BBMRI-ERIC GAINS MOMENTUM WITHIN ISO AND ITS WORKING GROUPS

Between 26 and 30 October 2015, the International Organisation for Standardisation (ISO) called for working group meetings within the TC 276 Biotechnology. The Mirror Committee of Japan welcomed more than 100 delegates, members and observers to Tokyo, Japan. The Forum for Innovative Regenerative Medicine (FIRM) excellently hosted meetings of all five Working Groups at the venue of the National Cancer Center (NCC) at Tsukiji Campus.

Deep, intense and constructive discussions were conducted in order to review created documents and all associated comments, received from the international mirror committees, liaisons and observers.

The Working Group 01 ‘Terminology’ is acting as a hub for the working groups of TC276 regarding harmonization of terms and definitions whenever these are found to conflict or overlap.

The Working Group 02 ‘Biobank and Bioresources’ has made major progress. The first draft of a manuscript reflecting basic requirements for biobanks was written and very thoroughly reviewed and commented. Many expectations for the content of a future standard for biobankers were expressed, creating fertile ground for the next steps in the development. There is no doubt that this working group faces a great challenge to meet the need for a standard or a package of international standards in the biobanking field, to be used by both the public and private sectors, and which will fill the gap between the material sources and the R&D laboratories using the samples and/or data.

‘Analytical methods’ are discussed in Working Group 03 of ISO/TC 276. The focus is on the development of standards for cell characterization, cell counting and viability and on nucleic acid quantification and sequencing, protein identification and quantification.

The Working Group 04 ‘Bioprocessing’ has identified standardization needs in four major technologies spaces such as component materials control; bioreactor processes; collection, separation, purification and formulation; and handling, transportation & storage. Each category of materials/technology space may affect many current and future applications. At the moment, no obvious overlap to BBMRI-ERIC human biobanks is observed.

Working Group 05 ‘Data Processing and Integration’ aims at developing standards for traceable and interoperable data together with integrated data processing for biotechnology/life science. The preliminary work item (PWI) has been received from the German expert group, which maps existing community standards in the field relevant to the Biotechnology scope of the TC 276. As the newly established working group, it is currently working on defining precise use cases and analysis of needs and gaps for the upcoming data integration standards. Point of contact: Petr Holub (IT / Data Protection Manager, petr.holub@bbmri-eric.eu)

The BBMRI-ERIC Work Programme 2016 is aligned with the developments of the technical committee TC276, which is seen as key development for reaching jointly agreed quality standards worldwide and as a substantial achievement for the biobanking community.