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Detection Background
For the detection of Host Cell Protein (HCP) residues, the double-antibody sandwich ELISA method remains the gold standard for HCP residue detection. However, this method highly relies on the coverage of HCP antibodies in the kit against the total host cell proteins. If the antibody coverage used in ELISA detection is insufficient, certain residual HCPs in the final product may be missed, potentially leading to risks of immune reactions and other drug safety issues in patients. Therefore, pharmacopoeias worldwide require validation of HCP antibody coverage.
Junyan Biotech uses the AAE-MS method to evaluate the antibody coverage for customer-provided samples, including host cell protein samples from mammalian cells (CHO, Vero, etc.), yeast cells (Hansenula yeast, Saccharomyces cerevisiae, Pichia pastoris, etc.), Escherichia coli, and other engineered cells.
Detection Principle (AAE-MS Method)
Antibody Affinity Extraction (AAE): First, anti-HCP antibodies are conjugated to magnetic beads, after which the HCP sample is loaded. During the enrichment process, HCP antibodies capture and recognize HCPs, while unrecognized HCPs flow through. This process is repeated multiple times until no additional HCP binding occurs. Finally, HCPs are eluted and enriched under low pH conditions. High-resolution mass spectrometry (LC-MS) is performed on the HCPs before and after enrichment to calculate antibody coverage. The combination of antibody affinity enrichment and mass spectrometry (AAE-MS) enables digital analysis of coverage and simultaneous identification of individual HCP protein identities, helping determine whether the detection results are suitable for process monitoring and product batch release.
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