LNPs have recently demonstrated their effectiveness through their use in as delivery vehicles for the mRNA COVID-19 vaccines. Now, this technology is being explored for its wider potential in vaccines, cancer drugs, and even gene therapies. LNPs allow for the efficient delivery of genetic material into human cells where they can deliver instructions, interrupt processes or edit DNA. In this presentation, Alex Kerr outlines The Sunny Suite: an end to end particle synthesis solution for lipid nanoparticles (LNPs).
LNPs are typically composed ionizable lipids, structural lipids, PEG lipids, and cholesterol. On top of this, additional targeting moieties can be added to the outside of the particle. Each of these components can affect the particles performance. Getting all of the lipid elements right can be a huge challenge, and its complexity goes even further, also dependant on the cargo and processing parameters.
Sunscreen
Unchained Labs’ solution is Sunscreen: designed for high-throughput formulation screening, Sunscreen uses 96-well plates and microfluidic precision to run 96 experiments in under six hours with low reagent volumes and reusable glass microfluidic chips, ensuring minimal dead volume and efficient cleaning.
Sunscreen’s glass mixing chips provide chemical compatibility. Their smooth surfaces and minimal roughness provide reduced material buildup and automated cleaning cycle capability, enhancing experimental fidelity and reproducibility.
The Sunny Suite comes with simple to use software. Experiment variables can be set using regular Excel spreadsheets for easy setup and automation. The system’s validated cleaning procedures ensure consistent results and high experimental fidelity across multiple formulations.
Stunner
For high-speed, large-volume analysis, Unchained provides the Stunner system. This tool complements the suite by providing 96-well plate DLS and UV-Vis analysis with minimal sample volume. Data is delivered on particle size, RNA concentration, particle concentration, and RNA per LNP, aiding rapid screening.
Sunshine
The Sunshine system for semi-automated screening enables rapid, semi-automated formulation screening. It features sample loops for up to 10 experiments, automated cleaning, and the same microfluidics and software as Sunscreen, facilitating process development and scale-up.
Sunbather
Finally, Kerr introduced a new tool to the Sunny family: the Sunbather for GMP manufacturing. It supports GMP-compliant LNP manufacture, sporting up to 1.8 litres per hour throughput, replaceable flow paths with extractables data, 21 CFR Part 11 software, and seamless protocol transfer from Sunshine, ensuring scalability and regulatory compliance.