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

This application note characterizes infliximab and a biosimilar candidate, produced in a different cell line, using Waters Biopharmaceutical Platform Solution. The objective is to screen multiple lots of both the innovator and biosimilar products at the subunit level to establish comparability at this higher level of structure. Lot-to-lot and batch-to-batch comparisons will show product variation, illustrating the range of quality attributes to be considered in a candidate biosimilar.