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, might remove the necessity for refrigeration for a whole bunch of life-saving medicines like insulin, monoclonal antibodies and viral vaccines.
“Over 80% of biologic medication and 90% of vaccines require temperature-controlled situations. This method might revolutionize their storage and distribution, making them extra accessible and reasonably priced for everybody,” mentioned Scott Medina, examine lead and William and Wendy Korb Early Profession Professor of Biomedical Engineering at Penn State.
This might save billions of {dollars} presently spent on conserving these merchandise chilly all through the availability chain and probably allow the usage of protein therapies in environments the place fixed refrigeration will not be potential.”
Scott Medina, Examine Lead and William and Wendy Korb Early Profession Professor, Biomedical Engineering, Penn State
The analysis was not too long ago revealed within the journal Nature Communications. By way of a sequence of experiments, the analysis crew changed the water-based answer generally utilized in protein-based drugs with a perfluorocarbon oil and examined 5 totally different proteins with a variety of health-related capabilities reminiscent of antibodies and enzymes.
When examined in mice, the researchers discovered the brand new answer was simply as efficient because the refrigerated variations and confirmed no indicators of toxicity, which means there have been no opposed well being results from the oil-based answer.
The researchers additionally discovered that the oil-based answer was naturally sterile for the protein samples, noting that they might not be contaminated by micro organism, fungi or viruses which require a water-based setting to develop and survive.
There was one downside: 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 crew developed a surfactant – a molecule that coats the floor of the protein – to protect the floor of the protein in a means that might 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.
“Consider it like raincoats for proteins,” mentioned Medina, who can also be affiliated with Penn State’s Huck Institutes of the Life Sciences. “Similar to a raincoat retains you dry, this protecting shell retains the protein protected from warmth and contamination, permitting it to remain secure and practical.”
Protein-based medication and vaccines are usually delicate to warmth, mild 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 treatment will stay efficient till it’s administered.
“At excessive temperatures, proteins will begin to unfold and change into inactive,” Medina mentioned. “The unfolding occurs as a result of when the temperature will increase, the power of the water molecules will pull the protein aside and unfold it. Due to this, protein therapies usually should be saved in fridges or freezers to stop the unfolding from taking place.”
Medina mentioned these findings have the potential to restrict or remove chilly chain logistics, which is the availability community needed for getting the therapies from the place it’s being produced to the assorted distribution facilities previous to being administered to the sufferers.
In 2020, one other crew of researchers discovered that chilly chain logistics are projected to value $58 billion globally by 2026.
“If one thing goes flawed within the course of, the exercise of the protein remedy may very well be misplaced, the drug might now not be efficient or it turns into contaminated and the sufferers might probably be harmed,” Medina mentioned.
The researchers mentioned their method has the potential to scale back prices and boundaries for pharmaceutical firms, which might result in extra financial savings and higher entry for the sufferers in want of those therapies.
“This new methodology might additionally decrease boundaries and permit the medication to be distributed in resource-scare environments throughout all populations,” Medina mentioned. “We might even use this for these on the battlefield, the place these therapies can be wanted however entry to refrigeration is restricted.”
Sooner or later, the researchers purpose to show that their methodology works with further proteins and accomplice with pharmaceutical firms to stabilize protein molecules or peptides that may very well be utilized in a variety of medicines.
“We’re presently within the strategy of securing patent rights and hope to accomplice with pharmaceutical firms to make their protein merchandise extra secure and accessible,” Medina mentioned.
The crew contains 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 pupil. The Protection Superior Analysis Tasks Company funded this work.
Supply:
Journal reference:
Lawanprasert, A., et al. (2024) Warmth secure and intrinsically sterile liquid protein formulations. Nature Communications. doi.org/10.1038/s41467-024-55304-9.
