Immunoassays And Orthogonal Characterization By Antibody Affinity Extraction And Mass Spectrometry Methods

By Alla Zilberman, Kerry Wooding, Jacob Stubbs, Jared Isaac, and Eric Bishop

Host cell proteins (HCPs) are process-related impurities in biological drugs produced using cell culture technology. Many HCPs are benign, but some are immunogenic. AAE chromatography with 2D-PAGE and AAE-MS analysis for identification and quantitation of HCPs from in-process samples and final drug substances are specific orthogonal methods to identify individual HCP impurities that persist through DS purification processes.

Because HCPs pose a risk to patients and affect the efficacy and stability of biological drugs, the quantity and nature of residual HCPs in a drug substance generally are considered to be critical quality attributes. Explore HCP immunoassays, antibody affinity extraction, how to identify HCPs in drug substances and some technology offering a solution.