Our good manufacturing practice (GMP) lab is focused on meeting our customers’ needs in Europe, the Middle East, and Africa (EMEA) with high-quality analytical testing based in our leading-edge Athlone, Ireland, facility.
As a result of our customers’ confidence in our abilities to deliver global scientific, technical and development expertise, Athlone is our fastest-growing lab location. We have more than doubled the scientific staff and the lab footprint and have significantly expanded the range of services we offer.
From our Athlone laboratory, we provide fully integrated solutions for small molecules/pharmaceuticals, biologics/biopharmaceuticals, and cell and gene therapies.
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 conducts testing for clinical programs and marketed products across all phases of drug development. This lab leverages more than 30 years of chemistry, manufacturing and controls (CMC) experience and deep expertise of the U.S. GMP lab through integration of data management systems, quality systems and scientific training programs.
Learn more about our GMP lab
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