Comparability of 5 Alternative AAV9 Downstream Processes from Ultracentrifugation to Chromatography

Improved analytical methods are helping improve the understanding of capsid heterogeneity in adeno-associated virus (AAV) therapeutic preparations. This understanding allows the development of manufacturing processes that produce AAV therapeutics with fewer non-functional capsids.
In this video, the speakers will present the results of a five-arm AAV9 comparability protocol that includes four alternative two-column downstream processes at 50-L scale and an ultracentrifugation (UC) process at 200-L scale. The UC process is the gold standard for functional capsid purification.
The expert speakers will outline simplified processes for both the capture and the empty/full (E/F) separation steps, including various combinations of cation exchange chromatography (CEX) and anion exchange chromatography (AEX) monoliths with different gradient types, as well as a process using an affinity resin and AEX monolith.
The speakers will also cover the analytical comparability of the drug substance lots, assessment of vector yields, host-cell proteins, plasmid and host-cell deoxyribonucleic acid (DNA) levels; capsid content by sedimentation-velocity analytical UC, charge detection mass spectrometry and mass photometry; vector protein purity by capillary electrophoresis; aggregation by size-exclusion chromatography; vector DNA purity by next-generation sequencing; potency by in vitro enhanced green fluorescent protein (eGFP) expression tests; and capsid protein charge heterogeneity and intact-capsid isoelectric point (pI) by capillary isoelectric focusing.
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