Light-Assisted Drying: A Novel Method for Stabilizing Inactivated Poliovirus Vaccine in a Sugar Glass for Room-Temperature Storage - PROJECT SUMMARY Cold chain logistics are critical for maintaining the stability of biological products, including vaccines, monoclonal antibodies, protein-based therapeutics, and diagnostic specimens. However, the reliance on continuous refrigeration poses substantial logistical and financial challenges, particularly in low-resource settings. Developing alternative stabilization methods that eliminate refrigeration requirements is crucial for improving global access and reducing costs. Current strategies, such as engineering inherently stable biomolecules, are labor-intensive and complex. Conventional techniques, including freeze, vacuum, spray, and thin-film drying, expose biologics to extreme temperatures and/or pressures, require long processing times, and depend on complex formulations. Thus, a more efficient, scalable, and cost-effective stabilization technology is needed to preserve biological activity while enabling ambient-temperature storage. We have developed a novel technique, light-assisted drying (LAD), to create trehalose-based amorphous solids for biologic preservation. Using a near-IR laser, LAD rapidly removes water from a liquid formulation, forming a protective trehalose matrix that stabilizes the biologic. By precisely controlling sample temperature, LAD prevents damage to thermally sensitive biologics. In contrast to traditional methods, LAD processes samples quickly and requires minimal excipients, while avoiding exposure to extreme temperatures or pressures. We have successfully applied LAD to the model protein lysozyme and nucleic acid nanoparticles used in nanomedicine. Additionally, we have demonstrated LAD’s capability to process volumes ranging from 0.25 to 1 mL—typical vaccine doses—and to process samples inside glass vials commonly used in industry. We have also developed a system capable of processing multiple samples simultaneously, highlighting LAD’s scalability and versatility for biologic preservation. This study will evaluate LAD’s ability to stabilize inactivated poliovirus vaccine (IPV). Our preliminary data suggest that LAD preserves IPV potency. We will build on these findings by assessing humoral immune responses in a mouse model following immunization with the LAD-processed vaccine. Long-term stability will be evaluated through storage trials at both freezing and elevated temperatures. Potency will be measured using ELISA assays, and immunogenicity for stored vaccine will be examined via in vivo testing. Additionally, transmission electron microscopy (TEM) will assess the structural integrity of the viral capsid both immediately post-processing and after storage. This project will validate LAD for IPV stabilization, marking the first application of the technology to a vaccine, and establish LAD as a versatile platform for preserving other biologics. The findings will provide essential data for broader applications of LAD and future translation and commercialization efforts.
