Researchers at the University of Pennsylvania have found a method to create shelf-stable drugs that do not require refrigeration to store and will be less expensive to manufacture.
The study's senior author Henry Daniell, University of Pennyslvania professor and interim chair in Penn Dental Medicine’s Department of Biochemistry, Daniell and his colleagues revealed their findings in the study published in “Biomaterials.”
The researchers developed a plant-based system, using freeze-dried lettuce leaves, to produce a drug that works to improve tolerance of clotting factors.
The new drug is dramatically cheaper and may give hemophilia patients another option for treatment.
“Current treatments for inhibitor formation in hemophiliacs cost almost a million dollars and are not affordable for a significant segment of the patient population," Daniell said. "Most importantly, developing a low cost platform for protein drug delivery will make these drugs affordable for a large majority of the global population."
Collaborators from the University of Florida led by Roland Herzog conducted animal studies and Fraunhofer USA's Steve Streatfield facilitated large-scale production of lettuce in the company's FDA-compliant facility.
The group has previously worked use genetically modified plants to make proteins that teach immune systems to tolerate clotting factors as treatment for hemophilia. The previous study, published in the journal “Blood” showed that a drug grown with a tobacco plant platform stopped and reversed the production of clotting factor inhibitors.
In this study, the team used two growing methods. First, they used the greenhouse in the Pennovation Works campus, which grows plants in soil with natural light. They also worked with Fraunhofer USA’s Steve Streatfield to grow extremely large quantities of lettuce using a hydroponic system and artificial lighting.
The hydroponic system is easy to expand, and during the study, researchers harvested a batch of the pharmaceutical containing lettuce every four to six weeks. This method could make it easier and less expensive to develop affordable traditional protein drugs because there’s no fermenter, no purification and no cold chain. Researchers also learned that their capsules were effective for up to two years.
"This is a milestone in our field, to make a fully functional drug in plants, produce it at a large scale and in quantities sufficient for human clinical trials," Daniell said.