Covid-19 vaccine maker AstraZeneca has been given planning permission for a $360 million (€326 million) “next generation” active pharma ingredient (API) manufacturing facility in north Dublin.
Fingal County Council granted permission to AstraZeneca subsidiary, Alexion Pharma Operations International Ltd (APOI), to expand in order to ramp up its production of small molecule APIs to meet the firm’s growing drug pipeline.
The AstraZeneca subsidiary proposal would generate an additional 105 jobs when operational within the 18.5 hectare Alexion biopharmaceutical campus in Blanchardstown.
The council has attached 19 conditions to the permission including one that requires the firm to pay €1.8 million in planning contributions towards public infrastructure.
No objections were lodged against the proposal.
[ AstraZeneca chose Republic over UK because of tax and green energy – CEOOpens in new window ]
Planning documents lodged with the application state that the proposed development construction is scheduled for 25 months with the proposed facility due to be operational in 2026 following commissioning.
The planning documentation also states that the new API manufacturing facility will principally comprise a new five-storey production building and supporting facilities including a four-storey extension to labs and a four-storey extension to warehouses which will manufacture small molecule API products to meet Alexion’s future product pipeline needs.
Alexion Pharma Operations International was acquired by AstraZeneca in July 2021 and the acquisition facilitated AstraZeneca’s entry into the area of medicines for rare diseases and enabled AstraZeneca and Alexion to further invest in the research and development of life-saving medicines for their patients.
The environmental impact statement (EIS) lodged with the application stated the new-build API facility would target the high-value, low-volume, highly potent products within Alexion’s future portfolio.
The EIS pointed out that the new facility was “expected to be a safe, smart, sustainable, good manufacturing practice (GMP)-compliant factory that is flexible and expandable with a mixture of traditional batch API and continuous flow API”.
[ Germany clashes with other EU states on pharma regulation overhaulOpens in new window ]
[ EU’s proposed pharma overhaul seeks to increase access to medicinesOpens in new window ]
The EIS said the proposed development would “use the latest technology, ideas and digital innovation to meet the needs of the Alexion’s developing portfolio and produce life-saving medicine for patients worldwide”.
The existing Alexion operational campus includes a total of 983 staff and contractor personnel and the EIS states that there are more existing personnel than previously envisaged due to the impact of the AstraZeneca acquisition of Alexion in 2021.
The AstraZeneca acquisition resulted in the relocation of 50 staff from Liffey Valley to College Park and the establishment of a global headquarters for global functions and regulatory affairs, with an additional 200 staff.
