s PAK PD™ purification system, with final product pools reaching 79% full-capsid content.
“This study brings integrated, continuous downstream processing to AAV purification, helping gene therapy manufacturers move toward more efficient manufacturing strategies,” said Joanna Pezzini, CEO of PAK BioSolutions.
Integrating Two Purification Steps Into One Process
As gene therapies advance toward commercialization, manufacturers face growing demands to increase production while maintaining product quality.
Traditional AAV purification workflows often separate capture and polishing into individual steps. The study, titled Streamlining AAV8 Purification with Cyclic Integrated Capture–Polishing Chromatography, examined whether these stages could operate together continuously.
Researchers combined AAVX affinity capture with Mustang® Q anion-exchange membrane polishing, using alternating columns to allow simultaneous loading, elution, and regeneration. PAK’s automated system coordinated the process, enabling both purification stages to operate in parallel.
Study Demonstrates 79% Full-Capsid Content
During 12 hours of continuous operation, researchers reported several findings:
- Full-Capsid Enrichment: Increased from 34% after affinity capture to 79% in the final purified product pools.
- Vector Genome Recovery: Reached 44% from the initial feed through the final product.
- Impurity Reduction: Double-stranded DNA fell below detection limits after capture, while host cell proteins fell below detection limits after polishing.
The final 79% full-capsid content was within the 68%–81% range reported for established batch AAV8 purification processes.
The findings demonstrate the feasibility of combining multiple purification stages into a continuous process without requiring custom control development or specialized system engineering.
Expanding Continuous Manufacturing Applications
The research extends PAK BioSolutions’ published work beyond monoclonal antibodies into viral vectors used in gene therapy.
PAK systems previously supported a 14-day integrated continuous monoclonal antibody purification study with AstraZeneca in 2023. The company’s technology has also supported Good Manufacturing Practice (GMP) clinical manufacturing associated with a first-in-human clinical trial application.
The latest study, published in Separation and Purification Technology, demonstrates another potential application for continuous processing in biopharmaceutical manufacturing. However, the 12-hour study does not establish commercial-scale performance.
About PAK BioSolutions
PAK BioSolutions develops automated continuous purification systems for biopharmaceutical manufacturing. Its product portfolio includes PAK PD™ for process development, PAK Pilot™ for pilot and clinical production, and PAK K-Series™ for commercial manufacturing.
About iBET
iBET is a Portugal-based biotechnology research organization focused on biological process development and related technologies.
