The Race to Phase III: A Cautionary Tale of Scalability

When aggressive timelines are a “must,” it’s critical that companies don’t gloss over early-phase scale-up throughout the development process. The time and effort spent on risk assessments and thinking about scalability early on will pay dividends in the long run as the path toward regulatory approval is smoother.

Author: Anil Kane, PhD, Executive Director and Global Head of Technical & Scientific Affairs, Patheon, by Thermo Fisher Scientific