Precision NanoSystems NanoAssemblr Ignite+ for preclinical drug development

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Gaining recognition for its speed and ease of use, the NanoAssemblr platform from Precision NanoSystems (PNI) is making critical contributions around the world to advance the development of treatments for cancer, rare genetic disorders and vaccines for current and future infections including COVID-19. As a global leader in non-viral delivery of genomic medicines, the NanoAssemblr platform with NexGen technology offers controlled mixing conditions for reproducible nanoparticle formulation at all stages from discovery to commercial manufacturing. The latest addition, the NanoAssemblr Ignite+, is designed to simplify the transition into clinical development and manufacturing by maintaining the same process parameters as the NanoAssemblr Blaze and GMP System.

Ignite+ expands the current capabilities of the 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. Using the NxGen 500 microfluidic mixer, which is also used in larger systems, should ensure consistent critical quality attributes (CQAs) with the 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).

Establishing new specifications for critical process parameters including total flow rate (TFR) for large-scale preclinical and clinical systems is critical for successful scale-up. Ignite+ allows users to 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 means CQAs are maintained across scales, saving time and resources while reducing risk during technology transfer.

Ignite+ is designed to lower the barrier to developing nanomedicines. The simple, low-volume workflow and automated synthesis of nanomedicines require minimal set-up and operator training to enable robust and reproducible formulations. This saves time and reduces raw materials, waste volumes and associated costs.

For more information: https://www.atascientific.com.au/products/nanoassemblr-ignite-2/.