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.
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.
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:
This application note describes the use of the NanoScaler, KNAUER’s new Impingement Jets Mixing (IJM) benchtop system, to formulate LNPs of adequate size and PdI. that enables the encapsulation of various nucleic-acid payloads with high reproducibility and efficiency. (8 pages)
"Having already a robust LNP production process in place, we were looking out for alternative techniques to support our scale-up activities. The Impingement Jets Mixing (IJM) equipment provided by KNAUER was the right fit for us! Even from early runs we were able to produce LNPs of high quality with a high encapsulation efficiency and low PDI values. We will further build on this and expand our knowledge into GMP production to further support our projects and partners by delivering high quality LNP production."
Iris Bombeke, Research Associate Drug Product Development, eTheRNA, Ghent, Belgium
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.
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.