A brand new storage method can preserve protein-based medication and vaccines steady with out protecting 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,” stated Scott Medina, research lead and William and Wendy Korb Early Profession Professor of Biomedical Engineering at Penn State.
This is able to save billions of {dollars} presently spent on protecting these merchandise chilly all through the availability chain and probably allow the usage of protein therapies in environments the place fixed refrigeration shouldn’t be potential.”
Scott Medina, Research Lead and William and Wendy Korb Early Profession Professor, Biomedical Engineering, Penn State
The analysis was lately printed within the journal Nature Communications. By way of a collection of experiments, the analysis staff changed the water-based resolution generally utilized in protein-based drugs with a perfluorocarbon oil and examined 5 completely different proteins with a variety of health-related capabilities reminiscent of 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 might not be contaminated by micro organism, fungi or viruses which require a water-based setting 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 protect the floor of the protein in a approach that will enable it to evenly disperse itself all through the answer.
The surfactant additionally created a protecting shell across the protein, protecting it steady 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,” stated 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 secure from warmth and contamination, permitting it to remain steady and practical.”
Protein-based medication and vaccines are sometimes delicate to warmth, gentle and motion, all of which may trigger them to lose their construction and performance over time, Medina defined. Refrigeration helps to decelerate that degradation course of, so the remedy will stay efficient till it’s administered.
“At excessive temperatures, proteins will begin to unfold and change into inactive,” Medina stated. “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 must be saved in fridges or freezers to forestall the unfolding from taking place.”
Medina stated these findings have the potential to restrict or remove chilly chain logistics, which is the availability 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 price $58 billion globally by 2026.
“If one thing goes flawed within the course of, the exercise of the protein remedy might be misplaced, the drug might now not be efficient or it turns into contaminated and the sufferers might probably be harmed,” Medina stated.
The researchers stated 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 stated. “We might even use this for these on the battlefield, the place these therapies could be wanted however entry to refrigeration is proscribed.”
Sooner or later, the researchers goal to reveal that their methodology works with further proteins and associate with pharmaceutical firms to stabilize protein molecules or peptides that might be utilized in a variety of medicines.
“We’re presently within the strategy of securing patent rights and hope to associate with pharmaceutical firms to make their protein merchandise extra steady and accessible,” Medina stated.
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. The Protection Superior Analysis Tasks Company funded this work.
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Journal reference:
Lawanprasert, A., et al. (2024) Warmth steady and intrinsically sterile liquid protein formulations. Nature Communications. doi.org/10.1038/s41467-024-55304-9.