
Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perform process development in silico? Do I need to be a math expert? Where is modeling applicable? Will I not set foot in the lab ever again?
Nora Ketterer, Manager of Modeling Services, Cytiva, explains how to perform in silico process development and comments on the application of mechanistic modeling.






