The NanoAssemblrTM Scale-Up System
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Continuous flow microfluidic platform designed for scale-up manufacturing of nanoparticles under cGMP conditions.
The NanoAssemblr Scale-up System developed for manufacturing clinical trial materials in the cGMP environment provides seamless scale-up of formulations developed on the NanoAssemblr Benchtop and Blaze platforms. The Scale-up System is installed and ready for cGMP manufacturing at a North American CMO, with the option of transferring the technology into alternative sites. The small footprint of the Scale-up system facilitates easy installation and operation.
Processes developed on pre-clinical instruments are directly transferred to scale-up using identical microfluidic mixers connected in parallel. Parallel mixers enable the execution of identical processes producing a single large volume batch in less time. The Scale-up System with 8 microfluidic mixers running in parallel can produce nanoparticle formulation volumes suitable for early stage clinical trials.