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

K E Y W O R D S Biosimilar, intact mass analysis, intact mass subunit analysis, light chain, heavy chain, glycosylation, glycoprofile, infliximab, mAb, biotherapeutic characterization A P P L I C AT IO N B E N E F I T S A streamlined workflow within an integrated UPLC-MS/MS system solution that features automated data acquisition, processing, and reporting, and that is deployable to both regulated and non-regulated laboratories, enables efficient structural analysis and comparative analysis of multiple batches of an innovator product and its biosimilar candidate within a comparability study. IN T RO DU C T IO N The expiration of patents and other intellectual property rights for originator biologics over the next decade opens up ample opportunities for biosimilars to enter the market and push industry competition to a high level.