Grants and Contracts Details
Description
The aging of the U.S. population and our increasing dependence on pharmaceutical
products to maintain health and reduce hospitalizations has become a major societal
concern, especially as the cost of drugs has become a greater burden for many
families. While governments can intervene in setting the price of drugs, this does not
change the cost to produce these live-saving therapies. It is incumbent upon our
society to explore all possible methods for lowering the cost of drugs for our citizens.
One of the reasons for high drug costs involves the current paradigm, dictated by a
strict regulatory climate, under which pharmaceutical products are manufactured. This
results in high failure rates of manufactured batches and high recall rates. Not only
does this drive up the cost of drug products, but it also eliminates some potentially lifesaving
therapies from reaching the market due to stability and manufacturability
concerns.
The Food and Drug Administration is beginning to address these issues with a new
initiative using a "risk-based approach" that employs the principles of Process Analytical
Technology. PAT involves the design of in-line, on-line or at-line sensors that operate
at critical points in a pharmaceutical manufacturing operation. These sensors will
markedly reduce the cost of producing pharmaceutical products by allowing
manufacturing activities to become decentralized. This will, in turn, allow for the
manufacture of "personalized medicines" and broaden the number of therapeutic agents
and drug delivery systems available for treating human disease by reducing stability and
scale-up concerns that might ordinarily prevent life-saving therapies from becoming
products.
The University of Kentucky proposes to develop a center that would contribute to sensor
research as well as address critical unmet needs of the FDA initiative: testbed facilities
for integrating sensor technology with lean manufacturing and visualization/virtual
environments. The team will include faculty members from various departments
(pharmaceutical sciences, chemistry, chemical engineering, electrical engineering, etc.)
as well as several Centers and research groups (University of Kentucky Center for
Pharmaceutical Science & Technology, Analytical Spectroscopy Research Group,
University of Kentucky Center for Computational Sciences, UK Mass Spectrometry
Facility, Center for Manufacturing, Center for Visualization and Virtual Environments).
The Center will be designed to complement existing research centers, federal funding
agencies, and industrial initiatives focused on modern manufacturing processes for the
pharmaceutical industry. Center facilities and programs will lead to the development of
new intellectual properties for Kentucky researchers, the creating of a new
pharmaceutical manufacturing industry, and educational opportunities for citizens of the
Commonwealth.
2
Status | Finished |
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Effective start/end date | 11/1/04 → 12/31/05 |
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