Biotechnology — Gene delivery systems Part 3: Guide for Methods for the Quantification and Characterization of Lipid Nanoparticles
| Standard Number | ISO/AWI 16921-3 |
|---|---|
| Organization |
International Organization for Standardization
|
| Level | International |
| Category | Guide | Practice |
| Status |
|
ABSTRACT
This document provides minimum requirements for quantifying and characterizing lipid nanoparticle (LNP) delivery systems containing nucleic acid. 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 the use of LNPs containing nucleic acids for human and animal nucleic acid-based vaccines and therapies.