{"id":1938,"date":"2025-12-03T13:36:47","date_gmt":"2025-12-03T13:36:47","guid":{"rendered":"https:\/\/www.chromacon.com\/?post_type=application&p=1938"},"modified":"2026-05-10T16:11:15","modified_gmt":"2026-05-10T14:11:15","slug":"aav-gene-therapy","status":"publish","type":"application","link":"https:\/\/www.chromacon.com\/en\/applications\/aav-gene-therapy\/","title":{"rendered":"Viral Vectors (AAV)"},"content":{"rendered":"
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\n GENE THERAPY <\/p>\n \n

\n Separate Empty and Full AAV<\/strong> Capsids with MCSGP \u2014 Gene Therapy Manufacturing.\n <\/h1>\n \n
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Continuous AIEX polishing for full capsids. Recover the full capsids that batch AIEX discards in the side-cut. Published on AAV2 by two independent research groups: 5\u00d7<\/strong> Higher full capsid yield | 2.5\u00d7<\/strong> Productivity | 3\u00d7<\/strong> Lower process mass intensity. Develop on the Contichrom\u00ae CUBE; manufacture on the TWIN LPLC.<\/p>\n

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M\u00fcller et al., Biotechnol. Bioeng., 2025; Grob et al., J. Chromatogr. A,\u00a0 2025 (independent AAV2 AEX studies)<\/em><\/strong><\/p>\n

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\n Talk to Our Gene Therapy Specialists<\/span><\/a><\/span> <\/div>\n
\n Read the Latest AAV2 Paper<\/span><\/a><\/span> <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n
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\n Talk to Our Gene Therapy Specialists<\/span><\/a><\/span> <\/div>\n
\n Read the Latest AAV2 Paper<\/span><\/a><\/span> <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n
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\n The AAV Downstream Bottleneck: Empty Capsids <\/h2>\n \n
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Adeno-associated virus (AAV) is the leading vector platform in gene therapy \u2014 with multiple approved products (Luxturna\u00ae, Zolgensma\u00ae, Hemgenix\u00ae, Roctavian\u00ae, Elevidys\u00ae) and over 130 clinical trials underway. But manufacturing recombinant AAV at the yields and quality needed for clinical and commercial supply remains a defining challenge.<\/p>\n

A critical problem is the high proportion of empty capsids<\/strong> in every AAV harvest. Empty capsids \u2014 identical in size and shape to full, genome-containing capsids but lacking therapeutic DNA \u2014 routinely comprise 50\u201395% of total viral particles in crude material. They are therapeutically inactive and at high levels may trigger immune responses and increase patient dosing burden.<\/p>\n

Empty and full AAV capsids are near-identical in size and surface chemistry, differing only slightly in isoelectric point \u2014 meaning they co-elute across a narrow, overlapping zone in anion exchange chromatography. Full capsid yield using Batch AEX chromatography can be very low, leaving much room for optimization of the polishing step.<\/p>\n <\/div>\n \n <\/div>\n\n

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\n The Solution: MCSGP with AutoPeak\u00ae for AAV Full Capsid Enrichment <\/h2>\n \n
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MCSGP (Multi-column Countercurrent Solvent Gradient Purification) resolves the yield-purity trade-off that makes batch AEX polishing of AAV so wasteful. Two identical columns operate in a continuous countercurrent mode \u2014 recycling the overlapping empty\/full capsid fractions that batch chromatography discards. The process uses the same AEX resins, buffers, and gradient conditions<\/strong> as your existing batch AAV method \u2014 these conditions are the starting point for MCSGP process development.<\/p>\n

AutoPeak\u00ae dynamic process control monitors the AAV elution profile in real-time via the UV260\/280 absorbance ratio \u2014 a reliable online indicator of the empty\/full capsid transition zone \u2014 automatically adjusting the recycling and collection windows to maintain robust, unattended full-capsid enrichment.<\/p>\n

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Same resin. Same buffers. Superior performance.<\/strong> MCSGP works with the AEX resins and gradient methods already validated for your AAV serotype \u2014 Capto Q, POROS HQ, Fractogel TMAE, or others. The online UV260\/280 ratio provides a reagent-free PAT signal for the empty\/full transition, enabling AutoPeak\u00ae to deliver consistent full-capsid enrichment run-to-run, even as upstream empty\/full ratios fluctuate.<\/p>\n<\/blockquote>\n <\/div>\n \n Learn About MCSGP + AutoPeak\u00ae<\/span><\/a><\/span> <\/div>\n\n

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Proven Results: MCSGP vs. Batch for AAV Empty\/Full Capsid Separation<\/h2>\n\n\n\n
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\n 5\u00d7 <\/h2>\n \n

\n Higher Full Capsid Yield <\/p>\n \n \n <\/div>\n\n<\/div>\n\n <\/div><\/section><\/div>\n\n\n\n

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\n 2.5\u00d7 <\/h2>\n \n

\n Higher Productivity
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\n 3\u00d7 <\/h2>\n \n

\n Lower Process Mass Intensity (PMI)
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\n 30% \u2192 68% <\/h3>\n \n

\n Full Capsid Enrichment
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