Biologics, vaccines, and gene therapies are emerging as novel pharmaceutical modalities. These products contain complex macromolecules such as proteins, polysaccharides, lipid nanoparticles, and viral vectors. Biophysical attributes of these molecules, such as molar mass, particle size, and particle concentration, inform product critical quality attributes (CQAs).
Light-scattering analysis following downstream operations, such as chromatographic purification and polishing, can rapidly provide CQAs, enabling process control and quality monitoring in real time. This webcast will review the principles, capabilities and limitations of real-time multi-angle light scattering (RT-MALS), and then present case studies covering downstream processing of viral vectors, proteins, polysaccharides and lipid nanoparticles.
Key Learning Objectives:
- The capabilities of multi-angle light scattering for in-process, real-time analytics
- How RT-MALS integrates with various downstream unit operations to provide deep process knowledge and rapid process optimization
- The benefits of timely feedback on relevant product attributes and CQAs for controlling the recovery and purification of biologics and gene vectors
Who Should Attend:
- Downstream process development scientists who wish to accelerate process development
- PAT SMEs looking for in-line and on-line analytical technologies to monitor biopharmaceutical product attributes, control downstream processing, optimize yield and maintain quality