Sbir phase i: scaling up tunable high-frequency microwave heating for pharmaceutical and biologics manufacturing

This Project Grant award from the National Science Foundation (NSF) under the Technology, Innovation, and Partnerships (CFDA 47.084) program will fund research by Lyowave, Inc. to address the scale-up challenge for using high-frequency microwave heating in the manufacturing of freeze-dried medicines, diagnostics, and other sensitive materials. The $304,436 award aims to develop new experimental methods, physics-based models, and control strategies to enable the noninvasive retrofitting of microwave drying capabilities onto both new and legacy freeze-drying systems. This research is expected to improve manufacturing capacity and address supply chain issues for a variety of critical freeze-dried products. The findings will facilitate regulatory acceptance of microwave drying and provide a pathway to commercialize this technology, initially targeting R&D organizations with viable manufacturing applications.

Abstract

This small business innovation research (sbir) phase i project will result in fundamental knowledge needed to solve the scale-up problem for fast, uniform, volumetric heating during manufacturing of freeze-dried medicines, diagnostics, preservative-free foods, and other high-value sensitive materials. The findings will facilitate a significant improvement in manufacturing capacity for most freeze-dried goods and ultimately provide a pathway towards addressing recurring shortages and securing long-term availability. This sbir research will produce data critical for process understanding as well as new quality control methodologies necessary for regulatory acceptance of microwave drying. The technology will be initially marketed to research and development units or organizations having a clear and viable downstream pathway towards manufacturing. The key competitive advantages offered by the technology are its ability to be noninvasively retrofitted to both new and legacy freeze-drying systems and its capability of producing uniform high-frequency electromagnetic fields specifically targeted towards frozen materials. This small business innovation research (sbir) phase i project aims to improve manufacturing performance of high-value freeze-dried materials having limited shelf life using high-frequency microwave heating. The overall goal of the project is to gain the fundamental knowledge required to effectively scale the technology from laboratory to large-volume manufacturing freeze-drying systems. Key research objectives to be addressed include developing new experimental methods for estimating the effective dielectric properties of frozen aqueous solutions and primary packaging, identifying appropriate physics-based models and parameters for system modeling, and implementing model-based closed-loop control strategies to drive the freeze-drying process at optimal rates. To accomplish these tasks, multiple microwave sources will be fabricated and installed on a modified laboratory freeze-dryer together with a suite of temperature sensing technologies. Experimental measurements will provide the data necessary to develop the coupled unsteady electromagnetic and heat and mass transfer simulations for identifying the scale-up characteristics, microwave source interaction, and volumetric heating performance. Free radical production in the vacuum environment and material compatibility with the electric fields over the system bandwidth will also be assessed either explicitly using appropriate probes or implicitly via bioindicators. 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.- subawards are not planned for this award.