Biotherapeutics, such as monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), constitute an increasingly important class of molecular drugs. Accelerating our society’s access to novel biotherapeutics-based therapies and diagnostic tests for existing and new clinical indications, including those caused by COVID-19, is critical. The exceptional specificity and selectivity of mass spectrometry (MS) renders this analytical technique a powerful tool in development of biotherapeutics-based drugs and clinical diagnostics. Nevertheless, even Orbitrap Fourier transform mass spectrometry (FTMS), which dominates the high-performance MS field, may demonstrate limited performance in structural analysis of the very complex mAbs and ADCs. Indeed, while the user-accessible Orbitrap data (processed mass spectra with reduced information) may be of a sufficient quality and information content for small molecule and isolated proteins analysis, it is not for the complex biotherapeutics. We identified the limiting factor that inhibits biotherapeutics structure analysis being the absence of hardware and software tools to acquire (access and provide to the end-users) and analyze the un-reduced data (e.g., time-domain signals or transients). With these tools in hands, the end-users would be able to increase performance and productivity of their biopharma workflows on the Orbitraps (e.g., leading to increased sensitivity and resolution, and thus leading to faster identification of more species and their deeper sequencing), as well as create novel workflows, not possible otherwise. The A2MStools (access & analysis MS tools) aims to address this limitation by: (i) providing access to the currently unavailable un-reduced data (transients) for the Orbitraps FTMS platforms with enabled BioPharma capabilities, and (ii) empowering analytical scientists with the data analysis tools capable of handling the datasets of unprocessed data in the most comprehensive and innovative ways.
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