Current status of Imaging Mass Spectrometry in drug discovery and development: A survey highlighting technical...

Imaging mass spectrometry (IMS) is used in various fields of pharmaceutical research and development, including the targeted delivery of administered drugs, drug distribution in tissues, drug toxicity analysis, and disease mechanisms. However, IMS is a relatively new technology that requires further validation before being accepted by authorities for regulatory compliance of new drugs. In 2020, an international survey was conducted in collaboration with the Imaging Mass Spectrometry Society (IMSS) and the Japan Association for Imaging Mass Spectrometry (JAIMS) to understand the status of IMS and to identify problems with its application. The survey revealed technical challenges in sample preparation, quantitative analysis of drugs in tissues, and data acquisition. Based on the 2020 survey results, we recently conducted a further detailed survey and had discussions within the JAIMS aimed at translating the results into specific experimental procedures and proposing feasible standard methods. This survey involved detailed questions on five themes: sample collection and storage, tissue section preparation, sample preparation, data analysis (including quantitative analysis and data correction methods), and data reproducibility. The questions were answered by JAIMS members working for ten companies. To resolve technical issues identified by the survey, we propose some realistic approaches toward standardization.