Cork, Ireland

The Cork facility is focused on process development and cGMP manufacturing of APIs and intermediates for clinical and commercial supplies. The facility contains 5 Commercial API buildings (450-16,000L) and 2 x Cat 3b HPAPI facilities (up to 400L), which are supported by over 400 employees. The facility is fully compliant with all applicable regulations and meets the most stringent production, quality, cGMP, safety and environmental standards.

Unique Offerings

• Flexible small molecule API process development
• Scale-up and commercialization in one integrated, FDA inspected site
• Comprehensive capabilities to undertake a broad range of chemistries and supply API for all phases of development and commercialization
• A Center of Excellence for the manufacture of highly potent APIs

Specialized Capabilities

• New process technology transfer and evaluation
• Process optimization and development
• Solid state assessment
• Analytical method development and validation
• Process validation
• Pilot Plant (up to 2,500 L) to support clinical and small volume commercial API supply
• Manufacture API and registered intermediates under cGMP conditions from kilo scale to metric tonnes
• Range of flexible, multipurpose API production buildings with reactors up to 16,000 L
• Dedicated highly potent API facilities up to Cat 3b
• Range of milling capabilities including air classifier, pin and hammer mills
• Aqueous spray drying
• Comprehensively equipped analytical development and QC laboratories
• On-site stability chambers
• On-site waste treatment and wind turbine

Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.