Utilizing dynamic light scattering as a process analytical technology for protein folding and aggregation monitoring in vaccine manufacturing

The authors, of Sanofi Pasteur in Toronto, show how DLS may be used to monitor key quality parameters following processing steps in biotherapeutic production: dissolution of inclusion bodies, proper protein re-folding, and aggregation. For the conditions tested, DLS correlated well with SEC-MALS but was signficantly faster and easier to implement at the production line.

Yu, Z.; Reid, J. C.; Y.P. Yang, Y. P. Journal of Pharmaceutical Sciences  2013, 102, 4284-4290. doi:10.1002/jps.23746