The focus of the Hovione Cork site is Contract Development and Manufacturing offering both drug substance and particle engineering. The plant has been regularly inspected by the FDA and the Health Products Regulatory Authority (From a HSEE perspective the site has been regularly inspected by the local Health and Safety Authority and the Environmental Protection Agency.

The site prides itself on its project teams capability to deliver multiple projects with accelerated timelines.

“Hovione Cork is unique, it combines hard to find capacity and quality people”

US Biotech, West Coast

The site has extensive facilities for Drug Substance manufacturing with approximately 430 cubic meters of cGMP manufacturing capacity ranging in scale from 2.5m³ to 16m³ across two chemistry buildings. In addition, the site has both ultrafiltration and nanofiltration capabilities in both chemistry buildings. Equipment is flexible via manifold connectivity and multipurpose and the potential for up to 12 discrete process trains across two chemistry buildings with the potential for future expansion. The site has experience across a wide variety of chemistries.

The site houses the largest commercial pharmaceutical spray dryer available on the market, a Niro PSD-5, which is particularly suited for large volume products. A PSD4 equipment train is currently being installed and going live in 2024.

The site is expanding its offering and capabilities for process development and industrialization with the expansion of the Process R&D group in 2024.  A highly potent small scale equipment facility to support clinical trial and Registration campaigns is also planned for the site. 
 

Areas of Focused Expertise

The site has leading capabilities and physical assets in the following areas:

• Cryogenic (Volume 8000L to 10,000L, Temperature Range -150 to 120ºC)
• Metal catalyst handling and Hydrogenation (Volume 2500L to 6000L, Pressure Rating 6 to 12 bar)
• Large scale spray drying (PSD5 and PSD4)
• Pyrophoric material handling (2 stations)
• Ultra filtration (2 UF skids per building with 160m2 surface area per skid) and Nano filtration unts.
   

For details about production equipment – click here

Operations

• The Cork plant operates 24 hours a day 7 days a week.
• Quality Control labs supports production 24 hours a day 7 days a week.
• Plant maintenance shutdown period takes place for 2 to 3 weeks in August.

10 years in Cork, 60 years in the world

In 2019 Hovione celebrated its 10th anniversary at the Cork site in Ireland. Learn more.