EPA - Ireland's Environment, An Integrated Assessment - 2020

Chapter 10: Environment and Industry Topic Box 10.4 Transition to Cleaner and More Efficient Biologically Based Pharmaceutical Production The chemical/pharmaceutical industry represents the largest share of total hazardous waste generated in Ireland. The industry is making significant efforts to develop cleaner and more efficient processes for manufacturing pharmaceuticals. In recent years in Ireland there has been a transition from the manufacture of active pharmaceutical ingredients (APIs) by bulk synthesis and chemical API manufacture to biologically based production processes. Over the last 10 years, Ireland has received over €10 billion of investment in biopharmaceutical production. This investment has resulted in Ireland’s biotechnology manufacturing base increasing from 3 facilities in 2004 to over 20 facilities in operation, under construction or in planning today. Six of the top 15 best-selling pharmaceuticals worldwide are produced in Ireland (Central Bank of Ireland, 2020). Figure 10.11  Location of biologically-based pharmaceutical production installations in Ireland P0019-02 Amgen Technology (Ireland) Dun Laoghaire, Dublin P0652-01 Pfizer Ireland Pharmaceuticals Clondalkin, Dublin 22, Dublin P0693-01 Takeda Ireland Limited Nangor Road, Dublin 22, Dublin P1030-01 Alexion Pharma Blanchardstown, Dublin 15, Dublin P0552-02 Swords Laboratories Mulhuddart, Dublin 15, Dublin P1106-01 MSD Ireland (Biotech Dublin) Swords, Co. Dublin P1073-01 Takeda Dunboyne Biologics Ltd. Dunboyne, Meath P1060-01 Mallinckrodt Pharmaceuticals Blanchardstown, Dublin 15, Dublin Ireland Ltd, P0110-02 Arran Chemical Company Ltd. Athlone, Roscommon P0638-01 Zoetis Belgium S.A. Tullamore, County Offaly P1094-01 Alexion Pharma Athlone, Roscommon P0005-02 MSD Ireland (Brinny) Innishannon, Cork P0009-03 Eli Lilly Kinsale Limited Kinsale, Cork P0864-01 BioMarin International Ltd. Ringaskidddy, Cork P0778-02 Janssen Sciences Ireland UC Barnahely, Ringaskiddy, Cork. P0126-03 Allergan Pharmaceuticals Ireland Westport, Mayo P0991-01 Regeneron Ireland Raheen, Limerick P1087-01 AbbVie Ireland NL B.V. Ballytivnan, Sligo P1122-01 Wuxi Biologics Ireland Dundalk . Co Louth 18 16 14 15 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 23 4 5 6 7 19 8 9 10 11 12 13 17 Biologically based production processes represent a clean and safe option for the manufacture of human medicines by virtue of the following characteristics: n low emergency or fire risk due to small quantities of chemicals n low hazardous waste generation (no hazardous chemicals involved in the manufacturing process other than minor quantities for chromatography storage and cleaning purposes) n low atmospheric emissions (little or no volatile organic compound emissions due to the small quantities of solvents or other hazardous chemicals in manufacturing process) n inherently low environmental risk because of the water-based process. The data are not yet available to undertake a fully robust analysis of the environmental performance of pharmaceutical production by biologically based production methods, as there are only a small number of sites currently in full production, although a number are moving into full-scale production in the coming years. (See Figure 10.11). Based on the available data to date, it is apparent that hazardous waste generation is a fraction of that from traditional chemical production. Non-hazardous waste generated and water use are of a similar order of magnitude based on the small number of actual biologically based production sites that are fully operational at present. The EPA plans to undertake a fuller analysis of the environmental footprint of the biologically based production installations in the coming years when there is a greater number of sites in full production. 269