UK's Center for Pharmaceutical Science and Technology
On its hopeful way to FDA approval, a drug is poked and prodded, weighed and measured. Every move it makes is analyzed and then reanalyzed. The process is tricky, time-consuming and daunting. But at UK's Center for Pharmaceutical Science and Technology (CPST), this process is streamlined in the manner of one-stop shopping.
Frank Manella is managing director of UK's Center for Pharmaceutical Science and Technology (CPST), one of two university-based, FDA-registered pharmaceutical manufacturing centers with the unique ability to freeze-dry products.
"We're a full-service facility," says Mike Jay, director of the center and a professor in UK's College of Pharmacy. "We can work with someone from the idea stage all the way through Phase I and early Phase II manufacturing of the drug for clinical trials, and we can do all of this right here in the College of Pharmacy building." Phase I testing involves giving a drug to a small number of people to see what dose is safe; Phase II testing entails giving a larger number of participants the appropriate dose over a longer period of time to see if the drug is working and whether it has any long-term side effects.
The CPST, which opened its doors in 1986, has formulated drugs into injectable liquids, freeze-dried products, tablets and capsules, dermatological products, and produced up to 5,000 units at a time. UK is one of two university-based, FDA-registered pharmaceutical manufacturing centers with the unique ability to freeze-dry products. To date, the CPST, which utilizes strict, current Good Manufacturing Practices, has completed over 200 contract projects.
"We target four classes of clients: university researchers, biotech companies, pharmaceutical companies that gross $25 million to $250 million a year, and the NIH," says Frank Manella, managing director of the center. He adds that the center has increased client billings from $200,000 in 1996 to $1.5 million last year. "We've been on a pretty solid growth curve, thanks to the leadership of Dr. Jay and the College of Pharmacy's solid support. We plan to take it even higherto $10 million plus by 2007."
Manella, who was hired in November of last year, is a "wonderful, new addition" to the center, Jay says.
Manella started out 30 years ago as a bench research chemist, working on new semi-synthetic penicillins. He eventually ended up heading Pfizer's worldwide sterile penicillin packaging and freeze-drying operation in Terre Haute, Indiana.
"I got involved in new business development along the way and traveled extensively in the U.S., Japan and Europe looking for new pharmaceutical compounds to license, develop, and finallyafter FDA approvalmarket to physicians and pharmacists," Manella says. "This is much the same thing the CPST does for its current clients." He says he wanted to come to UK because of the ambience of a university settingthe camaraderie, curiosity and stimulation he saw here when he worked last year with the College of Pharmacy as a consultant.
The CPST will be growing soon, and moving. "We'll be moving to UK's Coldstream Research Campus [near the crossroads of I-75 and I-64, six miles from the Lexington campus] next year and plan to open our doors early in 2005," Manella says. "We're hoping that our presence there will also entice the building of commercial manufacturing facilities alongside us. That way entrepreneurs could easily segue from Phase II to Phase III clinical manufacturing and then scale up for commercial quantities."
"We'll retain the current facility here in the College of Pharmacy building, too." Jay says. "What will happen is the manufacturing of sterile products will be done at Coldstream, and the manufacturing of non-sterile products will continue here on campus."
Manella mentions another tangible benefit of the CPST expansion. "Historically, way too many of the top College of Pharmacy graduates leave Kentucky. I'd love to see some of this brain drain stop."
The center will provide the opportunity for UK graduates and others to put their skills to work right here at home. "We hope to add more than 40 people to the center in the next 12 to 18 months," he says, "and if things go according to plan we could be up to around 100 people at Coldstream doing a three-shift operation by 2007."