August 15, 2017

Authors:
Sanjay Konagurthu, Ph.D, Senior Director of PDS Global Science and Technology, Patheon
John W. Burke, Manager of Pharmaceutical Process Technologies, Steriles, Patheon

Regardless of whether your group has been diligently planning for scale-up since Phase I or you have delayed scale-up work until now, it would be a mistake to assume Phase III will be clear sailing. The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process development teams may be.