Application of mass photometry in GMP-regulated environments for characterization of AAV samples

In this whitepaper, Refeyn defines how the Samux^MP and Samux^MP Auto can be applied in a GMP-regulated environment and outlines the key features of the Samux^MP software package. The whitepaper addresses challenges in the commercial manufacturing of adeno-associated viruses (AAVs), commonly used vectors for gene delivery. It highlights the limitations of current AAV characterization methods, such as analytical ultracentrifugation (AUC), electron microscopy (EM), or qPCR/ELISA. Mass photometry is introduced as a solution that overcomes bottlenecks, providing reliable data at the single-particle level and aligning with traditional characterization methods.