Current lipid nanoparticle (LNP) methods primarily rely on bulk measurements, failing to provide critical insights into individual particles. Two emerging quality attributes, the fraction of empty particles and RNA payload quantity and its distribution in LNPs, remain challenging to quantify with existing technologies, leading to challenges in process development, quality control, and regulatory compliance.
Our team has developed a novel single particle analyzer based on Cylindrical Illumination Confocal Spectroscopy (CICS) technology that achieves single-molecule sensitivity, enabling the accurate quantification of the unaddressed properties at single-particle resolution. This analytical platform has demonstrated the potential to accelerate product development, improve manufacturing consistency, and enhance regulatory compliance and address key challenges in RNA-LNP research and development, and manufacturing settings.
Technical innovation with better analytical methods for product and process understanding to facilitate the improvement of product quality and manufacturing consistency
Economic and market impact by advancing analytical instruments for cell and gene therapy specifically for LNP characterization for competitive pricing for instruments and consumables
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Johns Hopkins University
CICS Analytics Corporation
Federal Stakeholder: National Institute of Standards and Technology
Sartorius Stedim
