Thermal Stabilization of Vaccines and Biologicals at Room Temperature

This proposal outlines a 6-month Phase I research plan to demonstrate the feasibility and efficacy of Inaedis Inc.’s breakthrough Rapid Room-Temperature Aerosol Dehydration (RTAD) technology for producing shelf-stable, bioactive powders with controllable nanoparticle morphology. This proposal aligns with the DoD's objectives under SBIR Topic CBD254-001 by addressing acute logistical challenges associated with cold chain requirements while showcasing Inaedis' innovative RTAD technology as a transformative solution for thermostabilizing critical medical countermeasures (MCMs). Towards this, modified vaccinia Ankara (MVA) non-replicating smallpox and mpox vaccine designed for individuals with weakened immune systems will be used as a model to generate thermally stable powder formulations. The novel solution is poised to mitigate vaccine supply shortages and ultra-cold storage at -80°C requirements, which have posed significant challenges, particularly during the 2022 mpox virus outbreak, when demand surged beyond production capacity. The powdered form simplifies storage and transport, overcoming manufacturing constraints, stockpile shortages, and distribution bottlenecks to ensure timely immunization and stronger supply chain resilience during public health emergencies, while also offering a novel administration route by being reconstituted for injection or used in inhalants or transdermal microneedle patches.Temperature-sensitive medical products, including proteins, monoclonal antibodies, mRNA-encapsulating lipid nanoparticles, viral vectors, and bacteriophages, are vital for treatments ranging from gene therapy to oncology and vaccinations, making up 75% of the world’s top-selling pharmaceuticals. However, their inherent instability demands strict temperature control throughout the supply chain, known as cold chain management (CCM). Failures in CCM result in billions of dollars in losses annually, with up to 20% of temperature-sensitive pharmaceuticals and over 50% of vaccines wasted due to inadequate storage and transport conditions. These challenges are even more severe in forward-deployed military operations and remote regions, where secure supply chains are unreliable or nonexistent. The rapidly growing need and application for mRNA vaccines that need ultra-cold storage further exposed these weaknesses and created significant barriers to distribution in underserved areas. Inaedis’ proprietary RTAD technology directly aligns with this mission by enabling the production of thermostable biologics capable of maintaining potency at room temperature. This Phase I effort serves as a proof of concept that the technology can deliver a scalable, effective solution to these persistent challenges. Inaedis’s RTAD process uniquely enables the dehydration of certain biologics and biopharmaceuticals that other methods cannot handle, removing fundamental barriers to their conversion into shelf-stable dry powders of controllable and tunable size.