Wednesday, July 21, 2021

UI Pharmaceuticals is a small but mighty branch of the UI College of Pharmacy tree that has existed for nearly half a century. Despite that, it is still “the best kept secret” on the University of Iowa campus, according to Dean Donald Letendre.

The secret is beginning to “get out”, as it continues to grow quickly in capacity and employees. It also became better known for its vital work during the COVID-19 pandemic.

“Alumni have told me ‘I graduated in 1990, and you weren’t there yet.’ And I have to say ‘Yes we were.’ As we grow, I’m working to get our name out there’ said Joshua Sestak, chief operating officer of UI Pharmaceuticals. The venture has operated as a cGMP-compliant, FDA-registered service for client organizations beyond the university since 1974.

Sestak is one of the most recent leaders hired for the organization. He is working closely with UI Pharmaceuticals’ Executive Director, Dennis Erb, who began in July 2019.

The large majority of UI Pharmaceuticals’ clients have worked with the organization before or come to them through word of mouth. They work with clients to develop, analyze, manufacture, and ship out potential future medicines to partners across the world. Its clients include small biotech and large pharmaceutical companies, university researchers, and governmental laboratories.

Many of them form a relationship with UI Pharmaceuticals very early on in their development process when researchers are thinking of applying for grant money to support a study that could end up—far down the road—as a new drug on the market. Many need help design how they will formulate and then manufacture their product; by developing these relationships, these groups come back to UI Pharmaceuticals when the grant is awarded months or years later. Due to excellent work processes and customer service, clients often return to UI Pharmaceuticals to produce more of the drug product or a completely new product.

“Our niche is early-stage clients who have never been in clinical trials before or are very early in the clinical trial process. There are unique issues that come up for clients in this window of time, and our strength is in working closely with them to find solutions,” said Sestak.

COVID-19 Impact

COVID Impact Photos

A few months before the pandemic hit, the newly-hired Erb was quoted in an article: “The University of Iowa [would be] the place to come if you want to develop a drug (and receive) expert advice and applied research to progress your programs.” When the COVID-19 pandemic shut down much of daily life and the economy in February 2020, many clients came knocking for assistance trying to begin to battle it.

UI Pharmaceuticals kept running, its workers coming in for staggered shifts to support social distancing. When hand sanitizer was in short supply, UI Pharmaceuticals made it for the University of Iowa Hospitals and Clinics (UIHC) and the larger university. The organization did this while continuing to manufacture its most needed and important medications for patients.

To date, UI Pharmaceuticals has contributed to the development and manufacturing of seven coronavirus-focused therapies or vaccines: all aimed at stopping the virus, treating it, or even preventing it from spreading.

“Early in the pandemic many COVID projects were focused on treating people,” Sestak said. “If something helped with lung function in another indication, they’d look to try to apply it to COVID and give Intensive Care Unit patients a better opportunity to recover.”

Now groups are approaching the organization that are looking to develop new vaccines to address issues with some of the current approaches, including those that would not need to be kept at very cold temperatures.

UI Pharmaceuticals grew clients and projects at a quick clip during the pandemic. As Erb has noted, “when we seize opportunities that benefit patients, we also can help the college and university. It all comes down to benefiting patients and contributing to society.”

The fate of many of the drug products shipped out for the pandemic is unknown, as is most anything else that ever leaves its doors. “We follow all the projects that go into clinical trials” to be tested on human volunteers, said Sestak. “Not all end up a viable product, but others are successfully repurposed for something that seems to come out of left field.”

“We have clients across North America, in the European Union, China, South Korea, India, and Brazil. One project is going to sub-Saharan Africa. These products are aiming to fight cancer, cure pediatric diseases, prevent diabetes, or treat rare diseases. Every client product we load on a truck is a big deal. They all go out and help people.”

Future Growth

Future Impact Photo

UI Pharmaceuticals has grown its labor force and physical space rapidly, anticipating the future needs of the industry.

The laboratories that perform analytical testing moved to a larger space on campus, saving transportation costs, helping with communication, and project stability. “The labs and manufacturing were apart which limited how soon we could help clients,” Sestak said. “Now we can ask ourselves: Can we help come alongside potential clients even earlier in their process?”

But the biggest growth is in manufacturing.

UI Pharmaceuticals is currently operating in the lower levels of what remains in use of the older pharmacy facilities on campus. In the lower level of the new building--located on the site of the former Quadrangle Hall dorm--new massive, intricate, state-of-the-art production lines are being tested.

“The new facility will expand our capacity for sterile products five-fold from what we have right now,” said Erb. UI Pharmaceuticals will also continue making capsules, tablets, and other nonsterile products, as well as sterile products, in its current facility.

As human drug trials advance, ever-larger numbers of volunteers generally participate, so more doses are needed. For sterile products overall, UI Pharmaceuticals’ batch size capability will jump from 4,000 to 20,000 vials per batch. This is expected to support current clients longer than is possible now, and to keep them coming back.

To keep up, hiring is exploding; for years, there were 45 employees across all levels of the organization. In October 2019 there were 65, and in July 2021 there were 85. Numbers should top off next year around 100.

One of the leaders hired recently before the pandemic hit is Louay Ghonaym, the organization’s director of engineering and facilities. He has been preparing the new lines in the new building by doing test runs and working out the bugs in the system. It is not a small task.

UI Pharmaceuticals’ specialized lines have to be extremely flexible and are custom to the facility, which has its challenges. “Between both buildings, we are doing more than 120 projects per year for 80-100 clients,” Sestak said. “We’re manufacturing two to three different things every week in sterile (products) alone.”

The two manufacturing lines in the new building are enormous and couldn’t be put together and tested before arriving at the facility pre-pandemic. The equipment came from more than one company, including from Spain. “Countless hours of planning and 3-D modeling went into the development and installation of this equipment,” said Dan Cassidy, construction manager for the project with Miron.

“Now that the instruments are in there, Louay needs to put the Legos from the three companies together, and make sure everything works as it should,” explained Sestak. “It’ll be expensive to turn on the machine, and once we are making client materials, the whole process needs to run itself. People won’t be able to step in and correct any errors, so intense testing now is essential.”

“Additionally, the equipment UI Pharmaceuticals ordered had to be capable of both liquid (or serum batches) as well as products that would need to be freeze-dried. With two lines, UI Pharmaceuticals also needed the flexibility to use both lines either independently or to use some components of each line for a single batch,” he said.

The first batch is expected to be made in the new building in summer 2022.