ArticleMolecular therapy. Methods & clinical development2021
Development of a scalable and robust AEX method for enriched rAAV preparations in genome-containing VCs of serotypes 5, 6, 8, and 9.
Article in Molecular therapy. Methods & clinical development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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Who cites it
33 citing papers in PubMed.
- Viral gene replication enhances AAV vector quality and reduces manufacturing costs.Molecular therapy : the journal of the American Society of Gene Therapy · 2026Article
- Anion-Exchange Membrane Chromatography for the Separation of Empty and Full Adeno-Associated Viral Capsids.Biotechnology journal · 2026Article
- Optimization and scale up strategies for reproducible AAV enrichment step on CIMmultusGene therapy · 2026Article
- Mechanistic Insights into AAV Capsid-Stationary Phase Interactions Governing Native Stability and Chromatographic Separation Using AAV8 as a Model System.Pharmaceutics · 2026Article
- A two-pass anion-exchange chromatography strategy for enrichment of full capsids in manufacturing of adeno-associated viral vectors.Molecular therapy. Methods & clinical development · 2025Article
- AAVone: A cost-effective, single-plasmid solution for efficient AAV production with reduced DNA impurities.Molecular therapy. Nucleic acids · 2025Article
- Tracking Particle-Encapsulated DNA Across the Anion-Exchange Chromatography Fractions of Recombinant Adeno-Associated Virus Using Droplet Digital PCR and High-Throughput Sequencing.Biotechnology journal · 2025Article
- Chromatography in Downstream Processing of Recombinant Adeno-Associated Viruses: A Review of Current and Future Practises.Biotechnology and bioengineering · 2025Review
- Rapid At-Line AAVX Affinity HPLC: Enabling Process Analytical Technology for Bioprocess Development of Adeno-Associated Virus Vectors.Biotechnology journal · 2025Article
- Development and Validation of AAV Capsids Separation on Specimen Columns for Reproducibility Evaluation of Large-Scale Chromatographic Monoliths.Journal of separation science · 2025Article
- Consecutive Affinity and Ion-Exchange Chromatography for AAV9 Vectors Purification.Biomedicines · 2025Article
- Application of aqueous two-phase extraction for separation and purification of various adeno-associated viruses.Biotechnology letters · 2025Article
- Recent Advances in Therapeutics and Manufacturing Processes of Recombinant Adeno-Associated Virus for the Treatment of Lung Diseases.Current gene therapy · 2025Review
- Structural Changes Likely Cause Chemical Differences between Empty and Full AAV Capsids.Biomedicines · 2024Article
- Efficient AAV9 Purification Using a Single-Step AAV9 Magnetic Affinity Beads Isolation.International journal of molecular sciences · 2024Article
- Analytical characterization of full, intermediate, and empty AAV capsids.Gene therapy · 2024Article
- Stimulus-responsive assembly of nonviral nucleocapsids.Nature communications · 2024Article
- Recombinant AAV genome size effect on viral vector production, purification, and thermostability.Molecular therapy. Methods & clinical development · 2024Article
- Article
- Recombinant AAV Purification.Methods in molecular biology (Clifton, N.J.) · 2024Article
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6 authors.
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Abstract
Removal of empty capsids from adeno-associated virus (AAV) manufacturing lots remains a critical step in the downstream processing of AAV clinical-grade batches. Because of similar physico-chemical characteristics, the AAV capsid populations totally lacking or containing partial viral DNA are difficult to separate from the desired vector capsid populations. Based on minute differences in density, ultracentrifugation remains the most effective separation method and has been extensively used at small scale but has limitations associated with availabilities and operational complexities in large-scale processing. In this paper, we report a scalable, robust, and versatile anion-exchange chromatography (AEX) method for removing empty capsids and subsequent enrichment of vectors of AAV serotypes 5, 6, 8, and 9. On average, AEX resulted in about 9-fold enrichment of AAV5 in a single step containing 80% ± 5% genome-containing vector capsids, as verified and quantified by analytical ultracentrifugation. The optimized process was further validated using AAV6, AAV8, and AAV9, resulting in over 90% vector enrichment. The AEX process showed comparable results not only for vectors with different transgenes of different sizes but also for AEX runs under different geometries of chromatographic media. The herein-reported sulfate-salt-based AEX process can be adapted to different AAV serotypes by appropriately adjusting elution conditions to achieve enriched vector preparations.
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