Tunable RF/Microwave Drying of Biologics

This project’s main goal is the development of tunable RF/Microwave lyophilization technology in application to vaccine and biopharmaceutical manufacturing.
Categories
Vaccines
Drug product
Project status
100% Completed

Solution

Performance Period: 9/1/2021 to 6/30/2024

Vaccines are often developed in freeze-dried (lyophilized) presentations due to improved stability, shipping, and generally faster timelines in early clinical development. The current lyophilization technology is capital and energy-intensive, largely due to the use of indirect, conductive heat exchange. The heat removal and input in freezing, primary drying, and secondary drying are via contact between the product and shelves cooled or heated by a circulating working fluid such as silicone oil. This is slow, inefficient, and leads to non-uniform freezing and drying, especially in large-scale production systems. This project’s main goal is the development of tunable RF/Microwave lyophilization technology in application to vaccine and biopharmaceutical manufacturing. The tunable RF/microwave heating technology uses solid-state electromagnetic sources with variable frequency for optimizing power absorption by the frozen and liquid phases. It applies statistical electromagnetics theory and electromechanical actuators to provide average power distribution that is uniform to a specified standard deviation within product volume and complex geometries. The RF/Microwave drying offers significantly increased throughput for manufacturing of vaccines and biopharmaceuticals with a target speed up of 5-10 times in the batch mode.

Publications

Darwish, A., Strongrich, A. D., Alexeenko, A., & Peroulis, D. (2024). Optimizing Statistical Field Uniformity for RF Heating in Lyophilization: Modeling and Experimental Validation. IEEE Transactions on Instrumentation and Measurement, 73, 1-9. https://doi.org/10.1109/TIM.2024.3381275

Mutukuri, T. T., Darwish, A., Strongrich, A. D., Peroulis, D., Alexeenko, A., & Zhou, Q. T. (2023). Radio Frequency – Assisted Ultrasonic Spray Freeze Drying for Pharmaceutical Protein Solids. Journal of Pharmaceutical Sciences, 112(1), 40-50. https://doi.org/10.1016/j.xphs.2022.09.024

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Project Lead

Purdue University

Purdue University

Participating Organizations

IMA Life North America Inc.

IMA Life North America Inc.

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC