The Chief Executive of the National Standards Authority of Ireland (NSAI) has called for more Irish biotechnology firms, researchers and manufacturers to participate in the development of the world’s first international standards for the biotechnology sector.
Maurice Buckley’s call came as over 120 experts from 26 countries around the world gathered in Dublin Castle to continue their work developing new standards for the biotechnology industry.
The ISO Technical Committee established in December 2013, developing standards in key areas of Biotechnology such as bio banking, bioprocessing, analytical methods, and data processing.
There is just one active Irish participant on this committee from Ireland. Emma Snapes is Biobank Manager at the INFANT Centre in University College Cork. This is Ireland’s first dedicated perinatal research centre.
Addressing the delegates in Dublin Castle, Maurice Buckley said these new international standards will contribute to society, the economy, the regulatory environment and the further enhancement of the biotechnology industry.
“Ireland must be a key player in the development of these new international standards, because Ireland is home to many of the world’s top biopharmaceutical firms and experts,” said Mr Buckley.
“9 of the world’s top 10 pharmaceutical companies are based here and the industry employs over 50,000 people directly in Ireland. Therefore it is essential Irish biotechnology researchers and specialists play a pivotal role and have their say on these new standards, which could shape the market or regulations in the future.
“There may also be some financial benefits. According to a study by the French standards body, AFNOR, companies involved in standardization saw an extra 20% growth in annual sales. By actively participating in standards development you will be able to see what is coming down the tracks and more importantly you will be able to have your say on international best practice which will affect your industry, “he added.
Best practice guidelines have already been established for various fields of biotechnology, but there are still no clear set of agreed internationally accepted standards.
“I’ve worked in biobank facilities all over the world and scientists everywhere have the same concerns,” said Emma Snapes, Biobank Manager at the INFANT Centre in UCC.
“Are we doing things in the right way? Can we be doing things a little bit better? There are over 80 best practices guidelines. This leads to a very confusing area, particularly for new and emerging biobanks. Which guideline is best? How do we seek the right information for setting up and improving our processes for bio banking? By standardizing the mechanisms and introducing international benchmarks of excellence; research methodologies will become more rigorous, enhancing the quality of the research,” she added.
The ISO Technical Committee for Biotechnology is made up of five working groups; (1) Terminology, (2) Biobanks and Bioresources, (3) Analytical methods, (4) Bioprocessing and (5) Data Processing and integration. Emma Snapes participates on Working Group 2, Biobanks and Bioresources.
Biotechnology is considered one of the key enabling technologies of the 21st century. Its work impacts and benefits many different sectors and many different people; such as medicine, agro-food, energy and the biotechnology production of chemicals. The research of today will become the new methods, medicines, treatments, and vaccines of the future.
These new standards will facilitate technological development, contribute to regulations and support the exchange of goods and services through the elimination of technical barriers to trade and support market access.
Addressing the delegates in Dublin Castle, Head of Clinical and Applied Biomedical Research at the Health Research Board Anne Cody said accreditation to these new international standards will become mandatory for anyone seeking funding from the Health Research Board in future.
“Our funding is driven by excellence and we want to drive quality of bio banking. We will need to work with universities in reaching the new quality standards, once they are agreed and we appreciate that will take time. But we do want to move incrementally towards mandatory accreditation of every bio banking activity that’s asking for funding from us. So if you want research funding in the future, we will be looking for accreditation,” said Ms Cody.