ISO Technical Committee 276 Biotechnology holds meeting in Washington, D.C.

International experts met in Washington, D.C., from 9 to 13 May to discuss biotech harmonisation projects within the five working groups of the ISO Technical Committee 276 Biotechnology (ISO/TC 276).

Members of the ISO Technical Committee 276 Biotechnology; last row on the far left: Michael Kahnert, BIO Deutschland. © Clare Allocca

Members of the overarching Working Group 1 “Terminology” prepared a compendium of currently used terms and definitions, which they will now develop further into a technical document. The compendium is intended to help guide future work of the entire ISO/TC 276 and contains terms and definitions related to the work of the ISO/TC 276 Biotechnology. The group’s members 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 1 will regularly review the compendium and keep it up to date.

The Working Group 2 “Biobanks and bioresources” is working on several proposals in the field of biobanks. Its draft document “Biotechnology – Biobanking – General requirements for Biobanks” adresses general requirements for biobanks, which aim to ensure consistent quality in sample collection. The Working Group is also working on a draft document on the validation and examination of processing methods used in biobanks. The group’s members plan to compile various expert proposals on the processing, storage and transport of biobank materials and then discuss these in detail at its autumn meeting in Dublin.

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. The Working Group is currently working on six draft documents on various topics such as cell counting, cell characterization and oligonucleotides.

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 aims to develop standards for ensuring consistent, controlled and tracked processes to give confidence to suppliers and users of products. In this vein, the Working Group is working on draft documents on “Raw materials control for bioprocessing – Part 1: General definitions and requirements for quality control”, “Part 2: Best practice guide for suppliers” and “Part 3: Best practice guide for developers”.

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 related to the activities of the other Working Groups, Working Group 5 will collaborate closely with the other groups.

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