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NanoAssemblr®
GMP System
Power to Commercialize
Scale-Up System
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Accelerate the Path to Manufacturing

 

Built on our revolutionary NxGen™ technology found in our NanoAssemblr® family of instruments, NanoAssemblr® GMP System enables you to go from concept to clinic with speed and confidence. Combined with PNI’s expertise, we accelerate the clinical and commercial development of your unique nanomedicine drug products. 

 

Explore the rest of our NanoAssemblr® platform:

 

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Ready to learn more about how Precision NanoSystems helps you accelerate genetic medicine development? Contact a Scientific Specialist.
Learn how efficiently the GMP System helps get your drug to market.
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Clinical to Commercial. Confidently Covered.

With decades of LNP experience, our Biopharmaceutical Services team expertly helps you execute technology transfer and optimize processes for commercial production of genetic medicines. We provide you with all required documentation for the GMP System and its single-use fluid path, giving you full confidence during regulatory and compliance audits. 

 

 

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Versatile Scalability.
Trusted Performance.

Consistent particle size across NanoAssemblr® platforms means optimization of each step in the development and manufacturing process is quick, cost effective and dependable.

 

Nanoparticle Size at Every Scale
EE At Every Scale

 

Particle size, polydispersity and RNA encapsulation efficiency are consistent as production of epo-encoded mRNA-LNP was scaled using the NanoAssemblr® platform.

 

 

NanoAssemblr Platform
Manufacturing Made Easy

Our NanoAssemblr® family of products empowers you to model the full unit operations of the nanomedicine workflow, translating smaller scale parameters onto the GMP System. This means you perform fewer large scale experiments, accelerating timelines and preserving costly reagents.

 

Unit Operations Diagram

 

The NanoAssemblr® GMP System has a simple workflow with touchscreen interface, saved recipes and a single-use fluid path that integrates Pall and Cytiva processes for a complete unit operations. This versatile solution for commercial manufacturing provides you with the ability for scale-up and scale-out at a range of facilities.


GMP Case Study

PNI’s complete solution of innovative platforms accelerates the entire commercialization process. A recent study from Sirnaomics shows a less than 6-month timeframe for formulation development ready for GMP manufacturing.

 

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Sirnaomics Quote
Videos

 

Informational video of GMP System with Dr. Lloyd Jeffs

GMP System Demo with Dr. Lloyd Jeffs


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 Select...

G. Lou, G. Anderluzzi, S.T. Schmidt, S. Woods, S. Gallorini, M. Brazzoli, F. Giusti, I. F...

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Publication - Abstract

May 08, 2020

Vaccines

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 a...

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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...

D. Chatzikleanthous, S.T. Schmidt, G. Buffi, I. Paciello, R. Cunliffe, F. Carboni, M.R. Ro...

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Publication - Abstract

December 31, 2019

Vaccines

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

Vaccine

mRNA Vaccines Against H10N8 and H7N9 Influenza Viruses of Pandemic Potential Are Immunogenic and Well Tolerate...

R.A. Feldman, R. Fuhr, I. Smolenov, A. Ribeiro, L. Panther, M. Watson, J.J. Senn, M. Smith...

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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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Resource Center 资源中心