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Pre-Clinical
Only a small percentage of the thousands of compounds tested during the discovery phase possess the desired activity and are now designated as “hits”.
Pre-clinical Formulation Approaches

Untitled-1A handful of the most promising hits are chosen for modification to improve target specificity, potency, chemical and metabolic stability, water solubility, and other pharmacological parameter

 

Before anything is given to humans, safety and efficacy tests are conducted using computerized models, cells and animals.The NanoAssemblr™ Blaze was developed to bridge the gap between nanoparticle discovery and clinical development.

 

The development of an overall formulation strategy to support in vivo studies should be considered carefully as it can reduce cycle time and resources. This strategy must be comprehensive, encompassing early studies designed to identify and validate drug targets, to long-term toxicology studies and ultimately, to support clinical studies in humans.

 


 

 


Pre-Clinical Phase – PNI Solutions
Lawrence-mayer
During the Pre-Clinical stage the NanoAssemblr Benchtop manufactures 1 – 15 mL of nanomedicine per run for continued optimization, preliminary stability studies and in vivo testing in small models.
martain-maier

 

The dynamic volume range allows researchers to use the Blaze for in vivo studies in larger models, preclinical toxicology testing, early Chemistry, Manufacturing and Controls (CMC) studies and downstream process development.


theresa-lavallee

 

Our services will provide you with a formulation and a technology transfer into a production facility that you can be confident will be suitable for clinical scale-up. PNI offers highly qualified scientist through our Formulation Solutions Team. 


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

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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Poster

August 04, 2018

Microfluidic Manufacture of PLGA Nano and Microparticle Drug Delivery Vehicles

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Poster

August 01, 2018

Microfluidics-based Manufacture of PEG-b-PLGA Block Copolymer Nanoparticles for the Delivery of Small Molecule Therapeutics

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Resource Center