International standards experts convene in Rome
In late November the international experts on the ISO Technical Committee 276 Biotechnology (ISO/TC) met in Rome. The Working Groups “Terms and Definitions”, “Biobanks/Bioresources”, “Analytical Methods”, “Bioprocessing” and “Data Processing and Integration” discussed the current status of their respective projects. Working Group 1 “Terms and Definitions” is working in an overarching way with the other four working groups to develop an inventory of currently used terms and definitions related to biotechnology (ISO/DTR 20386, “Inventory of biotechnology-related terms”). A second area of activity of WG 1 involves monitoring the definitions of terms in the other working groups’ documents in order to ensure uniformity.
Working Group 2 “Biobanks/Bioresources” is working to define the international norms and standards for the management of biobanks and biological resources. In a three-phase project for so-called horizontal standards that can be applied across all industrial sectors, WG 2 is establishing requirements for biobanks to ensure uniform sample quality. The draft document deals with biobanks that store biological material from humans, animals, plants and microbes. It does not cover biological material intended for therapeutic use or food production. WG 2 is in the final phase of defining this three-phase standard and plans to complete it in 2018.
Working Group 3 “Analytical Methods” is focusing on developing standards for the reproducibility and accuracy of biotechnological measurements. It is also working to establish horizontal standards. Within the areas of “Cell counting”, “Guidelines for evaluating the targeted nucleic acid quantification methods”, “Nucleic acid synthesis” and “General requirements for massive parallel sequencing”, WG 3 aims to develop a framework that ensures consistent measurement quality.
Working Group 4 “Bioprocessing” is concentrating its efforts on establishing standardised processes in bioprocess engineering/biotechnology companies that aim to ensure the consistent quality of starting materials used in research and development. To achieve this, it has developed three technical specifications: “Part 1: General definitions and requirements for quality control”, “Part 2: Best practice guide for suppliers” and “Part 3: Best practice guide for users”. These seek to guarantee the uniform quality and consistent management of biotechnological raw and auxiliary materials in the production of cell-based medicinal products. All three projects have reached an advanced stage and are scheduled to be completed in 2018.
Working Group 5 “Data Processing and Integration” aims to develop standards for traceable, searchable and interoperable data that enable integrated data processing for biotechnology/life sciences. WG 5’s 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. Since its work is in many cases linked to the other working groups’ activities, WG 5 collaborates closely with the other working groups and held joint meetings with WGs 2 and 3 in Rome. WG 5 is currently working on six projects, which are all at an early stage.