ISO/WD 16921-3

Biotechnology — Gene delivery systems — Part 3: Guide for Methods for the Quantification and Characterization of Lipid Nanoparticles

Scope

This document provides minimum requirements for quantifying and characterizing lipid nanoparticle (LNP) delivery systems containing nucleic acid cargo. It provides general attributes as well as key considerations for method selection, measurement process, data analysis, and reporting.
This document is applicable to LNPs containing gene coding and non-gene coding nucleic acids.
This document is primarily applicable to use of LNPs containing nucleic acids for human and animal nucleic acid-based vaccines and therapies.