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GMP System

A custom solution for clinical development and commercial supply, including:


Flexible GMP System Hardware


Formulation, process, and analytical development


Tech Transfer of Equipment and SOPs to cGMP Manufacturing Suite


Quality Management System (QMS) supports the manufacturing of the GMP System


Regulatory Support

Scale-Up System
Polymeric Nanoparticle & Liposome

Flexible, Efficient, & Cost-Effective

Clinical Development

Continuous flow microfluidic platform designed for scale-up manufacturing of nanoparticles under cGMP conditions.


The GMP System’s formulation results are in sync with NanoAssemblr® Benchtop and Blaze-generated particles.

Modular GMP System
Designed for flexibility, the modular GMP System can be customized to meet process requirements.
Modular Scale-Up System
Seamless Scale-Up of Formulations
Formulations transferred from the NanoAssemblr® Benchtop 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
Quality Management System

PNI internal QMS system developed to manage internal and external cGMP compliance requirements



Intended and designed to mitigate risks associated with drug product manufacturing



Flexibility to support the modular nature of the PNI platform



Full time dedicated Quality Assurance function demonstrates PNI commitment to quality



Ensures customers receive GMP System components in compliance with cGMP

Polymeric Nanoparticle & Liposome

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

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

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NanoAssemblr® GMP System CMC Considerations
With a fully disposable fluid path and the microfluidic mixer manufacturing process fully validated.
Scale-Up CMC Considerations
Fully Disposable Fluid Path

Single use to reduce risk and cost (re: cleaning validation)


Pumps customized to facilitate access and easy replacement (OEM)


Inert materials used throughout path (Stainless Steel, PEEK, EPDM, COC)


Initial compatibility testing for gamma irradiation of non-metallic fluid path  completed


Extractables/Leachables on microfluidic mixer material completed
Microfluidic Mixer Manufacturing Process Fully Validated


Experienced CMO (certified to ISO 13485) has executed full process validation


Proves process capable of manufacturing chips to required specifications, in a repeatable  fashion


De-risks most novel component of the system

Resource Center

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

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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...

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July 01, 2018

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

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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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Application Note

January 02, 2018

Seamless scale up of siRNA LNP formulations using the NanoAssemblr¬ģ platform

Read More PDF
Resource Center