Eurofins Central Laboratory Celebrates 30 Years of GLP

Posted by Sandra Hageman on Jan 7, 2019 9:00:00 AM
Sandra Hageman

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Celebrating Thirty Years of Good Laboratory Practice

The GLP (Good Laboratory Practice) Testing Facility of Eurofins Central Laboratory in Breda, The Netherlands has been accredited for OECD GLP for over 30 years. It all started at the BCO Centre for Research (B for Bergschot 71, the street address ever since) with the first inspection by the Dutch Health Care Inspectorate in June 1988. Over the years, BCO underwent several transformations and evolved into becoming one of the Eurofins Central Laboratory facilities, keeping the GLP Test Facility embedded in the Breda Clinical Laboratory.

Eurofins Central Laboratory offers exploratory and confirmatory biomarker analysis globally in 4 CAP-accredited Central Laboratory locations: United States, Europe, Singapore, and China. For modern global clinical trials, utilizing disease-related biomarkers as surrogate endpoints is standard practice. Harmonization and standardization across all laboratory locations is critical for the validity of biomarker utilization. Commercial clinical analyzers and their associated testing kits find great utility in conducting such analyses, and verification of manufacturer specifications is often sufficient for the use in clinical (CAP/CLIA) laboratories.


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Biomarker data that is used for decision-making and for regulatory purposes requires advanced method validation beyond CAP/CLIA verification. Eurofins Central Laboratory is uniquely positioned by uniting GLP and CAP/CLIA in one synergetic approach. We are one-of-a-kind in offering advanced validation for biomarker assays on clinical analyzers. Our hybrid system allows us to combine the best of both worlds when utilizing laboratory biomarkers to prove safety and efficacy, support decisions, stratify patients, develop companion diagnostics and to support the submission of data sets to regulatory agencies worldwide.

With Eurofins Central Laboratory acting as the core of our service offering, we provide clients access to over 100 specialized laboratories in the Eurofins BioPharma Services network. This model offers an exhaustive range of state-of-the-art technology platforms to support all laboratory biomarker testing requirements spanning protein, genomic and histopathology biomarker analysis in the support of clinical trials. The network provides our clients with access to scientists of all laboratory specializations within our organization and allows us to provide highly consultative services. Eurofins is unparalleled in its portfolio of testing, its innovative technology and its history of having a global presence.

Here at Eurofins Central Laboratory, we are exceptionally proud of having thirty years of uninterrupted GLP, and are delighted that we still have several staff members with us at our Breda facility that have been with us since the beginning. Thank you to one and all!

To learn more about our Biomarker Services, click here

 

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Tags: Bioanalytical Testing, BioPharma, Central Laboratory, Quality, Results