Intact Mass Analysis of a Therapeutic Monoclonal Antibody Biosimilar

28th Mar 2022

Biologics represent a growing class of pharmaceuticals being developed to target a variety of disease and illness vectors. Monoclonal antibodies (mAbs) represent the main class of these with twelve more being approved in 2020 by the FDA for cancers, viruses, and other targets. In contrast to traditional small molecule drugs, mAbs are much more complex with a large degree of heterogeneity. Some of these features such as glycan profile and accurate mass are defined as critical quality attributes (CQAs). Identifying and confiriming these CQAs can play a critical role in development or production of mAbs.

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