C&EN App Note
Real-time monitoring and control of viral vector purification

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Many gene therapies use viruses as vectors to carry genetic material. Processing of these products involves a purification step to gather full capsids, that contain the genetic material. Typically this purification and enrichment step involves chromatography monitored by UV-absorbance to assess quality. The absorbance measurement, however, 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.

Light-scattering analysis, connected in-line to bench-scale chromatography systems, can identify impurities and quantify attributes associated with safety, efficacy, and potency. This enables enables optimized control over the collection of purified product.

Key Objectives:
  • How real-time multi-angle light scattering (RT-MALS) determines empty and full adeno-associated virus (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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