Manufacturing Process Scale-up for Phase III: Clear Sailing or Storms Ahead?
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.