C&EN App Note
Real-time monitoring and control of AAV chromatographic enrichment with RT-MALS

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Downstream purification and enrichment of full AAV capsids for gene therapy products is typically accomplished by ion-exchange chromatography (IEX). While the UV260/UV280 ratio is often used to control pooling, it does not afford deep insight into accurate empty and full titers or discriminate desirable vectors from impurities. Only when detailed offline analysis of fractions is complete does that information make its way back to process developers or manufacturing teams.

Real-time multi-angle light scattering (RT-MALS) operates in-line with bench-scale FPLC systems to monitor and quantify critical quality attributes (CQA) and identify impurities. RT-MALS provides immediate results for CQA values and enables optimized control over collection of the purified product pool. In addition, with no additional effort, RT-MALS supports the acquisition of invaluable process knowledge.  

Key Objectives:
  • How RT-MALS determines empty and full AAV titers, in-line and in real time, while discriminating monomeric capsids from aggregates and impurities
  • How downstream process developers can use RT-MALS to optimize column loading and wash steps for viral vectors
  • How AAV elution behavior is monitored and optimized by RT-MALS, irrespective of serotype, column aging or buffer conditions
  • How RT-MALS may be utilized during polishing steps to ensure consistent pooling of optimally enriched product
  • Additional applications of RT-MALS for downstream processing of AAV

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Waters | Wyatt Technology
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