Advances in Downstream PAT for Biologics, Vaccines and Gene Vectors

Dan Some

Presented by: Dan Some, Ph.D., Wyatt Technology
Presented Live: August 23, 2022

Rapid process development and scale-up of novel complex drugs, as well as reliable unit operations during commercial production, require advanced PAT tools, capable of providing timely feedback on product attributes. Real-time multi-angle light scattering (RT-MALS) facilitates PAT for biologics, vaccines and gene vectors. It determines key biophysical product attributes, including molar mass, particle size and particle concentration. These attributes are further indicative of quality attributes such as titer, aggregation and full-empty ratio, and may be used for process control as well as quality monitoring.

This webcast reviews the principles, capabilities and limitations of RT-MALS, and then presents case studies covering downstream processing (DSP) of viral vectors, proteins and polysaccharides, as well as formulation, production and purification of lipid nanoparticles.

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