Comparative Peptide Mapping between Two Manufacturers of Trastuzumab using the X500B QTOF System

Samples of Trastuzumab from two different manufacturing sources were obtained for comparative analysis using peptide mapping. This analysis illustrates what is required for biosimilar characterization, or for analysis of processing and production alterations that may affect the final product. Presented here are the results of the investigation into the differences between the two batches. Also discussed is the ability of the proposed workflows and technologies to rapidly and simply characterize and quantify differences between batches.