Host-Cell Protein Characterization via Affinity Enrichment

The patent applies extraction by removing the active drug from the sample matrix before HCP analysis. The active drug is selectively bound to a capture reagent (such as protein A/G or specific antibody), allowing HCPs to remain in the supernatant for subsequent analysis. This separation eliminates signal suppression and interference from the high concentration active drug, thereby improving detection precision and accuracy while maintaining relatively simple and fast analysis procedures.

The patent employs affinity chromatography supports with universal binding capabilities that can capture multiple types of HCPs simultaneously through common mechanisms (such as Fc region binding for antibody-producing cells). This multi-functional approach enhances detection sensitivity across diverse HCP targets without requiring multiple separate enrichment steps, thereby reducing overall process complexity and time consumption while maintaining high sensitivity.

The patent implements fractionation by dividing the complex sample matrix into distinct fractions through chromatographic separation. HCPs are separated from the active drug based on differences in their physical or chemical properties (such as charge, hydrophobicity, or size). This segmentation allows for accurate characterization of HCPs in isolated fractions without interference from the active drug, improving characterization accuracy while enabling parallel processing that reduces overall analysis time.