Over the past decade, the pharmaceutical industry has experienced several important changes in its business environment that are driving efforts to reduce overall cost while improving process understanding and product quality without the traditional end-of-manufacture quality testing.
In their article in the June AIChE Journal, “Perspectives on the Continuous Manufacturing of Powder-Based Pharmaceutical Processes,” Marianthi Ierapetritou and Fernando Muzzio, both from Rutgers Univ., and Gintaras Reklaitis from Purdue Univ., discuss the changing pharmaceutical industry and the potential benefits of continuous manufacturing.
Several factors are driving changes in the pharmaceutical industry:
• Currently, 75% of total pharmaceutical sales occur in the developed economies. Demand in these markets will grow slowly over the next 5–10 years, while growth in developing economies will be much higher. Developing markets, however, do not recognize patent protection, so companies require a different business model than they employ in developed regions.
• The life cycle of pharmaceutical products, which spans discovery, development, clinical testing, and manufacturing, is heavily regulated by government agencies, such as the U.S. Food and Drug...
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