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.