NanoAssemblr™ commercial formulation system
Automated system with a single-use flow path for the clinical and commercial manufacturing of lipid nanoparticles (LNPs)
NanoAssemblr™ commercial formulation system
Automated system with a single-use flow path for the clinical and commercial manufacturing of lipid nanoparticles (LNPs)
Overview
- Automated: A guided workflow automates the processes of priming, calibration, formulation, and in-line dilution while in-process monitoring of flow rate and pump speed enables real-time control.
- Single-use flow path: Minimizes the need for sanitizing and performing cleaning validation, enabling efficient changeover and reducing cleanroom downtime for clinical development and commercial production.
- Reproducible: Scalable NxGen™ technology and low-pulsation pumps ensure controlled mixing conditions, resulting in consistent flow rates for robust particle formation.
- Intuitive software: Intuitive software supports electronic batch records and enables 21 CFR Part 11 compliance, ensuring data integrity and the user-friendly interface reduces the risk of operator error.
- Hazardous location rating: ATEX and IECEx rating minimize environmental, health, and safety risks when using flammable solvents during RNA encapsulation.
NanoAssemblr™ commercial formulation system overview
Learn how the NanoAssemblr™ commercial formulation system simplifies workflows and enables efficient changeover for the clinical and commercial production of LNPs.
Single-use flow kit
The single-use flow kit can be installed in less than 60 minutes and includes the cartridge, pump heads, flow meters, and flow path. Composed of biocompatible and animal-derived ingredient-free materials, the flow kit is assembled in a cleanroom, packed in double bags, and gamma-irradiated (25.0 to 45.0 kGy) for bioburden reduction.
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 critical process parameters (CPPs) during scale-up using the NanoAssemblr™ family of formulation systems.
Real-time 3D online tool
Want to see the NanoAssemblr™ commercial formulation system up close? Explore the system in 3D with this interactive, real-time online tool.
Maintain critical quality attributes (CQAs) throughout scale-up to clinical and commercial production
Self-amplifying RNA (saRNA)-LNPs prepared using NxGen™ technology maintain physicochemical characteristics throughout scale-up to commercial manufacturing. Size, polydispersity index (PDI), and encapsulation efficiency are consistent using A) the NxGen™, NxGen™ 500, and NxGen™ commercial cartridge 48 L/h and B) from Ignite+™ for early preclinical development through to the commercial formulation system for clinical and commercial manufacturing. Error bars represent 1 standard deviation and comparison values are from a post-hoc Tukey test after one-way ANOVA.
Transfer manufacturing processes and minimize process development
saRNA-LNPs are biologically potent in vitro and in vivo, inducing expression of SARS-CoV-2 antigen and robust immune responses. A) BHK 570 cells were transfected with decreasing amounts of saRNA-LNPs and B) the percentage of cells expressing SARS-CoV-2 spike protein was measured using an anti-spike conjugated AlexaFluor488 antibody with 95% confidence intervals in shaded areas. C) EC50 values were similar across systems. Error bars represent 95% confidence intervals. D) BALB/c mice were used for a 42-day prime and boost dose study. E) Robust SARS-CoV-2-specific IgG responses in serum were observed at day 21 and 42 post-injection for each condition. Error bars are 1 standard deviation. 1x PBS vs instrument comparison p-value for a given time point using post-hoc Tukey test after one-way ANOVA (p≤.05: *, p≤.01: **, p≤.001: ***, p≤.0001: ****).
