Standards Committee for Biotechnology

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Standards Committee for Biotechnology

New NSAI National Biotechnology Standards Committee established

To monitor the work of ISO TC 276 NSAI has established a new standards consultative committee and is currently seeking new members from interested stakeholders.

Scope of this Standards Committee

To monitor and participate in the work of ISO TC 276 and to advise the NSAI on the development and approvals of standards in the field of Biotechnology, ensuring Irish interests are represented in the development of any international standards.

Current Stakeholders

Biostor Ireland, Health Research Board, ICON Plc, Molecular Medicine Ireland, Open Innovation Partners, Pfizer, St.James’s Hospital, SuperTecBox Ltd., TCD, UCC, UCD

Background

The OECD definition of Biotechnology is: “defined as the application of science and technology to living organisms as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services” [Source: Second OECD Ad Hoc Meeting on Biotechnology Statistics, OECD, May 2001].

Biotechnology is an enabling technology, crossing conventional boundaries between physics, chemistry, biology, mathematics, information technology and engineering. The use of Biotechnology devices for different applications is developing rapidly and it is considered one of the key enabling technologies of the 21st century. It is a key area that supports research and development and applications in many areas such as medicine and health-care, primary production and agro-food, industrial production, energy and environment and the production of chemicals.

The technology has been developed and progressed over the last number of years and it is now timely that standards are being developed in this field. This will bring about a common understanding in terms and definitions as well as standardizing analytical methods and data processing to ensure comparability and reliability of data produced in this field. The development of standards in this area will contribute to society, the economy, the regulatory environment and the further enhancement of the biotechnology industry.

In 2013 ISO, the International Standard Organization, established a new Technical committee to develop standards in the field of Biotechnology – ISO TC 276. Outputs from the standardization efforts will facilitate technological development, support national and international competitiveness, contribute to the predictability of the regulatory environment, support the exchange of goods and services through the elimination of technical barriers to trade and support market access.

Currently there are currently 4 working groups established under TC 276

ISO/TC 276/WG 1 Terminology
ISO/TC 276/WG 2 Biobanks and bioresources
ISO/TC 276/WG 3 Analytical methods
ISO/TC 276/WG 4 Bioprocessing

Why get involved?

keep up to date on the development of international biotechnology standards
be in a position to influence the development of international standards
network with other experts nationally and internationally
be aware of new standard requirements before they become available and/or mandatory
opportunity to get involved in the work of the international working groups become an expert in international biotechnology standards

What is expected of members that get involved?

To be experienced experts currently working in the field and/or to be representatives of relevant trade associations or other networks
Attend committee meetings 3-4 times a year and contribute to the development of national positions
Review and comment on technical content of draft standards being developed
Participate in dissemination of information nationally regarding biotechnology standard development