Article | April 12, 2023

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.

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