A research team led by Andrew Zydney, Bayard D. Kunkle Chair and professor of chemical engineering at Penn State, has received the inaugural Most Impactful Project Award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).
The award recognizes NIIMBL-funded projects that exemplify innovation, collaboration and measurable impact in advancing biopharmaceutical manufacturing. The honor was awarded to the project, "Inline Spiking Method for Validation of Virus Clearance in Continuous Bioprocessing," which brought together researchers and industry partners to improve the efficiency and reliability of validating virus removal in a new, advanced approach to biopharmaceutical manufacturing.
Most biopharmaceutical products, including monoclonal antibodies used to treat cancers, autoimmune disorders and infectious diseases, are produced in mammalian cells. These cells, as well as the manufacturing environments they pass through, can harbor viruses responsible for illnesses like the flu. Since these medicines are injected directly into the body, any viruses present in the final product would bypass the body's natural defenses and pose serious health risks, meaning manufacturers must ensure therapeutic products are completely free of viral contamination before they are administered to patients.
While there are well established validation processes for traditional batch manufacturing, no effective method previously existed for continuous bioprocessing systems, which can operate for days or even weeks. To address this critical problem, the team introduced a novel strategy to validate membrane filtration systems, one of the primary methods used to remove viruses from biopharmaceutical products. Membrane filters contain pores small enough to trap viruses while allowing smaller therapeutic proteins to pass through. To confirm the filters perform as intended, manufacturers "spike" the manufacturing stream with a harmless test virus and demonstrate that the filtration system removes it.
The team's approach provides manufacturers with a reliable way to validate virus clearance in these continuous systems, which have the potential to significantly reduce the cost of manufacturing expensive biopharmaceuticals while maintaining product safety and quality.
"This award highlights the success that my research group has had in advancing the design and application of membrane systems for the purification of life-saving biopharmaceutical products," Zydney said. "The visibility provided by this award should help us continue to develop collaborations with leading industrial partners."
The project involved two postdoctoral scholars and one doctoral student from Zydney's lab. One of the postdocs, Seon Yeop Jung, is now an assistant professor at Dankook University in South Korea. The other postdoc, Anna Malakian, is now a lead process engineer at Carollo Engineers. The doctoral student, Mohammad Afzal, has since graduated and is a senior scientist at AbbVie, a global biopharmaceutical company.
The project included partnerships among Penn State researchers and several industry collaborators, including MilliporeSigma, Genentech and Merck. According to Zydney, the collaboration provided a unique opportunity to explore key issues in developing new methods to validate the performance of virus removal filters, which are critical for ensuring the safety of biopharmaceutical products used to treat cancers, autoimmune diseases like psoriasis and Crohn's, and infectious diseases.
"This project demonstrates how NIIMBL's collaborative model identifies industry challenges and creates and demonstrates solutions that advance biopharmaceutical manufacturing," said Kelvin Lee, NIIMBL's director. "The selection committee recognized the foundational nature of this project, as well as its durability and industry adoption over time. This project is a blueprint for the kind of impact possible through NIIMBL's Project Call work."
The award was presented at the 2026 NIIMBL National Meeting, held June 22-25 in Washington, D.C.
