While no specific limits exist in regulatory guidance for Host Cell Proteins (HCPs), according to ICH Q6B specifications, HCP impurities should be minimized using appropriate, well controlled manufacturing processes. The ELISA method has been traditionally used for HCP analysis, but it is limited in its ability to identify and quantitate individual HCPs that newer methods, like mass spectrometry, provide for more reliable data. Learn more at our webinar!

The demand for orthogonal methods providing detailed information on individual HCPs has increased. This has culminated in the establishment of the new USP-NF General Chapter 〈1132.1〉 Residual Host Cell Protein Measurement in Biopharmaceuticals by Liquid Chromatography-Mass Spectrometry, which outlines three methods for quantifying HCPs using mass spectrometry (MS). HCP analysis by MS is complex, expensive, and necessitates skilled professionals for setup and operation, and its implementation can pose significant challenges. This raises the question: how can these methods be integrated into practical testing, and what are the advantages, disadvantages, and potential pitfalls of each method?

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
Biopharmaceutical manufacturers
QC Staff/managers