NIBRT_Training_Catalogue_2014

2014 Training and Education Catalogue

Complete Process and Product Characterisation Facilities

NIBRT have developed a unique, world-leading bioanalytical laboratory to provide training programmes on complete product and process characterisation for (bio)pharmaceuticals. These programmes are delivered in state-of-the-art bioanalytical laboratories by leading experts with comprehensive industrial experience. The training focuses on providing clients with the practical skills, experience and theoretical knowledge to confidently perform an array of both basic and cutting-edge bioanalytical techniques. The training laboratory is fully equipped with a comprehensive suite of bioanalytical equipment for full characterisation of biopharmaceuticals, in terms of amino acid sequence, concentration, size, charge, purity, integrity, structure, post-translational modifications (particularly glycan structures) and process-related modifications. The lab also features state-of-the-art mass spectrometry and chromatography equipment including:  Two Waters Xevo G2 QToF mass spectrometers (for LC-MS/MS analysis).  One Waters Acquity UPLC.  Two Waters Acquity H-class Bio UPLCs with UV and fluorescence detectors and titanium flow cells. “There are many current and new tools available that enable scientific, risk-managed pharmaceutical development, manufacture, and quality assurance. These tools, when used within a system can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge. ” FDA Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

Please refer to www.nibrt.ie for full course details

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