Manufacturing Process Scale-up for Phase III: Clear Sailing or Storms Ahead?
Author: Sanjay Konagurthu, Ph.D, Senior Director of PDS Global Science and Technology, Patheon John W. Burke, Manager of Pharmaceutical Process Technologies, Steriles, Patheon
Tuesday, August 15, 2017
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.
Download our whitepaper and read about some factors that pharmaceutical companies of all sizes and experience levels must consider to ensure their formulations are successful during larger-scale manufacturing.
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