Covid-19 vaccine maker AstraZeneca has secured the green light for a $360m "next generation" active pharma ingredient (API) manufacturing facility for north Dublin.
This follows Fingal County Council granting planning permission to AstraZeneca subsidiary, Alexion Pharma Operations International Ltd (APOI), to expand its internal capability for late stage development and early commercial supply of small molecule APIs to meet the firm's future growing drug pipeline.
The AstraZeneca (AZ) subsidiary proposal is to generate an additional 105 jobs when operational within the 18.5 hectare Alexion Biopharmaceutical Campus at College Business and Technology Park at Blanchardstown in Dublin 15.
The Council has attached 19 conditions to the permission including one that requires the AZ firm to pay €1.8 million in planning contributions towards public infrastructure.
No objections were lodged against the proposal.
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 four-storey extension to labs and four-storey extension to warehouses which will manufacture small molecule API products to meet Alexion's future product pipeline needs.
APOI was acquired by AstraZeneca (AZ) in July 2021 and the acquisition facilitated AZ's entry into the area of medicines for rare diseases and enabled AZ 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 that the new build API facility will target the high value, low volume, highly potent products within Alexion's future portfolio.
The EIS pointed out that the new facility "is 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".
The EIS stated that the proposed development "will use the latest technology, ideas and digital innovation to meet the needs of the Alexion’s developing portfolio and produce lifesaving medicine for patients worldwide".
It added that "this proposed facility will also significantly reduce commercialisation lead times and costs, and introduce more sustainable manufacturing processes".
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.
Reporting by Gordon Deegan