Analytical Characterisation of Biotherapeutics focuses on the challenges of characterizing novel and complex modalities, while developing a toolbox .. Read more of advanced techniques, coupled with computational approaches and high-throughput analytics. The Analytical Characterisation of Biotherapeutics at PEGS Europe focuses on the challenges of characterizing novel and complex modalities, while developing a toolbox of advanced techniques, coupled with computational approaches and high-throughput analytics to meet the demands for robustness, sensitivity, accuracy and speed. An overview of these techniques will be presented with a focus on mispairing analysis and functional characterization of multispecific drug candidates. Over the past decade, a wide variety of separation methods have been successfully coupled to native MS to characterize the heterogeneity of mAbs and related products. Here, we report the development of several novel native LC-MS techniques and showcase their applications in drug product characterization. Integrated biophysical screening of these attributes, in combination with sequence quality assessment, offers a successful predictive tool for selecting risk-free candidates early on. This talk is designed to provide case studies highlighting the criticality of developing such an early tool kit in the discovery phase.
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