NanoAssemblr™ Blaze nanoparticle formulation system
Process development system with a single-use cartridge for the formulation of lipid nanoparticles (LNPs)
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The NanoAssemblr™ Blaze and Blaze+ systems streamline the process development of lipid nanoparticle (LNP) formulation, enabling the efficient scaling from early research through preclinical and early clinical development. With flexible volume options and a closed system environment, these systems support early chemistry, manufacturing, and control (CMC) studies and large-scale protocol development for upstream and downstream operations, providing valuable insights into processes and consumables required for GMP manufacturing.
- Efficient: Validate end-to-end clinical manufacturing processes, including tangential flow filtration (TFF), sterile filtration, and fill/finish operations on a preclinical system with a simplified setup and shorter run times, saving time and resources.
- Flexible volume options: Select the Blaze system for low-volume applications (up to 1 L) or upgrade to the Blaze+ system for high-volume applications (up to 10 L), enabling toxicity, stability, and large-cohort in vivo animal studies
- Closed system environment: The Blaze+ system provides a closed system environment that enables external vessel connections and includes a software upgrade, reducing the risk of contamination during scale-up.
- Scalable: Easily transfer critical process parameters (CPPs) to the NanoAssemblr™ commercial formulation system, enabling smooth technology transfer to a cGMP facility.
- Reproducible: NxGen™ technology ensures consistent, controlled mixing conditions, enabling reproducible, robust particle formation.
NxGen™ cartridges and tubing kits
Single-use NxGen™ cartridges reduce the risk of cross-contamination and are available with or without in-line dilution, which automates a key process and streamlines the LNP workflow. The cartridges use the same mixer as the NanoAssemblr™ Ignite+ and NanoAssemblr™ commercial formulation system, enabling the direct transfer of CPPs from bench to process development and clinical and commercial production.
The single-use tubing kit enables external vessel connections and a closed-system environment for the Blaze+ system.
As of June 2025, customers can purchase the new NxGen™ Blaze cartridges for the NanoAssemblr™ Blaze nanoparticle formulation system and will have the option to reuse them. Blaze system NxGen™ cartridges remain validated for single use only, up to 1 L on the Blaze system or 10 L on the Blaze+ system. Further information can be found in the Blaze user guide.
Scalable NxGen™ technology
NxGen™ technology enables controlled and reproducible mixing conditions through its innovative mixing architecture, consisting of unique toroidal structures within the flow route. It is designed to enable the transfer of CPPs during scale-up using the NanoAssemblr™ family of formulation systems.
