Comparative Multi-Supplier Lot Analysis of Trastuzumab using Subunit Analysis on the X500B QTOF System

Routine characterization of biosimilars or batch comparison of manufactured biologic samples is critical to maintain quality for biotherapeutics throughout development and production. The large size and inherent heterogeneity of biologics make these drugs highly complex, requiring robust mass analysis techniques to ensure accuracy in detection of the protein backbone composition as well as the presence of post-translational modifications. Mass spectrometry is a powerful and flexible tool for biotherapeutic characterization with the ability to analyze both large and small molecules with high mass accuracy. This application note demonstrates the use of a fast, reproducible and robust method for biologic subunit analysis on the X500B QTOF system with streamlined and rapid batch processing and product comparison using the BioPharmaView™ software.