Manufacturing Process Scale-Up for Phase III: Clear Sailing or Storms Ahead?
Some drug developers diligently design scalability into their formulations from day one and are fully prepared for larger-scale production during Phase III. Essentially, their only remaining task in preparation for full-scale manufacturing is to file the necessary regulatory paperwork and move forward. Unfortunately, more often than not, problems inevitably surface in Phase III that can be difficult to predict, regardless of whether the project involves tablets, vials or another delivery format.
Download this whitepaper to learn how building scalability into formulation throughout drug development, as well as transferring the project to a knowledgeable CDMO in Phase III, can help mitigate some of the challenges that arise in Phase III. Click here.
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