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Real-Time Monitoring in Continuous Manufacturing of Liposomal Nanoparticles
Liposomal nanoparticles, widely used in cancer therapies, mRNA vaccines, and immunotherapies, require precise quality control to ensure safety and efficacy—especially in light of concerns such as those raised by the EMA COVID-19 data leak. To meet these demands, the FDA and University of Connecticut have developed a GMP-compliant continuous manufacturing platform. This system uses real-time process analytical technologies (PAT), including Avantes UV-Vis spectrometers and multivariate algorithms, to monitor critical parameters like particle size and drug encapsulation in real-time. The integrated approach enables scalable, efficient production, combining nanoparticle formation, purification, buffer exchange, concentration, and drug loading into a streamlined process ready for fill-finish operations.