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Eurofins BioPharma Product Testing Ireland

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Eurofins Lancaster Laboratories Ireland

IDA Industrial Estate
Clogherane
Co Waterford
Dungarvan
Ireland X35 T628

Phone: +353 (0) 58 48300

pharma@eurofins.com
www.lancasterlabspharm.com

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Eurofins Lancaster Laboratories’  Ireland facility provides microbial, chemical and biologics analysis to the biopharmaceutical, biotech and medical device industries throughout the US, Europe and Japan.

The company currently employs nearly 400 people based in Dungarvan and at client companies throughout Ireland and UK as part of the award-winning Professional Scientific Services® (PSS) programme.

Services:

Eurofins Lancaster Laboratories has extensive experience in testing a full range of raw materials, intermediates and finished sterile and non-sterile products.

Microbiology and chemistry laboratories are fully equipped to offer complete testing services, including 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 biologics facility conducts a variety of assays, and analysis by CE.

Eurofins Lancaster Laboratories has broad experience using clients' methods and internationally recognised methods such as USP, BP or Ph. Eur. Alternatively, procedures can be developed in accordance with clients’ requests.

Chemistry

  • Compendial testing of raw materials
  • Process validation
  • Method development & validation in accordance with ICH guidelines
  • Stability storage and testing
  • Product Release Testing
  • Cleaning validation studies
  • Purified water and waste water testing
  • Contaminant identification

Microbiology

  • 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

Eurofins Lancaster Laboratories can support all aspects of the biopharmaceutical drug development process with a comprehensive range of services from the biochemical characterization of biologicals to product specific cell and non-cell-based assays for drug potency.

The laboratory provides industry-leading experience in the development, optimisation, qualification and validation of biopharmaceutical products that meet regulatory guidelines for all phases of the development cycle.

Impurity Testing

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

Protein Analysis

  • Capillary Electrophoresis (SDS/IEF)
  • SDS-PAGE/Western Blot/IEF
  • UV Spectroscopy
  • ELISA (Potency)
  • Biochromatography (UPLC/HPLC)

Medical devices

Eurofins Lancaster Laboratories offers a comprehensive range of analyses and support functions to the Medical Device industry. 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 provides contract facilities for the determination of API's associated with medical devices.

All data and results can be accessed via the LabAccess Web portal.

Accreditations:

  • Good Manufacturing Practice (GMP) approval of contract laboratory is granted by the Health Product Regulatory Authority (HPRA), formerly Irish Medicines Board (IMB). This approval is issued in accordance with Directive 2001/83/EC as amended by Directive 2004/27/EC for contract laboratory analysis of medicinal products and 2001/82/EC as amended by Directive 2004/28/EC for contract laboratory analysis of veterinary products for the pharmaceutical industry.

  • Operates in accordance with US-FDA Code of Federal Regulations (CFR) e.g. 21 CFR Part 210: cGMP General, 21 CFR Part 211: cGMP Finished Pharmaceuticals

  • Inspected and registered by the FDA as a contract laboratory to serve the biopharmaceutical industry