The Race To Phase III: A Cautionary Tale Of Scalability

By Anil Kane, Ph.D., Executive Director and Global Head of Technical & Scientific Affairs, Pharma Services, Thermo Fisher Scientific

As drug products move from preclinical through Phase IV development stages, clinical material demand grows tremendously. Production scale-up is rarely straightforward. Scaling up drug product manufacturing often requires time-consuming, expensive and unexpected challenge resolution.

How can firms mitigate risks and make scalability as smooth as possible? In this representative example, we follow the paths of two companies facing this challenge as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.