In-Line and On-Line Monitoring of CQAs for Biologics, Vaccines and Gene Vectors

Rapid process development, scale-up and production of novel complex drugs require advanced PAT tools, capable of providing timely feedback on product CQAs. Real-time multi-angle light scattering (RT-MALS) monitors key biophysical product attributes including molar mass, particle size and particle concentration. These attributes are used to confirm product identity, estimate aggregate content, discriminate product from impurities and quantify titer of viral vectors. For small gene vectors such as AAV, RT-MALS also monitors empty-full ratio and empty and full titer.

The technology operates in-line or on-line with downstream unit operations such as chromatographic purification, polishing, UF/DF or homogenization, providing CQAs with response times of seconds to tens of seconds, hence enabling real-time process control as well as quality monitoring and feed-forward data. This webcast will review the principles, capabilities and limitations of RT-MALS, and then present case studies covering downstream processing of viral vectors, proteins, polysaccharides and lipid nanoparticles.