Host cell proteins (HCPs) are impurities in drug products regularly created during the manufacturing process. HCPs are typically low-level endogenous proteins derived from the host organism which can often be difficult to purify or detect, yet can affect therapeutic activity. Detecting and characterizing HCPs is critical for biopharmaceutical characterization release assays.
HCPs can be identified throughout the processing stages or directly in the final drug product. Mass spectrometry can provide a more accurate characterization of the HCPs without affinity-based bias as with traditional antibody-based techniques such as ELISA and Western blot.
Using the latest high-resolution nano-liquid chromatography electrospray (nLC-ESI) OrbiTrap mass spectrometry, we can detect and characterize these impurities as the lowest levels possible with the highest degree of certainty.