A number of trends in the pharmaceutical industry are placing pressure on drug manufacturers to reduce both development times and costs.

Clinical trials have been typically on the critical path, and the CMC section had less time pressure and moved forward according to clinical trial results; new regulatory avenues have changed this. New manufacturing strategies are needed to overcome these issues. Continuous processing of both drug substances and formulated drug products is championed by the U.S. Food and Drug Administration (FDA) as an effective approach to addressing the need for increased efficiency and quality, and some may be better suited to changing paradigms.