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The
NanoAssemblr®
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
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.

Get in Touch
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

Poster

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 01, 2018

Neuron

Changes in the Synaptic Proteome in Tauopathy and Rescue of Tau-Induced Synapse Loss by C1q Antibodies

Dejanovic, B., Huntley, M. A., De Mazière, A., Meilandt, W. J., Wu, T., Srinivasan, K., . . . Sheng, M.

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Publication - Abstract

October 29, 2018

Nature Communications

Cell specific delivery of modified mRNA expressing therapeutic proteins to leukocytes

Nuphar Veiga, Meir Goldsmith, Yasmin Granot, Daniel Rosenblum, Niels Dammes, Ranit Kedmi, Srinivas Ramishetti & Dan Peer...

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