Zero gravity, big impact: Purdue University partners with Redwire to explore space-based drug manufacturing
Earth is certainly conducive to life, but maybe not so much to drug manufacturing. Gravity is the main culprit. For example, gravity-driven convection and sedimentation on Earth disrupt crystal growth, leading to defects and inconsistent quality, which hinder pharmaceutical development.
Purdue University College of Engineering researcher Zoltan Nagy, the Arvind Varma Professor in the Davidson School of Chemical Engineering, has launched a project, sponsored by Redwire, to the International Space Station (ISS) that will explore the potential of the microgravity environment to optimize pharmaceutical crystal formation, including cancer therapeutics. By utilizing microgravity, his study aims to enhance crystal quality, uniformity, and polymorphic (structure variation) control, thereby improving drug efficacy and stability.
Nagy’s research, which launched to ISS on Sept. 14, is contributing to Redwire’s microgravity research strategy which leverages the company’s Pharmaceutical In-Space Laboratory (PIL-BOX). PIL-BOX is already operational on the Space Station and is designed to offer pharmaceutical companies and researchers services that leverage the microgravity environment to grow small-batch crystals of pharmaceutically relevant molecules.
“This investigation will not only advance the understanding of crystal nucleation and growth mechanisms — it will also refine terrestrial manufacturing processes,” said Nagy, the project’s principal investigator. “Ultimately, the project aims to produce high-quality seed crystals, contributing to more effective cancer treatments and advancing pharmaceutical manufacturing processes.”
Nagy’s work is sponsored by Redwire, which is receiving direct funding from NASA for the project, and the team’s crystallization experiments are currently being conducted aboard of the ISS. Once returned to Earth, the resulting microgravity produced crystals will be analyzed at Purdue by Nagy and his two graduate students, Katherine Young and Nathaniel Michael, to prove the benefits of microgravity on improving the manufacture of pharmaceutical crystals. Other experiments on subsequent flights are also foreseen, which will integrate mechanistic modeling and artificial intelligence (AI) drive techniques to guide in flight experiments, Nagy indicated.
Nagy’s research overall is characterized by the development and application of process-systems engineering and optimization approaches and tools for engineered product design, with applications in pharmaceutical, fine chemical, biotechnology, food and agrochemical industries. The research combines modeling, optimization and advanced control approaches with experimental investigations using modern measurement techniques.
“The generic, overarching aim is to develop theoretically founded, practical methodologies for the optimization and control of complex processes,” Nagy said, “with quantifiable system performance improvements that can be supported in an industrial environment.”
The work at his lab, the Crystallization and Particle Technology Systems Engineering laboratory, is focused on providing better crystal engineering, which in turn enables more optimized design and production of particulate products with tailored properties and significantly reduced variability in quality.
“We develop novel approaches to control size and shape distribution, polymorphic form and purity of crystals,” Nagy said. “These techniques are based on using complex mathematical models to predict the final product quality, and on optimizing the operating conditions so that the best product quality, measured by parameters such as highest purity and therapeutic efficiency, can be achieved at a minimum of time and cost.”
The end goal is to provide rapid design and scale-up approaches for crystallization systems for commercialization at industrial scale. The techniques are investigated across broad scales, from microfluidic and droplet crystallization systems to large-scale industrial processes.
The researcher expects to publish papers in the relevant journals once the crystals are back from ISS and analyzed.
Indiana is already the No. 1 state in the United States for pharmaceutical exports. Pharmaceutical manufacturing has been tagged as a strategic pillar for sourcing and strengthening manufacturing across the U.S. for products previously produced globally by multiple and diverse outsourced supply chains, with their associated risks of disruption.
“We believe this is a vital project with potential broad impact, and given Purdue, Redwire and U.S. efforts in both pharmaceutical and space research, I believe it could have huge potential upside for researchers and pharmaceutical companies, with therapeutic benefits ultimately flowing through to the nation and population at large,” Nagy said.
