NIIMBL’s Viral Vector Program has awarded funding to Michigan Technological University to evaluate methods for detecting adeno-associated virus (AAV) aggregation in gene therapy manufacturing. The project will help the biopharmaceutical industry identify a reliable analytical method to support safe, cost-effective gene therapy production.
The project is scheduled to begin in spring 2026 and is expected to last approximately six months. The award stems from the Program’s AAV Aggregate Testing Method Request for Applications, released in September 2025.
AAV aggregates are impurities formed when viral particles or capsids bind together instead of remaining as individual, properly formed particles. These aggregates compromise the quality, safety, and efficacy of gene therapies. The industry uses several techniques to detect and quantify aggregates with varying levels of robustness and dependability.
Michigan Technological University will evaluate leading testing methods using representative samples, including dynamic light scattering (DLS) and size exclusion chromatography (SEC-HPLC) coupled with ultraviolet (UV), fluorescence, bio-inert dual angle and dynamic light scattering detectors for aggregate detection. These methods will be evaluated for performance attributes, including specificity, repeatability, limits of detection/quantification, range, and robustness. The project will provide detailed protocols for AAV stress studies and a validated analytical method for aggregate detection.
“Reliable measurements of product quality are critical for gene therapy manufacturing and control,” said NIIMBL Viral Vector Program Lead Chris Williams. “This project will give the industry confidence in tools for measuring AAV aggregation. Application of these methods will improve process consistency, reduce costs, and accelerate technical development; bringing gene therapies closer for the patients who need them.”
NIIMBL’s Viral Vector Program is building an open-access AAV manufacturing and testing platform to streamline development. NIIMBL will host Building a Shared AAV Manufacturing Resource: A Public Workshop on February 26 to gather input that will influence the design, usability, and future development of the platform. Register here.
For more information about the Viral Vector Program, visit NIIMBL.org
About NIIMBL
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a network of federally sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with additional support from its members.
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