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Cork, Ireland
Active pharmaceutical ingredient (API) development and manufacturing
Thermo Fisher Scientific’s state-of-the-art contract API development and manufacturing facility in Cork supports our customers in bringing medicines to patients through the relentless application of science in process and analytical development.
We take chemistry from laboratory-scale development through to large-scale commercial supply, made possible by our driven and dedicated employees — a team of 500+ highly skilled chemists, engineers, analysts, operators, and crafts personnel.
Our facility meets the most stringent production, compliance, safety, and environmental standards. We take pride in our mission to enable our customers to make the world healthier, cleaner, and safer through API development and manufacturing.
Site offerings
- Flexible small molecule API process development, scale-up, and commercialization all within one integrated, FDA-inspected facility
- Fully compliant with all applicable regulations and meets the most stringent production, quality, cGMP, safety, and environmental standards
- 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
Capabilities
This site provides flexible and multipurpose facilities, including these onsite offerings:
- Space to support clinical and small-volume commercial API supply (up to 2,500L)
- Dedicated highly potent API facilities for up to cat 3B projects, with reactors up to 16,000L
- Stability chambers and comprehensively equipped analytical development and QC laboratories
- A center of excellence for sustainability, it also features waste treatment and a wind turbine
Specialized capabilities:
- Analytical method development and validation
- Process validation, optimization, and development
- Solid state assessment
- New process technology transfer and evaluation
- Manufacturing of API and registered intermediates under cGMP conditions from kilo scale to metric tones
- Range of milling options including air classifier, pin, and hammer mills
- Aqueous spray drying
Learn more about the specific equipment and capabilities at this site by downloading our fact sheet.
Helpful Resources
Brochure
Brochure
Small molecule API solution: Taking a big picture approach
With competitive options for API outsourcing in all geographical regions, it can be difficult to choose the right partner for your project, regardless of its complexity. Thermo Fisher Scientific...
View brochure
Fact sheet
Fact sheet
Bioavailability enhancement technologies for poorly soluble molecules
It’s estimated that about 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly soluble. This can impede drug absorption, leading to reduced bioavailability and compromised therapeutic efficacy. Explore how Thermo Fisher Scientific’s Quadrant 2 platform leverages AI/ML tools to identify solubility enhancement technologies.
View fact sheet
Webinar
Webinar
Route Scouting for a cost-effective process development
In this webinar, experts from across Thermo Fisher Scientific’s global network will describe key benefits of route scouting and polymorph screening at early stages of clinical trials to ensure scalability for early clinical supplies to commercial manufacturing.
Watch webinar
Whitepaper
Whitepaper
Advancing drug development using in silico modeling
This report provides a framework for that understanding by outlining some of the processes that stand to gain the most from computational modeling and identifying the in silico capabilities that can be used to accelerate and de-risk each phase of development.
View whitepaper
Case study
Case study
Midsize pharma company stabilizes API - Accelerates time to clinic from three months to three weeks
A midsize pharma company wanted to progress its therapy from early development to late-phase clinical trial stage, but needed a CDMO partner to provide support in formulation analysis so that it could stabilize its product and successfully reach its clinical studies milestones.
Download case study
Blog
Blog
Mastering complex small molecule APIs and formulations
Complex small molecule APIs are characterized by their intricate structures, higher molecular weights, and sophisticated delivery requirements, which pose unique challenges in their formulation and manufacturing processes.
Read blog