Comprehensive GMP analytical testing services in Athlone, Ireland
Our good manufacturing practice (GMP) lab is focused on meeting customer needs in Europe, the Middle East, and Africa (EMEA) with high-quality analytical testing based in our leading-edge Athlone, Ireland, facility.
With expertise in chemical, manufacturing, and control (CMC) activities and commercial release testing, Athlone is a purpose-built lab providing comprehensive GMP lab support for DS (Drug Substance) and DP (Drug Product).
Our GMP lab capabilities, expertise and experience
sq. ft. of leading-edge lab space
highly skilled scientists and staff
years advancing customers’ drug development programs
Analytical testing services
- Method development, transfer and validation for inactive ingredients, drug substances, drug products and medical devices
- Stability testing and storage
- Release and quality control testing
- Physicochemical characterization
- Extractables and leachables analysis
Industry-leading inhalation testing
- Commercial release and stability in the EU
- Device performance, aerosol and particle characterization
- Dry powder inhalers (DPI)
- Pressurized metered dose inhalers (pMDI)
- Nasal and nebulizer testing
Biologics testing
- Commercial release and stability in the EU
- Solutions, lyophilized powders, pre-filled syringes (PFS) and vials
- Antibodies, proteins, peptides, antibody drug conjugates (ADCs) and gene therapy products (AAVs)
- Mass, identity, purity, activity, binding protein content and impurities
- Bioassay and molecular biology labs
- Oligonucleotide testing
Small molecule and specialty testing
- Commercial release and stability in the EU
- Tablets, capsules, lyophilized powders, pre-filled syringes (PFS), vials, solutions, stents, catheters and other medical devices
- Oligonucleotide analysis
- Assay, purity, content uniformity, dissolution, related substances and residual solvent determinations
- Identification and quantification of low-level impurities (genotoxic, nitrosamine and elemental)
Our GMP lab in Athlone, Ireland is one of the largest labs of its kind in Europe
Our GMP lab in Athlone conducts testing for clinical programs and marketed products across all phases of drug development. This lab leverages more than 30 years of experience and deep expertise of the U.S. GMP lab through integration of data management systems, quality systems and scientific training programs.
Our lab is easily accessible from multiple international airports – Dublin, Shannon, Cork, and Belfast.
Learn about our GMP labs’ advancements and planned growth to support increasingly complex drug development.
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