BLOG ENTRY 11/05/2015

Update to the ongoing development of ISO Standardisation processes for „Biobanks and bioresources”, most relevant for the BBMRI-ERIC community.

On 13-18 April 2015, the 3rd Meeting of ISO/TC 276 Biotechnology took place in Shenzhen, China. It was my pleasure to attend this meeting getting in contact with the Experts and Members of the technical committee (TC). The BBMRI-ERIC community received a very friendly welcome from all members around the globe.  If you are not familiar with the proceeding of how ISO develop standards, and who are the Experts and the Members, please have a brief look here.

The most relevant Standard development for biobanks and bioresources are proceeded within the technical committee (TC) of ISO 276 which is aiming for standardisation in the field of biotechnology processes and includes the topics: Terms and definitions, biobanks and bioresources, analytical methods, bioprocessing, data processing including annotation, analysis, validation, comparability and integration, metrology.

The ISO/TC 276 Biotechnology is working closely with related committees in order to identify standardisation needs and gaps, and is collaborating with other organisations to avoid duplications and overlapping standardisation activities. The committee will not pursue subjects within the scope of other TCs including but not limited to ISO/TC 212 and ISO/TC 34/SC 16.

Within this technical committee, there are five work groups assembled. Experts of the field, discussing and finding consensus on the following topics:

ISO/TC 276 WG 1 „Terminology”

Is working on the identification of currently used national and international standards, guidelines and other relevant documents, as well as terms and definitions, related to ISO/TC 276 Biotechnology. The work of this Working Group focuses initially on harmonisation (where possible) rather than on standardisation.

ISO/TC 276 WG 2 ” Biobanks and bioresources”

Is elaborating a package of International Standards in the Biobanking field including human, animal, plant and microorganism resources for Research & Development, but excluding therapeutic products.

ISO/TC 276 WG 3 „Analytical Methods”

Is developing standards for accurate, reproducible and robust measurement and analysis in support of biotechnologies. WG 3 will develop a package of International Standards for biologically relevant molecules and entities, including nucleic acids, proteins, and cells. This WG will develop horizontal standards and, when applicable, vertical/particular standards for industry sectors. The WG will also coordinate with relevant technical committees and standardisation initiatives.

ISO/TC 276 WG 4 „Bioprocessing”

Is identifying standardisation needs in four major technology spaces: 1) component materials control; 2) bioreactor processes; 3) collection, separation, purification and formulation; and 4) handling, transportation & storage. Each category of materials/technology space may affect many current and future applications.

ISO/TC 276 WG 5 „Data Processing and integration”

Will develop standards in the field of processing and integration of life science data and derived models, simulations and graphical representations. This includes annotation, analysis, validation, integration and comparison of data and models from heterogeneous sources. The main focus is the definition of interfaces, formats and metadata connecting related data and models.

BBMRI-ERIC will track for you the developments and will keep you updated, but if you have any questions, concerns or needs, please don’t hesitate to contact us.

Please feel free to share with us your comments, and if requested, we will act like a spokesperson to the Technical Committee of 276 bringing your suggestions to the table.
Yours, Andrea
andrea.wutte@bbmri-eric.eu

Picture: Members and Observers of the TC 276 in the plenary meeting in Shenzhen, China.