Analytical Chemistry, Journal Year: 2021, Volume and Issue: 93(40), P. 13505 - 13512

Published: Sept. 29, 2021

Monoclonal antibodies (mAbs) and related products undergo a wide range of modifications, many which can often be directly associated to culture conditions during upstream processing. Ideally, such should monitored fine-tuned based on real-time or close information obtained by the assessment product quality attribute (PQA) profile biopharmaceutical produced, is fundamental idea process analytical technology. Therefore, methods that are simple, quick robust, but sufficiently powerful, allow for generation comprehensive picture PQA protein interest required. A major obstacle analysis proteins from cultures presence impurities as cell debris, host DNA, small-molecule compounds, usually requires series capture polishing steps using affinity ion-exchange chromatography before characterization attempted. In current study, we demonstrate direct coupling with native mass spectrometry (ProA-MS) development robust method used generate mAbs in little 5 min. The developed was applied several samples ranging complexity stability, simple more complex monoclonal antibodies, well cysteine-conjugated antibody–drug conjugate mimics. Moreover, demonstrated suitability amounts <1 μg, suggests applicability early-stage activities.

Language: Английский