The biotechnology industry is facing a crucial moment, as national standards slowly combine into one internationally accepted set of protocols. But who is making the final call?
Biotechnology in general has seen many unique branches emerge in recent decades, as specialism reigns. Advances in science mean the likes of biobanking and bioprocessing, specifically since the turn of the millennium, have emerged as genuine professions.
The reason biobanking is mentioned in particular is due to Ireland and its current role as an international leader in pharmaceuticals and biotechnology. Also, it is one of the few areas that Ireland is making an impact on with regard to international frameworking.
At present, nine of the world’s top 10 pharmaceutical companies are based here, and the industry employs over 50,000 people directly in Ireland. Biobanking, one of the latest niche areas to capture major attention, is booming in the country.
The Irish Centre for Fetal and Neonatal Translational Research (INFANT) in Cork is an example of that.
INFANT works with Cork University Maternity Hospital, with its development of a burgeoning and rapidly expanding collection of samples – relevant to mothers and babies – potentially improving the health and wellbeing of thousands of people in the future.
“Biobanks like this allow us to explore large amounts of data and use the results to reduce and eventually prevent life-threatening complications in pregnancy and early life,” said Prof Louise Kenny, founding director of INFANT and speaker at Inspirefest last year.
“That is what we are working towards, saving the lives of mothers and their babies.”
However, as yet, there are no internationally unified protocols for biotechnology and, more acutely, for biobanking. If someone invests in a new facility, it’s quite hard to work out any form of value for money. If someone wants to build one, there’s no way of knowing what the best way to go about it is.
Essentially, there’s no sense of direction and, given that the international scientific community loves to work together, this is not good.
There are national standards, general norms, tools and techniques used for biobanking that were originally developed and validated for other functions.
A recent Dublin meeting between 120 experts from 26 countries discussed this very subject, with a special ISO technical committee now three years into the process of cleaning up these issues.
With five working groups – terminology; biobanks and bioresources; analytical methods; bioprocessing; and data processing and integration – the committee is gradually establishing what will represent an international standard.
Ireland’s voice in this, though, is quite small. Emma Snapes, who works with INFANT, is the country’s sole representative. Given the plethora of companies and experts in the country, this doesn’t seem enough.
According to a study by the French standards body, AFNOR, companies involved in standardisation saw an extra 20pc growth in annual sales.
Maurice Buckley, Ireland’s National Standards Authority (NSAI) chief executive, argues that by actively participating in standards development, “you will be able to see what is coming down the tracks” and tailor best practice to suit your industry.
Snapes is flying the flag for Ireland, and she’s feeling the strain.
“ISO standards are voluntary and will only have international acceptance if they are based on sound principles, are applicable and attainable,” she said. “This is why the opinion of national experts is so important as it is our opportunity to shape the standard.”
INFANT supports Snapes’s work with the technical committee, with the Health Research Board (HRA) covering her travel costs to attend the second working group (WG2), specific to her particular field.
“I have concerns that Ireland does not have sufficient active experts to participate in other working groups involved in the technical committee,” she said.
WG3: analytical methods, WG4: bioprocessing and WG5: data processing – including annotation, analysis, validation, comparability and integration – are areas she highlights as of utmost importance to Ireland.
Snapes would happily attend all but, unfortunately, each group meets concurrently. Bodies are needed, and they’re effective, too. When Snapes first attended WG2 as an observer, she was surprised at how much weight her opinions held.
“With the approval of one’s national standards body (NSAI, in Ireland’s case), it is amazing how much one can influence both the scope and the content of the standard,” she said.
“I certainly was not expecting this at that early stage, but it became one of the key elements that persuaded me that non-participation could not be justified.”
At the moment, there are over 80 best practices guidelines around the world – leading to a very confusing area, particularly for new and emerging biobanks.
What guideline should you follow? What guideline will assure investors that this is the right way? How do we seek the right information for setting up and improving our processes for biobanking?
Snapes’s work on the project means that biobanking is probably primed for a smoother future in Ireland, in comparison to the areas the other four groups are negotiating, without an Irish voice.
“By standardising the mechanisms and introducing international benchmarks of excellence, research methodologies will become more rigorous, enhancing the quality of the research,” said Snapes.
These new standards, hopefully published in 2018, 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.
Anne Cody, head of clinical and applied biomedical research at HRA, said accreditation to these new international standards will become mandatory for anyone seeking funding from her organisation in future.
So getting involved now makes sense.
If you are interested in getting involved in this process, Linda Hendy, NSAI standards business development officer, is happy to hear: firstname.lastname@example.org