The NanoAssemblr Ignite+ expands the capabilities of Ignite with increased flow rates of up to 200 mL/min pre-dilution and volumes of up to 60 mL, enabling larger preclinical and early process development studies.
NanoAssemblr Ignite also simplifies scale-up by maintaining the same critical process parameters (CPPs) as the NanoAssemblr Blaze and GMP System. Using the NxGen 500 microfluidic mixer which is also used in larger systems ensures consistent CQAs as you transition to clinical development and manufacturing while maintaining the familiar workflow of Ignite.
Larger volumes enable the incorporation of downstream process development including tangential flow filtration (TFF) at the earliest stages of preclinical development and expand efficacy and toxicity testing for large-cohort small-animal and larger animal studies including non-human primates (NHPs).
Ignite+ for Seamless Transfer of Manufacturing Processes
Establishing new specifications for CPPs including total flow rate (TFR) for large-scale preclinical and clinical systems is critical for successful scale-up. Perform these studies at the bench scale, enabling the direct protocol transfer of formulation and process parameters to larger systems, new teams or manufacturing facilities. This ensures CQAs are maintained across scales, saving time and resources while reducing risk during technology transfer.