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Is Ireland ready for the next wave of biopharmaceutical manufacturing?

Image provided by NIBRT

Colin Clarke

Science Foundation Ireland Principal Investigator – Systems Biology and Data Analytics Laboratory, Nibrt & Associate Professor, School Of Chemical and Bioprocess Engineering, UCD

Ireland is uniquely positioned to play a significant role in the next generation of biopharmaceutical manufacturing, and continuing to deliver life changing medicines.

A revolution in healthcare

Biopharmaceuticals (drugs derived from biological sources) have transformed the treatment of chronic diseases such as cancer and inflammatory disorders with more than 350 million patients worldwide benefiting from these medicines. The discovery of potential new biopharmaceuticals continues at a staggering pace, encompassing more than 50% of all new medicines in drug discovery pipelines. There are tremendous opportunities to improve human health in the years to come.

Making biological medicines

Traditional chemical drugs are made through organic or chemical synthesis, combining well defined chemical components to produce a reasonably pure active pharmaceutical ingredient with a relatively simple chemical structure.

In contrast, biopharmaceuticals utilise living cells to produce a drug substance, which is not only significantly larger, but also several orders of magnitude more structurally complex. Producing safe, uniform products efficiently in a biological system presents a significant challenge for the biopharmaceutical industry.

Increasing pressure on the industry

Biopharmaceutical companies must invest considerable resources to develop highly controlled, efficient and robust manufacturing processes, that adhere to strict regulatory guidelines. For example, vaccine production can involve in excess of 500 processing steps, 400 raw materials and require more than 650 individual tests to ensure safety of the final product. The sheer number and diversity as well as increasing sophistication of emerging biopharmaceuticals is putting the industry under considerable pressure.

Can we be at the forefront of biopharmaceutical manufacturing?

Ireland is uniquely positioned to play a significant role in the next generation of biopharmaceutical manufacturing and continuing to deliver life changing medicines to patients. In Ireland, Biopharma capital assets now exceed nine billion Euros, with 40 manufacturing plants approved by US FDA which are employing more than 30,000 people. Allied to the presence of these companies are Universities and National Institutes, with unique infrastructure training highly skilled employees and perform cutting-edge research through support from Enterprise Ireland and Science Foundation Ireland.

Leading the way in Biopharma 4.0

In recent years, biopharmaceutical companies have recognised the impact of data analytics in other manufacturing sectors and are now beginning to utilise the technology in their manufacturing processes. An additional factor in our ecosystem is the presence of tech and ICT companies that, through collaboration with biotech companies and academics, can support the digitalisation of the industry.

For instance, the National Institute for Bioprocessing Research Training (NIBRT) and Siemens, with support by the IDA, have been working to develop a state-of-the-art data analytics infrastructure to gain new knowledge and harness artificial intelligence. The award-winning initiative, called BioMac, is now supporting biotechnology companies based in Ireland and abroad to accelerate their digital transformation.

Adapting to change

20 years ago, the Irish government recognised that when patent protection for traditional chemical medicines lapsed, there would be a significant impact on the products being manufactured here. The resulting strategy to attract biopharma companies to Ireland has been tremendously successful.

We are in an enviable position, having attracted the biggest wave of new biotech investment anywhere in the world. However – the industry is rapidly changing and we now find ourselves at a critical point in the evolution of drug production – we must not stand still. The last five years have seen the approval of exciting cell and gene therapies with transformative outcomes for patients. Manufacturing these new medicines is extremely complex, and in many cases they are radically different from those currently made here. A new coordinated strategic response, including investment in education and research in new drug manufacture and related technologies, is urgently needed to ensure this next wave of potential investment into Ireland is not missed.

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