Knowledge Center

Article / Feb 25, 2016

Continuous Processing: Meeting the Need for New Manufacturing Strategies

Authors:
  • Filipe Gaspar
  • Marco Gil
  • Nuno Matos
Source:
Pharma鈥檚 Almanac, February 2016

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

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