Horizon’s ambition to expand its development and manufacturing facility in Waterford to add new drug substance biologics development and manufacturing capabilities is on track as conditional planning permission has now been granted by Waterford City and County Council.
The planned facility would expand Horizon’s footprint, adding approximately 320,000 square feet to its current 44,000 square foot drug product (fill-finish) biologics facility, and would create approximately 350 jobs over time.
Horizon purchased its existing facility in June 2021 for $65 million with the understanding that adjacent IDA land was available for further manufacturing and development expansion. Horizon continues to work with Ireland’s Health Products Regulatory Authority (HPRA) and the U.S. Food and Drug Administration (FDA) to obtain HPRA and FDA licensure for sterile fill-finish manufacturing and anticipates the first medicine approved for release from the existing facility in 2023. Both facilities are expected to be used for Horizon’s on market rare disease biologics as well as development-stage medicines.
Tim Walbert, chairman, president and chief executive officer, Horizon, said:
“As we grow as a global biotechnology company, it is important to continue to invest in our development and manufacturing capabilities to supplement our current network of contract manufacturing organizations to maintain flexibility over our production and supply. The planned expansion to add this drug substance facility is important to the long-term growth of our commercial and pipeline biologics as well as our commitment to Ireland.”