BioDRUMs: An Open-Source Python Pipeline for Automated Mean Drug-to-Antibody Ratio and Biologics Structural Integrity Analysis from High-Resolution Mass Spectrometry Data

Intact mass spectrometry analysis of biologics is crucial to understanding the behavior of a new candidate, especially for complex modalities. Sample preparation is relatively robust and easy to reproduce in different laboratories and by different operators.

However, mass spectrometric analysis and data processing represent the two most limiting steps. So far, no automated open-source pipeline has been published, which can automatically postprocess deconvoluted spectrum outputs from different vendors, plot data, and provide an overall interpretation of mean DAR and deep ADC characterization, especially on <i>in vivo</i> samples. BioDRUMs offers different features that complement existing commercial mass spectrometry deconvolution tools, such as customizable degradation-hypothesis generation, isobaric-species ambiguity reporting, vendor-neutral postprocessing of deconvoluted mass tables, structural-integrity scoring, automated plotting, and reporting.