RT-MALS: Real-Time Process Analytics And Control For Vaccine Nanoparticles and Macromolecules

By Daniel Some, Ph.D., Wyatt Technology Corporation

Analytical techniques combining multi-angle light scattering with size-exclusion chromatography (SEC-MALS) or field-flow fractionation (FFF-MALS) are widely applied in product and process development of many vaccine classes, including the recently developed mRNA-based vaccines. These techniques quantify essential product attributes.

Real-time MALS (RT-MALS) represents a new paradigm in PAT: instead of process parameters, it directly monitors product attributes. Implementation of RT-MALS promises to speed up process development and scale-up, increase yield during production and enhance end-product quality.