The Global Leader in GMP Biopharma Product Testing

View PDF

BPI_A_141207AR07_O_F0001gWith the largest network of harmonized biopharmaceutical good manufacturing practice (GMP) product testing labs worldwide, Eurofins BioPharma Product Testing provides comprehensive laboratory services for the world’s largest pharmaceutical, biopharmaceutical, and medical device companies. We successfully enable companies to advance candidates from development through commercialization while ensuring regulatory compliance, cost effectiveness, and achievement of timelines.

The Most Comprehensive Range of Large- and Small-Molecule Testing Services Available Worldwide

Choose from a wide range of testing services that support all functional areas of biopharmaceutical drug development and manufacturing, including method development, microbiology, process validation, and quality control. Our service offerings are fully comprehensive and include testing of drug substances, final products, intermediates, and starting materials for both small- and large-molecule drug products, including

  • testing of all starting materials
  • process and product related impurities
  • method development and validation
  • stability and release testing
  • process/facility validation
  • virus clearance and safety
  • testing of packaging components.

Global Facilities

Work with any of our state-of-the-art facilities to receive the highest level of instrument technology and capacity to support projects of any size and scope. Our global capacity of more than 50,000 m2 among our 14 facilities includes

  • Gent, Belgium
  • Copenhagen, Denmark
  • Colmar, Lyon, and Paris France
  • Hamburg and Munich, Germany
  • Dungarvan, Ireland
  • Milan and Siena, Italy
  • Barcelona, Spain
  • Uppsala, Sweden
  • Michigan and Pennsylvania, United States

In addition to these laboratory locations, we have teams of scientists placed at more than 35 client facilities throughout the United States and Europe through our Professional Scientific Staffing insourcing program.-

Harmonized Systems

Receive the same level of service at any of our facilities. From technology and expertise to laboratory procedures and standards, our laboratories offer you a single resource to meet all of your GMP testing needs with the same LIMS, strict quality procedures, centralized billing system, and online data access.

Today, nearly 2,000 employees of Eurofins BioPharma Product Testing operate under the same Global Quality Policy Manual and use the same CAPA/exceptions management system and document management system.

Strategic Service Models

Manage your projects more efficiently through your choice of four unique service models. From our traditional fee-for-service model, to our managed hours, full-time-equivalent, and award-winning professional scientific staffing programs, you can choose the best, most cost-effective service solution for your project goals at any of our global facilities.

Convenient Online Data Access

Get timely and secure access to comprehensive laboratory information through LabAccess.comSM  our innovative, online data access tool. View extensive, live project information such as submitted samples, analysts notebooks, chromatograms, approved test results, certificates of analysis, raw data packages, and invoices for any project within any of our laboratories. Our system can provide

  • 24/7 data access on virtually any desktop, laptop, or mobile device
  • export results to measure product performance over time
  • a stability calendar to view your stability studies in progress
  • certificates of analysis that contain our laboratory’s QA-release electronic signature.

Timothy S. Oostdyk, PhD, is senior vice president of Eurofins BioPharma Product Testing; 1-717-656-2300; TimothyOostdyk@eurofinsUS.com.

Leave a Reply