Structural Comparison of Infliximab and a Biosimilar via Subunit Analysis Using the Waters Biopharmaceutical Platform Solution with UNIFI

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Henry Shion and Weibin Chen
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In this work, we illustrate the Biopharmaceutical Platform Solution with UNIFI for intact protein mass analysis in comparing an innovator biologic with a biosimilar.

The platform features a streamlined workflow utilizing UPLC-QTof MS technologies with the UNIFI Scientific Information System. This integrated biopharmaceutical system solution features automated data acquisition, processing, and reporting that is deployable to both regulated and non-regulated laboratories. It enables efficient structural analysis and comparative analysis of multiple batches of an innovator product and its biosimilar candidate within a comparability study, here using infliximab as an example.

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