The Plough Center for Sterile Drug Delivery Solutions at the University of Tennessee Health Science Center was named Best Renovation (Large Category) by the Memphis Business Journal in its 2018 Building Memphis Awards.
The prestigious awards, given during a ceremony Tuesday evening at the Memphis Botanic Garden, recognize the best new developments in Memphis over the past year. More than two dozen companies were finalists. Categories recognized renovations and new construction, and were based on the size of the project. The Plough Center won the award for renovations costing more than $10 million.
The university has transformed a former warehouse at 208 South Dudley Street on the eastern edge of campus into a state-of-the art facility for the sterile manufacture of pharmaceuticals. Scheduled to open in the first quarter of this year, the new Plough Center is the only pharmaceutical facility of its kind in Tennessee and one of the few university-owned, contract-manufacturing facilities in the United States.
The $20 million facility houses a total of 20,000 square feet, including support labs, offices, and training facilities, and boosts the university’s standing in the national and global pharmaceutical marketplace. It also gives UTHSC the most up-to-date conditions for training students and professionals from the drug industry and government regulatory agencies in sterile pharmaceutical production.
Once operational, it will allow for production of small-batch drugs in injectable and freeze-dried forms for preclinical, Phase 1, and Phase 2 human clinical trials; orphan drugs developed to treat specific and rare diseases; and innovative drug delivery systems to meet various unmet clinical needs. It will also allow the university to help speed the process of bringing new drugs to market. In addition, the university has corporate strategies that would extend manufacturing capabilities for veterinary medicines.
Construction included gutting and renovating the interior of the building and updating the exterior. Begun in late 2015, the work has involved ensuring that a major portion of the building meets the most-stringent regulations for sterile pharmaceutical manufacture. The building houses three 800-square-foot prefabricated PODs, trailer-like structures, which serve as cleanrooms or sterile environments for manufacturing the pharmaceuticals. The PODs allow the facility to attain and maintain aseptic conditions as specified and regulated by Good Manufacturing Practices (GMP) guidelines, the pharmaceutical industry’s standard for sterile facilities.
The building’s three cleanroom structures were custom-designed and prefabricated by G-CON Manufacturing in College Station, Texas. The PODs were transported to Memphis by flatbed truck, loaded by cranes into the building through an opening made in a side wall, installed, and fitted together to provide contiguous space for manufacture.
The new facility expands the capacity of the university’s smaller, existing Plough Center in the Van Vleet Building at 3 N. Dunlap Street. Originally called the Parenteral Medication Laboratories, it has half a century of experience in manufacturing drug products and offering training in sterile product preparation on a much smaller scale.
The Plough Foundation gave $4.5 million in seed money to support the new facility. Ken Brown, JD, MPA, PhD, FACHE, executive vice chancellor and chief operations officer for UTHSC, has led the development of the new Plough Center for Sterile Drug Delivery Solutions. As a member of the Asia-Pacific Economic Cooperation (APEC), Dr. Brown has been involved in global pharmaceutical supply chain safety efforts for several years. He has made presentations in China, the Philippines, Peru, and elsewhere to senior officials of APEC about the university’s desire to be involved in the global effort surrounding patient safety and product security. He has also hosted delegates from China and Africa at UTHSC to discuss pharmaceutical manufacturing, delivery, and safety issues.
The facility operations are designed in compliance with FDA regulations, WHO (World Health Organization), and ICH (International Conference on Harmonization) guidance and regulations to manufacture sterile medications with the highest quality. The building is undergoing the final work toward receiving the necessary accreditations to begin operation.
Designed on one floor with room for expansion, the interior includes office space and conference rooms. The two Plough locations together offer approximately 3,900 square feet of GMP-compliant core processing space, along with 9,000 square feet of research and training labs.
Initially, the building will employee 20 to 25 people in four departments. Beyond that, the new facility enables the university to help scientific faculties across the country and beyond in their research and development programs at a significantly higher level. It enables UTHSC to meet the demands from any pharmaceutical company for contract manufacturing needs, from clinical trials to commercial products. Operations are fully automatic with minimal operator exposure to drug products manufactured. This nearly zero-exposure of operator to product eliminates human intervention and mediates drug product recalls and batch failures due to cross-contaminations.
The new facility will be a resource for hospitals, pharmacies, and other organizations for pharmacy level compounding, pharmaceutical-level manufacturing, and hospital-level cleanroom products. It also sets UTHSC up to have a role in helping to make pharmaceuticals safer, and puts UTHSC in a position to have a global impact on drug development and delivery, particularly to countries where shortages exist.