NanoAssemblr™ Ignite and Ignite+ nanoparticle formulation systems
Easy-to-use, scalable lipid nanoparticle formulation systems designed to accelerate progress from preclinical to clinical development
1. Max flow rate
2. Max volume
Overview
The NanoAssemblr™ Ignite and Ignite+ systems provide an easy-to-use, scalable platform for reproducible lipid nanoparticle (LNP) formulation, supporting genomic medicine development from preclinical through clinical manufacturing.
- Accelerate development timelines – Streamlined Ignite workflows support smooth scale‑up, while the Ignite+ system enables small‑scale clinical manufacturing, allowing the same workflow to be used in both preclinical and clinical environments.
- Deliver reproducible results – Advanced NxGen™ mixing technology minimizes batch-to-batch and user variability to reproducibly generate homogenous, high-quality nanoparticles.
- Easy to use – Simple workflows and intuitive software allow users to quickly implement and operate the system with minimal training.
- Reduced operational risk – A robust system design reduces user error, troubleshooting, and downtime. NxGen™ cartridges are validated for single use, eliminating cleaning validation and lowering contamination risk while providing operational flexibility.
- Scale with confidence – The system enables modeling of clinically relevant parameters at small volumes to predictably scale up or scale down clinical manufacturing processes for cost-effective troubleshooting.
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 extends these capabilities with increased throughput and flexibility, enabling formulation of up to 60 mL at flow rates of up to 200 mL/min (12 L/h). This supports early process development while reducing scale-up risk of large-scale systems using simple, low-volume workflows. When paired with the NxGen™ scale-ready cartridge 12 L/h, the Ignite+ system also supports small-scale clinical manufacturing, allowing the same workflow to be used across development stages for a more streamlined transition and reduced development risk.
Scalable NxGen™ technology
NanoAssemblr™ Ignite and NanoAssemblr™ Ignite+ systems feature NxGen™ technology, an advanced mixing architecture that integrates toroidal structures within the flow path that rapidly and gently folds two fluids together. This design delivers tightly controlled, highly reproducible mixing conditions. A shared NxGen™ mixing geometry across systems and scales enables direct transfer of critical process parameters (CPPs), helping accelerate development while reducing scale-up risk.
Cartridges designed for clinical readiness and flexibility
All NxGen™ cartridges are validated for single use. As of September 2025, existing customers may request an Ignite system software upgrade that enables the reuse of NxGen™, NxGen™ 500, and NxGen™ scale-ready cartridges. All new NanoAssemblr™ Ignite systems ship with this functionality enabled.
The new NxGen™ scale-ready cartridge 12 L/h is a gamma irradiated, animal origin-free (AOF), and fully traceable cartridge that supports regulatory and clinical readiness. Designed with GMP in mind, it helps you maintain the same workflow on the Ignite+ system, reducing risk and minimizing waste as your program advances. Request a software upgrade to enable cartridge reusability and/or learn more about the NxGen™ scale-ready cartridge.
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.
Related products
Instrument cartridges
NanoAssemblr™ Ignite and Ignite+ cartridges feature NxGen™ technology that allows scale-up through a single mixer from mL/min to L/h.
No priming or cleaning required for an efficient workflow. Ignite cartridges are compatible with a wide range of solvents to make a diverse array of nanomedicine formulations.
Automatic In-line dilution cartridges
Automated in-line dilution allows modelling of the processes that will be required for future GMP production of nanoparticles.
Reagents
Expand formulation capabilities and advance genomic medicines with specialized accessories and optimized LNP delivery reagents.
GenVoy-ILM is an off-the-shelf LNP reagent designed to enable the rapid and easy production of RNA-loaded LNPs using the NanoAssemblr™ Ignite system.
GenVoy-ILM T Cell Kit for mRNA is an off-the-shelf LNP reagent mix optimized for the delivery of mRNA or Cas9 mRNA/sgRNA into activated human primary T cells.
Cytiva CD34+ HSC LNP kit is an off-the-shelf LNP reagent mix optimized for the delivery of mRNA or Cas9 mRNA/sgRNA into hematopoietic stem cells.
Cytiva RNA delivery LNP kit is an off-the-shelf LNP reagent with ready–to–use ionizable lipid mix and buffers to fast-track payload screening and RNA drug delivery validation, progressing lead candidates quickly through preclinical studies accelerating clinical evaluation.
Heating Package
The heating package empowers users to heat and keep their formulations in syringes at temperature when operating the Ignite and Ignite+ instruments.
As we continue integrating Precision NanoSystems into Cytiva, NanoAssemblr™ Ignite and Ignite+ systems may still display Precision NanoSystems branding. All instruments, regardless of branding, are manufactured to Cytiva’s quality standards.
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