Quantify API loading and particle concentration by nano-flow cytometry

The NanoAnalyzer platform (NanoFCM) is rapidly being adopted to provide fast single-particle analyses yielding particle concentrations, size distributions, and cargo determination in one minute run times.

Lipid Nanoparticle (LNP) technology is revolutionizing the field of drug delivery, enabling the effective delivery of RNA-based therapeutics to target cells in vivo. However, despite its tremendous potential, LNP development and production remains challenging. One of the major hurdles is the characterization of the physical and chemical properties of LNPs, which is crucial for understanding their stability, drug-loading efficiency, and targeting ability.

The NanoAnalyzer is a powerful tool for screening and optimization of LNP formulations. Analysis of multiple parameters of individual particles at high throughput can be achieved simultaneously:

• Label-free analysis, utilizing single particle light scattering, quantifies particles >40 nm, measuring concentration in particles/ml and sizing of diameter for each particle allowing for average, range, and deviation from the mean.
• Fluorescent labeling of target cargo such as mRNA or surface moiety’s is achieved using commercially available dyes, antibodies, and a variety of fluorescently labeled reagents. Protocols for labeling samples can take as little as 30 minutes, often requiring no further steps except dilution prior to nFCM analysis.

• Particles carrying cargo are easily identified as distinct from empty particles and from free unencapsulated material. Many cargos such as mRNA can be quantified in terms of copy number per particle, providing a distribution profile detailing the range of copies carried by particles, the average copy number per particle, the relation to particle size, and the relation to other fluorescently labeled material.

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