Advancing Drug Discovery and Development through Method Development and Applications of High-Resolution Mass Spectrometry

With the introduction of advanced ionization techniques, high-resolution mass spectrometry (HRMS) has become a vital analytical tool in the drug discovery space for identifying and characterizing biological targets, elucidating structures of synthetic organic compounds, and conducting early studies on drug metabolism and pharmacokinetics. Moreover, even in the pharmaceutical development landscape, HRMS plays a pivotal role in characterizing process-related impurities and degradants across various modalities, including small molecules and biologics. HRMS-based analytical techniques also enable trace-level analysis of mutagenic impurities, such as nitrosamines, which pose significant challenges for pharmaceutical companies, and necessitates adherence to comprehensive derisking strategies that align with regulatory guidelines.

The goal of this session lies in highlighting the various applications of HRMS in expediting workflows in pharmaceutical R&D, across modalities, encompassing both drug discovery and development. The session will open with a focus on (ultra) high-throughput mass spectrometry (uHT-MS) platforms that can be deployed to accelerate high throughput screening in order to eliminate analytical bottlenecks arising from slower data acquisition and data analysis times. The focus of the session will then shift to HRMS-based applications in drug metabolism and pharmacokinetics, which can provide further insights into identifying promising drug candidates for development. Finally, the session will explore how current HRMS tools can be employed in the drug development space to accurately quantify genotoxic or mutagenic impurities and will conclude with an emphasis on the criticality of innovation needed to develop HRMS techniques and platforms that can support the pharmaceutical pipeline from end to end.