NanoAssemblr™ Ignite and Ignite+ nanoparticle formulation systems
Easy to use, robust, and scalable systems to accelerate preclinical development of nanomedicines
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Excellent apparatus
Pharmaceutical development
It is very useful for the development of nanoparticles.
Review Date: 18 Apr 2023 | Cytiva
Game changer for nanomedicine
Scaling drug encapsulations
This system would have to be the most useful device for any drug delivery application. Fully scalable to GMP manufacture.
Review Date: 30 Mar 2022 | Cytiva
Great consistent instrument! So good!
Lipid nanoparticle formulation
The Ignite instrument by Precision NanoSystems along with the consumable lipid packages make something as tricky as nanoparticle formulation easy for a non-technician to use and to produce better in-vitro results. It has compacted the timescales of my workflow substantially, while some of precision nanosystems customized offerings has allowed me to do some interesting new science in the realm of nanoparticle formulation.
Review Date: 27 Jan 2020 | Cytiva
The NanoAssemblr™ Ignite and Ignite+ systems enable scalable, reproducible, and easy-to-use formulation of lipid nanoparticles (LNPs) for preclinical genomic medicine development.
- Accelerated timelines – Simplified workflows and comprehensive technical support expedite drug development and data generation
- Reproducible – Automated and advanced NxGen™ mixing technology minimizes batch-to-batch and user variability to reproducibly generate homogenous particles
- Easy to use – Simple workflows and intuitive software allow users to be up and running quickly
- Minimized risk – The robust design of the system greatly reduces the chances of contamination and user errors, minimizing troubleshooting and downtime
- Controlled assembly – Precise control over fluid flow rates and ratios allows fine-tuning of the critical quality attributes (CQAs), including particle size, to your specifications
- Scalable – The system enables modeling of clinically relevant parameters and processes at small volumes to predictably scale optimized formulations on the NanoAssemblr™ Blaze system and NanoAssemblr™ commercial formulation system
The NanoAssemblr™ Ignite system formulates at the bench scale with volumes of up to 20 mL and flow rates of up to 20 mL/min.
The NanoAssemblr™ Ignite+ system builds on these features with expanded capabilities, formulating up to 60 mL at up to 200 mL/min. This flexibility supports small-scale de-risking of large-scale systems and initiates process development activities using simple, low-volume workflows.
Scalable NxGen™ technology
NanoAssemblr™ Ignite and NanoAssemblr™ Ignite+ systems feature NxGen™ technology, an advanced mixing architecture that uses toroidal structures within the flow path to maintain steady, consistent mixing conditions. This enables effective transfer of critical process parameters (CPPs) during scaling up while maintaining reproducibility and control.
All cartridges are validated for single use only. Beginning in September 2025, customers can request a software upgrade that allows optional reuse of current NxGen™ and NxGen™ 500 cartridges. For advanced applications, the new NxGen™ scale-ready cartridge (coming soon) is a gamma-irradiated version of the NxGen™ 500 cartridge, designed with GMP in mind and optimized to minimize risks in early-phase and small-scale clinical trials.
Simple, easy workflow
Quickly prepare LNP formulations using a simple, easy to use workflow requiring minimal setup and training.
Optimize formulations and process parameters
Optimize your formulations by controlling critical process and chemical parameters including flow rate, concentration, and charge. Quick formulation times allow for an efficient systematic approach to finding lead genomic medicine candidates.
Polymer and liposome formulations were optimized by controlling critical process and chemical parameters. A) Starting concentration, B) total flow rate and C) flow rate ratio parameters were varied, and 5 replicates were performed for each data point.
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. Performing these studies at the bench scale enables 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.
Critical quality attributes are maintained across a range of flow rates and volumes. Using SARS-CoV-2 self-amplifying RNA (saRNA)-LNPs as a model system, volumes were scaled from 5 mL to 40 mL on Ignite+™ while changing CPPs from the bench scale (12 mL/min, 5 mL) to clinical scale (200 mL/min, 40 mL). CQAs of in-process and finished SARS-CoV-2 saRNA-LNPs including A) size and polydispersity following formulation, in-line dilution and sterile filtration and B) encapsulation efficiency are similar across a range of flow rates and volumes when prepared on Ignite+™. C) Lipid content is also similar across flow rates and volumes.
