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Lipid Nanoparticles
Lipid nanoparticles (LNPs) are the most clinically advanced non-viral gene delivery system. Lipid nanoparticles safely and effectively deliver nucleic acids, overcoming a major barrier preventing the development and use of
Lipid nanoparticles offer many advantages over previous lipid-based nucleic acid delivery systems including:
• High nucleic acid encapsulation efficiency and potent
transfection
• Improved penetration into tissues to deliver therapeutics
• Low cytotoxicity and immunogenicity
These characteristics make lipid nanoparticles excellent candidates for nucleic acid delivery.
The first RNAi drug (Patisiran) uses lipid nanoparticles and was approved by FDA in 2018.
Overcome Key Challenges in Advancing LNP Production
| Challenges with Conventional Production Methods | Solutions with the NanoAssemblr® Platform | |
| The formulation process has significant batch-to-batch variability |  | Reproducible lipid nanoparticle manufacturing |
| Limited process control leads to lipid nanoparticle heterogeneity | | Controlled manufacturing conditions result in homogeneous lipid nanoparticle formulations |
| Loading nanoparticles with nucleic acids are inefficient | | High nucleic acid loading efficiency in a one-step formulation process |
| Production is time-consuming and labor-intensive | | Rapid, effortless lipid nanoparticle production, and optimization |
| The manufacturing process is difficult to scale-up | | A seamless path to scaling up production |
A Reproducible Lipid Nanoparticle Manufacturing Process
Lipid nanoparticle size was consistent for identical lipid composition formulated by three independent users.Controlled Manufacturing Conditions Result in Homogeneous Lipid Nanoparticle Formulations
Hydrodynamic diameters and PDI were consistent between mRNA lipid nanoparticle fractions collected throughout the entire continuous flow manufacturing on the GMP System.
High Nucleic Acid Loading Efficiency in a One-Step Formulation Process
siRNA-LNPs manufactured by three NanoAssemblr® instruments exhibited encapsulation efficiencies of higher than 95%.
A Seamless Path to Scaling Up LNP Production
Factor VII siRNA knockdown efficacy was maintained for nanoparticles produced on the NanoAssemblr® Benchtop, Blaze, and GMP System.
The NanoAssemblr® Platform Generates a More Homogenous Nanoparticle Population
Particles generated by the NanoAssemblr® platform are more uniform than those made by conventional T-Tube mixing method.
NanoAssemblr®
T-tube generated lipid nanoparticles (left) exhibit a multilamellar morphology vs the homogeneous-core structure for the NanoAssemblr® generated lipid nanoparticles (right).
NanoAssemblr®
Serum Factor VII siRNA knockdown efficacy was higher for NanoAssemblr® siRNA lipid nanoparticles compared to conventional T-tube lipid nanoparticles, 72 hours following systemic administration.
1) An organic solvent containing dissolved lipids and an aqueous solution containing nucleic acids are injected into the two inlet channels of the
NanoAssemblr® cartridge.
2) Under laminar flow, the two solutions do not immediately mix, but microscopic features engineered into the channel cause the two fluids to
intermingle in a controlled and reproducible way.
3) Within a millisecond, the two fluids are completely mixed, causing a change in solvent polarity that triggers the self-assembly of lipid
nanoparticles loaded with nucleic acids.
4) Changing the speed and ratio of fluid injection controls the size of the lipid nanoparticles.
5) Lipid nanoparticles mimic low-density lipoproteins, which allows them to be taken up by an endogenous cellular transport pathway to deliver
nucleic acids to cells.
6) Using pH-sensitive lipids allow lipid nanoparticles to release encapsulated nucleic acids into the cytoplasm when vesicle pH decreases.
Lipid Nanoparticle Resources
Application Note
March 15, 2022
Publication - Abstract
July 01, 2020
Journal of Controlled Release
Publication - Abstract
May 08, 2020
Vaccines
Publication - Abstract
May 31, 2019
Vaccine
Publication - Summary
May 18, 2019
Annals of Hematology
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