As a chemical engineering student in the 1980s, Ted Randolph volunteered on a vaccine campaign against diphtheria, measles, pertussis, and tetanus in Guatemala, and came away with a focus for his career.
“There was typically no electricity where we were in Guatemala, and so we would buy up all the popsicles from a street vendor with a kerosene-powered cooler when we arrived so that we’d be able to keep the vaccines fresh,” recalls Randolph, the Gillespie Professor of Bioengineering and co-director of CU-Boulder’s Center for Pharmaceutical Biotechnology.
Vaccines offer a tremendous benefit to human health, but creating vaccines that provoke a reliable, protective immune response in a formulation with adequate shelf life is a serious challenge, Randolph says.
Over the last 20 years he has created a vibrant laboratory program at CU that focuses on the formulation and stabilization of protein-based therapeutics and vaccines.
His work has resulted in numerous professional awards, 19 patents, and two spinoff companies—BaroFold, which applies Pressure Enabled Protein Manufacturing technology developed in Randolph’s lab to improve the safety and reduce the manufacturing cost of a variety of protein-based drugs; and RxKinetix, a pharmaceutical company specializing in cancer treatments.
Around a decade ago Randolph started to work on a new type of vaccine—one that he hopes he’ll never have to give to anyone. The National Institutes of Health is funding his research to develop vaccines against bioterrorism agents such as anthrax, botulinum, and ricin—a naturally occurring protein that is one of the most toxic substances in the world.
While the chance of anyone needing to be vaccinated against such substances may be small, the need for an effective vaccine could be massive and immediate if such a threat were to arise. And those are two challenges the pharmaceutical industry would be hard pressed to handle.
“If we were attacked,” Randolph hypothesizes, “then we’d need to get a vaccine to a whole lot of people right away. And then there’s the milk-in-the-refrigerator problem, because the natural shelf life of most proteins is only a few weeks. Like milk, vaccines and other protein drugs quickly go bad, especially if left too long at room temperature, and often must be stored at ultra-low temperatures that make them impractical for rapid deployment.
“We have to figure out how to stabilize the vaccines so we can stockpile them,” he concludes.
Borrowing a technique that plants use to protect the proteins in their seeds, Randolph’s group discovered they could stabilize vaccine proteins by encasing them in glass made of naturally occurring sugars, which protects the proteins against degradation.
“We’re three for three so far,” Randolph says, referring to successes with anthrax, botulinum, and ricin vaccines. “We can keep the vaccines for four months at over 100 degrees Fahrenheit and they’re still 100 percent potent.”
The bioterrorism vaccines are in the form of a dry powder, which makes them even easier to distribute in the event of a widespread attack, he adds.
There’s a chance the new technology also could be applied to the vaccines needed to immunize people in developing countries.
“We’re hoping we could apply similar processes to other vaccines,” said Kim Hassett, a doctoral student who is doing her research in Randolph’s lab. “If we could have unrefrigerated vaccines, they’d be able to get more places.”
Hassett is supervising chemical and biological engineering undergraduates Megan Cousins and Lilia Rabia, who are engaging in the research with funds from the college’s Discovery Learning Apprenticeship Program and other campus programs for undergraduate researchers. Both students are pursuing careers in the medical field and were drawn to the research because of its potential applications.
Randolph often recruits undergraduates to work in his laboratory, and those who are really interested in the research can turn it into a senior thesis—or even a paper published in a sponsored journal, he says.
Most of his graduate students go to work with pharmaceutical companies after graduation, where they manage other researchers in much the same way that they have done with the undergraduates at CU-Boulder.
“Our graduates are now iin leadership positions at biopharmaceutical companies around the world, and the research management skills that they develop at CU are a big part of their success,” says Randolph.
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