Foreword

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This document was prepared by Technical Committee ISO/TC 276, Biotechnology, Subcommittee SC 1, Analytical methods.

A list of all parts in the ISO 16921 series can be found on the ISO website.

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Introduction

Modern and emerging biotechnology is underpinned by the ability to manipulate the genes and genomes of living systems. Gene delivery systems are foundational to genome engineering. Gene delivery technology is evolving rapidly with numerous types of gene delivery systems providing a comprehensive set of tools and capabilities for in vitro or in vivo targeted delivery.

The ISO I6921 series consists of multiple parts to provide common understanding, guides, and analytical methods for characterizing these emerging biotechnology tools. This document provides terms and definitions to enable common understanding. Other parts of the ISO I6921 series will focus on measurements for various gene delivery systems.

1 Scope

This document defines terms related to gene transfer for mammalian systems, including the use of viral and non-viral gene delivery systems and via mechanical mechanisms.

This document is applicable to the development, measurement, and use of gene delivery systems for all applications.

2 Normative references

3 Terms and definitions

3.1 General terms

3.2 Gene delivery system attributes and function

3.3 General terms for viral vectors

3.4 General terms for lipid nanoparticles

3.5 Analytical methods

Bibliography