“Continuous Manufacturing
of Liposomes and Lipid Nanoparticles.”

Customer Case Study

This case study shows a GMP-compliant continuous manufacturing system for liposomes and lipid nanoparticles, developed by FDA and UConn.

The NanoFlowSizer was integrated as an online particle size analyzer to monitor nanoparticle formation and provide feedback control during processing. The system enabled real-time particle size control, rapid assessment of process parameters, and good agreement between inline and offline measurements.

It demonstrates how inline particle size data can support robust continuous manufacturing and process control.

Key take aways:

• Inline particle size monitoring during continuous liposome and LNP manufacturing.
• Real-time feedback control of critical process parameters such as flow rate.
• Controlled particle size state reached in 6 minutes at a 110 d.nm target.
• Mean particle size of 111.5 d.nm with a standard deviation of 5.35 d.nm over the run.
• Good agreement with offline measurement for particle size and other quality attributes.
• Supports continuous manufacturing and process control for lipid-based nanoparticle formulations.

Clean room at UConn