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Commercial Formulation System

Automated, single-use system for clinical and commercial production of lipid nanoparticles 


Scale-Up System

The NanoAssemblr® commercial formulation system is an automated, single-use system for the clinical and commercial production of lipid nanoparticles (LNPs) under cGMP conditions. Designed for efficient changeover and robust manufacturing processes, the system enables operational flexibility and standardized manufacturing of genomic medicines. 



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NanoAssemblr System Commercial Formulation System Left Side
Accelerate Time to Market with Built-in Automation and Operational Flexibility

The NanoAssemblr commercial formulation system supports an automated workflow of priming, calibration, formulation, and in-line dilution to simplify GMP manufacturing of mRNA-LNP drug products. Its intuitive software interface enables 21 CFR Part 11 compliance* and electronic batch records that capture in-process monitoring of flow rate and pump speed. Scalable NxGen™ technology and low-pulsation pumps provide precise control of mixing parameters, resulting in consistent flow rates from 6 to 48 L/h that produce homogenous and reproducible nanoparticles. 

The single-use flow path minimizes the need for sanitizing and performing cleaning validation, enabling efficient changeover between production runs while minimizing the risk of cross-contamination. The flow kit can be easily installed and ready for formulation in <60 minutes. 



  • Electronic batch records
  • In-process monitoring of flow rate
  • Workflow for priming, calibration, formulation, and in-line dilution



  • NxGen™ technology accelerates scale-up and minimizes process development
  • Directly transfer CPPs from clinical development to commercial manufacturing



  • NxGen architecture and low-pulsation pumps enable efficient mixing and consistent flow rates
  • Particles maintain CQAs for a robust manufacturing process

Regulatory Compliant

Regulatory Compliant

  • Intuitive software interface enables 21 CFR Part 11 compliance*
  • ATEX and IECEx** rated for use with flammable solvents
  • Validation guide with extractables data for single-use flow kit

Single Use Icon

Single-use Technology

  • Single-use flow kit reduces the risk of contamination between batches and campaigns
  • Enables multi-product manufacturing in GMP facilities

Qualification & Expertise

Qualification & Expertise

  • Installation and qualification with on-site IOQ
  • Leverage Precision NanoSystems’ technical knowledge and LNP expertise

*Pending third party audit

**Pending final certification

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Learn more about the NanoAssemblr® commercial formulation system and how it accelerates clinical and commercial manufacturing of genomic medicines.

Single-Use Flow Kit
The single-use flow kit includes the NxGen cartridge, pump heads, flow meters, and flow path. Composed of biocompatible and animal-derived ingredient free materials, the flow kits are assembled in a cleanroom, packed in double bags, and gamma-irradiated (25.0 to 45.0 kGy) for bioburden reduction before delivery. Validation guides, certificates of quality, and extractables data are available for all manufacturing flow kits.
Flow Kit Diagram

Scalable NxGen™ Technology and DVBM Architecture

NxGen technology enables controlled and reproducible mixing conditions using the scalable DVBM architecture, consisting of unique toroidal structures within the flow route that reduce the mixing time by increasing the contact area between fluids. This enables the transfer of critical process parameters (CPPs) and ensures consistent critical quality attributes (CQAs) during scale-up using the NanoAssemblr family of formulation systems.


NxGen Mixer

Maintain Critical Quality Attributes During Scale-up to Commercial Manufacturing



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 are 1 standard deviation and comparison values are from a post-hoc Tukey test after one-way ANOVA.



Transfer Manufacturing Processes and Minimize Process Development
immune response data
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: ****). 

Videos and Tools

NanoAssemblr Commercial Formulation System Overview




Watch the video to learn more about the system 


NanoAssemblr Commercial Formulation System Real-Time 3D Tool


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Explore the tool in 3D and understand key features


Brochure and Application Note

Learn more about the NanoAssemblr commercial formulation system and NxGen technology.


Resource Center


September 01, 2022

Scale Up Genome Editing of CAR T Cells using Lipid Nanoparticles

Read More 阅读更多 PDF

Application Note

March 15, 2022

Genome Editing of Human Primary T Cells with Lipid Nanoparticles

Read More 阅读更多 PDF

Publication - Abstract

July 01, 2020

Journal of Controlled Release

Delivery of Self-amplifying mRNA Vaccines by Cationic Lipid Nanoparticles: The Impact of Cationic Lipid Select...

G. Lou, G. Anderluzzi, S.T. Schmidt, S. Woods, S. Gallorini, M. Brazzoli, F. Giusti, I. F...

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Publication - Abstract

May 08, 2020


Investigating the Impact of Delivery System Design on the Efficacy of Self-Amplifying RNA Vaccines

G. Anderluzzi, G. Lou, S. Gallorini, M. Brazzoli, R. Johnson, D.T. O'Hagan, B.C. Baudner a...

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Publication - Abstract

April 02, 2020

Journal of Controlled Release

Design of a Novel Vaccine Nanotechnology-based Delivery System Comprising CpGODN-protein Conjugate Anchored to...

D. Chatzikleanthous, S.T. Schmidt, G. Buffi, I. Paciello, R. Cunliffe, F. Carboni, M.R. Ro...

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Publication - Abstract

December 31, 2019


Investigating Prime-Pull Vaccination through a Combination of Parenteral Vaccination and Intranasal Boosting

C.B. Roces, M.T. Hussain, S.T. Schmidt, D. Christensen and Y. Perrie

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