New formulation helps RNA vaccines withstand high temperatures like room temperature for up to a year

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"RNA vaccines, which have been proven effective against Covid-19, are now being developed for many other diseases, including cancer. One of the drawbacks to these vaccines is that they require ultracold storage, but researchers from MIT have found a promising way to overcome that limitation.

With help from an AI algorithm, the researchers tweaked the formulation surrounding the lipid nanoparticles that are typically used to deliver mRNA vaccines, making the vaccines more heat-resistant. Using this approach, they formulated vaccines that could remain stable even when stored at room temperature for up to a year, or at nearly 100 degrees Fahrenheit for two months. ..."

From the abstract:

"The instability of mRNA−lipid nanoparticles (LNPs) necessitates ultra-cold storage, limiting global distribution and their broader application in advanced delivery systems.

Solid-state, water-free formulations enhance thermostability and enable integration into emerging delivery modalities such as microneedle patches.

Previous efforts to stabilize mRNA−LNPs have been constrained by narrow formulation scope and low-throughput screening methods.

Here we introduce Algorithm-Guided Experimental design for lipid Nanoparticle Thermostabilization (AGENT), an artificial intelligence (AI)-driven framework that couples high-throughput experimentation with Bayesian optimization to identify thermostable mRNA−LNP formulations.

AGENT extracts maximal information from sparse experimental datasets, enabling efficient formulation optimization in six iterations completed within 1 month.

We stabilized mRNA vaccines with two clinically relevant LNPs representative of the Moderna (SM-102-based) and Pfizer-BioNTech (ALC-0315-based) compositions into solid-state formulations that retained 100% bioactivity after storage at 37 °C for more than 2 months.

In rodents and non-human primates, thermostable, solid-state vaccine formulations induced antigen-specific immune responses non-inferior to those elicited by intramuscular delivery of freshly prepared soluble vaccines."

New formulation helps RNA vaccines withstand high temperatures | MIT News | Massachusetts Institute of Technology "MIT engineers have found a way to stabilize the lipid nanoparticles used to deliver RNA vaccines, which could allow the vaccines to be more widely distributed."

Accelerated discovery of thermostable mRNA–lipid nanoparticle vaccines using data-efficient AI (no public access)

Accelerated discovery of thermostable vaccines using data-efficient AI (preprint, open access)

Fig. 1 Exploration of the design space for solid-state mRNA-LNPs formulated via vacuum drying.