“More than 80% of biologic drugs and 90% of vaccines require controlled temperatures. This innovative technique may transform how these medicines are stored and transported, enhancing accessibility and affordability for all,” stated Scott Medina, the lead researcher and the William and Wendy Korb Early Career Professor of Biomedical Engineering at Penn State. “This could potentially save billions of dollars spent on refrigeration throughout the supply chain and allow protein therapies to be used in places where refrigeration isn’t feasible.”

The findings were recently published in the journal Nature Communications. The research involved a series of experiments where the traditional water-based solution typically used in protein medications was substituted with a perfluorocarbon oil. The team assessed five different proteins with various health-related functions, including antibodies and enzymes.

In tests conducted on mice, the researchers discovered that the new oil-based solution was as effective as the refrigerated alternatives and did not show any signs of toxicity, indicating there were no harmful health effects associated with the oil-based formulation.

Additionally, the researchers noted that the oil-based solution remained sterile for the protein samples, demonstrating that it could not be contaminated by bacteria, fungi, or viruses that thrive in water-based environments.

One challenge identified was that proteins typically disperse evenly in water, but become less soluble in oil. To solve this, the team created a surfactant—a molecule that coats the protein’s surface—which allows it to distribute uniformly throughout the oil.

This surfactant also forms a protective layer around the protein, ensuring its stability and preventing degradation even at temperatures up to 212 degrees Fahrenheit, a level that would normally cause water to boil.

“Imagine it as raincoats for proteins,” said Medina, who is also part of Penn State’s Huck Institutes of the Life Sciences. “Just like a raincoat keeps you dry, this protective layer safeguards the protein from heat and contamination, ensuring it stays stable and functional.”

Protein-based drugs and vaccines are generally sensitive to heat, light, and movement, which can disrupt their structure and function over time, Medina noted. Refrigeration helps slow this degradation, prolonging the medication’s efficacy until it’s needed.

“At elevated temperatures, proteins begin to unfold and lose their activity,” added Medina. “Unfolding occurs because increased temperature gives water molecules enough energy to pull the protein apart. As a result, protein therapies often need to be stored in fridges or freezers to prevent this unfoldment.”

According to Medina, these findings might minimize or entirely eliminate the cold chain logistics essential for transferring therapies from production sites to various distribution centers before patient administration.

In 2020, researchers estimated that cold chain logistics would incur costs of $58 billion globally by 2026.

“If something goes wrong in this process, the effectiveness of the protein therapy could diminish, the drug might become ineffective, or it could get contaminated, posing risks to patients,” Medina remarked.

The research team believes that their method could decrease costs and obstacles for pharmaceutical companies, potentially leading to substantial savings and improved access for patients needing these treatments.

“This innovative technique could also break down barriers, allowing medications to be distributed in resource-limited settings across all demographics,” Medina noted. “It could even be utilized for soldiers in the field, where access to refrigeration is often limited.”

Moving forward, the researchers plan to validate their method with additional proteins and collaborate with pharmaceutical companies to stabilize protein molecules or peptides applicable in various medications.

“We are in the process of securing patent rights and hope to partner with pharmaceutical firms to enhance the stability and accessibility of their protein products,” Medina concluded.

The team comprises Girish Kirimanjeswara, associate professor of veterinary and biomedical science; Atip Lawanprasert, Mariangely González Vargas, and Arishya Dewan, graduate students from Penn State; as well as Harminder Singh, postdoctoral scholar; and Sopida Pimcharoen, undergraduate student. This work was funded by the Defense Advanced Research Projects Agency.