BioReliance comissioned a new world-class US Clearance facility on August 1, 2013. The new facility design includes four lounge work areas and four large clearance laboratories with modular benchtops. The facility's design is based on direct client feedback and is built to optimally serve client needs for conducting critical downstream bioprocessing studies. All studies performed at the facility are completely secure and supported by dedicated BioReliance scientists and state-of-the-art chromatography equipment. 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.
Client Benefits Include:
The Clearance Services group at our BioReliance facility in Stirling has performed thousands of clearance studies including virus, TSE, bacteria, mycoplasma and DNA clearance. This extensive experience helps us to design the most cost effective studies for our clients. We have performed both virus and TSE clearance studies on a wide range of different products and different process steps allowing us to advise our clients on potential problems with these types of study and on the most appropriate process steps to validate in order to satisfy their needs. The assays used are validated and all work is completed to be GLP compliant. Dedicated QA personnel audit specific steps and procedures during each study.
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