SBIR Phase II: Rapid Dehydration and Stabilization of Biopharmaceutical Formulations at Room Temperature

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is the development of a platform technology for rapid room-temperature dehydration of biopharmaceutical formulations. This innovation addresses critical challenges in drug formulation, delivery, and storage of temperature-sensitive biologics such as proteins, antibodies, and vaccines. The technology enables production of shelf-stable, bioactive powders with controllable particle characteristics, compatible with various administration routes including inhalation, nasal delivery, and transdermal microneedle patches. By eliminating the need for high and low temperatures during processing, this approach preserves the integrity of heat- and freeze-sensitive biologicals while significantly reducing energy consumption. The innovation has two major impacts: 1) it reduces reliance on the complex and costly pharmaceutical cold chain, which currently requires maintaining specific temperature conditions during transport and storage, and 2) it provides a scalable, continuous system for biopharmaceutical powder production at room temperature. This technology has the potential to revolutionize the biopharmaceutical industry by improving drug safety, reliability, and accessibility worldwide. Ultimately, this innovation could lead to more effective and widely available treatments, benefiting patients and healthcare systems globally. The proposed project aims to address critical challenges in biopharmaceutical manufacturing through the development of a rapid room-temperature aerosol dehydration platform technology. This innovation tackles significant issues in formulation, delivery, and storage of temperature-sensitive biologics, offering an alternative to complex cold chain infrastructure and mitigating product degradation risks during conventional drying. Research objectives include scaling up the system to ~100 g/h pilot production capacity, optimizing the process for diverse biomolecules and nanoparticles, and developing formulations for various drug delivery modes. A pilot-scale system will be constructed, guided by experimental studies, theoretical modeling and Computational Fluid Dynamics simulations. The system will produce and characterize proteins, enzymes, viral vectors, and PLGA nanoparticles. Process parameters will be optimized using Design of Experiments and Quality by Design principles. The project will investigate pulmonary, nasal, and transdermal delivery modes, focusing on excipient selection, particle engineering, and stability enhancement. In silico and in vitro studies will assess formulation performance. Anticipated results include a scalable platform producing stable, bioactive powders with controlled particle characteristics, suitable for various administration routes and offering improved shelf-life compared to conventional formulations. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.