Sigma-Aldrich Corporation’s BioReliance, the biologics and early-development services business under SAFC, has opened a new Clearance Services facility in Rockville, MD. This world-class facility, commissioned on August 1, 2013, allows BioReliance to offer increased capacity and flexible scheduling while maintaining its core focus on providing industry-leading quality, expertise and value. The new U.S. facility more than doubles the amount of space available to clients to conduct their critical downstream bioprocessing studies.
Designed with input from clients and built to complement BioReliance’s global viral clearance services capabilities, the Rockville facility features four large clearance suites with modular layouts that allow for customized laboratory setups. All studies performed at the facility are completely secure and supported by dedicated scientists and state-of-the-art chromatography equipment, such as GE Healthcare’s AKTA avant. Every project is fully compliant with applicable global guidelines and regulations, including those from the U.S. Food and Drug Administration and European Medicines Agency. Completed studies receive a consolidated report that includes comprehensive titration and/or process data. BioReliance has already successfully conducted several client studies and quality audits in the new facility.
“Combining our deep knowledge and proven experience with a global investment in modern facilities and equipment enables BioReliance to offer robust validation packages and proprietary CompleteClearance services to our clients. It’s all about simplifying the viral clearance process through an unrivaled combination of scientific expertise, client-focused service and decades of experience,” said Archie Cullen, president of BioReliance. “Any time a client comes to work with us, they are assured that their study is expertly designed and performed by personnel that have participated in thousands of successful studies in support of clinical and commercial biopharmaceutical products.” Clients using BioReliance’s U.S. facility will have access to a wide range of resources, including personalized modular laboratory suites with spacious, technology-enabled lounges, unique “suite-to-lounge” monitoring, and support from industry-leading personnel.
The Rockville Clearance Services facility investment completes BioReliance’s upgrade to its global offering designed to deliver a total client solution and experience. The Stirling, Scotland (U.K.), Clearance Services laboratories were completely renovated and expanded in 2011.