Approved Work Item
ISO/AWI 16921-3
Biotechnology — Gene delivery systems — Part 3: Guide for Methods for the Quantification and Characterization of Lipid Nanoparticles
Reference number
ISO/AWI 16921-3
ISO/AWI 16921-3
Edition 1
© ISO 2025
Approved Work Item
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.
General information
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Status: Under developmentStage: New project registered in TC/SC work programme [20.00]
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Edition: 1
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Technical Committee :ISO/TC 276/SC 1
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