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Researchers try to improve pharmaceutical production
Thursday, November 03, 2005

Research and development often are blamed for the high costs of new pharmaceuticals, but researchers at Duquesne University and 10 other universities say outmoded production methods also are major culprits.

Those universities have joined in a collaboration called the National Institute for Pharmaceutical Technology and Education that, in cooperation with the U.S. Food and Drug Administration, is seeking new sources of federal funding for pharmaceutical manufacturing research.

The universities, which include Rutgers, Purdue, Iowa, Maryland and Minnesota, are announcing the new partnership this morning in Washington, D.C.

Last year, the FDA reported that the cost of bringing a new drug to market had increased 50 percent over a five-year period to as high as $1.7 billion. The reasons for that jump are complex, said Michael J. Pikal, a pharmaceutical technology professor at the University of Connecticut, but manufacturing is one component.

"The industry uses the most sophisticated research tools to discover new drugs," he said in a statement, "but the actual development and manufacturing of these pharmaceuticals is very inefficient."

Pharmaceutical production methods are heavily regulated by the FDA and that's understandable, said James K. Drennen III, division head of pharmaceutical sciences at Duquesne's Mylan School of Pharmacy.

"But that has maybe slowed the pace of innovation," he added. "We haven't kept pace with many other industries."

Officials of the new organization, which initially is focused on lobbying Congress for funding, say a better understanding of the physics and chemistry that underlie drug production is needed so that new technologies can be introduced.

Each of the universities will host centers of excellence that support this effort. Duquesne will focus on "process analytical technology" that can improve the monitoring and control of production processes.

Near-infrared spectroscopy, for instance, uses laser light to continuously scan materials as they are being processed into drugs, analyzing their chemical and physical properties. Among other things, that makes it possible to ship drugs immediately once they have been produced, rather than wait for laboratory testing to confirm that the drugs meet specifications, Dr. Drennen said.

The technology already is being installed in many plants, he added, but a better understanding of drug production processes could identify additional applications for the technology.

First published on November 3, 2005 at 12:00 am
Post-Gazette science editor Byron Spice can be reached at bspice@post-gazette.com or 412-263-1578.
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