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Eurofins’ US and European BioPharma Product Testing labs have operated individually and successfully for decades, but there are quality and data access advantages of these sister labs now partnering to serve clients, as Timothy S. Oostdyk, President, Eurofins Lancaster Laboratories and Senior Vice President, Eurofins BioPharma Product Testing 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 resources and technology, which we at Eurofins are making in order to achieve full harmonisation.” Today, nearly 2,000 employees of Eurofins BioPharma Product Testing operate under the same Global Quality Policy Manual and utilise the same CAPA/Exceptions Management System and Document Management System. “Starting in 2014, clients working with any of our laboratories will also be able to review project data and reports 24 hours a day, seven days a week with our global online portal, LabAccess.com. Whether a client is working with our laboratory in Lancaster, Munich or Paris – or all three for various projects – project information such as reports, test results, status of samples and project information for any project within the Eurofins BioPharma Product Testing network will be available through this single, online portal,” says Oostdyk. By working with one harmonised international biopharm GMP product testing provider, Eurofins’ clients will see various enhanced capabilities perquisites. “It is very important that our laboratories operate with a consistent level of scientific expertise, and offer a consistent, market leading product to our customers. Therefore we routinely and deliberately drive collaboration on services, regulations and new technology across our network. Most recently, our scientists in Pennsylvania have been actively working with our team in Munich to launch our European Viral Safety and Clearance services, an exciting addition to our rapidly growing service offerings in the EU,” reveals Oostdyk. “Active collaboration is also ongoing between the US and Copenhagen to set up harmonised service offerings in trace metals testing to address the emerging requirements in this area, including newly designed labs and protocols. We have also harmonised our rapid sterility methods in the US and Ireland and collaborate regularly to support products being released in both the US and EU. Further, our scientists at Eurofins IDmyk in France are bringing enhanced microbial identification capabilities to the network.” These types of active collaborations drive consistency and excellence in science and services. Importantly Eurofins BioPharma Product Testing has also harmonised its service models to offer all global clients the same flexible service models with the ability to tailor programs to maximise cost effectiveness and meet project needs. “This includes our traditional fee-for-service model, our managed hours program, full time equivalent program, and our award-winning Professional Scientific Staffing SM program, which has grown to include more than 35 locations in seven countries,” explains Oostdyk. This harmonisation and collaboration among the global Eurofins BioPharma Product Testing sites will enhance the clients’ overall service experience. Oostdyk elaborates: “With the most comprehensive range of large and small molecule testing services available worldwide, coupled with 14 state-of-the-art facilities in nine countries, we have the proximity backed by our global breadth of harmonised capabilities to deliver a personalised local lab experience to our customers. “We support all functional areas of bio/pharmaceutical manufacturing, 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 starting materials, process and product related impurities, method develop- ment and validation, stability and release testing, process/facility validation, virus clearance and safety, and testing of packaging components. We make it our business to effectively balance delivering the most complete range of harmonised testing services on a global platform, while meticulously treating each client as if they were our only one. When our clients are delighted, we’ve achieved our goal.” As the largest global network of harmonised BioPharma GMP product testing labs, Eurofins BioPharma Product Testing’s fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs. Eurofins’ clients develop and release products in many different markets and require the same consistent level of expertise, quality, best practices, and service options to be delivered across its network of 14 harmonised GMP labs, located in nine countries. Timothy S. Oostdyk, PhD, President of Eurofins Lancaster Laboratories; Sr. Vice President, Eurofins BioPharma Product Testing Group, discusses harmonising policies, quality and services among 14 global facilities VOLUME 19 ISSUE 2 2014 European Pharmaceutical Review 21 For more information, please visit: www.eurofins.com/biopharm PRODUCT HUB
