A drug stability program is a fundamental part of ensuring product quality,
safety, and efficacy. Here, we summarize essential guidelines, differences between large- and small-molecule stability, and the analytical methods used.
In response to regulatory concerns, host cell protein (HCP) analysis is now often conducted using LC–MS/MS. Unlike ELISA, LC–MS/MS can positively identify and quantify specific HCPs and characterize the total amount of HCPs present.
Intact mass analysis is becoming increasingly useful for characterizing biologics. We describe the current application of intact mass analysis, including quantitation, sequencing, and structural characterization.