Hybrid Mass Spectrometry Applied across the Production of Antibody Biotherapeutics.

ABSTRACT: Post expression from the host cells, biotherapeutics undergo downstream processing steps before final formulation. Mass spectrometry and biophysical characterization methods are valuable for examining conformational and stoichiometric changes at these stages, although typically not used in biomanufacturing, where stability is assessed via bulk property studies. Here we apply hybrid MS methods to understand how solution condition changes impact the structural integrity of a biopharmaceutical across the processing pipeline. As an exemplar product, we use the model IgG1 antibody, mAb4. Flexibility, stability, aggregation propensity, and bulk properties are evaluated in relation to perfusion media, purification stages, and formulation solutions. Comparisons with Herceptin, an extensively studi

SUBMITTER: Christofi E 

PROVIDER: S-EPMC11697328 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature