VOL. 132 | NO. 167 | Wednesday, August 23, 2017
UTHSC Readies New Pharmaceutical Manufacturing Facility
By Michael Waddell
UTHSC is putting the final touches on its new $20 million Plough Center for Sterile Drug Delivery Systems, a pharmaceutical manufacturing facility at the site of a former warehouse at 208 S. Dudley St. in the Memphis Medical District.
Construction, which has been ongoing for nearly two years, will finish up in the next few weeks before the building is commissioned this fall and then made ready to open by the end of the year.
“We’re very excited about this particular project,” said University of Tennessee Health Science Center executive vice chancellor and chief operating officer Dr. Kennard Brown, who spearheaded the project. “It will enhance some of the work the college of pharmacy and the pharmaceutical scientists do to get new drugs to market. Even as we speak, there are potentially life-saving drugs being developed that need an expeditious pathway through the rigors of clinical trials and FDA approval to get to patients in need.
“This is but one effort of the Health Science Center to facilitate getting those drugs to patients who need them.”
This compounding glove-box isolator and bulk compounding tank are elements that will help keep lab work at the Plough Center contamination free. (Submitted)
The center will have approximately 10,000 square feet of support labs, offices and training facilities. Three 800-square-foot prefabricated modular rooms, or PODS, (made in College Station, Texas) were delivered last year and put inside the building to be sterile environments for manufacturing the drugs. The PODs were built and installed by Texas-based G-CON Manufacturing, and Flintco Construction was the project’s overall general contractor.
Once the building is commissioned, it will be a sterile environment, and only authorized personnel will be allowed into production areas in the facility.
“For drug manufacturing, certain things are critical, including the grade of water that’s used,” said facility director Dr. Harry Kochat. He said Memphis water is used and then purified in several stages on site. “Steam is also very important, and we make clean steam from the clean water.”
The facility will manufacture only liquid medications for injectables, no solids or pills other than lyophilization in which solvents are removed from liquids to increase their shelf life. The liquids produced are then put into sterilized vials, ampules and ready-to-use syringes.
“Ready-to-use syringes are the best way, and it’s the way drug manufacturing is going right now,” Kochat said. Ampules can break, and nurses can get wounds from the broken glass.
Keeping the facility free of all contamination is a key concern. Each production area has state-of-the-art equipment, including air locks and eco air filters, to ensure that the facility remains contamination free.
“Ninety-five percent of the time that a drug is adulterated or contaminated, it is from human beings shedding particles from their body,” Kochat said. “So if you can separate the human being from what you do that’s the best way to control the quality.”
Ultimately, the facility can produce 50 vials per minute, or 80 to 90 pre-filled syringes per minute, which equates to easily producing 50,000 vials per day, or 100,000 to 200,000 syringes.
UTHSC already has inquiries from companies wanting to contract for production of clinical trial drugs, orphan drugs for specific diseases, specialty batches and drugs that are in development.
“If you look at the past 10 to 15 years, the number of innovative drugs that come to the market for various diseases – cancer, cardiovascular, obesity, diabetes, anything – zero of them came from Big Pharma directly,” Kochat said. “All came from small- and medium-sized companies licensed with Big Pharma and made under their name. Innovations and discovery happens at the smaller and newer companies with new ideas.”
There are many companies out there that want to develop by themselves and not sell to Big Pharma, he said, but they don’t have the capital.
The Plough Center for Sterile Drug Delivery Systems is a manufacturing facility located at the site of a former warehouse at 208 S. Dudley St. in the Memphis Medical District. (Submitted)
“Since we are a nonprofit organization, we can take in companies that are virtual or startups and bring them here to support their early manufacturing,” said Kochat, who has worked in the pharmaceutical industry for 25 years.
UTHSC will become a partner for those companies (with revenue not being the driving force), and they will sell together to the marketplace.
“That’s the biggest thing we can do for the community as a payback,” Kochat said.
Another important purpose of the private contract-manufacturing facility is for faculty and students to receive training.
The new center also puts UTHSC in a position to have a global impact on drug development and delivery, particularly to countries where shortages exist, such as Kenya.
“We are willing to work with developing countries that either have drug shortages and/or major challenges with a secure pharmaceutical supply chain to teach them how to build these facilities and how to do pharmaceutical manufacturing and compounding to hopefully mitigate some of the drug shortages or the introduction of adulterated drugs in their economies,” Brown said. “So theoretically, this project has a much more global reach in its evolution than just what it means for us here locally.”
About 20 people will work at the facility when it opens.
The center has plenty of room to expand, with a second phase of construction already in place once production increases to a point that warrants it.
Longer-range plans include moving into the biologics and genomics areas at some future time.