Fluorous dispersion of proteins by way of PFNA coatings. Credit score: Nature Communications (2024). DOI: 10.1038/s41467-024-55304-9
A brand new storage approach can maintain protein-based medication and vaccines secure with out conserving them chilly. The invention, led by researchers at Penn State, may remove the necessity for refrigeration for a whole bunch of life-saving medicines like insulin, monoclonal antibodies and viral vaccines.
“Over 80% of biologic drugs and 90% of vaccines require temperature-controlled conditions. This approach could revolutionize their storage and distribution, making them more accessible and affordable for everyone,” mentioned Scott Medina, research lead and William and Wendy Korb Early Profession Professor of Biomedical Engineering at Penn State.
“This would save billions of dollars currently spent on keeping these products cold throughout the supply chain and potentially enable the use of protein therapies in environments where constant refrigeration is not possible.”
The analysis was lately revealed within the journal Nature Communications. By means of a sequence of experiments, the analysis staff changed the water-based resolution generally utilized in protein-based drugs with a perfluorocarbon oil and examined 5 totally different proteins with a variety of health-related capabilities comparable to antibodies and enzymes.
When examined in mice, the researchers discovered the brand new resolution was simply as efficient because the refrigerated variations and confirmed no indicators of toxicity, that means there have been no opposed well being results from the oil-based resolution.
The researchers additionally discovered that the oil-based resolution was naturally sterile for the protein samples, noting that they may not be contaminated by micro organism, fungi or viruses which require a water-based surroundings to develop and survive.
There was one drawback: proteins in water-based environments unfold themselves evenly all through the liquid. In oil, they don’t seem to be so soluble, Medina defined. So, the staff developed a surfactant—a molecule that coats the floor of the protein—to defend the floor of the protein in a manner that will enable it to evenly disperse itself all through the answer.
The surfactant additionally created a protecting shell across the protein, conserving it secure and stopping it from breaking down even at temperatures as much as 212 levels Fahrenheit, which might usually trigger water to boil.
“Think of it like raincoats for proteins,” mentioned Medina, who can be affiliated with Penn State’s Huck Institutes of the Life Sciences. “Just like a raincoat keeps you dry, this protective shell keeps the protein safe from heat and contamination, allowing it to stay stable and functional.”
Protein-based medication and vaccines are usually delicate to warmth, gentle and motion, all of which might trigger them to lose their construction and performance over time, Medina defined. Refrigeration helps to decelerate that degradation course of, so the medicine will stay efficient till it’s administered.
“At high temperatures, proteins will start to unfold and become inactive,” Medina mentioned. “The unfolding happens because when the temperature increases, the energy of the water molecules will pull the protein apart and unfold it. Because of this, protein therapies often have to be stored in fridges or freezers to prevent the unfolding from happening.”
Medina mentioned these findings have the potential to restrict or remove chilly chain logistics, which is the provision community crucial for getting the therapies from the place it’s being produced to the varied distribution facilities previous to being administered to the sufferers.
In 2020, one other staff of researchers discovered that chilly chain logistics are projected to value $58 billion globally by 2026.
“If something goes wrong in the process, the activity of the protein therapy could be lost, the drug could no longer be effective or it becomes contaminated and the patients could potentially be harmed,” Medina mentioned.
The researchers mentioned their strategy has the potential to cut back prices and boundaries for pharmaceutical firms, which may result in extra financial savings and higher entry for the sufferers in want of those therapies.
“This new method could also lower barriers and allow the drugs to be distributed in resource-scarce environments across all populations,” Medina mentioned. “We could even use this for those on the battlefield, where these therapies would be needed but access to refrigeration is limited.”
Sooner or later, the researchers purpose to exhibit that their technique works with extra proteins and accomplice with pharmaceutical firms to stabilize protein molecules or peptides that could possibly be utilized in a variety of medicines.
“We are currently in the process of securing patent rights and hope to partner with pharmaceutical companies to make their protein products more stable and accessible,” Medina mentioned.
The staff consists of Girish Kirimanjeswara, affiliate professor of veterinary and biomedical science; Atip Lawanprasert, Mariangely González Vargas and Arishya Dewan, Penn State graduate college students; in addition to Harminder Singh, postdoctoral scholar; and Sopida Pimcharoen, undergraduate scholar.
Extra info:
Atip Lawanprasert et al, Warmth secure and intrinsically sterile liquid protein formulations, Nature Communications (2024). DOI: 10.1038/s41467-024-55304-9
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