Mass Spec - an Essential Tool for Characterization of mAbs during Development

Presented by

Dr Wei Xu & Dr Henry Shion

About this talk

Monoclonal antibodies (mAbs) represent a big portion of therapeutic proteins. Mass spectrometry (MS) coupled with modern separation technologies has become an essential tool in characterization of mAbs within the Quality by Design (QbD) paradigm during development. In this article, we use case studies to discuss the application of MS analysis in clone selection, optimization of fermentation conditions, development of purification and formulation. Specifically, simultaneously detect and monitor variants due to incomplete leader sequence processing, accurately determine afucosylation level of N-glycosylation, characterize host cell proteins (HCPs), identify degradation pathways and critical quality attributes (CQAs) will be discussed.

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