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NanoAssemblr®
GMP System

 

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

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  • 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
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  • Fully disposable fluid path components to reduce risk and cost (re: cleaning validation)
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  • 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
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  • 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
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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
Liposome

 

Lipid Nanoparticles

 

Liposomes

 

 

 

Scale-Up Tech: Multiple Cartridges

 

 

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




Emulsion
Polymeric Nanoparticle

 

Emulsions

 

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 - Summary

April 04, 2019

The Journal of Neuroscience

PTCD1 is required for mitochondrial oxidative-phosphorylation: possible genetic association with Alzheimer's disease

D. Fleck, L. Phu, E. Verschueren, T. Hinkle, M. Reichelt, T. Bhangale, B. Haley, Y. Wang, R. Graham, D.S. Kirkpatrick, M...

Read More

Publication - Summary

February 07, 2019

Nano Research

Chemotherapy drugs derived nanoparticles encapsulating mRNA encoding tumor suppressor proteins to treat triple-negative breast can...

C. Zhang, X. Zhang, W. Zhao, C. Zeng, W. Li, B. Li, X. Luo, J. Li, J. Jiang, B. Deng, D.W. McComb, Y. Dong

Read More

Application Note

January 16, 2019

mRNA Lipid Nanoparticles: Robust low-volume production for screening high-value nanoparticle materials

Read More PDF

Publication - Summary

September 24, 2018

Nucleic Acid Therapeutics

MicroRNAs Enable mRNA Therapeutics to Selectively Program Cancer Cells to Self-Destruct

R. Jain, JP. Frederick, EY. Huang, KE. Burke, DM. Mauger, EA. Andrianova, SJ. Farlow, S. Siddiqui, J. Pimentel, K. Cheun...

Read More

Poster

July 01, 2018

Robust low-volume production of nanoparticles for genetic manipulation of cells

Read More PDF

Publication - Summary

February 27, 2018

Cell Reports

A Single Administration of CRISPR/Cas9 Lipid Nanoparticles Achieves Robust and Persistent In Vivo Genome Editing

J. Finn, A. Smith, M. Patel, L. Shaw, M. Youniss, J. Heteren, T. Dirstine, C. Ciullo, R. Lescarbeau, J. Seitzer, R. Shah...

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