Characterization of bio therapeutic moieties typically involves the application of multiple orthogonal analytical methods to evaluate product quality and purity. Investigations into molecular traits include the evaluation of aggregates, variants, degradation products, and post-translational modifications such as glycosylation. As modalities evolve beyond monoclonal antibodies and increase in their complexity, strategies to resolve proteoforms within a bio therapeutic at the intact level have become increasingly critical. Here we showcase hyphenated approaches to profile a heavily glycosylated Fc fusion protein, the efficiency of high throughput peptide exchange in recombinant MHCI complex generation, and also characterize low level aggregation in antibody-related therapeutics.

Profiling a heavily glycosylated fusion protein and other heterogeneous bio therapeutics with native mass spectrometry

ACS Spring 2022

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