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

Colin L. Walsh1, Kevin Ou2, Aysha Ansari2 Timothy J. Leaver1, Andre W. Wild2, Robert J. Taylor1, Euan C. Ramsay1, Pieter R. Cullis1,2

1 Precision NanoSystems, Inc., Vancouver, BC, V6Z 1Z3, Canada; 2 Department of Biochemistry and Molecular Biology, University of British Columbia, Vancouver, BC, V6Z 1Z3, Canada.

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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.

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