WP8007: RT-MALS − Real-time product attributes, from lab to plant

Process analytical technologies are a key enabler of QbD and Bioprocess 4.0. Implementation of light-scattering based PAT, in-line and on-line, shifts the focus of PAT from process parameters to product parameters and hints at a pathway to real-time release. This white paper reviews the context of multi-angle light scattering as an analytical technology for biopharmaceuticals and nanomedicines, and the presents the methods available for utilizing realtime MALS as a PAT tool from process development to scale-up and production.