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The vaccines against COVID-19 revealed the power of mRNA. Nonetheless, that’s just the beginning of making use of these molecules in vaccines against infectious and other diseases. As one example, the U.S. National Cancer Institute reported: “As stunningly successful as the mRNA COVID-19 vaccines have been, researchers have long hoped to use mRNA vaccines for a very different purpose—to treat cancer.” To fuel such expanding applications, the biosciences industry needs easy access to research-ready and commercial-grade mRNA.
Although various companies make mRNA, Vernal Biosciences produces ready-to-use mRNA products that can be used in vaccine research and in commercial therapies. “We’re manufacturing and selling mRNA,” says Christian Cobaugh, PhD, founder and CEO of Vernal Biosciences, “but then we take it a step further—formulating the mRNA in lipid nanoparticles, which we also manufacture, so that our customers can start injecting animals.” With mRNA alone, a company would need to rely on transfection or find another vendor to put the molecules in lipid nanoparticles, and that slows down progress in vaccine research.
mRNA is now a validated drug product platform
Scientists who explore new mRNA-based vaccines, though, want to move faster. “mRNA is now a validated drug product platform for the vaccine industry in infectious disease, and it is fast becoming one for personalized cancer vaccines in which we’re essentially trying to reprogram the immune system to treat tumor cells like they’re an infectious disease,” Cobaugh explains. So, customers come to Vernal for the mRNA needed to move a vaccine into clinical research.
“The most successful projects are not just successful for Vernal, but also for the customer,” Cobaugh continues. A project can start with an amino acid sequence for a whole antigen or a series of epitopes. Then, Cobaugh adds, “We help them further design the amino acid–sequence landscape, the codon sequences, and even untranslated regions, and that work just feeds right into our manufacturing pipelines.” For vaccines, this process usually includes making a lipid-nanoparticle formulation, which goes to the customer for testing.
For a new order of mRNA formulated in lipid nanoparticles, the process usually takes 10–12 weeks. “If it’s a reorder of the same construct, we usually take two to three weeks off of that, because we don’t have to do the design and gene synthesis,” according to Cobaugh.
The scale of manufacturing depends on the project. “If a customer just wants to do a one-off animal study, it’s generally in the 2–5 milligram range,” Cobaugh points out. “At that point, they may be testing variants, such as sequence variants or lipid-nanoparticle variants.” After that testing, the production scales up to 10–50 milligrams.
Once a customer settles on a clinical candidate for a vaccine, Vernal can manufacture a GMP product. “Every sequence is going to need some amount of process development for GMP,” Cobaugh notes, “but if a customer started with us for its research-use-only product, we already have a lot of process knowledge on the customer’s specific asset and can therefore accelerate the work toward the GMP batch.”
Even if a customer starts with Vernal at the GMP stage instead of the research stage, Cobaugh says that the company’s extensive process technology experience minimizes the development time for a GMP product. Plus, “a regulatory provider embedded within Vernal can answer questions and provide the most recent guidance around what needs to be done to get into the clinic,” he adds.
To make mRNA available for even more of tomorrow’s vaccines, Vernal continues to improve turnaround time and costs—aiming to expand access to these molecules. “Our mantra is to democratize access to the supply of high-purity mRNA, because that is ultimately what’s going to drive cures,” Cobaugh emphasizes. “I’ve been in our customers’ shoes before, and I’m really, really passionate about seeing them succeed.”
To learn more, visit vernal.bio