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Scale-Up Program

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


Flexible Scale-Up 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 Scale-Up 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 Scale-up system’s formulation results are in sync with NanoAssemblr® Benchtop and Blaze-generated particles.

Modular Scale-Up System
Designed for flexibility, the modular Scale-Up 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 Scale-Up 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 Scale-Up 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

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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NanoAssemblr® Scale-Up Program 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 - Abstract

November 29, 2018

International Journal of Pharmaceutics

Rapid and scale-independent microfluidic manufacture of liposomes entrapping protein incorporating in-line purification and at-lin...

N. Forbes, MT. Hussain, ML. Briuglia, DY. Edwards, JH. terHorst, N. Szita, Y. Perrie

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July 01, 2018

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

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Application Note

July 01, 2018

Seamless scale up of liposomal verteporfin formulations using the NanoAssemblr® Platform

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Publication - Abstract

April 26, 2018

Small Methods

State‐of‐the‐Art Design and Rapid‐Mixing Production Techniques of Lipid Nanoparticles for Nucleic Acid Delivery

Evers, M. J. W., Kulkarni, J. A., van der Meel, R., Cullis, P. R., Vader, P., & Schiffelers, R. M.

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Publication - Abstract

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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Publication - Abstract

November 29, 2018

Carbohydrate Polymers

N-oxy lipid-based click chemistry for orthogonal coupling of mannan onto nanoliposomes prepared by microfluidic mixing...

E. Bartheldyová, et al.

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Resource Center