WG3 Analytical Methods

Summary

The ISO/TC 276/WG 3 Analytical methods aims to develop standards for accurate, reproducible and robust measurement and analysis in support of biotechnology.

WG 3 will develop a package of International Standards for biologically relevant molecules and entities, including nucleic acids, proteins, and cells. Horizontal standards and, when applicable, vertical/particular standards for industry sectors will be developed.

WG 3 is currently focusing on the development of standards for cell characterization, including cell counting and viability, and nucleic acid quantification and sequencing. Two International Standards (IS) are under development in the area of cell counting with targeted release dates in 2018; and one NP has been approved in the area of targeted nucleic acid quantification with a targeted release date in 2019. In addition, WG 3 has registered PWIs related to 1) quality of synthesized nucleic acids, 2) next-gen (massively parallel) sequencing, and 3) total nucleic acid quantification. 

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Description

Standard(s) Under Development

• ISO/WD 20391-1: Biotechnology - Cell Counting – Part 1. General Guidance on Cell Counting Methods
• ISO/WD 20391-2: Biotechnology - Cell Counting – Part 2. Experimental Design and Statistical Analysis to Quantify Counting Method Performance
• ISO/AWI 20395: Quality considerations for targeted nucleic acid quantification methods
• ISO/WD 20688:  Biotechnology -- Nucleic acid synthesis -- General definitions and requirements for the production and quality control of synthetic nucleic acids
• ISO/PWI 20397:  Methods to evaluate the quality of massive sequencing data
• Cell characterization

US TAG WG3 Convenor:  Sheng Lin-Gibson
TAG Administrator:  Clare Allocca