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The IJM NanoScaler: a benchtop system for lipid nanoparticle formulation

KNAUER's new benchtop IJM NanoScaler system is designed for lipid nanoparticle R&D – allowing scientists to screen for the optimal process parameters for the formulation of API-containing lipid nanoparticles.

The IJM NanoScaler is made with research and development and lab-scale production in mind.

Equipped with our lipid nanoparticle producing Impingement Jets Mixing (IJM) technology the NanoScaler allows researchers to determine the optimum encapsulation conditions for their mRNA based therapy before scaling up the process to run on a larger GMP-compliant IJM NanoProducer unit.

The NanoScaler is made for low sample consumption so as not to waste valuable API. Its small footprint means it can comfortably sit on the benchtop of a research and development lab. The system comes with five different KNAUER Impingement Jets Mixers to help researchers determine which conditions result in the optimum level of nucleotide encapsulation. In addition researchers can use their own custom mixing unit and benefit from the flexibility of the system set-up.

The encapsulation process can be remotely controlled by software; ran from a conventional PC or laptop, or even a tablet.

Which formulation parameters can be tested using the NanoScaler? 

The IJM NanoScaler allows for the testing of several key parameters during the lipid nanoparticle encapsulation stage:

Mixing unit - The five different impingement jets mixer geometries, plus the opportunity to integrate a custom mixing unit, allow determination of the process conditions required to achieve maximum efficiency, optimal particle size and homogeneous size distribution.

Mixing flow rate and ratio - Determine how the specific physicochemical properties of the lipid nanoparticle are impacted by the mixing flow – find out which flow rates and ratio provide optimum lipid nanoparticle encapsulation.

Lipid formulation - Testing of new lipid formulations, for example lipids with embedded antibodies for targeted medicines, is possible using the NanoScaler. Determine the conditions required to ensure lipid nanoparticle encapsulation takes place before producing the therapy at scale for trials.

Dilution protocols - The liquid flow path of the NanoScaler can be configured to either include or bypass the dilution step following lipid nanoparticle formation - allowing scientists to produce formulations at the exact concentration required.

 

LNP formulations for pre-clinical research

The NanoScaler can be used to produce lipid nanoparticle encapsulated mRNA in the quantities required e.g. for proof of concept testing or for pre-clincial studies.

The NanoScaler can be used to produce lipid-encapsulated nucleotides at a range from 1 mL to hundreds of milliliters meaning the system is perfect for:

  • Proof of concept testing and process optimization - pure nucleotides are an expensive resource. Carry out proof of concept testing and process optimization at the 1,000 μL scale to avoid wastage.
     
  • Pre-clinical trials - Pre-clinical testing can be carried out using 100 mL of nucleotides such as, for in vitro studies to determine the tolerability, efficacy and potential toxicity of the mRNA therapy of interest. 
Once proof-of-concept and safety testing have been succesfully conducted, production of LNP encapsulated mRNA can then be carried out using KNAUER's scaled-up, GMP-compliant IJM-NanoProducer Units.
 

Award-winning LNP technology for the next generation of pharmaceuticals

LNP formulations represent a new revolution in medicine and KNAUER is proud to be at the forefront - we were awarded the Berlin-Brandenburg Innovation Prize in 2021 for our IJM NanoProducer Units and won The German Innovation Award 2022 in the SME category.

The NanoScaler will bring this award-winning IJM technology to research and development labs to help develop the next generation of pharmaceuticals. 

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Disclaimer:
Depending on the process the end user must consider the legal situation of patents and intellectual property.
KNAUER is designing the customized hardware solution on customers request, process and chemistry are not inlcuded.
Technical information are subject to change.

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