Multi-angle light scattering (MALS) is primarily used with size-exclusion chromatography (SEC) or field-flow fractionation (FFF) to characterize macromolecules and nanoparticles in solution. SEC-MALS and FFF-MALS determine distributions of molecular weight (MW) and size (rms radius, Rg), which are key attributes determining the quality of advanced pharmaceuticals and biopharmaceuticals such as monoclonal antibodies, vaccines, gene vectors, and nanoformulations of small-molecule drugs. Currently, most process development and lot-release methodologies are based on offline analytics, wherein test samples are sent to a remote lab to measure MW and Rg post-process by SEC-MALS or FFF-MALS, inevitably leading to delays and increased costs.
This webcast introduces real-time MALS (RT-MALS), a novel process analytical technology that offers a first look at key quality attributes directly in the process stream. With RT-MALS, MW and Rg are measured to enable monitoring and control of the process according to actual product parameters, not just process parameters. RT-MALS can determine if an end point has been attained and the process is complete, or if the product deviates from acceptable criteria and the process must be terminated. In process development scenarios, RT-MALS provides immediate feedback on the impact of varying process parameters. This webcast will review the technology of RT-MALS, benefits and applications, and will feature case studies.
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