NanoAssemblr® Commercial Formulation System

The NanoAssemblr commercial formulation system supports an automated workflow of priming, calibration, formulation, and in-line dilution to simplify GMP manufacturing of mRNA-LNP drug products. Its intuitive software interface enables 21 CFR Part 11 compliance and electronic batch records that capture in-process monitoring of flow rate and pump speed. The system uses scalable NxGen™ technology and low-pulsation pumps for precise control of mixing parameters, resulting in consistent flow rates from 6 to 48 L/h that produce homogenous and reproducible nanoparticles.

The single-use flow path minimizes the need for sanitizing and performing cleaning validation, enabling efficient changeover between production runs while minimizing the risk of cross-contamination. The flow kit can be easily installed, calibrated, and ready for formulation in less than 60 minutes. Learn more about this automated, single-use system for the clinical and commercial production of LNPs under cGMP conditions.