LC-MS Advancement

How Modern LC-MS Tools Are Transforming HCP Analysis in Biopharmaceuticals

The addition of advanced LC-MS technologies, paired with thoughtfully designed analytical experiments, is providing deeper insight into host cell protein (HCP) characterization than ever before. With the recent updates to ICH Q14 and ICH Q2(R2), LC-MS is quickly becoming an essential tool for achieving specific, reliable quantitation of HCPs in complex biopharmaceutical products.

A recent publication further demonstrates these capabilities and the value LC-MS brings to modern HCP analysis. You can review the full study here: https://www.sciencedirect.com/science/article/pii/S0731708525003929?via%3Dihub

While HCP ELISA will continue to serve as a cornerstone for routine release testing, LC-MS offers a new level of accuracy and resolution that can significantly support process development—and may one day surpass ELISA in certain applications. Excellent work by the Alphalyse team continues to highlight how powerful this technology has become.