DIN biotechnology mirror committee meets in Berlin

The German experts on the national mirror committee (DIN) of the ISO Technical Committee 276 Biotechnology (ISO/TC) convened in mid-October in Berlin. The leaders of the Working Groups “Terms and Definitions”, “Biobanks/Bioresources”, “Analytical Methods”, “Bioprocessing” and “Data Processing and Integration” reported on the national standardisation activities. 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 Working Group 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.

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. At its last meeting in Seoul, WG 3 decided to completely reorganise its focal areas and concentrate on “Cell counting”, “Guidelines for evaluating the targeted nucleic acid quantification methods”, “Nucleic acid synthesis” and “General requirements for massive parallel sequencing”. It will address a number of special topics within these areas, with each topic covering a particular issue. WG 3 is now working to move these topics forward.

Working Group 4 “Bioprocessing” is concentrating its efforts on establishing standardized 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. 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 this year in Rome.

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 holds joint meetings. The secretariat of WG 5 moved from Germany to China in April 2017.

In addition, meeting participants discussed preparations for the next ISO/TC working group meetings, which will be held in late November in Rome.