Using mass spectrometry for robust identity release testing in a global quality control network.

Abstract

Product identity (ID) testing is a fundamental requirement in pharmaceutical quality control. Roche/Genentech has developed and established a mass spectrometry-based platform ID method for routine release testing of biologics in the global clinical and commercial quality control environment. The established method, using peptide mapping combined with liquid chromatography-mass spectrometry, allows automated data evaluation. Previous experience shows that this approach is highly user-friendly in regulated testing environments, significantly reduces validation work for new products, and, due to its high robustness, results in a reduced error rate during test execution and data evaluation. Due to the specific analysis of product peptides, the method also allows for a sensitive and high-resolution evaluation of further product variants that are attributable to chemical and/or post-translational amino acid modifications. The data already recorded for identity testing purposes can therefore be immediately reevaluated during a quantitative product quality impact assessment following unexpected events in the manufacturing process, thus saving additional analyses during root cause analysis and future failure mitigation. In summary, this technology, established and qualified at all Roche/Genentech quality control sites, enables improved product monitoring beyond the routine release and stability testing methods used.