LC–MS/MS has gained momentum as an orthogonal approach to ELISA for host-cell protein (HCP) analysis. LC–MS/MS can identify and quantify individual HCPs, and help ensure that no HCPs evade detection above a reportable limit.
These case studies illustrate how the pharmaceutical industry utilizes mass spectrometry–based solutions to address product quality concerns, particularly when extremely low detection limits are required and when development resources are limited.
Even compared to other biopharmaceuticals, chimeric antigen receptor (CAR) T-cell therapies are particularly complex. Mass spectrometry (MS)–based process analytical technologies can be a powerful tool in identifying and monitoring key attributes throughout the manufacturing process.
Recent developments in high-resolution mass spectrometry (HRMS) are aiding biopharmaceutical development and simplifying routine monitoring, with applications in areas like multi-attribute methods, coupling established purity methods with MS, and subunit analysis.