New Plough Center for Sterile Drug Delivery Systems to Expand UTHSC’s National and Global Position as a Pharmaceutical Manufacturer

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A rendering of the new Plough Center for Sterile Drug Delivery Systems, a $16 million facility for manufacturing pharmaceuticals planned for UTHSC. Renovations to an existing building on the eastern edge of campus are set to begin in September 2015.
A rendering of the new Plough Center for Sterile Drug Delivery Systems, a $16 million facility for manufacturing pharmaceuticals at UTHSC.

A nondescript building on the eastern edge of campus is poised to help launch the University of Tennessee Health Science Center (UTHSC) into the global pharmaceutical marketplace.

The building, a former warehouse at 208 S. Dudley Street, was purchased by UTHSC about five years ago. It is being transformed into the Plough Center for Sterile Drug Delivery Systems, a $16 million, state-of-the-art facility for manufacturing drugs and training students and professionals from the pharmaceutical industry and government regulatory agencies in pharmaceutical production. Construction, which includes gutting and renovating the interior of the building as well as updating the exterior, will begin in September 2015.

It is expected to take roughly 24 months for the center to become operational and begin producing small-batch drugs in injectable and semi-solid dosage forms for preclinical, Phase 1 and Phase 2 clinical trials; orphan drugs developed to treat specific and rare diseases; and innovative drug delivery systems.

Plough Pod photo cropped
The Plough Center for Sterile Drug Delivery Systems at UTHSC will house three PODs similar to these that will provide sterile environments for the manufacture of pharmaceuticals.

The building will house three 800-square-foot prefabricated PODs, which will serve as sterile environments for aseptically manufacturing the pharmaceuticals. The PODs, made by Texas-based G-CON Manufacturing, will allow the facility to attain and maintain the current Good Manufacturing Practices designation, the pharmaceutical industry’s measure of sterile conditions. The building will also house roughly 10,000 square feet of support labs, offices and training facilities.

“We’re very excited about this particular project,” said Ken Brown, JD, MPA, PhD, FACHE, executive vice chancellor and chief operations officer for UTHSC, who has helmed the effort. “It will enhance some of the work the College of Pharmacy and the pharmaceutical scientists do to get new drugs to market.”

The Plough Foundation gave $4.5 million in seed money to support the new facility, which will expand the capacity of the current Plough Center housed in the Van Vleet Building on campus at 3 N. Dunlap Street. The smaller existing center, formerly known as the Parenteral Medication Laboratories, has more than 50 years’ experience in manufacturing drug products and offering training in sterile product preparation. It has the capacity for manufacturing small-volume parenteral preparations for clinical investigation, and provides services to the pharmaceutical industry.

Dr. Brown said the new facility will enable UTHSC to better teach students and professionals how to operate in a sterile manufacturing facility with expanded production capacity, and puts UTHSC in position to speed the path for certain clinical trial drugs. “We can manufacture the drugs right here and we’ve got the clinical and research capacity to do those preclinical, Phase 1 and Phase 2 clinical trials, so hopefully this will expedite new drugs getting to market,” he said.

It also sets UTHSC up to have a role in helping make pharmaceuticals safer, Dr. Brown said. He has been vocal about his interest in pharmaceutical supply chain safety, making speeches nationally and internationally and serving on industry committees working on the subject. He points to the case of tainted steroids from a Massachusetts company that killed more than 60 people in several states, including Tennessee, as a cautionary example of why safety standards are so important for manufacturers and shippers of pharmaceuticals and why he is working so hard to improve them.

Dr. Brown said he hopes to use the facility as a catalyst for passage of more stringent laws regulating supply chain safety for drug manufacturers. “By building this facility and being able to bring people from the General Assembly here and being able to talk with them about what sterile and ideal conditions in a pharmaceutical manufacturing facility really look like in a real world, hopefully legislation gets created that at the very least protects the people of the state of Tennessee in terms of who can manufacture and compound pharmaceuticals,” he said.

The new facility also puts UTHSC in a position to have a global impact on drug development and delivery, particularly to countries where shortages exist.

“We talk to people in developing countries from the international community, from Kenya in particular, where there are significant drug shortages,” Dr. Brown said. “We will work with people in these developing countries to teach them how to build these facilities and how to do pharmaceutical manufacturing and compounding to hopefully mitigate some of the drug shortages. So theoretically, this project has a much more global reach in its evolution than just what it means for us here locally.”