Validation and scale up of vaccine stabilization for ambient handling using a pullulan/trehalose

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Developing a technique for safely storing and transporting vaccines is considered the "holy grail" in global health, with huge potential for positive social impact. Current systems rely on "cold" supply chains that are expensive, heavily regulated and require a stable source of energy, to ensure that vaccines are always transported, handled, and stored at controlled temperatures. However, these requirements greatly limit the market access of vaccines, especially to the world's most remote and impoverished regions, while greatly increasing manufacturing costs. Today, our goal is to revolutionize how vaccines are handled. Our team has experimented with a pullulan/trehalose formulation that, once added, encapsulates molecules and protects them from environmental conditions (heat, oxygen). This will allow sensitive reagents - such as vaccines - to be transported and stored at ambient conditions. We have developed a proof-of-concept (in vitro only) using the herpes simplex virus (HSV) as a model system; this performance is a strong proof of concept as HSV, in principle, is more difficult to stabilize relative to other viruses due to its enveloped structure. The goal of this project is to expand the commercial value of our pullulan/trehalose stabilizing technology by a) validating performance in vivo b) assessing technology's ability to stabilize different types of vaccines c) developing scale up and implementation procedures for successful user adoption. All research efforts are directed towards the goal of positioning our technology as an engineering solution and a platform for vaccine stabilization. Our proposed method is easy to use while keeping vaccination procedures the same, does not require extensive capital costs or additional manufacturing steps, and will not require external source of energy during storage or transportation. With cost reduction benefits, combined with the value of solving a global health equity challenge, this technology has great potential for commercial success.