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
By implementing optimized LNP formulation and enhanced quality control processes, an organization could reduce manufacturing costs by an estimated 15–25% through improved process efficiency and fewer batch failures, enabling faster development cycles and more reliable production for advanced therapeutics.
Microfluidic system development and validation.
Optical platform integration and performance optimization.
Analytical method development for manufacturing quality control LNP property structure-function correlation and quality system implementation
Biophysical database with biological attribute correlation and predictive models for defined quality metrics
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Johns Hopkins University
CICS Analytics Corporation
Federal Stakeholder: National Institute of Standards and Technology
Sartorius Stedim
