Critical Qualities of Biopharmaceuticals Revealed by Magnetic Resonance - Technical Seminar Sponsored by Bruker

Magnetic Resonance (MR) is a proven technology that provides detailed information on protein aggregation and conformational states, stability monitoring and structural changes and chemical modifications at atomic resolution.1 Information rich data and ease of use in the study of the Higher Order Structure (HOS) of biotherapeutic proteins make this technique a direct measure of their Critical Quality Attributes (CQA). Recently, new developments in acquisition and data analysis have emerged to establish MR as a powerful metric for validating the HOS and monitoring the self-association of biotherapeutics, utilizing both high resolution NMR and Relaxometry methods.2,3 This presentation describes examples of the technologies offered by Bruker BioSpin Corp. to validate the CQAs of biotherapeutics required for assessment by regulatory agencies and development by the pharmaceutical industry.