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Monitor Your mAb with Selectivity and Specificity for Upstream Bioprocessing

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"Monitor Your mAb with Selectivity and Specificity for Upstream Bioprocessing"

This application note from Bio-Techne introduces the Simple Western system, an automated, benchtop instrument that combines capillary electrophoresis (CE-SDS/cIEF) with immunoassay analysis for selective mAb analysis directly in complex samples, such as human serum.

This technology provides the resolution power of CE-SDS/cIEF with the sensitivity and specificity of ELISA, offering more accurate, quantitative results compared to traditional CE-SDS/cIEF platforms, ELISA, or Western blot. The system delivers results in just three hours, a substantial advantage for biosimilar mAb development in the context of patent expiry and the quest for biosimilars.

The paper also details an experiment where Simple Western was used to characterize Trastuzumab, a monoclonal antibody-based cancer treatment. The instrument provided rich, quantitative results and revealed cross-reactivity of the detection antibody with other IgG1 drug products, which might be difficult to identify with ELISA. The system demonstrated a high level of selectivity and specificity for upstream bioprocessing, underlining its value as an analytical tool for mAb analysis and biosimilar development.

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