Eurofins’ US and European BioPharma Product Testing labs haveoperated individually and successfully for decades, but there are qualityand data access advantages of these sister labs now partnering to serve clients, as Timothy S. Oostdyk, President, Eurofins LancasterLaboratories and Senior Vice President, Eurofins BioPharma ProductTesting Group, explains: “While a global presence is very valuable, what is essential to international clients is the ability for all labora-tories to operate under the same policies, procedures and guidelines.This kind of consistency requires a significant investment of resourcesand technology, which we at Eurofins are making in order to achieve full harmonisation.”

Today, nearly 2,000 employees of Eurofins BioPharma ProductTesting operate under the same Global Quality Policy Manual and utilisethe same CAPA/Exceptions Management System and DocumentManagement System. “Starting in 2014, clients working with any of ourlaboratories will also be able to review project data and reports 24 hoursa day, seven days a week with our global online portal, LabAccess.com.Whether a client is working with our laboratory in Lancaster, Munich orParis – or all three for various projects – project information such asreports, test results, status of samples and project information for anyproject within the Eurofins BioPharma Product Testing network will beavailable through this single, online portal,” says Oostdyk.

By working with one harmonised international biopharm GMP producttesting provider, Eurofins’ clients will see various enhanced capabilitiesperquisites. “It is very important that our laboratories operate with aconsistent level of scientific expertise, and offer a consistent, marketleading product to our customers. Therefore we routinely and deliberatelydrive collaboration on services, regulations and new technology across our network. Most recently, our scientists in Pennsylvania have beenactively working with our team in Munich to launch our European ViralSafety and Clearance services, an exciting addition to our rapidly growingservice offerings in the EU,” reveals Oostdyk.

“Active collaboration is also ongoing between the US andCopenhagen to set up harmonised service offerings in trace metalstesting to address the emerging requirements in this area, includingnewly designed labs and protocols. We have also harmonised our rapid

sterility methods in the US and Ireland and collaborate regularly tosupport products being released in both the US and EU. Further, ourscientists at Eurofins IDmyk in France are bringing enhanced microbialidentification capabilities to the network.”

These types of active collaborations drive consistency andexcellence in science and services. Importantly Eurofins BioPharmaProduct Testing has also harmonised its service models to offer allglobal clients the same flexible service models with the ability to tailorprograms to maximise cost effectiveness and meet project needs. “Thisincludes our traditional fee-for-service model, our managed hoursprogram, full time equivalent program, and our award-winningProfessional Scientific StaffingSM program, which has grown to includemore than 35 locations in seven countries,” explains Oostdyk.

This harmonisation and collaboration among the global EurofinsBioPharma Product Testing sites will enhance the clients’ overall serviceexperience. Oostdyk elaborates: “With the most comprehensive rangeof large and small molecule testing services available worldwide,coupled with 14 state-of-the-art facilities in nine countries, we have theproximity backed by our global breadth of harmonised capabilities todeliver a personalised local lab experience to our customers.

“We support all functional areas of bio/pharmaceuticalmanufacturing, including method development, microbiology, process validation and quality control. And we provide testing for nearly all stages of the drug development process, ranging from pre-clinical through post-product approval, including: testing of all startingmaterials, process and product related impurities, method develop -ment and validation, stability and release testing, process/facilityvalidation, virus clearance and safety, and testing of packagingcomponents. We make it our business to effectively balance deliveringthe most complete range of harmonised testing services on a globalplatform, while meticulously treating each client as if they were our onlyone. When our clients are delighted, we’ve achieved our goal.”

As the largest global network of harmonised BioPharma GMP product testing labs, Eurofins BioPharma ProductTesting’s fundamental philosophy is to help clients efficiently allocate their research and manufacturing expendituresby strategically engaging them to meet their unique outsourcing needs. Eurofins’ clients develop and releaseproducts in many different markets and require the same consistent level of expertise, quality, best practices, andservice options to be delivered across its network of 14 harmonised GMP labs, located in nine countries.

Timothy S. Oostdyk, PhD, President of EurofinsLancaster Laboratories; Sr. Vice President,Eurofins BioPharma Product Testing Group,discusses harmonising policies, quality andservices among 14 global facilities

VOLUME 19 ISSUE 2 2014 European Pharmaceutical Review 21

For more information, please visit:www.eurofins.com/biopharm

PRODUCT HUB

epr214 Lancaster product hub_Layout 1 09/04/2014 15:18 Page 1