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About Eurofins BioPharma Product Testing Ireland Limited

With 50 years of expertise in delivering comprehensive laboratory services, Eurofins Biopharma Product Testing Ireland operates as a GMP-certified laboratory with extensive experience in chemical and microbiological testing. We support the analysis of raw material, intermediates, finished sterile & non-sterile pharmaceutical products for the Human and animal health industries.

We offer a full range of testing services, including but not limited to: extensive chromatography facilities (HPLC, GC and LC-MS), spectroscopy (UV-VIS, AA and FTlR), metals analysis via AA, GFAA, dissolution testing, physical testing of tablets, full media preparation facilities, class A/B and C cleanrooms, isolator technology and MicroSEQ® genotypic bacterial and fungal identification and Bruker Maldi-TOF bacterial identification. Our site has extensive expertise in cell and gene therapy testing, offering molecular biology, qPCR, sequencing, ELISA, and cell-based assays.

Our expertise spans everything from routine standardised testing to complex, tailor-made studies designed to meet your unique requirements. We have been inspected successfully by the FDA & HPRA .

Our teams of scientists and project managers partner with you throughout the outsourcing process from testing to monthly reports to 24-hour online data access at LabAccess.comSM.

In close cooperation with our Eurofins BioPharma Product Testing network of laboratories across Europe, we are able to offer the full service package, including microbiological and potency assay testing. Our local presence ensures personalised customer support for all analytical needs.

In addition to BioPharma Product Testing, Eurofins Medical Device Services delivers comprehensive testing, consulting, regulatory, sterilisation and packaging solutions for medical devices from development through market approval and beyond.

Locations

Dungarvan

Laboratory

IDA Industrial Estate, Clogherane, County Waterford, Dungarvan,X35 T628, Ireland

Laboratory

Accreditations

Certificate of GMP Compliance of a Manufacturer

Issuing Body Health Products Regulatory Authority (HPRA)

Issuing Body Country IE - Ireland

Issuing Body Website www.hpra.ie

Certificate of GMP Compliance of a Manufacturer (H)

Issuing Body Health Products Regulatory Authority

Issuing Body Country IE - Ireland

Issuing Body Website www.hpra.ie

Certificate of GMP Compliance of a Manufacturer (IMP)

Issuing Body Health Products Health Authority (HPRA)

Issuing Body Country IE - Ireland

Issuing Body Website www.hpra.ie

Testing

Chemistry

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Microbiology

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  • Microbial limit testing of raw materials and finished products
  • Method development for sterility and bioburden analysis
  • Validation and bioburden analysis according to the relevant pharmacopoeia
  • Bacteriostasis and fungistasis analysis
  • Sterility analysis (isolator and clean room)
  • Identification of micro-organisms
  • Preservative efficacy testing
  • Use dilution and surface challenge testing of detergents and disinfectants

Biopharmaceutical

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  • Biochemical characterisation of biologicals
  • Product specific cell and non-cell-based assays for drug potency
  • Development, optimisation, qualification and validation of biopharmaceutical products

Impurity testing

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  • qPCR for residual DNA impurities (CHO/E.coli)
  • Host cell protein and protein A contamination (ELISA)

Protein analysis

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  • Capillary electrophoresis (SDS/IEF)
  • SDS-PAGE/western blot/IEF
  • UV spectroscopy
  • ELISA (potency)
  • Biochromatography (UPLC/HPLC)

Medical devices

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A comprehensive range of analyses and support functions to the Medical Device industry is available. Microbiological laboratory facilities include class A/B and C clean rooms and a microbial identification laboratory. Experience in the validation of analytical methods and analysis of a wide range of medical devices, including prosthetic implants, ophthalmic implants, cutaneous adhesives and cardiac implants. Also providing contract facilities for the determination of API's associated with medical devices.

Contact us

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Browse our career opportunities

At Eurofins BioPharma Product Testing Ireland, we believe that our people are the foundation of our success. As part of the global Eurofins Scientific network, we offer a dynamic, supportive, and science-driven environment where your work contributes directly to food safety and public health.