MSI-TX film (Jurata Thin Films)
29 Sept. 2020. A new enterprise is creating thin films for vaccines, including Covid-19, to make possible their mass production and distribution at room temperatures. Jurata Thin Film in Chapel Hill, North Carolina, is commercializing research conducted by its scientific founder at University of Texas pharmacy school in Austin, Texas.
The company was founded last year by Maria Croyle, professor of pharmaceutics at UT-Austin. Croyle’s lab studies delivery of gene therapies with benign viruses, such as adeno-associated and adenoviruses, but also techniques for reducing associated immune responses and toxicities with viral deliveries. The lab’s research led to discoveries in methods for preparing and packaging biologics, including vaccines, that improve their durability and stability, thus reducing the need for refrigeration and individualized glass vials.
Much of the recent research by Croyle and colleagues involves vaccines for dangerous pathogens, such as Ebola. Among the pressing needs for Ebola vaccines are stable delivery techniques that can survive harsh tropical conditions at sites far removed from refrigerated storage. The lab’s work includes work on thin films loaded with vaccines that dissolve under the tongue, using biocompatible polymers to store the vaccine’s active ingredients.
Jurata Thin Film’s lead product is called MSI-TX, a thin film biologic packaging and storage technology using a bio-friendly cellulose matrix material stabilized with surfactants that lower the surface tension between liquids and solids. In 2015, Croyle and colleagues tested an Ebola vaccine in lab monkeys with the vaccine loaded on this film surface for dissolving under the tongue. A more recent version of the technology is described earlier this year in the journal Science Advances.
The company says 500 individual doses of a vaccine for syringe delivery, such as Covid-19 vaccines now being developed, can be stored on a single letter-sized (8.5 x 11 inch) sheet of film, weighing 5 grams. In addition, these vaccine films can be stored at room temperatures for extended periods of time. Croyle says MSI-TX can be applied today to Covid-19 vaccines that face daunting manufacturing and supply chain challenges, even after clinical trials show the vaccines’ efficacy and safety.
“Eight thousand uncut sheets of MSI-TX thin film can hold more than four million vaccine doses,” says Croyle in a company statement, “can be distributed in envelopes through standard shipping methods to anywhere in the world, and stored in a two-drawer file cabinet under a desk. Using current technology, this same amount of vaccine would require a 20-foot temperature-controlled container at either -20°C (-4°F) or -70°C (-94°F) to keep the vaccine viable.”
Jurata says for Covid-19 and other vaccines delivered with syringes, single doses can be cut from MSI-TX films, then rehydrated in about 15 minutes. Delivery films can be stored at room temperature for up to three years without loss of potency. After rehydration, the doses can remain stable for up to eight months. The company also says MSI-TX retains at least 90 percent of its biologic payload regardless of temperature changes, including multiple freeze and thawing cycles.
Jurata says MSI-TX films, as well as transfer and reconstitution processes are thoroughly tested and now ready for commercial use, with large films produced in about eight hours. Dose counts per sheet would vary depending on dosage size and concentration of active ingredients.
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