The only constant in today’s world is change, and this could not be truer for the current state of pharmaceutical manufacturing. “Right now the manufacturing experts from the 1950s would easily recognize processes today. In 25 years these same processes will be obsolete,” said Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration in her keynote address at the AAPS annual conference in 2011. Continuous manufacturing will be a significant component in the future of pharmaceutical manufacturing.
The advantages of continuous manufacturing over batch manufacturing are well established. When properly implemented, continuous processes are almost completely steady, can be designed at scale, and can be used reliably to minimize segregation and agglomeration of ingredients. Moreover, a continuous process is also the perfect scenario for implementation of Process Analytical Technology (PAT) methods, which are required to ensure closed-loop control of the continuous process. The business case for continuous manufacturing is very robust. In product development, continuous manufacturing systems allow the user to perform complex DOE matrices in just a few days, and using a tiny fraction of the material required to perform a comparable study in batch mode [1] [2], thus enabling enormous savings in labor, analytical costs and capital [2].
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