Manufacturing Process Scale-Up For Phase III

By Sanjay Konagurthu, PhD, Senior Director, Science and Innovation, Thermo Fisher Scientific; John W. Burke, Manager of Pharmaceutical Process Technologies, Steriles, Thermo Fisher Scientific

Your compound has been progressing well through small-scale studies. The data collected in early trials suggest the formulation is safe and has great potential for improving its intended target condition. Critical make-or-break Phase III studies are on the horizon to demonstrate safety and efficacy in large numbers of patients. Is your team ready to manufacture larger batch sizes to support this endeavor? Possibly.