New UTHSC facility embraces orphan drugs
by Samuel X. Cicci
If the demand for a certain drug isn’t there, what business incentive do companies have to manufacture it? That unfortunate reality creates orphan drugs, pharmaceuticals that remain undeveloped due to a lack of commercial viability. Many people with rare diseases might go without treatment due to this phenomenon.
Take away profitability as a primary factor, however, and you end up with the Plough Center for Sterile Drug Delivery.
The center is at 208 S. Dudley, the renovated Holliday’s Fashion Building that the University of Tennessee Health Science Center purchased seven years ago. Construction on the $16 million facility began in September 2015, and the project is expected to be finished later this year.
The Center houses three 800-square-foot PODS that act as sterile environments in which the drugs are produced. They will allow the facility to attain the Good Manufacturing Practices designation, which indicates that the premises meet the pharmaceutical industry standards. Initially, the center will produce small-batch drugs in either injectable or semi-solid dosage forms for pre-clinical, phase one, and phase two trials.
“Hundreds if not thousands of drugs are in the pipeline for phase one and phase two trials,” says Dr. Kennard Brown, executive vice chancellor and COO of UTHSC. “So part of this facility’s objective is to support drug discovery research and enhance the expediency with which drugs can reach the market.”
Getting drugs to market has always been difficult for smaller ventures for a variety of reasons. As a result, many patients don’t realize the benefits of drug research, as ideas may be trapped in the conceptual stage indefinitely if developers don’t have connections or funding. The Plough Center’s mission is intended to allow for an easier transition from the research pipeline to consumers. Orphan drugs will be the main focus going forward, making UTHSC poised to be at the forefront of drug discoveries.
This won’t be the first iteration of the Plough Center. The new facilities will expand upon the original location in the Van Vleet Building on UTHSC’s campus. Formerly known as Parental Medication Laboratories, it has more than 50 years of drug manufacturing experience. While the old lab was capable of small-volume pharmaceuticals, the new facility will offer production capabilities on a much larger scale.
With the advent of a large manufacturing base, however, comes the need for safe products. There can be serious repercussions when standards slip. “In 2011, a compounding company in Massachusetts made a steroid,” says Harry Kochat, manager of the Plough Center. “They were making and selling it, but their quality went down. They made something which got contaminated, and they sold it. Sixty-four people died, of which 40 were from Memphis and Nashville.”
That kind of business practice goes against everything Kochat believes the Plough Center should stand for. “Giving somebody a second life is the most precious thing nowadays,” he says. “That’s why we are here.” With its standing, UTHSC can make the Plough Center a turning point in the battle to make pharmaceuticals safer. Brown has always been a vocal supporter of more stringent manufacturing laws, and the dialogue that’s already been opened with national and international colleagues should help with that push.
The building doesn’t skimp on quality measures. The first big room is dedicated solely to water purification. The FDA is strict about water regulation when it comes to pharmaceuticals. Purified water is necessary to ensure that drugs don’t get contaminated, while clean water is also required for cleaning equipment between shipments. Microbes are the first big threat to the process; if the water is kept still, they’ll grow and likely ruin a product. The water is continuously pumped to avoid such a situation. Once purified, it can be turned into steam for sterilization. Another container holds the chilled water for cooling. All the water comes directly from the city, and two large generators behind the Plough Center ensure that the purification process is never halted in case of an outage.
Further into the complex, several rows of large windows along the inner and outer corridors allow workers to be observed as they carefully attend to every critical step of the manufacturing process. Once past the outer corridor, every employee and visitor is required to wear shoe covers and hair nets. Before setting foot into the main lab, a sterilization chamber ensures that no excess microbes or bacteria enter the area where the drugs are made, called a farm. All equipment, such as vials and syringes, is thoroughly cleaned before being placed into an oven to destroy pathogens, microorganisms that can cause disease. When everything is sterilized, manufacturers can begin creating a large shipment and use a belt similar to a bottling line to place the medicine into containers. The setup is equipped to bottle up to 50,000 10 mL vials in a day.
Once the containers are filled, each is monitored under a microscope to make sure that there are no microbes. Contaminated products are immediately discarded. If the shipment is pure, each container is labeled and prepared for shipping. The attention to detail is impressive, with a different type of cleaning station around almost every corner.
In the modern medical world, the Plough Center’s de-emphasis on profit becomes critical when thinking of orphan drugs. “For example, 20,000 people might get a rare disease in the United States,” says Kochat. “There is no drug to treat it because big pharma looks at the big picture and sees they won’t make even a few million dollars. They become neglected diseases and neglected people. If we won’t do it, there’s nobody there to develop them.”
Several different groups have already drawn up contracts with the Plough Center, ensuring a steady flow of work. “There’s one Chinese company we’re contracted with,” says Brown, “and then we’ve got around 20 companies that we have nondisclosure agreements with to do drug manufacturing for. Before the facility is online, we’ve got a huge book of business already, so we’re optimistic about the potential level. And maybe we’ll even make some money!”
In addition to the pharmaceuticals, the center will also act as a teaching hub for students and fellow professionals. Doctors from Kentucky to Japan work with UTHSC at quarterly training sessions and delegations from Mid-South universities have plans to visit and learn from the facility. The experience that the Plough Center offers is one of the best in the country for training pharmaceutical inspectors. Plenty of extra office spaces, meeting rooms, and classrooms provide space for students at the College of Pharmacy to get a more hands-on approach. Its proximity to the Medical District gives other medical institutions the chance to work together to further pharmaceutical production. “We are properly situated,” says Kochat. “With this many hospitals, we can do so many clinical trials.”
The Plough Center’s features provide a very philanthropic feel. Professionals come from all over to learn from the facility while the proximity of FedEx means that the school can partner with the delivery company for easy logistics. That partnership gives UTHSC an even broader reach and the ability to ship drugs to countries with a severe shortage of medical supplies.
Kochat, with his decades of experience in pharmaceuticals, remains devoted to helping as many people as possible. That passion can be traced back to the early 1990s in San Antonio. A young brain tumor survivor had come to personally thank Kochat, who had developed the oncology drug used to treat tumors at St. Jude. “That young boy walked around the table, came to me and asked, ‘Can I touch the finger that saved my life?’ Those kinds of moments are enough. We are not for profit. We are here for patients and we are here for quality. That’s how we came into the picture. This is the right thing we can give back to the community.”
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