Unique sterile manufacturing facility opens in Kentucky
pharmaceutical manufacturing site which is unique among others
worldwide as it is the first to produce cytotoxic and non-cytotoxic
drugs in the same room at the same time.
The Centre for Pharmaceutical Science & Technology (CPST), a 20,000 square-foot building costing $17m (€13m), will provide analysis, formulation and manufacturing of sterile drug products for early phase clinical trials.
Current pharmaceutical industry practice dictates separating cytotoxic and non-cytotoxic drug manufacturing by entire buildings, however, by using custom-made mobile isolators, the CPST will be able to manufacture potent and more conventional drugs in the same room at the same time, making classical cleanroom processing obsolete.
These isolators will allow scientists to quickly switch from one project to another, eliminating the risks of cross-contamination.
Moreover, the facility can manufacture sterile liquids for injection and freeze dry injectables, a service rarely found outside of large pharmaceutical companies.
It is hoped the CPST will draw pharmaceutical and biotech industries to central Kentucky to build new manufacturing facilities and supporting services.
"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."
By the year 2011, the centre is expected to bring in $15m and employ up to 100 scientists, engineers and professional staff at yearly earnings ranging from $50,000 to $150,000.
The facility, based in the UK Coldstream Research Campus in Lexington, will be staffed by 25 professionals with expertise in the technical and engineering aspects of pharmaceutical manufacturing, as well as in regulatory and scientific areas.
The new facility is an expansion of the University of Kentucky College of Pharmacy, which is home to a US Food and Drud Administration (FDA)-registered pharmaceutical manufacturing facility utilising current Good Manufacturing Practices (cGMP) 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, active pharmaceutical ingredient (API) manufacturing and pharmacokinetic analysis.
"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 added.
The opening ceremony earlier this month was attended by the state's governor Ernie Fletcher, Lexington mayor Teresa Isaac and University of Kentucky president Lee T. Todd, Jr.
Lexington is the eighth most highly educated city in the the US, according to 2000 census data, and in each of the past two years, Forbes magazine ranked Lexington among the top cities in America to locate a business.
