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GMP System


Customized, Modular, Client-specific Scale-up System for cGMP manufacture of Nanoparticles

  • The GMP System can deliver manufacturing volumes in the range of 200 ml to tens of liters. The flexibility and scale in manufacturable volumes is achieved by “scaling out” made possible by arraying multiple microfluidic devices in parallel thus increases volume output without changing manufacturing conditions
  • Fully disposable fluid path components to reduce risk and cost (re: cleaning validation)
  • HPLC pumps designed for ultra-low pulsations in fluid flow. Specifically designed and custom made for the PNI’s system to facilitate access and easy replacement
  • Components made of inert materials (Stainless Steel, PEEK, EPDM, COC) and microfluidic mixer material tested and cleared for extractables
  • Designed to work with downstream processing systems (e.g. Tangential Flow Filtration) in a standard drug product manufacturing workflow

NanoAssemblr GMP System: Is a modular and configurable system, fit-for-purpose and phase appropriate, for the GMP manufacturing of nanomedicines.

Scale-Up System
Polymeric Nanoparticle & Liposome

Flexible, Efficient & Reproducible 

Clinical Development

NanoAssemblr Technology: Ensures that the nanoparticle formation conditions are uniform, controlled and reproducible. Results in faster development times, easier scale up and higher production yields.


Continuous flow microfluidic platform designed for scalable manufacturing of nanoparticles under cGMP conditions.


Nanoparticles manufactured on the GMP System are functionally similar to those produced with the NanoAssemblr® Benchtop and Blaze.

Seamless Scale-Up of Formulations
Formulations transferred from the NanoAssemblr® Benchtop and Blaze to the GMP System show equivalent size, polydispersity and in-vivo activity of siRNA nanoparticles.
Scale-Up: Consistent Size
Scale-Up: Consistent Composition
Scale-Up: Consistent Activity
Scalability Through Parallelization



Nucleic Acid Lipid Nanoparticle


Lipid Nanoparticles






Scale-Up Tech: Multiple Cartridges



Multiple microfluidic devices can perform the same operation in parallel to increase throughput. 

Polymeric Nanoparticle




Polymeric Nanoparticles






Microfluidic lipid nanoparticle (LNP) formulation. Nucleic acids in buffer (left) and LNP precursors in a solvent (right) are injected into the two inlets of a microfluidic cartridge, where they are mixed in a controlled fashion. LNPs of different sizes (far right) can be produced by varying the relative and total flow rates.

Scale-Up Technology: Formulation

Get Started

To learn how Precision NanoSystems accelerates nanomedicine development from an idea to clinical applications, contact our Technical Sales Team.

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Resource Center

Publication - Abstract

July 01, 2020

Journal of Controlled Release

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

G. Lou, G. Anderluzzi, S.T. Schmidt, S. Woods, S. Gallorini, M. Brazzoli, F. Giusti, I. Ferlenghi, R. Johnson, C.W. Rob...

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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 and Y. Perrie

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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 Liposomes

D. Chatzikleanthous, S.T. Schmidt, G. Buffi, I. Paciello, R. Cunliffe, F. Carboni, M.R. Romano, D.T. O'Hagan, U. D'Oro, ...

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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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Publication - Abstract

May 31, 2019


mRNA Vaccines Against H10N8 and H7N9 Influenza Viruses of Pandemic Potential Are Immunogenic and Well Tolerated in Healthy Adults ...

R.A. Feldman, R. Fuhr, I. Smolenov, A. Ribeiro, L. Panther, M. Watson, J.J. Senn, M. Smith, Ö. Almarsson, H.S. Pujar, M....

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Publication - Summary

May 18, 2019

Annals of Hematology

Lipid Nanoparticle-mediated siRNA Delivery for Safe Targeting of Human CML In Vivo

N. Jyotsana, A. Sharma, A. Chaturvedi, M. Heuser et al.

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