Structural Comparison of Infliximab and a Biosimilar via Subunit Analysis Using the Waters Biopharmaceutical Platform with UNIFI
19 Feb 2015This 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.
Related Products
Request Quote for All Products
ACQUITY UPLC H-Class PLUS Bio System
WatersThe ACQUITY UPLC H-Class PLUS Bio System delivers the benefits of UPLC's resolution, sensitivity, and throughput in a system purpose-built for the analysis of proteins, peptides, nucleic acids, and glycans.
Biopharmaceutical Platform Solution with UNIFI
WatersThe Waters Biopharmaceutical Platform Solution with UNIFI® integrates robust UPLC®/MS characterization technology with the UNIFI Scientific Information System for applications in bioseparations, intact protein mass analysis, peptide mapping and released glycan analysis.This platform unites all aspects of biotherapeutic analyses and workflows, enabling organizations to apply high resolution analytics across the development process continuum. The platform captures complex mass spectrometry and chromatography data, and enables laboratories to comprehensively and routinely acquire, process, and share LC and MS characterization information throughout a biotherapeutic’s lifecycle. Results can be shared from discovery to development to GxP quality control.