Method for simultaneous quantification of lipid and nucleic acid components in lipid nanoparticle formulations

The IPRP-HPLC with UV and CAD detection method allows simultaneous quantification of lipid and nucleic acid species in LNPs, addressing the complexity of separate analytical procedures and enhancing formulation characterization and quality control.

WO2026128686A1PCT designated stage Publication Date: 2026-06-18GENENTECH INC
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
GENENTECH INC
Filing Date
2025-12-11
Publication Date
2026-06-18

AI Technical Summary

⚠Technical Problem

Current methods for analyzing lipid and nucleic acid components in lipid nanoparticles (LNPs) require separate analytical procedures, leading to increased complexity and turnaround time, especially when dealing with complex formulations and diverse lipid libraries.

⚗Method used

A method combining ion-pair reversed-phase high-performance liquid chromatography (IPRP-HPLC) with ultraviolet (UV) and charged aerosol detection (CAD) for simultaneous quantification of lipid and nucleic acid species in a single chromatography run, using a single sample preparation protocol.

🎯Benefits of technology

Enables efficient, accurate, and sensitive quantification of multiple lipid and nucleic acid species in LNPs with reduced analytical time, facilitating comprehensive characterization and quality control of LNP formulations.

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Abstract

The present disclosure relates to methods for quantifying both lipid and nucleic acid cargo components of LNP formulations simultaneously, i.e., in a single chromatography separation process. In some embodiments, the methods comprise ion-pair reversed-phase high performance liquid chromatography (IPRP-HPLC) separation coupled with ultraviolet (UV) and charged aerosol detection (CAD). In some cases, the methods allow for quantification of the content of several different lipid and nucleic acid species in a single LNP formulation simultaneously, thus allowing for efficient characterization of LNP formulations, for example, for process control of pharmaceutical or test formulations.
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