Implementation of a High-Resolution Liquid Chromatography–Mass Spectrometry Method in Quality Control Laboratories for Release and Stability Testing of a Commercial Antibody Product

Liquid chromatography–mass spectrometry (LC–MS) has been widely used throughout biotherapeutic development. However, its implementation in GMP-compliant commercial quality control (QC) laboratories remains a challenge. In this publication, we describe the covalidation and implementation of an automated, high-throughput, and GMP compliant subunit LC–MS method for monitoring antibody oxidation for commercial product release and stability testing. To our knowledge, this is the first report describing the implementation of a high-resolution LC–MS method in commercial QC laboratories for product release and stability testing in the biopharmaceutical industry. This work paves the road for implementing additional LC–MS methods to modernize testing in commercial QC with more targeted control of product quality.