International standards committee for biotechnology convenes in Tokyo
International experts met in Tokyo from 10 to 15 June to discuss biotech harmonisation projects within the five working groups of the ISO Technical Committee 276 Biotechnology (ISO/TC 276).
BIO Deutschland’s Michael Kahnert heads the overarching Working Group 1 “Terminology”. It will now begin its work to harmonise terms relating to biotechnology. Definitions have already been formulated for the terms “biotechnology”, “biobanking” and “bioprocessing”. In addition, the compendium that WG 1 prepared is being used as a source for the further work of the entire ISO/TC 276. It contains terms, including definitions, related to the work of the ISO/TC 276 Biotechnology. WG 1 gathered the terminology worldwide from publicly accessible sources. The compendium also provides information on different interpretations of the terms and on the sources used.
The Working Group 2 “Biobanks and bioresources” is working on several proposals in the field of biobanks. Its standard “Biotechnology – Biobanking – General requirements for Biobanks” addresses general requirements for biobanks, which aim to ensure consistent quality in sample collection. WG 2 is also working on a draft document on the validation and examination of processing methods used in biobanks.
The Working Group 3 “Analytical methods” aims to develop standards for accurate, reproducible and robust measurement and analysis in support of biotechnologies. The focus here is on biologically relevant molecules and entities, including nucleic acids, proteins and cells. WG 3 is currently working on seven further draft documents on various topics.
The Working Group 4 “Bioprocessing” focuses its work on the development of biotech products, whereby the emphasis is on the processes and not the end products. It has developed a three-part standard for ensuring consistent, controlled and tracked processes to give confidence to suppliers and users of biotech products (Part 1: General definitions and requirements for quality control”, “Part 2: Best practice guide for suppliers” and “Part 3: Best practice guide for developers”). WG 4 also plans to develop a standard to ensure a uniform understanding of the requirements for the transport of cellular therapeutic products.
The Working Group 5 “Data processing and integration” aims to develop standards for traceable, searchable and interoperable data together with integrated data processing for biotechnology and the life sciences. Its work focuses on the definition of data and model formats and their interfaces, the definition of metadata, and quality management of processed data and models. As this work is almost always related to the activities of the other working groups, WG 5 collaborates closely with the other groups.