The NanoAssemblr™ Platform: Scalable, Microfluidics-based Manufacture of siRNA Lipid Nanoparticles

Category
Advances in Process Engineering -- New Methods for the Production of Particles, Capsules, and Coatings
Year
2014
Authors
Colin L. Walsh, Kevin Ou, Aysha Ansari Timothy J. Leaver, Andre W. Wild, Robert J. Taylor, Euan C. Ramsay, Pieter R. Cullis
Institutions
Precision NanoSystems, Inc., Vancouver, BC, V6Z 1Z3, Canada; Department of Biochemistry and Molecular Biology, University of British Columbia, Vancouver, BC, V6Z 1Z3, Canada.
Summary

Here, we describe the NanoAssemblr™ platform: a novel, scalable microfluidics-based system for the development and manufacture of nanoparticles for drug delivery applications.1-3 The NanoAssemblr™ uses automated instrumentation and custom engineered microfluidic chips to enable millisecond mixing of nanoliter reaction volumes containing nanoparticle components. This well-controlled process mediates bottom-up self-assembly of siRNA lipid nanoparticles (siRNA-LNP) with reproducible sizes (25-150 nm) and low polydispersity (PDI < 0.1). Additionally, this system facilitates rapid formulation screening at small volumes, and is easily scaled by parallelizing microfluidic mixers, which maintains identical reaction conditions for batch sizes from milliliters to liters.