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New pharmaceutical facility is “Factory of the Future”
LEXINGTON, Ky. (May 1, 2006) − The University of Kentucky’s new $17 million Center for Pharmaceutical Science & Technology facility was officially unveiled today in a ceremony led by Gov. Ernie Fletcher, Lexington mayor Teresa Isaac and UK president Lee T. Todd, Jr.
The 20,000 square-foot building is the largest sterile pharmaceutical manufacturing facility in Kentucky. Located at the UK Coldstream Research Campus in Lexington, the new CPST facility will provide analysis, formulation and manufacturing of sterile drug products for early phase clinical trials. It will be staffed by 25 professionals with experience in the global pharmaceutical industry who bring expertise in the technical and engineering aspects of pharmaceutical manufacturing, as well as in the regulatory and scientific realms.
“With the opening of CPST, Coldstream Research Campus and the Commonwealth are about to enter a new economic era,” said UK president Lee T. Todd, Jr. “This state-of-the-art facility will be a boon to Kentucky’s pharmaceutical and biotech industries, creating the type of knowledge-based jobs, innovations and opportunities that will allow this state to compete in the global economy.”
“Because of our uniqueness, customers will come to us,” said CPST managing director Frank Manella. “The CPST also will be a magnet that draws a variety of health care companies to the area.”
The new CPST facility will be unique among others worldwide as it becomes the first pharmaceutical manufacturing facility to produce cytotoxic and non-cytotoxic drugs in the same room at the same time.
Current pharmaceutical industry practice dictates separating cytotoxic and non-cytotoxic drug manufacturing by entire buildings. By using custom-made mobile isolators, the new facility will be able to manufacture potent and more conventional drugs in the same room at the same time, revolutionizing the industry and making classical cleanroom processing obsolete. These isolators will allow CPST scientists to quickly switch from one project to another, eliminating the risks of cross-contamination.
Other features of the new facility include the ability to manufacture sterile liquids for injection and the capability to freeze dry injectables, a service rarely found outside of large pharmaceutical companies.
The new facility is an expansion of the CPST in the University of Kentucky College of Pharmacy, which is home to an FDA-registered pharmaceutical manufacturing facility utilizing current Good Manufacturing Practices to produce oral and topical products. The on-campus location of the CPST provides analytical method development and validation, pre-formulation studies, formulation development, manufacturing process development, manufacturing for animal studies and human clinical studies, ICH stability studies, API manufacturing and pharmacokinetic analysis.
The new facility is viewed as a “business incubator” because it has significant potential to draw pharmaceutical and biotech industries to central Kentucky to build new manufacturing facilities and supporting services, leading to the economic growth of the Commonwealth.
“When the General Assembly approved higher education reform in 1997, UK was asked to use its research capabilities to drive Kentucky into the world economy,” Todd said. “CPST is precisely the type of facility that will help us – and our talented faculty and staff at the College of Pharmacy – do that.”
“The CPST will have trained personnel and an infrastructure to help businesses build new companies here,” said CPST operations manager Mark Gilbert.
By the year 2011, annual revenue forecasts predict the CPST operation will bring in $15 million and employ up to 100 scientists, engineers and professional staff at yearly earnings ranging from $50,000 to $150,000.
“The cascade effect on the local economy and increase in prestige for the Commonwealth, university and college will clearly show a wise investment on the part of the university and the Commonwealth,” Manella said.
Lexington is the eighth most highly educated city in the nation, according to 2000 U.S. Census data. In each of the past two years, Forbes magazine ranked Lexington among the top cities in America to locate a business.