Healthcare (Commonwealth Union) – Researchers at Stanford Engineering have created a novel drug delivery system that could allow patients with certain cancers, autoimmune disorders, and metabolic conditions to receive protein-based therapies through simple injections.
Currently, patients with these conditions often rely on lengthy intravenous (IV) infusions to access effective protein treatments. These therapies typically need high doses but are formulated at low concentrations to maintain stability, making IV delivery the only practical method—until now.
The Stanford team’s new platform enables these medications to be concentrated at much higher levels while remaining stable. According to a study published on August 20 in Science Translational Medicine, this approach could allow many protein-based drugs to be administered quickly and easily using a standard syringe or autoinjector.
“This is a platform that potentially works with any biologic drug, so that we can inject it easily,” explained Eric Appel, who is an associate professor of materials science and engineering and senior author on the paper. “That takes these treatments from a several-hour ordeal at a clinic with an IV infusion to something you can do in seconds with an autoinjector at your house.”
Researchers of the study indicated that when concentrated at high levels, many protein-based drugs tend to clump together. This makes them too thick to inject, likely to form aggregates that can trigger immune reactions, and at times ineffective—or even dangerous—once inside the body. Appel and his team needed a method to load proteins into a liquid at high concentrations while still preserving their stability and function.
To solve this, the researchers designed a polyacrylamide copolymer, called MoNi, which has an unusually high glass transition temperature. In simple terms, it remains solid and glass-like even at warmer conditions, whereas standard drug additives would become soft and sticky. By blending MoNi with a protein solution, turning it into tiny droplets, and then removing the water through spray drying, they created a fine powder of protein particles, each coated in a thin glassy shell of MoNi.
Appel pointed out that it is kind of like a candy-coated chocolate,and the protein forms the center, and their special polymer makes a hard, protective coating around it.
The powder was then mixed into a liquid that suspends the particles with no dissolving involved. Thanks to the MoNi shell, the particles don’t stick together, and the proteins remain in a dry, stable form until the suspension is injected into the body.
Carolyn Jons, a PhD student in Appel’s group and one of the study’s lead authors stated that since the microparticles are round and have smooth exteriors, they can slide past one another, allowing them to pass through extremely fine needles for injection, even at very high concentrations.
The team applied this approach to three types of proteins—albumin, human immunoglobulin, and a monoclonal antibody therapy for COVID-19. They successfully achieved concentrations above 500 mg/mL, meaning that half the weight of the solution consisted of the protein drug, yet it could still be injected without difficulty. This is more than twice the concentration typically seen in standard injectable formulations. In addition, the mixtures proved more durable across a broader range of temperatures than conventional liquid drugs, showing no degradation after undergoing 10 freeze-thaw cycles or being stored under higher-than-normal heat conditions.
Spray drying is a widely used method in the pharmaceutical field, and MoNi has already been tested in multiple preclinical models without showing harmful side effects. Because of this, the researchers are hopeful it will gain approval for clinical application. The technology has already been licensed to a local startup, which is now focused on improving the process and ultimately applying it to create new drug formulations.
